DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
February 28, 2017

Medtronic, Inc.
Laura Danielson
Principal Regulatory Affairs Specialist
8200 Coral Sea Street Ne
Mounds View, Minnesota 55112

Re: K163008
Trade/Device Name: Carelink SmartSync Device Manager Pacing System Analyzer
Regulation Number: 21 CFR 870.3605
Regulation Name: Pacing System Analyzer
Regulatory Class: Class II
Product Code: DTA, DTE
Dated: January 25, 2017
Received: January 26, 2017

Dear Laura Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must comply
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Laura Danielson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
or (301) 796-7100 or at its Internet address
[Link] Also, please note
the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
[Link] for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
[Link]

Sincerely,

Bram D. Zuckerman, M.D.

Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

K163008

Device Name
Carelink SmartSync Device Manager Pacing System Analyzer

Indications for Use (Describe)

The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to
analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the
base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is
intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@[Link]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 Page 1 of 20

510(k) Summary
Date Prepared: January 13, 2017
510(k) Owner / Address: Medtronic, Inc.
Cardiac Rhythm and Heart Failure
8200 Coral Sea Street
Mounds View, MN 55112
Contact: Laura L. Danielson
Principal Regulatory Affairs Specialist
Telephone: (763) 526-2385
Fax: (651) 367-0603
E-mail: [Link]@[Link]
Trade / Proprietary Name: CareLink SmartSync™ Device Manager
Pacing System Analyzer
Common Name: Pacing System Analyzer
Classification / Class II
Classification Name: Pacing System Analyzer
(21 CFR 870.3605)
Product Code: DTA, DTE

Predicate Devices
The intended use, design, materials and performance of the CareLink SmartSync™ Device
Manager Pacing System Analyzer with associated Applications (Models: D00U001, D00U002,
M01G02, M01A02, M01G01, and M01A01), cables (previously approved) and accessories are
substantially equivalent to the following predicate device:
• Medtronic Model 2290 Lead Analyzer approved on 13MAR2002 P890003/S065.
• Medtronic Model 5311B A-V Pacing System Analyzer cleared on 07MAY1991 K910595.

Device Description
Device Identification:
The following is a list all key device components included in the submission:
• CareLink SmartSync Device Manager base (PSA hardware), Model 24970A
• CareLink SmartSync PSA App, Model D00U002
• CareLink SmartSync Host, Model D00U001

K163008
 Page 2 of 20

• CareLink SmartSync Common Application, Model M01G02 (Android) and Model

M01A02 ( iOS)
• CareLink SmartSync Platform, Model M01G01 (Android) and Model M01A01 (iOS)
• Non-Medical Mobile Platform (i.e. Tablet)
The following compatible accessories are available for the CareLink SmartSync Device Manager
base (PSA hardware) that Medtronic is seeking clearance for in this 510(k) submission:
• ME20A054F03 power supply (Medtronic re-order number: 249701), 1.8 m
(approximately 6 ft.): a floor mount that connects through the 249705 AC power cord to
the wall on one end, and through a DC power cord to the base station on the other end
with a right angle barrel plug
• 249705 AC power cord, 1.8 m (approximately 6 ft.): Connects the power supply to AC
power
• 249702 USB cable, approximately 3 m (10 ft.): connects to the Model 24967 patient
connector (not the subject of this submission, but in another 510(k) but only upon
approval of both models)
• 249672 Tether Kit: Secures the USB cable 249702 and Power supply 24951 to the Model
24967 patient connector (Not the subject of this 510(k) submission). Contains an Allen
wrench, screw, and cable retainer
• 249703 Wall mount: mounts the base to the wall when table space is a concern
The above listed accessories are considered off the shelf and non-medical.
The following compatible cables and adaptors are available for the base. These are the same
adaptors and cables used with the current market approved and released Model 2290 PSA
predicate and are considered medical devices.
Surgical and patient cables connect the base to cardiac leads for lead analysis. Adaptors allow
surgical and patient cables to be connected to the base when their plugs are not compatible with
the Type CF connection port on the base. Ground cables connect to the base (via alligator clip
connecting to a cable) and complete the electrical circuit when connected to unipolar implantable
cardiac device leads.
• 2292 Surgical cable, 3.66 m (12 ft.) – Approved: P890003/S065, 13MAR2002
• 5103 A/V adaptor – Approved: P890003/S054, 24SEPT1998
• 5104 Analyzer Adaptor – Approved: P890003/S054, 24SEPT1998
• 5114 Adaptor – Approved P890003 (initial submission), 24AUG1989
• 5832 Surgical cable, approximately 3.5 m (12 ft.) – P890003/S070, 31OCT1995
• 5833S Surgical cable, 1.83 m (6 ft.) – Cleared: K923407, 19OCT1992
• 5833SL Surgical cable, 3.66 m (12 ft.) – Cleared: K923407, 19OCT1992
• 5473 Ground cable - Cleared: K961520, 13NOV1996
• 5436 Analyzer patient cable, 3.66 m (12 ft.) – Approved: P890003/S054, 24SEPT1998

