AUTOSUTURE ABSORBABLE TACK AND APPLICATOR

K071920 · United States Surgical, A Division of Tyco Healthc · GDW · Sep 28, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071920
• Device Name: AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Sep 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

Device Story

Syneture™ Absorbable Tack and Applicator are sterile, single-use devices designed for securing prosthetic material, such as hernia mesh, to soft tissue. The system consists of an applicator and absorbable tacks manufactured from a synthetic polyester copolymer of lactic and glycolic acid. Used by surgeons in minimally invasive or open general surgical procedures. The device functions by mechanically deploying tacks into soft tissue to fixate mesh, providing structural support during the healing process. The tacks are designed to be absorbed by the body over time.

Clinical Evidence

Bench testing only.

Technological Characteristics

Absorbable tacks composed of synthetic polyester (lactic acid and glycolic acid copolymer). Applicator is a sterile, single-use mechanical delivery system. Range of 5 to 20 tacks per applicator.

Indications for Use

Indicated for fixation of prosthetic material (e.g., hernia mesh) to soft tissue during minimally invasive or open general surgical procedures.

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™ and Applicator (K071061)
• E-Z Tac™ (K961585)

Submission Summary (Full Text)

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## SEP 2 8 2007

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP<br>150 Glover Avenue<br>Norwalk, CT 06856<br>Tel. No.: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Daniel Campion<br>Associate II, Regulatory Affairs |
| DATE PREPARED: | July 10, 2007 |
| TRADE/PROPRIETARY NAME: | Syneture™ Absorbable Tack and Applicator |
| COMMON/USUAL NAME: | Absorbable Tack and Applicator |
| CLASSIFICATION NAME: | Implantable Staple |
| PREDICATE DEVICE(S): | AbsorbaTack™ and Applicator (K071061)<br>E-Z Tac™ (K961585) |
| DEVICE DESCRIPTION: | The Syneture™ Absorbable Tack and Applicator are sterile<br>single use devices for the fixation of prosthetic material, such<br>as hernia mesh, onto soft tissue. The Absorbable Tack is<br>formed from synthetic polyester derived from a lactic acid and<br>glycolic acid copolymer. The Applicator is offered with a range<br>of 5 to 20 tacks. |
| INTENDED USE: | The Syneture™ Absorbable Tack and Applicator are intended<br>for fixation of prosthetic material to soft tissue in various<br>minimally invasive and open general surgical procedures, such<br>as hernia repair. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Syneture™ Absorbable Tack and Applicator is identical<br>to the predicate device in terms of intended use and mode of<br>operation. |
| PERFORMANCE DATA: | Performance testing was conducted to verify that the<br>Syneture™ Absorbable Tack and Applicator is safe and<br>effective and performs as intended. |

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Public Health Service

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United States Surgical, a Division of Tyco Healthcare Group, LP % Mr. Daniel Campion Regulatory Affairs Associate II 150 Glover Avenue Norwalk, Connecticut 06856

SEP 2 8 2007

Re: K071920

Trade/Device Name: Syneture™ Absorbable Tack and Applicator Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: September 18, 2007 Received: September 19, 2007

Dear Mr. Campion:

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 etther class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Campion

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

for

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number (if known):

Device Name: Syneture™ Absorbable Tack and Applicator

Indications For Use:

The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|---|--------|------------------------------------------------|
|-------------------------------------------------|---|--------|------------------------------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | L071926 |
|---------------|---------|
|---------------|---------|