PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION

K040119 · Synovis Surgical Innovations · FTM · Mar 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040119
• Device Name: PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
• Applicant: Synovis Surgical Innovations
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures. Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

Device Story

Peri-Strips Staple Line Reinforcement is an implantable surgical patch composed of crosslinked bovine pericardium. It is used by surgeons during procedures involving surgical staplers to reinforce staple lines in soft tissue. The device acts as a prosthesis to address soft tissue deficiencies. It is applied during lung, bronchus, bariatric, gastric, small bowel, mesentery, colon, and colorectal resections. By providing reinforcement to the staple line, the device aims to improve tissue integrity at the site of the staple line, potentially reducing complications associated with stapling in these surgical contexts.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison to predicate devices.

Technological Characteristics

Implantable surgical patch; material: crosslinked bovine pericardium; form factor: sleeve or strip configuration; intended for use with surgical staplers; non-electronic/mechanical device.

Indications for Use

Indicated for patients undergoing surgical procedures requiring staple line reinforcement, including lung, bronchus, bariatric, gastric, small bowel, mesentery, colon, and colorectal surgeries.

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

• Peri-Strips® Staple Line Reinforcement (K983162)
• SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (K032865)

Submission Summary (Full Text)

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## 3.0 510(k) SUMMARY

| Submitted by | Synovis Surgical Innovations |
|--------------|-----------------------------------------------|
| | A Division of Synovis Life Technologies, Inc. |
| | 2575 University Ave. W. |
| | St. Paul, MN 55114 |
| | Tel: [phone] |
| | Fax: [phone] |

Angela Mallery Contact Person At address above

Peri-Strips® Staple Line Reinforcement - Sleeve Configuration Device Trade Name: Peri-Strips® Staple Line Reinforcement -- Strip Configuration Peri-Strips® Dry Staple Line Reinforcement

- Common Name Surgical Mesh
- Classification Name Mesh, Surgical 878.3300

Peri-Strips® Staple Line Reinforcement (Synovis Surgical Predicate device Innovations, a division of Synovis Life Technologies, Inc.) -K983162 SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (W.L. Gore & Associates, Inc., Flagstaff, AZ) K032865

- Device Description An implantable surgical patch comprised of crosslinked bovine pericardium

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Peri-Strips Staple Line Reinforcement is intended for use as a Statement of prosthesis for the surgical repair of soft tissue deficiencies using Intended use surgical staplers when staple line reinforcement is needed.

1040115

Peri-Strips® Staple Line Reinforcement yage 2 46 7

Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.

Peri-Strips can also be used for remforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

## Technological Comparisons

Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device, having the same technological characteristics.

## Testing

Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2004

Ms. Angela Mallery Regulatory Affairs Manager Synovis Life Technologies, Inc. 2575 University Avenue W. St. Paul, Minnesota 55114

Re: K040119

Trade/Device Name: Peri-Strips Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: January 16, 2004 Received: January 20, 2004

Dear Ms. Mallery:

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 Mcdical 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 cither 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); labcling (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 - Ms. Angela Mallery

This letter will allow you to begin marketing your device as described in your Scction 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
for

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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K040119

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Peri-Strips Staple Line Reinforcement Device Name:

Indications For Use:

Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.

Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

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)

Muriam C. Provost

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

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**510(k) Number** K040119