K163008
 Page 3 of 20

The following compatible ECG interface cables, ECG cables, and adaptors are available for the
base. These are the same Adaptors and Cables used with the current market approved and
released Model 2290 PSA predicate and are considered medical devices.
ECG cables and leads connect the base to surface electrodes on the patient for the display of live
waveforms. Adaptors allow ECG monitors with phono connectors to be connected to the base.
• 5437 ECG Interface cable, 6.4 m (20 ft.) – Approved: P890003/S065, 13MAR2002
• 5437A Adaptor – Approved: P890003/S065, 13MAR2002
• 2090EC ECG cable, approximately 2.6 m (103 in.) – Approved: P890003/S065,
13MAR2002
• 2090ECL ECG cable, approximately 5.5 m (215 in.) – Approved: P890003/S065,
13MAR2002
• 9790LA ECG leads, approximately 1 m (40 in.) – Approved: P890003/S027,
29NOV1994
• 9790XLA ECG leads, approximately 1 m (40 in.) – Approved: P890003/S027,
29NOV1994
Medtronic recommends the use of Medtronic-supplied components only. Use of unapproved
components may reduce device effectiveness or impact user or patient safety.

Device Characteristics:
The CareLink SmartSync PSA is comprised of Base, software applications, associated cables and
power cords. The software applications reside on a mobile platform or tablet and pair via
Bluetooth® with the base hardware. The mobile platform is considered non-medical. The
Operating System is also non-medical software that is delivered with and resides on the Mobile
Platform.
The CareLink SmartSync Device Manager base (Model 24970A) is not considered a single-use
device.
The CareLink SmartSync Device Manager base (Model 24970A) is not provided sterile.

Environment of Use:
The base is intended to be used by healthcare professionals only in operating environments under
direct medical supervision.

Brief Written Description of the Device:

The CareLink SmartSync Device Manager system (referred to from now on as the device
manager system) is comprised of the Model 24970A Base and CareLink SmartSync Device
Manager app installed and running on your mobile device.
The CareLink SmartSync Device Manager Base (referred to from now on as the base) pairs with
the Medtronic CareLink SmartSync Device Manager app on your mobile device to analyze the
cardiac lead system for an implantable Medtronic device. The base includes these features:
• Analyzer hardware and patient cable connections to support electrical assessment of
cardiac leads during implant.

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 Page 4 of 20

• ECG cable connections to collect live cardiac waveform data that can be viewed,
measured, and recorded using the app running on your mobile device.
• Bluetooth® wireless technology to communicate with the app running on your mobile
device.1
The Model 24970A Base contains a microprocessor that maintains the pacing engine logic
function for the PSA.
The PSA hardware within the Base consists of two main integrated circuits (ICs) which provide
a variety of functions as listed below:
• Micro Controller Unit: the microprocessor is used to provide timing support and also
onboard memory for the device.
• Mixed Signal Integrated Circuit: the mixed signal IC chip takes the input signals from the
cables (connected to a lead) and digitizes it for use by the device. This IC is also
responsible for the electrogram (EGM) waveform and power management.
The App is the primary user interface for the device manager system. The App for the CareLink
SmartSync PSA is comprised of four main components:
• A Host Application component that provides the system user interface necessary to
initialize, and set-up the CareLink SmartSync Device Manager and launch the PSA
Clinician Application
• a Platform Application component for the transfer/exchange, storage/retrieval,
electronic conversion, and electronic display of medical device data
• a Common Application component that is a collection of software components that are
utilized by the PSA or Device Applications
• a PSA Application component that is a Mobile Platform Application that allows user to
use the PSA device
The App includes these features:
• Bluetooth® connectivity to pair with the base.
• Integration with the base to start a lead analysis session.
• Mobile device connectivity tools for sharing and printing Analyzer reports.
• Updates to app software using an Internet connection.
The Analyzer tools in the App form the primary user interface to the Base). These tools display
and report on the cardiac lead and ECG data transmitted from the base. Clinicians use this data to
perform these tasks:
• Analyze electrical performance of cardiac leads during implant.
• Assess proper placement of cardiac leads during implant.
• View, measure, and document live cardiac waveforms.
CareLink SmartSync Application Models installed on a clinician’s off-the-shelf non-medical
mobile device. The Operating System is also non-medical software that is delivered with and
resides on the non-medical Mobile Platform.

