Venaflo II arteriovenous vascular grafts have a pre-formed venous cuff to promote venano II atterrovenous variate at the venous anastomosis. Venaflo II grafts are available in various lengths and diameters, in straight and stepped configurations, with and without external support.

AI/ML Overview

The provided Venaflo II Vascular Graft 510(k) Summary of Safety and Effectiveness document describes a medical device, not a software algorithm or AI. Therefore, most of the requested information (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, etc.) is not applicable to this type of submission.

This document pertains to a physical medical device – a vascular graft – and its substantial equivalence to a predicate device. The "study" mentioned is a design verification process based on industry standards and FDA guidance for physical implants, which differs significantly from studies performed to evaluate AI/software performance.

Here's an attempt to address the applicable parts of your request based on the provided text, while clearly indicating where information is not relevant:

Acceptance Criteria and Device Performance for Venaflo™ II Vascular Graft

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Implied from document)	Reported Device Performance
Design / Functionality	Optimization of venous cuff sizing for veins 8mm and smaller. Improved hemodynamic performance at the venous anastomosis.	The modified device (Venaflo™ II) is described as having "printed trim lines on a more pronounced venous cuff profile to enhance the good hemodynamic performance of the predicate design." The changes "optimize venous cuff sizing... and improve hemodynamic performance at the venous anastomosis."
Technological Equivalence	Substantial equivalence to predicate device in intended use, operation, user population, basic design, performance, labeling, packaging, and sterilization method.	"The technological characteristics of Venaflo II vascular grafts are substantially equivalent to those of the predicate Venaflo vascular graft in terms of intended use, operation, user population, basic design, performance, labeling, packaging, and sterilization method."
Non-Clinical Performance	Conformance to or evaluation based on specific FDA guidance and industry standards for vascular prostheses and biocompatibility.	"All test results confirm the modified device to be substantially equivalent to the predicate device." "Venaflo II Vascular Grafts met all predetermined acceptance criteria of design verification and validation as required by the risk analysis, and as specified by applicable standards, guidance's, test protocols and/or customer inputs."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes a 510(k) submission for a physical medical device (vascular graft) which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study with a "test set" in the context of an AI algorithm. The performance evaluation is based on non-clinical performance data which refers to engineering and laboratory testing (e.g., in vitro, material characterization, mechanical stress tests). There's no mention of human patient data "test sets" or data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As above, there is no "test set" in the AI sense, and therefore no ground truth established by experts for such a set. The "ground truth" here is the established safety and effectiveness of the predicate device and the conformance to recognized industry standards and guidance documents.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or direct expert adjudication in the context of AI evaluation is described. The "validation" is implied through meeting the requirements of specified guidance documents and standards.

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

Not Applicable. This is a physical vascular graft, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this device.

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

Not Applicable. As mentioned, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate device (IMPRA Venaflo™ Vascular Graft, K981079) and conformance to recognized industry standards and FDA guidance documents related to vascular prostheses and biocompatibility (e.g., ANSI/AAMI VP20-1994, ANSI/AAMI/ISO 7198: 1998/2001, ISO 10993 series). The modified device is deemed safe and effective because it meets these standards and is substantially equivalent to a device already deemed safe and effective.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of AI development for this physical device.

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

Not Applicable. There is no "training set" for AI.

Summary

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Venafio II Vascular Graft 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).

General Information:

Submitter Name:	Bard Peripheral Vascular, Inc.
Address:	1625 W. Third StreetP. O. Box 1740Tempe, AZ 85280-1740
Telephone Number:	(480) 894-9515 ext. 2836
Fax Number:	(480) 449-2546
Contact Person:	Glenn Norton
Date of Preparation:	August 19, 2005

Device Information:

Device Name:	Venaflo™ II Vascular Graft
Trade Name:	Venaflo™ II
Common/Usual Name:	Arteriovenous Vascular Graft
Classification Name:	74 DSY - Prosthesis, Vascular Graft,Of 6mm and Greater Diameter21 CFR 870.3450 - Class IIVascular graft prosthesis
Classification Panel:	Cardiovascular

Predicate Device:

IMPRA Venaflo™ Vascular Graft, K981079, concurrence date 05/07/1998.

Summary of Change:

The Venaflo Vascular Graft is being modified with printed trim lines on a more The Vehance Vaboutived venous cuff profile to enhance the good hemodynamic surformance of the predicate design. All other aspects of the modified device remain performance of the predicate device. The changes optimize venous cuff sizing for the the bains as are rimming the cuff for veins 8mm and smaller, and improve hemodynamic performance at the venous anastomosis.

