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AbsorbaTack TM Absorbable Fixation Device

510(k) Summary of Safety and Effectiveness

Name: Inomto:Surgical Solutions, a global business unit of Covidien r2

Address: 60 Middletown Avenue
North Haven, CT 06473
Name of contact person: Renee Borgesano
Manager, Regulatory Affairs
Covidien
Phone: (203) 492-5325
Fax: (203) 492-5029
Establishment Registration: 1219930

Date prepared: September 27, 2012

Name of device:
Trade or proprietary name: AbsorbaTackTM Absorbable Fixation Device
Common or usual name: Absorbable Tack and Applicator
Classification name: Implantable Staple
Device Classification: Pursuant to 21 CFR 878.4750, this product is a Class 11device.
Classification panel: General and Plastic Surgery (79)
Regulation: 21 CFR 878.4750
Product Code: GDW
Reason for 510(k) submission: To obtain premarket clearance for the change in the design of the
AbsorbaTackw Absorbable Fixation Device with no changes in the
indications or intended use of the device.
Predicate Device(s): AbsorbaTack TM Absorbable Fixation Device (K090470)
Device description: - Absorba-rackm Absorbable Fixation Devices are
sterile single use devices for the fixation of
prosthetic material such as hernia mesh to soft
tissue. The Tack isconstructed of an absorbable
synthetic polyester copolymer derived from lactic
and glycolic acid and isdyed with D&C violet #2.The device is
offered with 5,10, 15, 20, or 30 tacks.
Intended use of the device: AbsorbaTackTM Absorbable Fixation Devices are intended for
fixation of prosthetic material to soft tissue in various minimally.
invasive and open general surgical procedures such as hernia
repair.
Technological characteristics: Absorba~rack Absorbable Fixation device is similar to the
predicate device except for the revised shaft design. The design
modifications include adding a flex cable in the inner drive tube of
the shaft to allow for continuous rotation if the outer tube is bent to
ensure tack deployment, shortening an existing stiffener to
reinforce the interface between the outer shaft tube and the body
Covidien Page 23
Premarket Notification TmTrademark
 Ri 22-'(6% pct1e z~t.
AbsorbaTackTM Absorbable Fixation Device

halves, and extending the spring up the entire length of the outer
shaft tube that is outside of the body halves.
Material characteristics: Devices are comprised of materials which have been evaluated in
accordance with ISO 10993-1: 2003, Biological Evaluation of
medical devices - Part 1, Evaluation and Testing and is identical to
the predicate device. No new materials are introduced in the
proposed device.

Performance data: There has been no change to the performance specifications of the
AbsorbaTackw" Absorbable Fixation Device. The modified design
does not change the performance of the device for its intended
use.

Covidien Page 24
Premarket Notification ThTrademark
 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

-~ Food and Drug Administration

10903 Newv Hampshire Avenue
Document Control Room -W066-G609
Silver Spring, MD 20993-0002

Covidien
%/Ms. Renee Borgesano OCr 2 a
Manager, Regulatory Affairs l!
60 Middletown Avenue
North Haven, Connecticut 06473

Re: K123109
Trade/Device Name: ABSORBATACK M Absorbable Fixation Device
Regulation Number: 21 CFR 878.4750
Regulation Name: Iimplantable staple
Regulatory Class: Class 11
Product Code: GDW
Dated: October 03, 2012
Received: October 04, 2012

Dear Ms. Borgesano:

We have reviewed your Section 5 10(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 11 (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
Page 2 - Ms. Renee Borgesano

forth in the quality systems (QS) regulation (21 CFR ?art 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CPR Part 801), please
go to http://ww-w.fda.2ov/AboutFDA/CentersOffices/CDPH/CDRHOfflces/ucmf 15 809.htm for
the Center for Devices and Radiological Health's (CDRI-'s) Office of Compliance. Also, please
note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (2]
CFR Pant 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.

You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 63 8-2041 or (301) 796-7100 or at its Internet address
http://www.fda.g~ov/MedicalDevices/ResourcesforYouIndustrv/default.htm.

Sincerely yours,

tewesff
Mark Ntelrs
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
 Indications for Use

510(k) Number (if known): Kk3109

ABSORBATACK M Absorbable Fixation Device

Device Name:

Indications For Use:

The device is intended for fixation of prosthetic material to soft tissue in various
minimally invasive and open surgical procedures such as hernia repair.

Prescription Use -_X AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (?1 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Surgical, Orthopedic,

and Restorative Devices

5I1O(k) Numb4r k 21316