K163008
 Page 5 of 20

The Analyzer has the following features:

• Dual and single chamber pacing modes.
• Automatic measurement of P-wave and R-wave amplitudes.
• Lead impedance measurement.
• Real-time display of atrial and ventricular EGM and ECG waveforms.
• Rapid atrial stimulation to 850 min−1 (ppm).
• Advanced pulse width versus amplitude pacing threshold tests.
• Measurement reports.

The CareLink SmartSync Device Manager provides the essential capabilities for analysis of and
the electrical performance of cardiac leads during device implant in a hospital environment (See
Tables 1 through Table 4).
Table 1: PSA Base Physical Characteristics
Parameter Value
Footprint 548 cm2
Mass 0.91 kg (2.0 lbs.)
Dimensions H x W x D 1.8 in x 9.45 in x 8.2 in
Device identification code Device serial number prefix
“SPM”
Power Source 5V Direct Current provided by
Medical Grade External Power
Supply. PSA Battery info in the
following table.

Table 2: PSA Base (off the shelf) AA Battery Characteristics

Parameter Value
Manufacturer Panasonic
Model/type IEC LR6 Alkaline Battery (AA)
(n=2) per Base
Chemistry Alkaline
Battery Life dependence upon utilization 2 years required replacement as
monitored by the Mobile Application on the indicated by the Maintenance
user mobile device. schedule

Table 3: PSA Base ECG Signal Characteristics

Parameter Description Fixed Value
ECG Gain Surface ECG User Interface display 1.0
Sampling Rate at which the ECG signal is digitized 500 Hz
Rate
Sampling Number of bits per sample used in the digitization 16 bits /
Resolution of the ECG signal sample

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 Page 6 of 20

Table 4: PSA Base EGM Signal Characteristics

Parameter Description Fixed Value

EGM Gain, Atrial Amplification of the atrial EGM signal 75X
EGM Gain, Ventricular Amplification of the ventricular EGM signal 18.75X
High Pass Pole -3dB high pass filter frequency 2.0Hz to 3.0Hz
Low Pass Pole -3dB low pass filter frequency 80Hz to 110Hz
Sampling Rate Rate at which the EGM signal is digitized 256 Hz
Number of bits per sample used in the
Sampling Resolution 8 bits / sample
digitization of the EGM signal

Materials of Use
The following is a list of exposed materials included in the manufacture of the Model 24970A:
Component Material
Plastic:
SABIC LEXAN EXL-9330 Polycarbonate
White Resin per Medtronic color chip M954239A001
Top Enclosure Base Elastomer Edge:
Eraprene A6060N-SP
Thermoplastic Elastomer
Blue per Pantone 301
Plastic:
SABIC LEXAN EXL-9330 Polycarbonate
White Resin per Medtronic color chip M954239A001
Graphics:
Lid Base Pantone 301 Blue
Elastomer Edge:
Eraprene A6060N-SP
Thermoplastic Elastomer
Blue per Pantone 301
Plastic:
SABIC LEXAN EXL-9330 Polycarbonate
Bottom Enclosure Base White Resin per Medtronic color chip M954239A001
Graphics:
Pantone 301 Blue
Graphics:
Autotex-2(V200)
Polyester
Button:
Membrane Keypad Base Silicone Rubber
60 Shore A
Clear
Top Coat:
Polyurethane
Per color chip Pantone Cool Grey 8

K163008
 Page 7 of 20

Component Material
Battery Cover Base SABIC LEXAN EXL-9330 Polycarbonate
White Resin per Medtronic color chip M954239A001
Silicone Rubber 70 Shore A
Foot Rear Base
Color: Pantone Cool Grey 8
Lexan PC 8B35
Device Label Base Polycarbonate
Clear
Lexan PC 8B35
QR Code Label
Polycarbonate
Base
Clear
Hypertronics D02 Housing
PSA Connector
Polyethermide
Base
Black

The device does not include biologics, drugs, or coating additives. The pacing system analyzer is not
intended for patient contact.

