PRECLUDE IMA SLEEVE by W.L. GORE & ASSOCIATES,INC

Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve configuration. The sleeve configuration allows a surgeon to use the device as is without the need to form and shape the device during surgical procedures. The sleeve has a nominal 17-24 mm internal diameter and a length of 10-20 cm.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "GORE PRECLUDE® IMA Sleeve". The device is an expanded polytetrafluoroethylene (ePTFE) sleeve intended for use as a wrap for pedicled arterial conduits during reoperative cardiac surgery. The basis for substantial equivalence is comparison to a predicate device, the PRECLUDE™ Pericardial Membrane.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense as might be seen for a diagnostic AI device (e.g., minimum sensitivity, specificity). Instead, the acceptance of the device is based on demonstrating substantial equivalence to a legally marketed predicate device. This equivalence is shown through shared material, manufacturing process, intended use, indications, and comparable performance in specific tests.

Acceptance Criterion (Established by Predicate Equivalence)	Reported Device Performance (Applicant Device)
Material Composition	Biocompatible ePTFE (same as predicate)
Manufacturing Process	Same as predicate
Intended Use	Same as predicate: surgical membrane for covering and physical barrier of pedicled arterial conduits; identifies and protects during reoperative cardiac surgery.
Indications for Use	Same as predicate: wrap for pedicled arterial conduits.
Biocompatibility	No histopathological complications in animal studies (consistent with predicate).
Tissue Attachment Characteristics	In animal studies, consistent with predicate.
Mechanical Strength - Mean Suture Pull-Out Force	0.67 kg (compared to predicate's 0.93 kg). Considered "substantially equivalent."
Mechanical Strength - Mean Peak Load	9.56 kg (compared to predicate's 4.49 kg). Considered "substantially equivalent."
Quality Tests & Criteria	Subjected to essentially the same as predicate.
Packaging Processes & Materials	Will not differ from predicate.
Sterilization Methods	Same as predicate.
Post-Sterilization Release Criteria	Same as predicate.
Sterility Assurance Level (SAL)	≤ 10^-6 (same as predicate).

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

Sample Size for Test Set: Not explicitly stated for mechanical tests. For animal studies, the number of animals used is not specified.
Data Provenance: The studies are described as "animal studies." The country of origin is not specified, but the applicant (W.L. Gore & Associates, Inc.) is based in Flagstaff, AZ, USA. The studies are prospective in the sense that they were conducted for this submission, although the raw data might have been collected over a period.

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

This information is not provided in the document. For animal studies, veterinary pathologists would typically establish ground truth regarding histopathological findings and tissue reactions.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to the device described. The PRECLUDE™ IMA Sleeve is a physical medical device (implant), not an AI/software device that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to the device described as it is not an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility and tissue attachment, the ground truth was based on histopathological findings from animal studies (pathology).
For mechanical strength, the ground truth was the measured values from laboratory testing.
For manufacturing and sterilization, the ground truth relates to adherence to established quality system processes and predetermined criteria.

8. The Sample Size for the Training Set

This concept is not directly applicable. This is a physical medical device, not a machine learning model requiring a "training set." The development and refinement of the ePTFE material and sleeve configuration would have been informed by prior research and manufacturing experience with similar materials and devices (like the predicate), which could be considered analogous to a "training" process in a very broad sense, but not in the context of an AI training set.

9. How the Ground Truth for the Training Set was Established

As above, the concept of a training set ground truth, as used in AI/ML, does not apply here. The material characteristics and performance expectations of ePTFE were established through scientific research, material engineering principles, and experience with similar devices over time.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simple line drawing.

FEB 23 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W.L. Gore & Associates, Inc. c/o Mr. R. Larry Pratt Regulatory Affairs 3450 West Kiltie Lane Box 500 -P.O. Flagstaff, AZ 86002-0500

Re: K960532 GORE PRECLUDE® IMA Sleeve Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II (two) Product Code: MFX Dated: February 5, 1996 Received: February 7, 1996

Dear Mr. Pratt:

This letter corrects our substantially equivalent letter of May 23, 1996.

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 (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 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 (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 continue 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Duna D. 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): K960532

Device Name: Gore PRECLUDE IMA Sleeve

Indications For Use: For use as a wrap for pedicled arterial conduits.

Intended Use: The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Voelker

(Divin 1 Sign-Off) Division of Cardiovascular Devices

510(K) Number_K960532

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K960532

v. 510 (k) Summary

MAY 23 1996

A. Submitted By: W.L. Gore & Associates, Inc. Flagstaff, AZ 86002
Contact : R. Larry Pratt 520-779-2771
B. PRECLUDE™ IMA Sleeve Device Name:
C. Applicant Device Description:

D. Intended Use and Indications
A surgical membrane indicated for use as a cover and physical barrier of pedicled arterial conduits which are used as coronary artery bypass grafts. The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.
E. Predicate Device:
The surgical membrane, PRECLUDE™ Pericardial Membrane, is cited as a predicate device which has been found to be substantially equivalent through the premarket notification process.
г. Technological Characteristics:
The applicant device has the same intended use and the same indications as the predicate device.

The applicant device is manufactured using the same inert, biocompatible ePTFE material as the predicate device. Mechanical strength test results show the applicant device to have material characteristics which are substantially equivalent to the predicate device.

	Applicant	Predicate
Mean Suture Pull-Out Force	0.67 kg	0.93 kg
Mean Peak Load	9.56 kg	4.49 kg

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Data from animal studies show the applicant device to exhibit no histopathological complications and to have tissue attachment characteristics consistent with the predicate device.

G. Safety and Effectiveness Conclusions:

The applicant PRECLUDE™ IMA Sieeve is equivalent in materials and manufacturing processes to the predicate PRECLUDE™ Pericardial Membrane. The applicant device is composed of the same inert, biocompatible expanded PTFE as the predicate device. As demonstrated in animal studies, tissue attachment characteristics and the histological reactions and effects of the applicant device are equivalent to those of the predicate device. Mechanical testing data reveal the applicant device has strength values which are substantially equivalent to the predicate device. The applicant device is subjected to essentially the same quality tests and quality criteria as is the predicate device. The packaging processes and materials used for the applicant device will not differ from those used for the predicate device. The applicant device will be sterilized using the same sterilization methods, utilize the same post-sterilization release criteria and have the same Sterility Assurance Level of ≤ 10° as the predicate device.

The sleeve feature of the applicant device does not affect the safety or effectiveness of the product. No new types of safety and effectiveness questions are raised by the applicant device when comparec to the predicate device.

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).