The Cryocare Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition the system is intended: for use in the following indications:

General Surgery

Destruction of warts or lesions
Palliation of tumors of the oral cavity, rectum and skin
Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions

Urology

Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia

Gynecology

Ablation of malignant neoplasia or benign dysplasia of the female genitalia

Oncology

Ablation of cancerous or malignant tissue
Ablation of benign tumors
Palliative intervention

Neurology

Freezing of nerve tissue in pain management/cryoanalgesia

Dermatology

Ablation or freezing of skin cancers and other cutaneous disorders

Proctology

Ablation of benign or malignant growths of the anus or rectum
Ablation of hemorrhoids

Thoracic Surgery

Ablation of arrhythmic cardiac tissue
Ablation of cancerous lesions

Device Description

The Cryocare Surgical System consists of a compact, easy-to-operate console and associated accessories that include CryoProbes to deliver cold temperatures to the targeted tissue and TempProbes to monitor temperatures in the surrounding tissue.
The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert Argon gas. The console can control up to eight, single-use, disposable CryoProbes.
The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal tip of the probes. Each CryoProbe incorporates a thermocouple to monitor probe temperature. Helium gas is used after the freezing process. As the gas passes through the J-T port, there is a significant pressure drop which conversely results in an increase in the gas temperature.
The console can also monitor up to eight independent TempProbes. The TempProbes are standard T-type needle thermocouples.
An IBM-compatible microprocessor serves as the host computer. System control is accomplished through a remote control keypad.
The system can be operated manually or using the AutoFreeze option, which allows users to pre-program specific treatment parameters.

AI/ML Overview

The provided text describes a 510(k) summary for the Cryocare Surgical System. It details the device, its intended use, and indicates that "in-vitro testing" and "software validation" were performed. However, it does not provide specific acceptance criteria or the results of a study that directly proves the device meets those criteria, especially in a clinical context.

The document states:

"In-vitro testing of the Cryocare Surgical System included time and temperature performance under simulated use conditions."
"Software validation was performed in accordance with IEC 60601-1-4 and the General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)."
"All testing of the product yielded acceptable results."

This is a general statement of compliance, not a detailed report of findings against specific performance metrics. The submission is a 510(k) for a modified device, declaring substantial equivalence to a predicate device (K011074 Cryocare Surgical System), rather than a de novo submission requiring extensive new clinical performance data to establish safety and effectiveness from scratch.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from "Testing")	Reported Device Performance
Time and Temperature Performance (simulated use)	Acceptable results
Software Validation (IEC 60601-1-4 & FDA Guidance)	Acceptable results

Note: The document only states that "All testing of the product yielded acceptable results." It does not provide specific numerical targets for temperature, time, or specific metrics for software validation.

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

Sample Size: Not specified. The testing mentioned is "in-vitro testing," so it refers to bench testing rather than patient data.
Data Provenance: Not applicable in the context of human data. It refers to "simulated use conditions" in a laboratory setting. No country of origin for clinical data is mentioned as no clinical data is presented.
Retrospective/Prospective: Not applicable as it's not clinical data.

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

Not applicable. Ground truth for in-vitro testing would be based on validated measurement instruments and physical principles, not expert human assessment.

4. Adjudication method for the test set

Not applicable. This is typically for discrepancies in expert assessments in clinical studies.

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 is a medical device (cryosurgical system), not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable in the context of AI. The device has software for control ("IBM-compatible microprocessor serves as the host computer," "remote control keypad," "AutoFreeze option"), and software validation was performed, but this is for controlling the medical device's physical functions, not for diagnostic or predictive algorithms.

7. The type of ground truth used

For "time and temperature performance": Likely physical measurements and calibration against known standards.
For "software validation": Compliance with software lifecycle processes, functional requirements, and safety standards (IEC 60601-1-4) through testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable.

Summary

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DEC 0 5 2002

| 04 7

endocare.