Key Performance Specifications/Characteristics of the Device

Base Specifications
Standards (The base complies with the following:)
Radio frequency wireless specifications and applicable standards
EN / IEC 60601-1-2
EMC
EN 300 328
EN 301 489
EN 302 195
EN 301 839
EN 55011 Class A

Radio FCC CFR 47

Patient safety UL/CUL 60601-1, Type BF applied part, Type CF applied parta
EN 60601-1, Class 2, continuous operation, Type BF, Type CFa

AC power requirement
Voltage 100–240 VAC nominal
Frequency 50/60 Hz nominal

Battery
Type AA Alkaline (LR6) or Lithium-ion, non-rechargeable (quantity of 2)
Voltage 1.5 V each

Base Electrical Specifications

Power Supply

Model ME20A0540F03 power supply (Medtronic re-order number 249701)

Voltage in 100-240 VAC 0.5A at 50-60 Hz
Voltage out 5 VDC 3 A

USB Cable

K163008
 Page 8 of 20

Model 249702 USB cable

Voltage 5 V 0.8 A
Power 4W

Charge cradle

Model 24970A
Voltage 5 V 0.8 A
Power 4W
IEC 60529 Degrees of Protection Provided by Enclosures (IP Code)

Ingress This product complies with international electrical safety rating

IP2X with regard to ingress of dust, other foreign objects, and
water as required by IEC 60601-1.
Physical dimension and weight

Height 4.6 cm (1.8in)

Width 24 cm (9.5 in)
Depth 20.8 cm (8.2 in)
Weight 0.91 kg (2 lbs)

Temperature Limits

Operating 10°C to 35°C (50°F to 95°F)

Storage 15°C to 30°C (59°F to 86°F)
Transport - 30°C to 55°C (-22°F to 131°F)
Humidity Limits

Operating 8%-80%
Storage 15%-93% at 35°C (95°F
Transport 15%-93% at 35°C (95°F)
Altitude

Maximum 3000 m
Connectivity
Conexus wireless telemetry
Frequency range 402-405 MHz
Modulation frequency Frequency shift key
Output power 25 µW EIRP max

Bluetooth 2.1 and 4.0

Frequency range 2.4-2.483 GHz
Modulation frequency Gaussian frequency shift key
Output power Less than 10 mW EIRP
a
The ECG cable (Type BF), 24967 Patient Connector (Type BF) and patient or surgical cable (Type CF) are the only accessories
that come into direct contact with the patient. The base itself is not intended to come into contact with the patient during normal
use.
Expected Service Life: 5 years

Disposal of the base: Return the base to Medtronic for proper disposal. Contact Medtronic at the address or telephone number on
the back cover for information on returning the base.
Electromagnetic compatibility declaration
The following list of accessories is compliant with the requirements of IEC 60601-1-2.
Accessory Maximum length

K163008
 Page 9 of 20

ME20A0540F03 Power supply 1.8 m (6 ft)

249705 AC power cord 1.8 m (6 ft)
249702 USB cable 3 m (10 ft)
24967 Patient Connector N/A
2292 Surgical cable 3.66 m (12 ft)
5832 Surgical cable 3.5 m (12 ft)
5833S Surgical cable 1.83 m (6 ft)
5833SL Surgical cable 3.66 m (12 ft)
5346 Analyzer patient cable 3.66 m (12 ft)
5437 ECG Interface cable 6.4 m (20 ft)
2090EC EKG cable 2.6 m (103 in)
2090ECL EKG cable 5.5 m (215 in)
9790LA EKG leads 1 m (40 in)
9790XLA EKG leads 1 m (40 in)
Use of accessories other than what is specifically listed may result in increased emissions or decreased immunity of the 24970A
base.
The 24970A base needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and used
according to the EMC information provided in the accompanying documents.
The 24970A base should not be used adjacent to or stacked with other equipment that is not part of the device manager system
(base, mobile device, and accompanying accessories). If adjacent or stacked use is necessary, the 24970A base should be observed
to verify normal operation in the configuration in which it will be used.
The 24970A base contains RF transmission and receiving capabilities. Consequently, it is possible that other equipment may
interfere with the 24970A base even if that other equipment complies with CISPR emission requirements. The following is a
technical summary of the RF communication properties:
Transmitting and receiving:
• Technology type: Conexus wireless telemetry, Bluetooth wireless technology
• Frequency of operation: 402 MHz to 405 MHz, 2.4 GHz to 2.483 GHz
• Modulation characteristics: Frequency shift key, Gaussian frequency shift key
• Field strength: 25 µW EIRP max, less than 10 mW EIRP
Guidance and manufacturer’s declaration—electromagnetic emissions
The 24970A base is intended for use in the electromagnetic environment specified below. The customer or the user of the 24970A
base should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment—guidance
RF emissions Group 1 The 24970A base uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to
RF emissions Class A cause any interference in nearby electronic equipment.
CISPR 11
Harmonic emissions Class A The 24970A base is suitable for use in all establishments other
IEC 61000-3-2 than domestic, and may be used in domestic establishments and
those directly connected to the public low-voltage power supply
network that supplied buildings used for domestic purposes,
provided the following warning is heeded:
Voltage fluctuations/flicker Complies Warning: This equipment/system is intended for use by
emissions healthcare professionals only. This equipment/system may cause
IEC 61000-3-3 radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such
as re-orienting or relocating the 24970A base or shielding the
location.
Guidance and manufacturer’s declaration—electromagnetic immunity
The 24970A base is intended for use in the electromagnetic environment specified below. The customer or the user of the 24970A
base should assure that it is used in such an environment.

