The Dynaflo bypass graft has a pre-formed cuff at the distal end to promote good hemodynamic performance at the distal anastomosis. Dynaflo grafts are available in various lengths and diameters, with and without external support.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Dynaflo Bypass Graft. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving a device meets those criteria in a typical sense for AI/software-as-a-medical-device (SaMD).

Instead, the "acceptance criteria" here are compliance with recognized standards and guidance documents for vascular prostheses, and the "study" is a series of non-clinical performance tests.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Guidance/Standard/Protocol)	Reported Device Performance
FDA Guidance Document for Vascular Prosthesis 510(k) Submissions, 11/01/2000	Conformance was met.
ANSI/AAMI VP20-1994, Cardiovascular Implants Vascular Prosthesis	Evaluated based on this standard.
ANSI/AAMI/ISO 7198: 1998/2001, Cardiovascular implants - Tubular vascular implants	Evaluated based on this standard.
AAMI/ANSI/ISO 10993-1: 1997, Biological evaluation of medical devices -- Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile	Evaluated based on this standard.
AAMI/ANSI/ISO 10993-7: 1995, Biological evaluation of medical devices -- Part 1: Ethylene Oxide Sterilization Residuals	Evaluated based on this standard.
AAMI/ANSI/ISO 11135:1994, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization	Evaluated based on this standard.
Predetermined performance criteria of design verification (as specified by applicable standards, guidance's, test protocols, and/or customer inputs)	"All test results confirm the modified device to be substantially equivalent to the predicate device." "Dynaflo Bypass Grafts met all the predetermined performance criteria of design verification."

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

This document does not specify a "test set" in the context of data for an AI/SaMD. The evaluation for the Dynaflo Bypass Graft was based on non-clinical performance data (e.g., mechanical tests, biocompatibility tests), not a data set of patient images or outcomes.

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

Not applicable. This device is a physical medical device (vascular graft), not an AI/SaMD that requires expert ground truth labeling of data.

4. Adjudication Method for the Test Set

Not applicable.

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 device, not an AI system.

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

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

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

The "ground truth" for this medical device's performance would be derived from:

Compliance with established engineering and biocompatibility standards: This includes physical and mechanical properties, material safety, and sterilization effectiveness.
Comparison to the predicate device: The fundamental "ground truth" for a 510(k) is that the new device performs as safely and effectively as a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical device undergoing a 510(k) submission, not an AI model requiring a training set of data.

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

Not applicable.

Summary

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JAN 3 1 2005

Dynaflo Bypass Graft 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).

General Information:

Submitter Name:	Bard Peripheral Vascular, Inc. (BPV)[Wholly owned Subsidiary of C. R. Bard, 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:	January 7, 2005

Device Information:

Device Trade Name:	Dynaflo™ Bypass Graft
Common/Usual Name:	Peripheral Vascular Bypass 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 Distaflo™ Bypass Graft, K983861, concurrence date 11/24/1998.

Summary of Change:

The modification to the Distaflo Bypass Graft incorporates a more smoothly contoured distal cuff to enhance the good blood flow performance of the predicate design, for improved hemodynamics at the distal anastomosis. The change increases the flow potential of the graft for larger anastomotic sites, such as found with a femoropopliteal above-the-knee bypass, and extra-anatomic bypass procedures (e.g., axillofemoral, femoral, and axillobifemoral). All other aspects of the modified device remain the same as the predicate.

Device Description:

Intended Use of Device:

Dynaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.

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Dynaflo Bypass Graft Special 510(k)

52

Technological Comparison to Predicate Device:

KOSO0-19 p.2012

The technological characteristics of Dynaflo bypass grafts are substantially equivalent to those of the predicate Distaflo bypass graft in terms of intended use, application, 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 recognized 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 -- Par1 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:

Dynaflo Bypass Grafts met all the predetermined performance criteria of design verification as specified by applicable standards, guidance's, test protocols and/or customer inputs. Dynaffo Bypass Grafts are substantially equivalent to the legally marketed predicate device, the IMPRA Distaflo Bypass Graft, K983861, concurrence date 11/24/1998.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

JAN 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Peripheral Vascular, Inc. c/o Mr. Glenn Norton Assistant Project Manager 1625 W. 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K050049

Bard® Dynaflo™ Bypass Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: January 7, 2005 Received: January 10, 2005

Dear Mr. Norton:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) premained insubstantially equivalent (for the indications for use stated in the enclosure) the acresed predicate devices marketed in interstate for use stated in the encrosule) to regally manation in the Medical Device Amendments, or to commerce prior to May 28, 1776, the enastinent assist of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMAN devices that have been reclassified in accordance was a premarket approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approval or and Cosmelle Act (Act) that do not require appear al controls provisions of the Act. The You may, therefore, market the devices, belyer of the set include registration, listing of general controls provisions of the rice 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 If your device is classified (see aboro) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I same 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 (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 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 (301) 594-4648. 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/dsma/dsmamain.html

Sincerely yours,

Dring R. Valines

Image /page/3/Picture/6 description: The image shows a signature. The signature is illegible and appears to be written in cursive. The signature is composed of a series of loops and curves, and it is difficult to discern any individual letters or characters.

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

Dynaflo™ Bypass Graft Special 510(k)

INDICATION(S) FOR USE STATEMENT*

I state in my capacity as Regulatory Affairs Assistant Project Manager of Bard Peripheral Vascular, Inc., that this notification [510(k)] for the Dynaflo™ Bypass Graft is indicated for the following:

"Dynaflo™ Bypass Grafts are intended for bypass or reconstruction of peripheral arterial blood vessels."

Signature of 510(k) Submitter:

Printed Name of Submitter:

Glenn Norton

Date:

1/7/05

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

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)

510(k) Number

KOSO049

Division Sign-Off

Dullar G becauses

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.”