.

BSDI



Lepu Medical Technology (Beijing) Co., Ltd.

℅ Arthur Goddard
President
FDA Regulatory and Quality Systems Consultant
31853 Cedar Road
Mayfield Heights, Ohio 44124-4445

Re: K172331
Trade/Device Name: Brilliant Introducer Kits
Regulation Number: 21 CFR 870.1340
Regulation Name: Catheter introducer
Regulatory Class: Class II
Product Code: DYB
Dated: January 26, 2018
Received: January 30, 2018

Dear Arthur Goddard:

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. However, you are responsible to determine that the medical devices you use
as components in the kit have either been determined as substantially equivalent under the premarket
notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the
enactment date of the Medical Device Amendments. Please note: If you purchase your device components
in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including
these components in your kit/tray. 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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.02.05
Silver Spring, MD 20993
www.fda.gov
Page 2 - Arthur Goddard K172331

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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone
(1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S
GPS
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)

K172331

Device Name
Brilliant Introducer Kit

Indications for Use (Describe)

The Brilliant Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other
accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such
introduction.

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
[email protected]
“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
 Section 5: 510k) Summary

K172331

Applicant: Lepu Medical Technology (Beijing) Co., Ltd.

No. 37 Chaoqian Road Changping District, Beijing 102200 P.R. China
Telephone: +86-10-80123510
Contact: Xiangdan Kim
Date: July, 31, 2017
Name: BrilliantTM Introducer Kit
Classification Name: Catheter Introducer, 870.1340
Product Code: DYB
Predicate: BrilliantTM Introducer Kit, Lepu Medical Technology, Ltd., K140768 with
market clearance date of November 25, 2014.
Modification to 1. Addition of six models to Type III (ACS061135, ACS062435,
Predicate K140768 ACS070735, ACS071135, ACS071635 and ACS072435);
2. Change of the radiocontrast agent in the Sheath Introducer from
Bismuth to Barium sulfate (BaSO4), and
3. Removal of the radiocontrast agent Bismuth in the Dilator;
4. Change of the coating location on the surface of Sheath Introducer,
Dilator and guidewire;
5. Removal of guidewire with guidewire collimator and puncture needle
in Type I, removal scalpel in Type IV.
Description: The Brilliant™ Introducer Kit classifies into four types (Type I, II, III,
and IV). Type I consists of a sheath introducer and a dilator. Type II
consists of a sheath introducer, a dilator, a guide wire with a guide wire
collimator and a puncture needle. Type III consists of a sheath introducer,
a dilator, a guide wire with a guide wire collimator. Type IV consists of a
sheath introducer, a dilator, a guide wire with a guide wire collimator, an
Intravascular catheter (with needle) and a syringe.
The puncture needle or an intravascular catheter incorporates a lumen,
which provides a conduit for the insertion of the guide wire into the
vascular system. The various types of guide wires, model dependent, are
utilized as a guiding mechanism for the insertion of the introduction
sheath into the vascular system. The guide wire contains a wire
collimator, which assists in funneling the wire through the lumen of the
puncture needle or the intravascular catheter. The guide wire is radio-
detective under fluoroscopy. The sheath introducer provides a conduit for
introducing other interventional devices, including guide wires and
interventional catheters, into the vasculature. The main components of
the sheath introducer assembly are a hydrophilic coated sheath introducer,
hemostasis valve housing, and a side port tubing with a 3-way
stopcock/valve. The hydrophilic coated dilator is used to provide support
and stability to the sheath introducer during deployment into the vascular
system. The proximal end of the dilator includes a luer port and has a
tapered, atraumatic distal tip. The sheath introducer contains Barium
sulfate (BaSO4), making the device visible under fluoroscopy. There is no
radiocontrast agent in the dilator.