K163008
 Page 10 of 20

Immunity test IEC 60601 Test level Compliance level Electromagnetic

environment—guidance

Electrostatic discharge ±6 kV contact ±8 kV contact Floors should be wood,

(ESD) ±8 kV air ±15 kV air concrete, or ceramic tile. If
IEC 61000-4-2 floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be
IEC 61000-4-4 ±1 kV for input/ output lines ±1 kV for input/ output lines that of a typical commercial or
hospital environment.
Surge ±1 kV differential Mode ±1 kV differential Mode
IEC 61000-4-5 ±2 kV common mode ±2 kV common mode
Voltage dips, short <5% UT (>95% dip in UT) <5% UT (>95% dip in UT) Mains power quality should be
interruptions, and voltage for 0.5 cycle for 0.5 cycle that of a typical commercial or
variations on power supply 40% UT (60% dip in UT) for 40% UT (60% dip in UT) for hospital environment. If the
input lines 5 cycles 5 cycles user of the 24970A base
IEC 61000-4-11 70% UT (30% dip in UT) for 70% UT (30% dip in UT) for requires continued operation
25 cycles 25 cycles during power mains
<5% UT (>95% dip in UT) <5% UT (>95% dip in UT) interruptions, it is
for 5 s for 5 s recommended that the 24970A
base be powered from an
uninterruptible power supply or
a battery. Note: UT is the AC
mains voltage prior to
application of the test level.
Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic
magnetic Field fields should be at levels
IEC 61000-4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.
Conducted RF 3 VRMS (volts root- 10 V Portable and mobile RF
IEC 61000-4-6 meansquare) communications equipment
150 kHz to 80 MHz should be used no closer to any
part of the 24970A base,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
d = 0.35√P

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 Page 11 of 20

Radiated RF 3 V/m 10 V/m d = 0.35√P for 80 MHz to 800

IEC 61000-4-3 80 MHz to 2.5 GHz MHz
d = 0.70√P for 800 MHz to 2.5
GHz
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, consider an electromagnetic site survey. If the measured field strength
in the location in which the 24970A base is used exceeds the applicable RF compliance level above, observe the 24970A base to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the 24970A base.
b
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the 24970A base
The 24970A base is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the 24970A base can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the 24970A base as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 0.35√P d = 0.35√P d = 0.70√P
0.01 W 0.035 m 0.035 m 0.070 m
0.1 W 0.11 m 0.11 m 0.22 m
1W 0.35 m 0.35 m 0.70 m
10 W 1.1 m 1.1 m 2.0 m
100 W 3.5 m 3.5 m 7.0 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.

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 Page 12 of 20

Indications for Use

The following is the Indications for Use Statement:
The base is intended to be used as part of the CareLink SmartSync device manager system.
Clinicians use the base to analyze the electrical performance of cardiac leads during device
implant or invasive troubleshooting. Clinicians use the base’s ECG connections along with the
app display to view, measure, and record live cardiac waveforms.
The base is intended to be used by healthcare professionals only in operating environments under
direct medical supervision.

