PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

K040415 · Synovis Surgical Innovations · DXZ · Apr 14, 2004 · Cardiovascular

Device Facts

• Record ID: K040415
• Device Name: PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
• Applicant: Synovis Surgical Innovations
• Product Code: DXZ · Cardiovascular
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• 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 be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures. Peri-Strips is intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Device Story

Implantable surgical patch comprised of crosslinked bovine pericardium; used as prosthesis for soft tissue repair and staple line reinforcement. Applied by surgeons during lung, bronchus, bariatric, gastrointestinal, and cardiac procedures. Functions as mechanical reinforcement for staple lines and suture lines; provides structural support to tissue. Used in OR setting. Benefits patient by reducing potential for leaks or tissue failure at surgical staple/suture sites.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Implantable patch composed of crosslinked bovine pericardium. Available in sleeve, strip, and dry configurations. Non-electronic, mechanical device. Sterilized for surgical implantation.

Indications for Use

Indicated for patients requiring soft tissue repair or staple line reinforcement during lung, bronchus, bariatric, gastric, small bowel, mesentery, colon, colorectal, or cardiac surgical procedures (including left atrial appendage occlusion).

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• Peri-Strips Staple Line Reinforcement (K983162)
• Peri-Guard Cardiovascular Patch (K983602)

Submission Summary (Full Text)

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## 510(k) SUMMARY

- Synovis Surgical Innovations Submitted by: 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® Device Trade Name: Staple Line Reinforcement — Sleeve Configuration Peri-Strips® Staple Linc Reinforcement – Strip Configuration Peri-Strips® Dry Staple Linc Reinforcement
- Surgical Mesh Common Name:
- Intracardiac patch or pledget made of polypropylene, Classification Name: polyethylene terephthalate, or polytetrafluoroethylene
- Peri-Strips® Staple Line Reinforcement (Synovis Surgical Predicate device: Innovations, a division of Synovis Life Technologies, Inc.) K983162 CV Peri-Guard Cardiovascular Patch (Synovis Surgical Innovations, a division of Synovis Life Technologies, Inc.) K983602
- An implantable surgical patch comprised of crosslinked Device Description: bovine pericardium

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| Statement of<br>Intended use: | Peri-Strips Staple Line Reinforcement is intended for use<br>as a prosthesis for the surgical repair of soft tissue<br>deficiencies using surgical staplers when staple line<br>reinforcement is needed. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peri-Strips can be used for reinforcement of staple lines<br>during lung and bronchus resections and during bariatric<br>surgical procedures. |
| | Peri-Strips can be used for reinforcement of staple lines<br>during gastric, small bowel, mesentery, colon, and<br>colorectal procedures. |
| | Peri-Strips is intended to be used for reinforcement of suture-<br>lines and staple-lines (i.e., occlusion of the left atrial<br>appendage during open chest procedures) during cardiac<br>surgery. |
| Technological<br>Comparisons: | Peri-Strips® Staple Line Reinforcement is substantially<br>equivalent to the predicate device, having the same<br>technological characteristics. |
| Testing: | Peri-Strips® Staple Line Reinforcement is substantially<br>equivalent to the predicate device in term of testing and<br>indications for use. |

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Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other, with a wavy line underneath them.

APR 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synovis Surgical Innovations c/o Ms. Angela Mallery Regulatory Affairs Manager 2575 university Avenue W. St. Paul, MN 55114-1024

Re: K040415

Peri-Strips Staple Line Reinforcement Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: February 20, 2004 Received: February 18, 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 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. Iisting 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.

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Page 2 - Ms. Angela Mallery

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. 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.

Dina R. Buchner

Bram
Director
Divisi

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040415

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 be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

Peri-Strips is intended to be used for reinforcement of suturelines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Prescription Use X (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)

Duana P. Voelkel

(Division Sign-Off) Division of Cardiovascular Devices

**510(k) Number** k040415