The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory to the Cook Vascular PERFECTA™ Electrosurgical Dissection System. The intended use of the Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is to add the option of continuous or intermittent activation to the Electrosurgical Dissection System when the footswitch is depressed. The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is supplied nonsterile and is reusable.

Device Description

The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory that can be used with the Cook Vascular PERFECTA™ Electrosurgical Dissection System. This device adds the option to automatically activate the Valley(ab Force FX electrosurgical generator at a predetermined rate when the footswitch is depressed.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the "Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set), and effect sizes of AI assistance cannot be extracted from this document.

The document states:

Substantial Equivalence: "This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency."
Predicate Device: ArthroCare Timer (510(k) DC# K021519).

The basis for clearance is demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device. This typically involves non-clinical performance data (e.g., electrical safety, EMC, biocompatibility) and comparison to the predicate, rather than a clinical study with acceptance criteria and a detailed statistical analysis of performance metrics.

Summary

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OCT 1 5 2003

510 (k) Premarket Notification Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch 7 of 8

510(k) SUMMARY H.

K032223 (pg 1 of 2)

Submitted Bv:

Thomas J. Kardos Vice President, Requlatory Affairs Cook Vascular Incorporated P.O. Box 529 Leechburg, PA 15656 Phone 724-845-8621 FAX 724-845-2848 May 23, 2003

Device: Trade Name:

Common/Usual Name:

Proposed Classification Name:

Cook Vascular PERFECTA™ Electrosurgical Dissection System Ergonomic Intermittent Activation Switch

Electrosurgical Device and Accessories

Electrosurgical Cutting and Coaqulation Device and Accessories 21 CFR Part 878.4400

Device Description:

Indications for Use:

The Cook Vascular PERFECTA™ EDS Erqonomic Intermittent Activation Switch is an accessory to the Cook Vascular PERFECTA™ Electrosurgical Dissection System. The intended use of the Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is to add the option of continuous or intermittent activation to the Electrosurgical Dissection System when the footswitch is depressed. The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is supplied nonsterile and is reusable.

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510 (k) Premarket Notification Cook Vascular SERPENTA™ Coronary Sinus Introducer System

Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Vascular Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.

Predicate Devices:

The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch has similar indications for use and similar technological characteristics as a predicate ArthroCare Timer. The predicate device is as follows:

Predicate Device	Manufacturer	510(k)
Timer	ArthroCare	DC# K021519

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas J. Kardos Vice President, Regulatory Affairs Cook Vascular Incorporated Rt. 66. River Road P.O. Box 529 Leechburg, PA 15656

Re: K032223

Trade/Device Name: PERFECTA™EDS Ergonomic Intermittent Activation Switch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 18, 2003 Received: July 22, 2003

Dear Mr. Kardos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 – Mr. Thomas J. Kardos

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) 594-4659. 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,

Mark N. Milbersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative 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):

Device Name: PERFECTA™ EDS Ergonomic Intermittent Activation Switch Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkeron
for

I. Rerative

510(k) Number_

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Perscription Use
(Per 21 CFR 801.109) X

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.