INSORB ABSORBABLE STAPLES, MODEL SP-B20

K024117 · Incisive Surgical, Inc. · GDW · Apr 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024117
• Device Name: INSORB ABSORBABLE STAPLES, MODEL SP-B20
• Applicant: Incisive Surgical, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Apr 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Device Story

INSORB™ Absorbable Staples are implantable fasteners used for subcuticular skin closure. Staples are 5.1mm long, 0.79mm thick, and 3.48mm wide, featuring barb tips. Fabricated from a synthetic polyester copolymer derived from lactic and glycolic acids; material degrades in vivo via hydrolysis into glycolic and lactic acids, which are metabolized by the body. Device is used in conjunction with a manual surgical stapler (Class I exempt) operated by surgeons in clinical settings. Staples provide temporary tissue approximation, eliminating the need for post-operative staple removal due to their absorbable nature.

Clinical Evidence

Bench testing included mechanical performance and package testing. Clinical evidence includes an animal study to verify functional characteristics and biocompatibility of the absorbable copolymer.

Technological Characteristics

Synthetic absorbable copolymer (polyglycolic/polylactic acid). Dimensions: 5.1mm length, 0.79mm thickness, 3.48mm width. Barb tips spaced 0.66mm apart. Implantable staple class II device.

Indications for Use

Indicated for patients undergoing abdominal, thoracic, gynecologic, orthopedic, plastic, or reconstructive surgery requiring subcuticular skin closure for temporary tissue approximation.

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

• Autosuture Absorbable Subcuticular Closure Staple (K915489)
• Proximate Absorbable Staple (K915693)
• Vicryl Synthetic Absorbable Suture (K022269, K974299, K962480)

Submission Summary (Full Text)

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KO24117
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# APR 2 2 2003

#### A. 510(k) Summary

| SUBMITTER: | Incisive Surgical Inc.<br>1409 Fairfield Road<br>Minnetonka, MN 55305<br>Phone: [phone]<br>Fax: [phone] |
|------------|-------------------------------------------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------------------------------------------|

- CONTACT PERSON: Jim Peterson Vice President, Regulatory and Quality Affairs
December 12, 2002 DATE PREPARED:

TRADE NAME: INSORB™ Absorbable Staple

- Implantable Staple COMMON NAME:
### CLASSIFICATION: 21 CFR 878.4750, Staple, Implantable Class II

#### PRODUCT CODE: GDW

PREDICATE DEVICE(S): The INSORB™ Absorbable Staple is substantially equivalent to the Autosuture Absorbable Subcuticular Closure Staple manufactured by United States Surgical (K915489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 510(k)'s e.g K022269, K974299, K962480).

- DEVICE DESCRIPTION: INSORBTM Absorbable Staples are 5.1mm in length, 0.79mm thick, 3.48mm wide overall, and have barb tips that are 0.66mm apart. They are used in conjunction with a manual surgical stapler from Incisive (Note: Incisive's manual surgical stapler is a Class I exempt device pursuant to 21 CFR 878.4800 and is not the subject of this submission).
INSORB™ staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

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K024117
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### INTENDED USE: Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation. FUNCTIONAL & SAFETY TESTING: Prior to commercialization INSORB™ Absorbable Staples underwent testing to verify appropriate functional characteristics. This testing included an animal study, mechanical performance testing, and package testing. This testing demonstrates that the INSORBTM Absorbable Staples meet all required specifications. CONCLUSION: The INSORB™ Absorbable Staples from Incisive are substantially equivalent to the Autosuture Absorbable Subcuticular Closure Staple manufactured by United States Surgical (K915489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 510(k)'s e.g K022269, K974299, K962480).

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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health. The logo consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. To the left of the profiles, the text "DEPARTMENT OF HEALTH" is arranged vertically, curving along the left side of the logo.

## APR 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Peterson Vice President, Regulatory and Quality Affairs Incisive Surgical, Inc. 1409 Fairfield Road Minnetonka, Minnesota 55305

Re: K024117

Trade/Device Name: INSORB™ Absorbable Staple Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 2, 2003 Received: April 8, 2003

Dear Mr. Peterson :

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 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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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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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 Page

Device Name: INSORB™ Absorbable Staple

Indications For Use:

Synthetic absorbable INSORB™ staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K624117

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