Device Description:

Venaflo II arteriovenous vascular grafts have a pre-formed venous cuff to promote venano II atterrovenous variate at the venous anastomosis. Venaflo II grafts are

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available in various lengths and diameters, in straight and stepped configurations, with and without external support.

Intended Use of Device:

Venaflo™ II Vascular Grafts are indicated for use as subcutaneous arteriovenous conduits for blood access only.

Technological Comparison to Predicate Device:

The technological characteristics of Venaflo II vascular grafts are substantially equivalent to those of the predicate Venaflo vascular graft in terms of intended use, oquireation, user population, basic design, performance, labeling, packaging, and sterilization method.

Non-Clinical Performance Data:

Design verification of the modified device was done with conformance to or evaluated based on the following FDA Guidance and industry standards:

Guidance Document for Vascular Prosthesis 510(k) Submissions, dated . 11/01/2000
ANSI/AAMI VP20-1994, Cardiovascular Implants Vascular Prosthesis ●
ANSI/AAMI/ISO 7198: 1998/2001, Cardiovascular implants Tubular . vascular implants
AAMI/ANSI/ISO 10993-1: 1997, Biological evaluation of medical devices -. Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile
AAMI/ANSI/ISO 10993-7: 1995, Biological evaluation of medical devices -. Part 1: Ethylene Oxide Sterilization Residuals
AAMI/ANSI/ISO 11135:1994, Medical Devices -- Validation and Routine . Control of Ethylene Oxide Sterilization

All test results confirm the modified device to be substantially equivalent to the predicate device.

Conclusions:

Venaflo II Vascular Grafts met all predetermined acceptance criteria of design verification and validation as required by the risk analysis, and as specified by applicable standards, guidance's, test protocols and/or customer inputs. Venaflo II Vascular Grafts are substantially equivalent to the legally marketed predicate device, the Venaflo Vascular Graft, K981079, concurrence date May 5, 1998.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized lines that appear to be a symbol or logo for the department.

SEP 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Peripheral Vascular, Inc. c/o Mr. Glenn Norton 1625 W. Third Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K052282

Venaflo™ II Vascular Graft Venano - Frances 21 CFR 870.3450 Regulation Number: 21 CFR 8 70.3430
Regulation Name: Vascular Graft Prosthesis of Less than 6MM Diameter
S Regulatiory Class: Class II (two) Product Code: DSY Dated: August 19, 2005 Received: August 23, 2005

Dear Mr. Norton:

Deal 110.00 We have reviewed your Section 510(t) premarket notification of the indications
referenced above and have determined the device is substantially equivalent in interstate welered above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device Amendents, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendents, or to for as a more of the mastment and of the wedness of the Federal Food. Dough, the Federal Food, Drug,
devices that have been reclassified in accordance with the provisited app devices that have been reclassified in accordance with the proval application (PMA).
devices that have been reclassified in accordance approval opproval oppiocions of the Ac de cosmetic Act (Act) that do not require approval of a previsions of the Act. The Act. The
You may, therefore, market the device, subject to the general ontrols provisions and Course, market the Act include requirements for amual registration, listing of
general controls provisions of the Act include requirements for annual misbranding and s and of the Act include requirements for millian regultents for minds regional would be
devices, good manufacturing practice, labeling, and prohibitions against misbranding adulteration.

additions is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class if (special connelle)
may be subject to such additional controls. Existing major regulations affecting your device n your article of Federal Regulations, Title 21, Parts 800 to 898. In addition, PDA may
may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may
b be found in the Code of Federal Regulations, Title 21, Farls C
publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Glenn Norton

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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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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Section 1-B

Venaflo™ II Vascular Graft Special 510(k)

INDICATION(S) FOR USE STATEMENT*

I state in my capacity as Regulatory Affairs Associate Project Manage of Bard I state in my capacity as regulatery - taxion [510(k)] for the Venaflo™ II Vascular Graft is indicated for the following:

" Venaflo ™ II Vascular Grafts are indicated for use as subcutaneous arteriovenous conduits for blood access only."

Signature of 510(k) Submitter: Printed Name of Submitter:

Glenn Norton

Date:

8/19/05

*Suggested language and format to meet the requirements of sections 513(i) of the *Suggested fallguage and format to meet the required and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

X 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 OF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
510(k) Number	K052282-Division of Cardiovascular Devices
	510(k) Number K052282
Division Sign-Off
	Office of Device Evaluation

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.”