Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of < 1 µm. The device is in sheet configuration with a variety of width and length dimensions.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the PRECLUDE® Pericardial Membrane. It details a modification to the labeling only of an already marketed device. Therefore, the information provided does not contain a study proving the device meets acceptance criteria as this submission is not introducing a new device or a change in technological characteristics. Instead, it relies on the substantial equivalence to its predicate device.

Here's an analysis based on the understanding that this is a labeling modification submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this submission is a modification to labeling only, there are no new acceptance criteria or reported device performance metrics established for this specific submission. The device's performance relies on the previous clearance of the predicate device.

Acceptance Criteria	Reported Device Performance
Not applicable.	Not applicable.
(This submission is for a labeling modification of an already cleared device.)	(No new performance data was generated for this submission.)

2. Sample Size Used for the Test Set and the Data Provenance:

No new test set was used for this submission. The efficacy and safety of the ePTFE material were previously established and are referenced as: "Reports of data from animal studies and from clinical experiences documented in the literature demonstrate that ePTFE material with a nominal pore size of < 1 µm limits tissue to membrane attachment and thus attachment between surfaces that it covers and surrounding tissue." The specific sample sizes, country of origin, or whether these historical studies were retrospective or prospective are not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. No new test set was created or evaluated for this labeling modification. The ground truth for the underlying material's performance was established via existing animal studies and clinical literature, but no details on expert panels for these historical studies are provided.

4. Adjudication Method for the Test Set:

Not applicable. No new test set or adjudication process was performed for this labeling modification.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This submission focuses on labeling changes, not comparative performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is not an AI/algorithm-based device.

7. Type of Ground Truth Used:

The document refers to "Reports of data from animal studies and from clinical experiences documented in the literature." This suggests that the ground truth for the material's efficacy in preventing tissue attachment was established through a combination of animal study outcomes and clinical outcomes data from human experiences.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that uses a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/machine learning device.

Summary

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SEP 2 0 2001

Attachment 4

510 (k) Premarket Notification

PRECLUDE® Pericardial Membrane

Premarket Notification 510(k) Summary

A. Submitted By: W.L. Gore & Associates, Inc. P.O. Box 500 Flaqstaff, AZ 86002-0500
Date Prepared: September 17, 2001

Contact : R. Larry Pratt

Phone: 928-779-2771

PRECLUDE® Pericardial Membrane Device Name: B.
c. Applicant Device Description:

Biocompatible, expanded polytetrafluoroethylene (ePTFE). The ePTFE material has a nominal pore size of < 1 µm. The device is in sheet configuration with a variety of width and length dimensions.

D. Predicate Device:
The currently marketed PRECLUDE® Pericardial Membrane is cited as the predicate device which has been found to be substantially equivalent through the premarket notification process.
E . Applicant Device Labeling:
Like the predicate device, the applicant device is indicated for the reconstruction or repair of the pericardium. The indication statement for the predicate device is not changed as a result of this submission's clearance.

The WARNINGS section and the PRECAUTIONS section of the Instructions For Use are modified to provide special care

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information for when the device is employed as a protective membrane and physical barrier to limit tissue attachment to the membrane and thus to the surface of a temporary mechanical circulatory assist device.

Technological Characteristics: F.

This premarket notification represents a modification to the labeling only. The technological characteristics of the predicate device are not changed. The applicant device the predicate doving the same inert, biocompatible ePTFE material as the predicate device, consequently bench testing was not performed.

Reports of data from animal studies and from clinical experiences documented in the literature demonstrate that ePTFE material with a nominal pore size of < 1 µm limits tissue to membrane attachment and thus attachment between surfaces that it covers and surrounding tissue.

Safety and Effectiveness Conclusions: G.
This submission represents only a modification to the WARNINGS section and the PRECAUTIONS section of the Instructions For Use for the currently marketed predicate device. Therefore, the similarities between the applicant and predicate device are numerous. These equivalencies combine to justify a substantially equivalent determination.

The only difference from the predicate device to the applicant device is that the WARNINGS section and the PRECAUTIONS section of the Instructions For Use for the applicant device provides special care information for when the device is employed as a protective membrane and physical barrier to limit tissue attachment to the membrane and thus to the surface of a mechanical circulatory assist device. This difference does not adversely affect the safety, integrity, therapeutic effect or functional characteristics of the applicant device when compared to the predicate device.

No new types of safety and effectiveness questions are raised by the applicant device when compared to the predicate device.

GORE-TEX®, GORE® and PRECLUDE® are trademarks of W.L. Gore & Associates

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Image /page/2/Picture/1 description: The image is a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized design of three human profiles facing to the right, stacked on top of each other.

Public Health Service

SEP 2 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. R. Larry Pratt Regulatory Affairs W. L. Gore and Associates, Inc. Medical Products Division 3750 West Kiltie Lane Flagstaff. AZ 86002

Re: K012098

Trade Name: PRECLUDE® Pericardial Membrane Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Made of Polypropylene, Polyethylene Terephthalate, or Polytetrafluoroethylene Regulatory Class: Class II (two) Product Code: DXZ Dated: September 17, 2001

Received: September 18, 2001

Dear Mr. Pratt:

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 - Mr. R. Larry Pratt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

James D. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PRECLUDE Pericardial Membrane

Indications For Use:

For reconstruction and repair of the pericardium

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011098

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
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.(b)
Classification. Class II (performance standards).