The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "VENAFLO™ Vascular Grafts," specifically the "Venaflo Graft with Carbon." This is a regulatory submission for a medical device and not a detailed study report describing acceptance criteria and device performance in the manner of a clinical trial or algorithm validation study.

Therefore, much of the requested information (like specific quantifiable acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, or ground truth establishment details) is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative sense.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Suitable for use as a subcutaneous arteriovenous conduit for blood access.	"The results of all testing indicated that the Venaflo Graft with Carbon is suitable for use as a subcutaneous arteriovenous conduit for blood access and the anticipated conditions of use imposed on the device."
Designed to perform in a manner substantially equivalent to predicate devices.	"The results demonstrated that the Venaflo Graft with Carbon has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices."
Compliance with ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses.	"Testing was conducted using methods recommended in ANSI/AAMI VP20-1994."
Compliance with 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses.	"Testing was conducted using methods recommended in... the 1993 FDA Draft Guidance."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "Device testing was performed on the cuffed portion of the Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo ePTFE Vascular Graft." This implies laboratory or bench testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the performance assessment appears to be based on physical device testing against recognized standards, not on expert-adjudicated clinical data.

4. Adjudication method for the test set

Not applicable for this type of device testing.

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

No. This is a vascular graft, not an AI or imaging diagnostic device.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device appears to be defined by established industry standards (ANSI/AAMI VP20-1994) and FDA guidance for vascular prostheses, as well as the performance characteristics of the predicate devices. The document implies that physical/mechanical tests were conducted to demonstrate compliance with these standards and equivalence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI model.

Summary of Device and Performance Information Provided:

Device Name: Venaflo™ Vascular Graft (specifically Venaflo Graft with Carbon)
Intended Use: Subcutaneous arteriovenous conduit for blood access only.
Predicate Devices: Venaflo Vascular Graft, Venaflo ePTFE Vascular Graft, IMPRA Carboflo® Vascular Graft.
Performance Basis: Device testing on the cuffed portion, compared to results from the Venaflo ePTFE Vascular Graft.
Testing Standards: ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance for Vascular Graft Prostheses.
Conclusion: The testing indicated suitability for intended use and substantial equivalence to predicate devices.

Summary

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7 1998 MAY

IMPRA

A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P. O. Box 1740 Tempe, AZ 85280-1740 TEL: 800-321-4254 602-894-9515 FAX: 602-966-7062

1981076

Image /page/0/Picture/4 description: The image shows the word "IMPRA" in bold, black letters. The letters are slightly slanted to the right, giving the word a dynamic appearance. The font is sans-serif, and the letters are closely spaced together. The background is plain white.

CONFIDENTIAL

510(k) Premarket Notification VENAFLOTM Vascular Grafts

510(k) SUMMARY

Submitter Information A.

Submitter's Name:	IMPRA, Inc.A Subsidiary of C. R. Bard, Inc.
Address:	1625 West Third StreetTempe, Arizona 85281
Telephone:	(602) 894-9515
Fax:	(602) 966-7062
Contact Person:	Kristi M. KistnerManager, Regulatory Affairs
Date of Preparation:	March 20, 1998

B. Device Name

Trade Name:	Venaflo™ Vascular Graft (Venaflo ePTFE Vascular Graftand Venaflo Graft with Carbon)
Common/Usual Name:	Vascular Graft Prosthesis
Classification Names:	Vascular graft prostheses of less than 6 mm diameter

March 20, 1998 (12:30PM) IMPRA, Inc., A Subsidiary of C. R. Bard, Inc., C:\MyFiles\VENACARBLT6.wpd23

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Predicate Device Name C.

Trade Name(s):

Venaflo Vascular Graft Venaflo ePTFE Vascular Graft IMPRA Carboflo® Vascular Graft

Device Description D.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

E. Intended Use

The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

F. Technological Characteristics Summary

The Venaflo Graft with Carbon is an IMPRA Carboflo Vascular Graft with a cuffed venous end having the same shape and dimensions as the cuff on the Venaflo ePTFE Vascular Graft.

G. Performance Data

Device testing was performed on the cuffed portion of the Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo ePTFE Vascular Graft. The testing was conducted using methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. The results of all testing indicated that the Venaflo Graft with Carbon is suitable for use as a subcutaneous arteriovenous conduit for blood access and the anticipated conditions of use imposed on the device. The results demonstrated that the Venaflo Graft with Carbon has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices.

Venaflo Grafts with Carbon are substantially equivalent to the currently marketed Venaflo ePTFE Vascular Graft and the IMPRA Carboflo Vascular Graft.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 7 1998

Ms. Kristi Kistner Impra, Inc. A Subsidiary of C. R. Bard, Inc. 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K981076 Venaflo™ Vascular Graft Regulatory Class: III (three) Product Code: 74 DYF Dated: March 20, 1998 Received: March 24, 1998

Dear Ms. Kistner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Kristi Kistner

This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K971076 and K 971079

Device Name:_ Venaflo Grafts with Carbon_

Indications For Use: The Venaflo Grafts with Carbon are indicated for subcutaneous arteriovenous conduit for blood access only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number: k 981076

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.”