INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS by INTERVASCULAR, INC.

InterGard Collagen Coated and Heparin Bonded vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Device Description

The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The InterGard Knitted Ultra-Thin, are Vascular Grafts made of Dacron fabric and coated with bovine collagen. These products are offered in numerous lengths and diameters exceeding 6 mm.

AI/ML Overview

The provided text is a 510(k) summary for the InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prosthesis. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way requested.

Instead, the document details a medical device (vascular prostheses/grafts) and aims to demonstrate its substantial equivalence to previously marketed predicate devices. The "study" mentioned refers to bench and animal studies to validate specifications and published clinical data, which are typically part of a traditional medical device clearance process, not an AI performance study measuring metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information in the format of AI acceptance criteria and study details because the document refers to a non-AI medical device and a different type of regulatory submission.

Here's a breakdown of what the document does describe, aligning with the general themes of your request but not specific to AI:

Device Type: InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses.
Purpose: Surgical repair, bypass, or replacement of arteries for aneurysmal and occlusive disease.
Regulatory Pathway: 510(k) submission, confirming substantial equivalence to predicate devices (InterGard Knitted Collagen Coated Vascular Prostheses and InterGard Knitted Ultra-Thin Collagen Coated Vascular Prostheses).
Performance Claim (Substantial Equivalence): The device has similar technological characteristics (underlying fabric, collagen coating material) and meets the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices.
Validation: These results were validated by bench and animal studies and further supported by published clinical data.

To directly answer your specific questions in the context of the provided document (even though it's not applicable to AI):

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (from document): Same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices.
- Reported Device Performance (from document): "[The products] meet the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices."
Sample sized used for the test set and the data provenance: Not specified in the provided summary for bench/animal/clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. The performance is based on physical/material properties compared to predicate devices.
Adjudication method: Not applicable/specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a traditional medical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: For the device's technical characteristics, the "ground truth" would be established physical and material property standards and performance benchmarks set by the predicate devices, likely through laboratory testing. For "clinical data," it would refer to patient outcomes from previous studies.
The sample size for the training set: Not applicable to this type of device and submission.
How the ground truth for the training set was established: Not applicable to this type of device and submission.

Summary

{0}------------------------------------------------

510(K) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with
This summer 1917 A 4980 - d 21 CFR . Part 807.92. I his suffifiary of safety and executive and 21 CFR, Part 807.92.

4990800

Robert Hill, Director Regulatory Affairs & Quality Assurance Name: InterVascular, La Ciotat, France Address: 33-442087786 Telephone: 33-442081349 Fax: InterGard Knitted Collagen Coated & Heparin Bonded Trade Names: Vascular Prostheses. Vascural Prosulesos.
InterGard Knitted Ultra-Thin Collagen Coated & Heparin Bonded Vascular Prostheses. Vascular Prostheses or Grafts Common Names: 21 CFR 870.3460, Vascular graft prostheses of 6 mm and Classification Name: greater diameter InterGard Knitted Collagen Coated Vascular Prostheses Predicate Names: InterGard Knitted Ultra-Thin Collagen Coated Vascular Prostheses

The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The Interesati Khinee Conagen Grafts made of Dacron fabric and coated with bovine Natied Onla-Xhin, are Visousan Shares are offered in numerous lengths and diameters exceeding 6 mm.

The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prosthesis is indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aotta, visceral arteries and pexipheral arteries. Due to the low porosity of the InterGard vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery. The Indications for these products are the same as the predicate devices.

The InterGard Knitted Collagen Coated and Heparin Bonded Vascular Prostheses have similar technological characteristics as their predicate devices, including the use of the same underlying fabric and collagen coating material. These products also meet the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability

{1}------------------------------------------------

specifications as the predicate devices. Testing was conducted consistent with AAMI
n benefit and specifications as the predicate cevits: "These results were validated by bench and animal studies and further supported by published clinical data.

Based on the conclusions drawn from the safety analysis conducted on this device, the Based on the conclusions wawn from the sace, and you conded grafts are safe and perform in a manner equivalent to the predicate devices mentioned above. .

