SURGISIS

K980431 · Cook Biotech, Inc. · FTM · May 28, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980431
• Device Name: SURGISIS
• Applicant: Cook Biotech, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: May 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SurgiS/S™ is intended to be used for implantation to reinforce soft tissue. It is intended for one-time use.

Device Story

SurgiSIS™ is a surgical mesh provided in sheet form (16 cm² to 360 cm²) for soft tissue reinforcement. The device is implanted by a surgeon during surgical procedures to provide structural support to compromised soft tissue. It is a single-use, sterile device. The device functions as a scaffold for tissue reinforcement.

Clinical Evidence

Bench testing only. The device was subjected to a panel of tests assessing biocompatibility, integrity, and performance, with all results passing established requirements.

Technological Characteristics

Surgical mesh supplied in sterile sheet form. Dimensions range from 16 cm² to 360 cm². Device is intended for implantation to reinforce soft tissue.

Indications for Use

Indicated for implantation to reinforce soft tissue in patients requiring surgical repair or reinforcement.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Supple Peri-Guard® Pericardium (K961810)
• GraftPatch® Soft Tissue Surgical Patch (K970561)
• DEXON Polyglycolic Acid Mesh (K830889)

Submission Summary (Full Text)

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K980431

510(k) Premarket Notification: SurgiS/STM 1

MAY 2 8 1998

# I. 510(K) SUMMARY

Submitted By:

Neal E. Fearnot. Ph.D. President Cook Biotech, Incorporated P.O. Box 2402 West Lafayette, IN 47906 [phone] February 2, 1998

## Names of Device:

Trade Name: Common/Usual Name: Proposed Classification Name:

SurgiSIS™ Surgical Mesh, Soft Tissue Patch Surgical Mesh (21 CFR §878.3300)

## Predicate Devices:

Supple Peri-Guard® Pericardium (K961810) manufactured by Bio-Vascular, Inc. GraftPatch® Soft Tissue Surgical Patch (K970561) manufactured by Organogenesis, Inc. DEXON Polyglycolic Acid Mesh (K830889) manufactured by Davis & Geck, Inc.

## Device Description:

SurgiS/S™ is supplied in sheet form in sizes ranging from 16 cm² to 360 cm². The device is packaged in sterile sealed pouches.

## Intended Use:

SurgiS/S™ is intended to be used for implantation to reinforce soft tissue. It is intended for one-time use.

#### Substantial Equivalence:

SurgiSIS™ is substantially equivalent to the predicate devices, having similar intended use and technological characteristics.

#### Discussion of Tests and Test Results:

The SurgiS/S™ material was subjected to a panel of tests to assess biocompatibility, integrity, and performance. SurgiS/S™ passed the requirements of all tests.

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Image /page/1/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 28 1998

Neal E. Fearnot, Ph.D. ·President Cook Biotech Incorporated P.O. Box 2603 3055 Kent Avenue West Lafayette, Indiana 47906

K980431 Re: SurgiSIS™ Surgical Mesh Trade Name: Regulatory Class: II Product Code: FTM Dated: April 30, 1998 Received: May 5, 1998

Dear Dr. Fearnot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Dr. Fearnot

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.,

Ph.D., M.D. a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

SurgiS/S™ is intended for implantation to reinforce soft tissue. This device is intended for one-time use.

(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 Devices
510(k) Number K980431

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_ (Optional Format 1-2-96)