The Cryocare CS 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 tumors, 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 V-probe is a CRYOprobe accessory to be used in conjunction with the CRYOcare CS Surgical System. The indications for use have not changed. The V-Probe delivers cold temperatures via Argon gas utilizing the Joules Thompson principle to targeted tissue. The patient contact V-Probe (an accessory item to the CRYOcare CRYOsurgical CS System) is supplied as a single use Sterile Disposable item.

AI/ML Overview

The provided document is a 510(k) summary for the Endocare Cryocare CS Surgical System. This type of regulatory submission establishes substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a de-novo study.

Therefore, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or the details of such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance data).

The "SUMMARY OF SUBSTANTIAL EQUIVALENCE" section explicitly states that the device is considered substantially equivalent to predicate devices due to similarities such as:

Same intended use
Same operating principle
Same system design
Same patient contacting materials
Same manufacturing materials
Same packaging and sterilization processes

Since the device is claiming substantial equivalence, a detailed performance study as outlined in your request is typically not required unless there are significant changes that raise new questions of safety and effectiveness.

In summary, the information requested in your prompt is not available in the provided 510(k) summary.

Summary

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K1013333

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510(k) Summary

Prepared – December 12, 2004

JUN 1 4 2010

TRADE NAME	Cryocare CS Surgical System
COMMON NAME	Cryosurgical unit and accessories
CLASSIFICATION	Class II (21 CFR 878.4350)
SUBMITTED BY	Endocare, Inc. as wholly own subsidiary of Healthtronics, Inc.9825 Spectrum DriveBuilding 2Austin, TX 78717Contact: Cheryl Blake949-285-3517e-mail: cheryl.blake@cox.net
PREDICATEDEVICE	K060279 - Endocare Cryocare CS Surgical SystemDecision date: February 26, 2006
DEVICEDESCRIPTION	The CRYOcare V-probe is a CRYOprobe accessory to beused in conjunction with the CRYOcare CS Surgical System.The indications for use have not changed. The V-Probedelivers cold temperatures via Argon gas utilizing the JoulesThompson principle to targeted tissue. The patient contact V-Probe (an accessory item to the CRYOcare CRYOsurgical CSSystem) is supplied as a single use Sterile Disposable item.

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INDICATIONS FOR USE

The CRYOcare CS Surgical System has the same intended use as previously cleared for the Cryocare CS Surgical System - K060279 Decision Date February 28, 2006.

The Cryocare CS Surgical system has the same intended use as previously cleared. The CRYOsurgical CS Surgical System and accessories 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 tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cvsts, 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

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	DermatologyAblation or freezing of skin cancers and othercutaneous disorders ProctologyAblation of benign or malignant growths of the anus orrectumAblation of hemorrhoids Thoracic surgeryAblation of arrhythmic cardiac tissueAblation of cancerous lesions
SUMMARY OFSUBSTANTIALEQUIVALENCE	The Cryocare CS Surgical System has the followingsimilarities to that of the previously cleared predicate devices:Has the same intended use; The 10LAP4 ultrasound probe is the same asTeratech's cleared under K043278and is intended forthe same clinical application; Uses the same operating principle and has not alteredthe fundamental technology; Incorporates the same system design; Incorporates the same patient contacting materials; Same manufacturing materials; and Packaged and sterilized using the same materials andprocesses. In summary, the modified Cryocare CS Surgical Systemdescribed in this submission is substantially equivalent to thepredicate devices.

DermatologyAblation or freezing of skin cancers and othercutaneous disorders ProctologyAblation of benign or malignant growths of the anus orrectumAblation of hemorrhoids Thoracic surgeryAblation of arrhythmic cardiac tissueAblation of cancerous lesions

SUMMARY OFSUBSTANTIALEQUIVALENCE

The Cryocare CS Surgical System has the followingsimilarities to that of the previously cleared predicate devices:Has the same intended use; The 10LAP4 ultrasound probe is the same asTeratech's cleared under K043278and is intended forthe same clinical application; Uses the same operating principle and has not alteredthe fundamental technology; Incorporates the same system design; Incorporates the same patient contacting materials; Same manufacturing materials; and Packaged and sterilized using the same materials andprocesses. In summary, the modified Cryocare CS Surgical Systemdescribed in this submission is substantially equivalent to thepredicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 4 2010

Endocare. Inc. % Underwriters Laboratories, Inc. Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062

Re: K101333

Trade/Device Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cyrosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 29, 2010 Received: June 02, 2010

Dear Mr. Devine:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Mr. Ned Devine

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A Milkersan

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

K101333

Cryocare CS Surgical System Device Name:

Indications for Use:

In addition, the system is intended for use in the following indications:

General Surgery

Destruction of warts or lesions t
Palliation of tumors of the oral cavity, rectum and skin 0
Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal � cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, 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)

Prescription Use _ (Per 21 CFR 801.109) ×

Michael P. Allen for mam
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101333

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Indications for Use Statement (Continued)

Urology

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

Gynecology

o Ablation of malignant neoplasia or benign dysplasia of the female genitalia

Oncology

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

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 .
t Ablation of hemorrhoids

Thoracic Surgery

Ablation of arrhythmic cardiac tissue t
Ablation of cancerous lesions a

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Prescription Use 510(k) Number ...

PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(k))

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.