Comparison of Technological Characteristics with the Predicate

Device
The following table contains a comparison of the CareLink SmartSync Device Manager Pacing
System Analyzer to the predicate devices (Models 2290 and 5311B).
CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary
Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
Analyzer Lead Analysis Device Analyzer Lead Analysis Device AV pacing System Analyzer Medtronic
Classification Name

Pacing System
Analyzer Model
2290

Same
Class III Class III
Class II

K163008
 Page 13 of 20

CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary

Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
The CareLink SmartSync Device The Analyzer is a microprocessor- The Medtronic Model 5311B All

Same
General Description

Manager is a microprocessor-based based accessory that installs into A-V Pacing System Analyzer
Device. The device is designed to the programmer. The Analyzer is (PSA) is a hand-held
analyze the electrical designed to analyze the microprocessor based device
performance of a cardiac lead electrical performance of a designed to test the
system, using the mobile device cardiac lead system, and uses electrical performance of the
platform and associated the programmer as a control pulse generator and the
applications as a control and display and display platform. The pacing lead system at the
platform. Analyzer can be operated time of pacemaker
"concurrently" with the implantation and during
Programmer desktop. That is, you invasive pacemaker
can switch to an analyzer session troubleshooting or
from the Select Model screen on evaluation procedures. The
the Programmer desktop, and you model 5311B A-V PSA
can toggle back and forth between combines the functions for a
an analyzer session and the Select multimode external pulse
Model screen using icons on the generator, a digital measuring
task bar. device, and a data processor
to provide the following
capabilities:
• External single and dual
chamber pacing in one of 10
selectable pacing modes to
support he patient during
pacemaker implantation and
pacing system test
procedures. The 5311B PSA
provides unipolar or bipolar
pacing for both single and
dual chamber applications.
• Measurement of cardiac
stimulation thresholds for
voltage and current or pulse
width.
• P-wave/R-wave analysis for
evaluation of the cardiac
signals detected by the
pacing lead system.
Information provided
includes the filtered and
unfiltered voltage amplitude
and the slew rate of the
detected depolarization
signal and an intracardiac
electrogram taken from the
pacing lead.
• A test for retrograde
conduction during evaluation
of a dual-chamber lead
system. This test is a feature
of the intracardiac
electrogram function.
• Automatic calculation of
pulse energy and lead
resistance from measured
pulse parameters.
• Implantable pulse generator
(IPG) tests include
determination of the pacing
mode and measurement of
the pacing mode and
measurement of up to 11
pacing parameters.
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 Page 14 of 20

CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary

Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
Other capabilities of the Model All

Same
General Description (Con’t.)

5311B A-C PSA include rapid

stimulation to 800 ppm in
VOOAOO, or Doo pacing
mode, total output inhibition in
any pacing mode, and an
emergency VVI pacing feature
that provides immediate
ventricular demand pacing at
preselected parameter values
by a single keystroke
command.
The PSA is a constant voltage
device. That is, the pulse
voltage is held constant at the
adjusted value, while the
resultant current flow is a
function of lead system
impedance (output load).
Constant voltage is the type of
output circuit used in most
implantable pulse generators.
External features of the Model
5311B A-V PSA include a
membrane keyboard from
which all PSA functions are
controlled, a multifunction liquid
crystal display (LCD), and a 12-
charactoer thermal printer
(Figure 1). Two jacks on the
end of the PSA provide for
connection of cables that link
the PSA to the lead system for
pacing and lead system tests or
to the implantable pulse
generator for parameter
measurements. IPG tests may
be conducted without
interruption of the PSA pacing
function
The PSA is powered by four,
9V, alkaline batteries located
under an access cover on the
back of the de vice.

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 Page 15 of 20

CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary

Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
The base is intended to be used as The Analyzer is intended for use The Medtronic Model 5311B Medtronic
part of the CareLink SmartSync by a clinician to analyze the A-V Pacing System Analyzer Pacing System
device manager system. Clinicians pacing and sensing in intended for use by a Analyzer Model
use the base to analyze the performance of the cardiac lead physician to measure 2290
electrical performance of cardiac system during the implant of a stimulation thresholds and
leads during device implant or cardiac arrhythmia management test the implantable pulse
invasive troubleshooting. device, or during invasive generator and pacing lead
Clinicians use the base’s ECG troubleshooting of a cardiac system during the surgical
Indication for Use

connections along with the app lead system. procedures of pacemaker

display to view, measure, and implantation or during
record live cardiac waveforms. invasive pacemaker

Same
The base is intended to be used by troubleshooting or
healthcare professionals only in diagnostic procedures. The
operating environments under direct Model 5311B A-V PSA is
medical supervision. designed to pace the patient
externally during pacing
system test and implantation
procedures. The pacing and
test functions of the Model
5311B A-V PSA are intended
for both single- and dual-
chamber pacemaker
applications.
DTA, DTC KRG and OSR DTC This medical
21 CFR 870.3720 21 CFR 870.3630 device has been
Product
Code

