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 Description

The modified Cryocare Cardiac Surgical system consists of a control unit that operates one single use, disposable cryoprobe. The control unit is software 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.

AI/ML Overview

The provided text describes a submission for a Modified Cryocare Cardiac Surgical System, which is a Class II device. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, expert qualifications, MRMC studies, and detailed ground truth methods for clinical performance) is not present in the provided documentation, as these are typically features of more rigorous clinical trials (e.g., for PMA applications) or detailed performance studies that go beyond demonstrating substantial equivalence based on in-vitro testing and intended use.

However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Dimensional Inspection	Yielded acceptable results
Flex Tests	Yielded acceptable results
Endurance Tests	Yielded acceptable results
Burst Pressure Tests	Yielded acceptable results
Performance under Simulated Use Conditions	Yielded acceptable results

Note: The document states "All testing of the product yielded acceptable results" without providing specific quantitative targets or results for each test. This is typical for a 510(k) summary focusing on substantial equivalence.

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

Sample Size for Test Set: Not specified. The document only mentions "In-vitro performance testing."
Data Provenance: The testing appears to be internal "in-vitro performance testing" conducted by Endocare, Inc. The country of origin is not specified but presumed to be where Endocare, Inc. is located (Irvine, CA, USA). The testing is not described as retrospective or prospective clinical data but rather as laboratory/bench testing.

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

Not applicable. The testing described is "in-vitro performance testing" rather than a clinical study requiring expert-established ground truth for diagnostic accuracy or similar clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As described above, this was "in-vitro performance testing," not a clinical study involving human judgment that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a cryosurgical system, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study. There is no mention of AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a medical instrument (Cryocare Cardiac Surgical System) and not an AI algorithm.

7. The Type of Ground Truth Used

For the in-vitro performance tests, the "ground truth" would be engineering specifications, physical measurements, and pass/fail criteria for the various mechanical and functional tests (dimensional, flex, endurance, burst pressure, simulated use). The document does not detail these specific criteria.

8. The Sample Size for the Training Set

Not applicable in the context of the described testing. This is a physical medical device, and the testing outlined is in-vitro performance testing, not a machine learning model's training. While the device is "software controlled," the document refers to "in-vitro performance testing" of the physical system, not the software's learning phase.

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

Not applicable, for the same reasons as #8.

Summary

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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 (949) 595 5424 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 (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 (240) 276-3150 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR	Over the Counter Use
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(Per 21 CFR 801.109)

Signature

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

510(k) Number	K021010	Page 44 of 50
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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.