The Fogarty® Valvulotome is intended to be used in the disruption of venous valves.
The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.

Device Description

The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a cutting blade at the distal tip and a handle at the proximal end. The mode of operation for both devices is the same. The device is inserted into the vessel in an antegrade direction until the blade is located above the cusp of a venous valve. The location of the valve is visualized via an angioscope or is directly visualized through the vein wall in an open procedure. The blade is withdrawn retrograde through the cusp, thereby rendering it incompetent. After the blade disrupts one cusp, it is then rotated 180° to disrupt the adjoining cusp segment.
The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure.
The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm.
A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop.
The blade is on the modified Fogarty® Valvulotome is retractable whereas the blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability.
The material used for the shaft and handle have been changed; the modified materials have been determined to be biocompatible.
The handle now includes a control button for extension and retraction of the blade and guidewire.

AI/ML Overview

The provided text is a 510(k) summary for the Fogarty® Valvulotome, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and non-clinical testing. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study details you've outlined for AI/standalone device performance.

This document predates modern AI-powered medical devices and thus does not discuss AI performance, ground truth establishment for large datasets, or MRMC studies in the context you're asking about. The "acceptance criteria" discussed are primarily related to safety, biocompatibility, and functional performance, rather than diagnostic accuracy metrics.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Found to be biocompatible and nontoxic, acceptable for intended use (per ISO 10993-1-1994 and FDA G95-1).
Functional/Bench Testing	Demonstrated to meet performance requirements for intended use.
Clinical Evaluation	Capable of disrupting venous valves during in situ saphenous vein grafting procedures.
Safety and Effectiveness	Safe and effective for its intended use (based on biocompatibility, functional, and clinical testing).

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

Test set sample size: Not explicitly stated for any of the tests.
Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by Baxter (the manufacturer). The clinical evaluation mentions in situ saphenous vein grafting procedures, implying human use, but no details on the patient cohort or study design are provided in this summary.
Retrospective/Prospective: Not explicitly stated. The clinical evaluation would typically be prospective, but the details are missing.

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

Not applicable/Not provided in this document. The "ground truth" here relates to successful valve disruption, biocompatibility, and functional performance, which are assessed through engineering tests and clinical observations rather than expert image interpretation.

4. Adjudication method for the test set

Not applicable/Not provided in this document. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on diagnostic imaging, which is not the subject of this 510(k). Decisions would have been made by the testing teams based on the test results.

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 device is a manual surgical instrument (valvulotome), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

No. This device is a physical instrument requiring human operation, not an algorithm.

7. The type of ground truth used

Biocompatibility testing: Ground truth was established by adherence to ISO 10993-1-1994 and FDA G95-1 guidelines, with results demonstrating non-toxicity and biocompatibility.
Functional/Bench testing: Ground truth was based on the device meeting its predefined "performance requirements" (details of which are not specified in the summary, e.g., cutting efficacy, blade retraction reliably, shaft flexibility, irrigation flow).
Clinical evaluation: Ground truth was the observation that the product was "capable of disrupting venous valves during in situ saphenous vein grafting procedures." This implies direct observation of the device's effect during surgery.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. As above, no training set for an algorithm is involved.

Summary

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Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome

K96513)

JUN - 4 1997

510(k) Summary

A. Determination of Substantial Equivalence

The Fogarty® Valvulotome is substantially equivalent to the Intramed® Valvulotome, which was cleared for marketing under premarket notification K925283.

B. Device Name

Fogarty Valvulotome, Model 700091

C. Predicate Device

The claim of substantial equivalence is based on the following device:

Intramed® Valvulotome, 510(k) No. K925283 .

D. Device Description

The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure.

The predicate valvulotome was available in two sizes, 3.8 mm or 4.6 mm, with a shaft length of 90 cm. The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm.

A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop.

Other modifications to the device that have occurred since FDA clearance of the original valvulotome (Intramed Valvulotome, K925283) are also included in this submission and include:

The blade is on the modified Fogarty® Valvulotome is retractable whereas the . blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability.

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Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome

The material used for the shaft and handle have been changed; the modified . materials have been determined to be biocompatible.
. The handle now includes a control button for extension and retraction of the blade and guidewire.

E. Intended Use of Device

The Fogarty® Valvulotome, like the predicate device, is intended to be used in the disruption of venous valves.

F. Intended Use of Predicate Device

The Intramed® Valvulotome is intended to be used in the disruption of venous valves.

G. Technological Comparison of the Fogarty Valvulotome and the Predicate Device

The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a stainless steel cutting blade at the distal tip and a handle at the proximal end. Both contain an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure. The mode of operation for both devices is the same as is the intended use. Therefore, the technological characteristics of Fogarty Valvulotome are equivalent to those of the Intramed® Valvulotome.

H. Discussion of Non-Clinical Tests, Clinical Evaluations and Conclusions

The following non-clinical testing was performed on the Fogarty® Valvulotome:

biocompatibility testing and .
functional/bench testing. �

Biocompatibility testing was performed on valvulotome samples in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The valvulotome was found to be biocompatible and nontoxic and acceptable for its intended use.

Functional testing was performed on the Fogarty® Valvulotome to evaluate the integrity and performance of the device. The testing demonstrated that the product meets its performance requirements for its intended use.

In addition. Baxter conducted a clinical evaluation of the Fogarty® Valvulotome which demonstrated that the product is capable of disrupting venous valves during in situ saphenous vein grafting procedures.

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Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome

Summary of Safety and Effectiveness i.

The above testing demonstrates that the Fogarty® Valvulotome is safe and effective for its intended use.

Patricia K. Garvey

Patricia L. Garvey, Ph.D. Director, Regulatory Affairs and Clinical Studies CardioVascular Group

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol. The bird figure is stylized with flowing lines, giving it a sense of movement.

11 2011 - 31

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 1997

Ms. Paula A. Torrianni Senior Clinical Affairs Spēcialist Baxter Healthcare Corporation 17221 Red Hill Avenue P.O. Box 11150 Santa Ana, California 92711-1150

K965137 Re: Baxter Fogarty® Valvulotome Requlatory Class: II (two) Product Code: MGZ Dated: April 4, 1997 Received: April 7, 1997

Dear Ms. Torrianni:

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 (for the indications for use stated in the enclosure) to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 620) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions.

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requlatory 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.

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) 594-4648. 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 motification" (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 at (301) 443-6597.

Sincerely yours,

Thomas J. Collechon

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 of

510(k) Number (if known): K965/37

Device Name: Baxter Fogarty® Valvulot

Indications For Use

Food and Drug Administration 510(k) Notification for the Fogarty® Valvulotome December 20, 1996 Page iii # Indications for Use

510(k) Notification for the Baxter Fogarty® Valvulotome Reference:

The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette L. Cooperle

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use_X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4885 External vein stripper.

(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).