Same
21 CFR 870.3630 reclassified to
New Class II
21 CFR 870.3605 18APR2016
21CFR870

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 Page 16 of 20

CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary

Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
Clinicians use this data to perform ■ Automatic measurement of P- Below are the functions of the Medtronic

Same
Features

these tasks: and R-wave amplitudes and PSA operating mode. For Pacing System
• Analyze electrical performance of slew rates pacing and lead system tests, Analyzer Model
cardiac leads during implant. ■ Automatic lead impedance the Model 5410 Surgical Cable 2290
measurement is used to connect the PSA to
• Assess proper placement of ■ Real-time display of atrial and an indwelling lead system.
cardiac leads during implant. ventricular EGM • Pacing Mode and Parameter
• View, measure, and document ■ Rapid atrial stimulation to 800 Adjustment
live cardiac waveforms. min-1 (ppm) • Emergency VVI Pacing
The PSA app includes these ■ Advanced analysis features,
including antegrade and • Stimulation Threshold
features for the analysis of cardiac
retrograde conduction tests, Measurement
leads:
and a pulse width versus • Lead System Resistance
• Dual and single chamber pacing amplitude threshold analysis • Filtered P-Wave / R-Wave
modes. ■ Measurement reports Amplitude
• Automatic measurement of P- Safety features
• Pulse Energy
wave and R-wave amplitudes. The Analyzer has the following
safety features: • Slew Rate and Unfiltered
• Lead impedance measurement.
■ Backup battery in the event of a Signal Amplitude
• Real-time display of atrial and power loss • Intracardiac Electrogram
ventricular EGM and ECG ■ Electrical isolation from the • Retrograde Conduction
waveforms. programmer
Test Function
• Rapid atrial stimulation to 850 ■ Emergency VVI pacing
• Inhibit Function
min−1 (ppm).
• Rapid Stimulation
• Advanced pulse width versus
amplitude pacing threshold
tests.
• Measurement reports.
The base includes these features:
• Analyzer hardware and patient
cable connections to support
electrical assessment of cardiac
leads during implant.
• ECG cable connections to collect
live cardiac waveform data that
can be viewed, measured, and
recorded using the app running
on your mobile device.
• Bluetooth® wireless technology
to communicate with the app
running on your mobile device.
• A cradle to charge the Medtronic
24967 Patient Connector (The
24967 patient connector is not
the subject of this submission).
• Optional USB connectivity to
charge the patient connector.
(The 24967 patient connector is
not the subject of this
submission).
5 year warranty 10 years 1 year warranty NA
Longevity

NA

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 Page 17 of 20

CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary

Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
The Base shall have the nominal The Analyzer will be installed into H x W x D: All
dimensions of approximately: the Model 2090 Expansion Bay.
Volume and

3.4” x 4.0” x 9.0”

Footprint

Length: 8.203” +/- 5% Width: 9.450” When installed the Analyzer will

Same
+/- 5% Thickness: 1.810” +/- 5%. not change the physical size of the
Model 2090 Programmer.
The Base will have a maximum
footprint of:
548 cm2.
The Base Station shall have a 16 ounces (1 lbs.). 1.5 kg (3.3 lbs.) All
maximum weight of 0.91 kilograms
Mass

Same
(2.0 lbs.).

No No No All
Compatibility

Same
MRI

30-200 pm 20-210 ppm 30-180 ppm Medtronic

Within the
Pacing System

range but
Basic

Same
Rate

Analyzer Model
2290

200-850 ppm 200-800 ppm 100 – 180 ppm Medtronic

Pacing System
High Pacing

Analyzer Model

Similar
Rate

2290

0.25 – 8.0 V 0.1 – 10 V 0.1 – 10 V Medtronic

Pacing System
Stimulation
Amplitude

Analyzer Model

Similar
2290

0.03 – 1.50 ms 0.02 – 1.5 ms 0.05 – 2.0 ms Medtronic

Pacing System
Width
Pulse

Same

Analyzer Model
2290

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 Page 18 of 20

CareLink SmartSync™ Medtronic Pacing System Medtronic A-V Pacing Primary

Device Manager (Model Analyzer (Model 2290) System Analyzer Predicate

Difference
24970A) and Applications P890003/S065 (Model 5311B)
Parameter

(D00U002, D00U001,
K910595 07MAY1991
Device

M01G02, M01A02, M01G01,

and M01A01)
KXXXXXX
0.15 – 11.30 mV 0.25 – 20 mV 0.75 – 10mV Medtronic
Pacing System
Sensitivity