Attachment 5

510(k) SummaryPrepared November 7, 2002
TRADE NAME	Cryocare Surgical System
CLASSIFICATION	Class II (21 CFR 878.4350)
SUBMITTED BY	Endocare, Inc.201 TechnologyIrvine, CA 92618	CONTACT	Eben GordonRegulatory Affairs949.450.5424949.450.5300
PREDICATE DEVICE	K011074 Cryocare Surgical SystemDecision date: January 25, 2002
DEVICE DESCRIPTION	The Cryocare Surgical System consists of a compact, easy-to-operateconsole and associated accessories that include CryoProbes to deliver coldtemperatures to the targeted tissue and TempProbes to monitortemperatures in the surrounding tissue.The control console operates off standard 120/230 VAC (60/50 Hz) wallpower and utilizes inert Argon gas. The console can control up to eight,single-use, disposable CryoProbes.The CryoProbes operate on the Joule-Thompson Principle and therefrigerative capacity is limited to the distal tip of the probes. EachCryoProbe incorporates a thermocouple to monitor probe temperature.Helium gas is used after the freezing process. As the gas passes throughthe J-T port, there is a significant pressure drop which conversely results inan increase in the gas temperature.The console can also monitor up to eight independent TempProbes. TheTempProbes are standard T-type needle thermocouples.An IBM-compatible microprocessor serves as the host computer. Systemcontrol is accomplished through a remote control keypad.The system can be operated manually or using the AutoFreeze option,which allows users to pre-program specific treatment parameters.

{1}------------------------------------------------

INDICATIONS FORUSE	The Cryocare Surgical System has the same intended use as previouslycleared for the Cryocare Surgical System - K011074.
	The Cryocare Surgical System is intended for use in open, minimallyinvasive or endoscopic surgical procedures in the areas in general surgery,urology, gynecology, oncology, neurology, dermatology, ENT, proctology,pulmonary surgery and thoracic surgery. The system is designed tofreeze/ablate tissue by the application of extreme cold temperaturesincluding prostate and kidney tissue, liver metastases, tumors, skin lesions,and warts.
TESTING	In-vitro testing of the Cryocare Surgical System included time and temperatureperformance under simulated use conditions. Software validation wasperformed in accordance with IEC 60601-1-4 and the General Principles ofSoftware Validation; Final Guidance for Industry and FDA Staff (January 11,2002).All testing of the product yielded acceptable results.
SUMMARY OFSUBSTANTIALEQUIVALENCE	The modified Cryocare Surgical System is substantially equivalent to thepredicate device in intended use and principles of operation.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endocare, Inc. c/o Mr. Eben Gordon Senior Director of Regulatory Affairs 201 Technology Drive Irvine, CA 92618

Re: K023757

Trade/Device Name: Cryocare Surgical System, Model Cryo 20 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II (two) Product Code: OCL, GEH Dated: November 7, 2002 Received: November 8, 2002

Dear Mr. Gordon:

This letter corrects our substantially equivalent letter of December 05, 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 yours,

Edgmee

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): Crvocare Surgical System

Attachment 2

Indications for Use Statement

510(k) Number:

K 023757

Device Name: Cryocare Surgical System

Indications for Use:

General Surgery

· Destruction of warts or lesions
· Palliation of tumors of the oral cavity, rectum and skin
· Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Millican

Prescription Use ________(Per 21 CFR 801.109)

Division of neral, Restorative and Neurol . ical Devices

510(k) Number

Page 74 of 80

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

Indications for Use Statement (Continued)

Urology

· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia

Gynecology

Ablation of malignant neoplasia or benign dysplasia of the female genitalia

Oncology

Ablation of cancerous or malignant tissue
· Ablation of benign tumors
· Palliative intervention

Neurology

· Freezing of nerve tissue in pain management/cryoanalgesia

Dermatology

· Ablation or freezing of skin cancers and other cutaneous disorders

Proctology

· Ablation of benign or malignant growths of the anus or rectum
· Ablation of hemorrhoids

Thoracic Surgery

· Ablation of arrhythmic cardiac tissue
Ablation of cancerous lesions

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Melburn
(Divisio (gn-Off)
Divisio General Restorati

Prescription Use _______ (Per 21 CFR 801.109)

510(k) Number K023751

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.