PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

K031948 · Pm Devices, Inc. · DXZ · Sep 16, 2003 · Cardiovascular

Device Facts

• Record ID: K031948
• Device Name: PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
• Applicant: Pm Devices, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.

Device Story

PeriPatch™ Sheet is a processed bovine pericardial patch used as surgical material for cardiac and vascular reconstruction and repair. Device is intended for use by surgeons in clinical/OR settings. It serves as a structural patch to facilitate tissue repair. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Processed bovine pericardium; surgical patch form factor; non-electronic; non-software; sterile.

Indications for Use

Indicated for patients requiring cardiac or vascular reconstruction and repair via surgical patch application.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem in the center, which is a stylized design of three overlapping human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

PM Devices, Inc. c/o Ms. Britta Dombovári Regulatory Affairs, Quality Assurance 2135-13700 Mayfield Place Richmond, British Columbia CANADA V6V 2E4

Re: K031948

Trade Name: PeriPatch™ Sheet Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: June 24, 2003 Received: June 25, 2003

Dear Ms. Dombovári:

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.

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Page 2 – Ms. Britta Dombovári

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 (OS) 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,

VDelartu

Bram D. Zuckerman, M.D.

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

Enclosure

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510(k) Number (if known) K031948

ﺍﻟﻤﺮﺍﺟﻊ

Device Name: PeriPatch™ Sheet - Processed Bovine Pericardial Patch

Indications For Use:

The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Velella

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031148

Х Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)