{2}------------------------------------------------

Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, curved shapes that resemble an abstract representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 2001

Mr. Vincent Bucci President President
Health Policy Associates, Inc. c/o InterVascular, Inc. C70 Walnut Street, Suite 12 Wellesley, MA 02181

K990800/S3
Trade Name: InterGard Knitted Ultra Thin Collagen Coated and Re : InterGard Knifted Urcra Thin Corpos and InterGard Heparin Bonded Vascular Proschebro and Grafts Regulatory Class: II Product Code: DSY Froddo. November 21, 2000 Baccived: December 11, 2000

Dear Mr. Bucci:

We have reviewed your Section .510 (k) notification of intent to market
is a more and show and shows and we have determined the device is We have reviewed your wection we have determined the device is the device referenced above and we indications for use stated in the
substantially equivalent (for the indications for use ted in substantially equivalent (for the increase devices marketed in enclosure) to legally marketed predicate activent date of the interstate commerce prior to May 20, 1970, che bare been reclassified
Medical Device Amendment, or to devices that have been Food, Drug, and Medical Device Amendments, of the Federal Food, Drug, and in accordance with the provisions of the rederal room, season of the productions of the productions Cosmetic Act (Act). You may, the Act. The general controls the general controls provisions of the neers for annual registration,
provisions of the Act include requirements for annual registration, and provisions of the Act Include requirements rise and the listing of devices, good mandidor.
prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device is classified (see above) incoles may be subject to such (Premiarket Approval)) is major regulations affecting your device additional controls. additional controls. Existing mayor roylations, Title 21, Parts 800
can be found in the Code of Federal Regioninations, assumes compliance can be found in the Code of regulvation assumes compliance
to 895. A substantially equivalent determination assumes as set to 895. A substantially equivating assessments, as set
with the Current Good Manufacturing Practice requirements, Devices: with the Current Good nameraccaring (QS) for Medical Devices:
forth in the Quality System Regulation (QS) for Medical periodic forth in the Quality System Regulation (20) - , through periodic QS
General regulation (21 CFR Part 820) and that, FDD) will verify Su General regulation (2) Crk rate book (FDA) will verify such the rood and brug Administration may result in assumptions. assumptions. Frailure to Compry with the end asy and any our ements
regulatory action. In addition, FDA may publish further announcements

{3}------------------------------------------------

Page 2- Mr. Vincent Bucci

concerning your device in the Federal Register. Please note: this concerning your actroon submission submission does not affect any response to your premains under sections 531 through 542 of the Act obligation you might have ander broduct Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described inis recei will arrow you co icention. The FDA finding of substantial in your 510(x) premainte noto a legally marketed predicate device equivalence or 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 809.10 for in vitro regulation (21 crk rare over and the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). MESDIanding by Formation on your responsibilities under the Act may other general information on your as a manufacturers Assistance at its be obtained rrom the broad-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Stacey Anthony Lee

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

{4}------------------------------------------------

PRODUCT INDICATIONS FOR USE (Page 1 of 1)

1990800

510(k) Number:

Device Names:

Indications for Use:

InterGard Knitted Collagen Coated and Heparin Bonded Vascular Prosthesis

: . .

InterGard Knitted Ultra Thin Collagen Coated and Heparin
Coated College Presthasis Bonded Vascular Prosthesis

InterGard Collagen Coated and Heparin Bonded vascular
Collagen Collage Collection ourgical repair, hypass, of InterGard Collagen Coated for surgical repair, bypass, or
prostheses are indicated for surgical repair, of aneurysmal prostheses are indicated in the treatment of aneurysmal replacement of arenes in the abdominal and and wisceral and occusive disease of the unceries. Due to the low porceity arteries, and penpheral arteries. Fecommended for use in of the grans, these products are resomment.
patients requiring heparinization prior to or during surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Aram Patrus. 1-5-

Division of Cardiovascular & Respiratory Devices
510(k) Number K990800

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”