PFA PATCH

K041736 · Peritec Biosciences, LLC · DXZ · Jan 13, 2005 · Cardiovascular

Device Facts

• Record ID: K041736
• Device Name: PFA PATCH
• Applicant: Peritec Biosciences, LLC
• Product Code: DXZ · Cardiovascular
• Decision Date: Jan 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines.

Device Story

PFA Vascular Patch is a cross-linked bovine peritoneal/fascia tissue device; used in peripheral arteries following endarterectomy, as tissue pledget for arterial surgery, or as buttress for over-sewing suture lines. Device is provided sterile in glutaraldehyde solution within a polymeric vial; intended for single use only. Surgeon operates device during peripheral vascular procedures. Clinical benefit derived from providing structural support and reinforcement to vascular tissue during reconstruction. Device performance validated through mechanical strength testing and canine implantation studies demonstrating vessel patency, lack of stenosis, and absence of aneurysm or adverse inflammatory reaction.

Clinical Evidence

Bench testing included mechanical strength parameters: failure tension, stiffness, relax slope, suture pull-out strength, extensibility, fatigue tension, and creep. In vivo animal study conducted in canines comparing PFA patch to a commercially available arterial patch. Results showed all vessels patent, no stenosis, no aneurysm formation, and no difference in inflammatory reaction between groups. No neointimal hyperplasia or scarring observed in PFA group.

Technological Characteristics

Cross-linked bovine peritoneal/fascia tissue. Packaged in glutaraldehyde solution. Available in sizes 0.8x3.0 cm, 1.0x8.0 cm, and 2.0x9.0 cm. Sterile, single-use. Mechanical properties include failure tension, stiffness, and suture pull-out strength.

Indications for Use

Indicated for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions in patients requiring arterial surgery.

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

• Vascu-Guard Peripheral Vascular Patch (K942010)

Submission Summary (Full Text)

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K041736

#### 510(k) Summary

General Information

| Classification | Class II |
|----------------|--------------------------------------------------------------------------------------------|
| Trade Name | PFA Vascular Patch |
| Submitter | Peritec Biosciences LTD<br>3291 Bremerton Road<br>Cleveland, OH 44124<br>Tel: [phone] |
| Contact | Robert M. Dickson<br>President & CEO |

#### Intended Use

The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines.

#### Predicate Devices

Vascu-Guard Peripheral Vascular Patch K942010 from Bio-Vascular, Inc.

#### Device Description

The PFA Vascular Patch is a cross-linked piece of bovine peritoneal / fascia tissue and is available in the following sizes:

0.8 cm x 3.0 cm 1.0 cm x 8.0 cm 2.0 cm x 9.0 cm

The device is packaged in an industry standard polymeric vial with a threaded cap sealed by a plastic shrink wrap. The tissue is packaged with a solution of glutaraldehyde. The sealed container is placed in a shelf

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carton with the Instructions for Use. The shelf carton contains a freeze warning indicator. The product is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.

### Materials

All materials used in the manufacture of the PFA Vascular Patch are suitable for this use and have been used in numerous previously cleared products.

### Testing

Product testing was conducted to evaluate conformance to product specification. Testing included mechanical strength testing for the following parameters: failure tension, stiffness, relax slope, suture pull out strength, extensibility, fatigue tension, and creep tests.

In vivo animal testing comparing the bovine PFA patch to a commercially available arterial patch was conducted. PFA patches and control patches were implanted in canines. All vessels examined were patent with no evidence of stenosis. There was no evidence of aneurysm formation in any vessel and no difference between groups in inflammatory reaction. There was no neointimal hyperplasia or scarring in animals that received the PFA.

## Summary of Substantial Equivalence

The PFA Vascular Patch is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 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 an abstract image of an eagle.

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PeriTec Biosciences, Ltd. c/o Mr. Robert M. Dickson CEO 3291 Bremerton Road Pepper Pike, OH 44124

Re: K041736

PFA Patch - Vascular Patch (Cellular or Unwashed Version) Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: 74 DXZ Dated: December 12, 2004 Received: December 20, 2004

Dear Mr. Dickson:

We have reviewed your Section 510(k) premarket notification of intent to market the device w Charle forlowed your becement of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to rial 2011 devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controlo profices in the 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 If your device is exassinod tion as controls. Existing major regulations affecting your device can may or subject to back access to back 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 r lease of act hour made a determination that your device complies with other requirements of the Act

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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]. 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,

Donna R. Vochner

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) : K041736

Device Name : PFA Patch - Vascular Patch

·

Indications For Use: The PFA Patch is intended for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.

Over-The-Counter Use AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lochner

n Sign-Of Division of Cardiovascular Devices

510(k) Number Ko 41730