MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE

K021010 · Endocare, Inc. · OCL · Jun 6, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021010
• Device Name: MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
• Applicant: Endocare, Inc.
• Product Code: OCL · General, Plastic Surgery
• Decision Date: Jun 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis.

Device Story

System comprises control unit and single-use disposable cryoprobe; operates on Joule-Thompson principle to freeze target tissue; creates inflammatory response or cryonecrosis to block electrical conduction pathways. Control unit powered by 120/230 VAC; operated via console keys. Cryoprobe tip contains T-type needle thermocouple for temperature monitoring. Used in clinical cardiac surgery settings by physicians. Output provides thermal feedback to monitor system operations; assists surgeons in precise tissue ablation to treat arrhythmias.

Clinical Evidence

Bench testing only; included dimensional inspection, flex tests, endurance tests, burst pressure tests, and performance under simulated use conditions.

Technological Characteristics

Joule-Thompson cryosurgical unit; T-type needle thermocouple for temperature sensing; 120/230 VAC power; single-use disposable cryoprobes; software-controlled console.

Indications for Use

Indicated for patients undergoing minimally invasive cardiac surgery, including treatment of cardiac arrhythmias.

Regulatory Classification

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.

Predicate Devices

• Endocare Cryocare Cardiac Surgical System (K011040)

Submission Summary (Full Text)

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## Attachment 5

# endocare.

Prepared March 28, 2002 Modified Cryocare Cardiac Surgical System TRADE NAME Class II (21 CFR 878.4350) CLASSIFICATION Eben Gordon CONTACT SUBMITTED BY Endocare, Inc. 7 Studebaker Regulatory Affairs [phone] Irvine, CA 92618 K011040 - Endocare Cryocare Cardiac Surgical System. PREDICATE Decision date: 06/15/2001 DEVICE The modified Cryocare Cardiac Surgical system consists of a control unit that DEVICE operates one single use, disposable cryoprobe. The control unit is software DESCRIPTION controlled and operates off standard 120/230 VAC wall power. System control is accomplished directly through keys on the console itself. The Cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited to the freeze zone of the probe. The cryoprobe incorporates a thermocouple to measure temperature at the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor some operations of the system. The temperature probe is a standard T-type needle thermocouple. The Cryocare Cardiac Surgical System is indicated for use in minimally INDICATIONS FOR invasive cardiac surgery procedures, including surgical treatment of cardiac USE arrhythmias. The Crvocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis In-vitro performance testing of the Endocare Modified Cryocare Cardiac TESTING Surgical System included dimensional inspection, flex tests, endurance tests, burst pressure tests, performance under simulated use conditions. All testing of the product yielded acceptable results. The Endocare Modified Cryocare Cardiac Surgical System is substantially SUMMARY OF equivalent to the predicate device in intended use and principles of operation. SUBSTANTIAL EQUIVALENCE

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 201 0003

Endocare, Inc. c/o Mr. Eben Gordon Director, Regulatory Affairs 7 Studebaker Irvine, CA 92618

Re: K021010

Trade/Device Name: Modified Cryocare Cardiac Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL Dated: May 8, 2002 Received: May 10, 2002

Dear Mr. Gordon:

This letter corrects our substantially equivalent letter of June 6, 2002.

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 (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, 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 (PMA), it may be subject to 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.

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#### Page 2 - Mr. Eben Gordon

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 continue 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Elmoll

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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#### Endocare, Inc. Special 510(k): Modified Cryocare Cardiac Surgical System

# Attachment 2

## Indications for Use Statement

510(k) Number (if known):

Modified Cryocare Cardiac Surgical System Device Name:

Indications for Use: The Cryocare Cardiac Surgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Cryocare Cardiac Surgical Probes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response or cryonecrosis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block; vertical-align:middle;"> <img alt="Tick" src="tick.png" style="width:20px;height:15px;vertical-align:middle;"/> </div> | OR | Over the Counter Use |
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(Per 21 CFR 801.109)


(Division Sign-Off)
Division of General, Restorative and Neurological Devices

| 510(k) Number | K021010 | Page 44 of 50 |
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