ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

K091900 · Covidien Lp, Formerly Registered AS United States · GDW · Jul 16, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091900
• Device Name: ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
• Applicant: Covidien Lp, Formerly Registered AS United States
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Absorbatack™ is a sterile, single-use absorbable fixation device used for securing prosthetic material (e.g., hernia mesh) to soft tissue. The device consists of an applicator and absorbable tacks made of a synthetic polyester copolymer derived from lactic and glycolic acid. It is used by surgeons in minimally invasive and open general surgical procedures. The device functions mechanically to deploy tacks into tissue to provide fixation. It is identical to the previously cleared predicate device.

Clinical Evidence

No clinical data. Substantial equivalence is supported by performance testing obtained for the predicate device and biological evaluation in accordance with ISO 10993-1:2003.

Technological Characteristics

Absorbable synthetic polyester copolymer (lactic and glycolic acid). Sterile, single-use. Mechanical fixation device. Evaluated per ISO 10993-1:2003. No software or electronic components.

Indications for Use

Indicated for fixation of prosthetic material to soft tissue in minimally invasive and open general surgical procedures, including hernia repair.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Absorbatack™ Absorbable Fixation Device (K071920)

Submission Summary (Full Text)

{0}------------------------------------------------

#### ട്. 510(k) SUMMARY:

510(K) Summary of Safety and Effectiveness:

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

DEVICE DESCRIPTION:

Note: There are no modifications

to the previously cleared devices.)

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473

K091900

JUL 1 6 2009

1881

Rebecca Ronner Associate, Regulatory Affairs Phone: [phone] Fax: [phone]

June 24, 2009

Absorbatack™ Absorbable Fixation Device

Absorbable Tack and Applicator

Implantable Staple

K071920 - Absorbatack™ Absorbable Fixation Device

Absorbatack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with of 5, 10 or 20 tacks.

Absorbatack™ 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.

Absorbatack™ Absorbable Fixation Device is identical to the predicate device.

Absorbatack™ Absorbable Fixation Devices is comprised of materials which have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices - Part I Evaluation and Testing and is identical to the predicate device

There has been no change to the Absorbatack ™ Absorbable Fixation Device. The modified labeling for the subject device is based on performance testing obtained for the predicate device.

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

MATERIALS: CHARACTERISTICS:

PERFORMANCE DATA: CHARACTERISTICS:

{1}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image contains the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus symbol, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the logo. The caduceus symbol is depicted with three intertwined snakes and a staff.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 6 2009

Covidien LP % Ms. Rebecca Ronner 60 Middletown Avenue North Haven. Connecticut 06473

Re: K091900

Trade/Device Name: Absorbatack™ Absorbable Fixation Device Regulation Number: 21 CFR 878:4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 24, 2009 Received: June 25, 2009

Dear Ms. Ronner:

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.

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.

{2}------------------------------------------------

## Page 2 - Ms. Rebecca Ronner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH'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 (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Poe Dhlson
Mark N. Melen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# 4. INDICATIONS FOR USE STATEMENT:

510(k) Number (if known): K091900

Device Names:

Indications For Use

Absorbatack™ Absorbable Fixation Device

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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 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)

Daind Krome for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number KD91900

Page 1 of