Analyzer Model

Similar
2290

Atrial: 150 – 500 ms Atrial: 200-500 ms Atrial: 235 or 400 ms Medtronic

Refractory or

depending on mode Pacing System

Ventricular: 150 – 500 ms Ventricular: 250 ms
Blanking

Analyzer Model
P i d

Similar
Ventricular: 233 or 325 ms 2290
depending on mode

No Yes Yes NA
Slew
Rate

NA
VOO; VVI; AOO; AAI; DOO; DDD; VOO, VVI,AOO, AAI, DOO, DDD, VVI, VVT, VOO, AAI, AAT, All

(excluding VVV
DDI; ODO; OOO VDD, ODO AOO, DDD, DVI, DOO, VDD
Pacing
Modes

mode)
Same
Model 2292 Analyzer Surgical Model 2292 Analyzer Surgical The Model 5311B A-V PSA is Medtronic

Same
Accessories

Cable Cable supplied with batteries, Pacing System

Model 5103 Analyzer Adaptor Model 5103 Analyzer Adaptor technical literature, and the Analyzer Model
Model 5104 Analyzer Adaptor Model 5104 Analyzer Adaptor following accessory cables: 2290
Model 5114 Adaptor Model 5114 Adaptor Model 5401B Test Cable
Model 5833S/SL Disposable Model 5833 Disposable Surgical Model 5410 Surgical Cable
Surgical Cables Cable Model 5803A Indifferent Lead
Model 5436 Analyzer Patient Cable Model 5436 Analyzer Patient
Model 5410/5410S Surgical Cable Cable
Model 5436 Patient Cable Model 5410/5410S Surgical Cable
Model 8190 Analyzer Software Model 5436 Patient Cable
Model 5832 Surgical cable Model 8190 Analyzer Software
and additionally: Replacement Batteries (9V)
Model 5473 Ground cable
Model 5437 ECG Interface cable
Model 5437 A Adaptor
Model 2090 EC ECG cable
Model 2090 ECL ECG cable
Model 9790 LA ECG leads
Model 9790 XLA ECG leads
Two AA Batteries

Performance Data
The following performance data were provided in support of the substantial equivalence
determination.

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 Page 19 of 20

Biocompatibility testing
The biocompatibility evaluation for the CareLink SmartSync Device Manager, Pacing System
Analyzer Base, Model 24970A was conducted in accordance with the FDA Blue Book Memorandum
#G95-1 “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part
1: Evaluation and Testing,’” May 1, 1995, and International Standard ISO 10993-1 “Biological
Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management
Process,” as recognized by FDA. The device was justified by similarity to the Medtronic Model
24967 patient connector (K163460). The battery of testing for materials used in the Model 24970A
included the following tests:
• Cytotoxicity
• Sensitization
• Irritation
The Model 24970A is considered non-tissue or patient contacting.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the CareLink SmartSync Device Manager,
Pacing System Analyzer Base, Model 24970A, associated applications and non-medical mobile
platform (i.e. Tablet) with associated cables as necessary for test. The system complies with the IEC
60601-1, standards for safety and the IEC 60601-1-2 third and fourth edition versions of the standard
for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as
recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices.” The software for this device
was considered as a “major” level of concern, since a failure or latent flaw in the software could
directly result in serious injury or death to the patient or operator.

Mechanical Testing
The following is a list of testing performed:
• Inspection of the required mechanical design features and function
• Workmanship inspection concerning all external surfaces that can cause injury such as
sharp edges or pinch points
• Product labeling inspection
• Forces required to activate controls
• Chemical resistance testing for effects of repeat cleaning cycles
• Environmental and drop testing
• Reliability testing of buttons, electrical contacts, user connector insertions, and
replaceable or moving mechanical components
• Performance and robustness testing of the Articulated Lid

K163008
 Page 20 of 20

Animal Study
There were no formalized animal studies performed for this 510(k) submission.

Clinical Studies
There were no formalized clinical studies performed for this 510(k) submission.

Conclusions
The non-clinical data, the hardware and software verification and validation support and demonstrate
that the CareLink SmartSync Device Manager, Pacing System Analyzer Base, Model 24970A should
perform as intended in the specified use conditions and is substantially equivalent to the predicate
device.

K163008