5-1A
 Section 5: 510k) Summary

Intended Use: The BrilliantTM Introducer Kits are intended for use to facilitate the
introduction of guide wires, catheters and other accessory medical devices
through the skin into a vein or artery and minimize blood loss associated
with such introduction.
Predicate Device Lepu Medical Technology (Beijing) Co., Ltd. added six models to Type
Comparison: III; the sheath introducer radiocontrast agent was changed from Bismuth
to Barium sulfate (BaSO4); radiocontrast agent in dilator is removed;
coating location on the surface of Sheath Introducer, Dilator and
guidewire is changed; guidewire with guidewire collimator and puncture
needle are removed in Type I, scalpel in Type IV is remove. Compared
with currently marketed Brilliant™ Introducer Kit, the subject device is
substantially equivalent to the predicate device in terms of intended use,
indication for use, operational characteristics, and fundamental design and
technology characteristics.
Biocompatibility: The BrilliantTM Introducer Kit produced by Lepu Medical Technology
was assessed against the International Standard ISO 10993-1,
"Biological evaluation of medical devices. Part 1. Guidance on
selection of tests." The Brilliant TM Introducer Kit would be classified
as an External Communicating Device in contact with the Circulating
Blood for a Limited Duration (<24 hours). The following test would
be required for any patient / user contacting material:
Test Standard Results
Cytotoxicity ISO 10993-5 Under the conditions of this
study, the Mem test extracts
would be considered no
cytotoxicity potential. The
negative controls, blank
controls, and the positive
controls performed as
anticipated.
ISO ISO 10993-10 Under the conditions of this
Intracutaneous study, the test article met the
study requirements of the test since
the difference between each
test extract overall mean
score and corresponding
control overall mean score
was 0.0 and 0.0 for the SC
and CSO test extracts,
respectively.

5-2A
Section 5: 510k) Summary

ISO Guinea ISO 10993-10 Under the conditions of this

Pig Maximum study, the test article extracts
Sensitization showed no evidence of causing
delayed dermal contract
sensitization in the Guinea pig.
The test article was not
considered a sensitizer in the
Guinea pig maximization test.
ISO Systemic ISO 10993-11 Under the conditions of this
Toxicity study, there was no mortality or
evidence of systemic toxicity
from the extracts injected into
mice. Each test article extract
met the requirements of the
study.
Complement ISO 10993-4 Under the conditions of this
Activation study, the Sc5b-9 concentration
Assay from the test article were not
significantly different from that
of negative control sample and
Control article (P>0.05).
ASTM ISO 10993-4 Under the conditions of this
Hemolysis ASTM F756 study, the Hemolytic Index for
the test article in direct contact
with blood was 1.9% and that
for the test article extract was
0.6%. Both the test article in
direct contact with blood and
test article were non-hemolytic.
USP Pyrogen ISO 10993-11 Under the conditions of this
Study USP <151> study, the maximum rise of each
rabbit temperatures did not show
a rise of 0.5 ℃ or more above its
baseline temperature during 3
hour observation period. The test
article was judged as
nonpyrogenic.
Partial ISO 10993-4 Under the conditions of this
Thromboplast study, the % negative control is
in Time 72.32%, the test article would be
considered mild thrombogenicity
response.
In Vivo ISO 10993-4 Under the conditions of this
Thromboresist study, the test article showed no
ance thrombosis which was similar
with the control article. The test
article would be considered as
thormboresistant.

5-3A
 Section 5: 510k) Summary

Performance The BrilliantTM Introducer Kit successfully passed all of the following
Testing: performance tests:

Test items
Radio-detectability
Peak Tensile Force between
Sheath Introducer
Side Port Tubing and
Homeostasis Valve
Dilator internal diameter
Dilator Radio-detectability
Guidewire accessibility
Coating integrity
Coating performance
Coating efficacy
Particulate evaluation
Residual EO and ECH
Sterile
Bacterial endotoxin

Sterilization: The method used is based on practices recommended by AAMI /

ANSI / ISO 11135:2014 and provides a Sterility Assurance Level
(SAL) of 10-6.

Conclusion: The information provided in this submission and comparing intended

use, principle of operation and overall technological characteristics
(i.e. puncture needle, guide wire, dilator, and sheath introducer to
obtain access to the vascular system), the BrilliantTM Introducer Kit
supports a determination of substantial equivalence to existing legally
marketed predicate device Brilliant ™ Introducer Kit (K140768).

5-4A