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 .

The intended use of the 10LAP4 probe, when used as a part of the Cryocare CS Surgical System, is for diagnostic ultrasound imaging or fluid flow analysis of the human body and is a subset of the uses cleared under K043278, and is documented in Section 4.3 of this submission.

Device Description

The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).

The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.

The Cryocare CS Surgical system unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures.

The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views.

Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings.

The 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows:
Frequency: 7.0 MHz

Elements: 128

Array type: Linear
Pitch (mm): 0.30
Elevation width (mm): 5.0
Geometric focus (mm): 25
Azimuth radius (mm): N/A
Azimuth length (mm): 38.4

The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.

AI/ML Overview

The provided text is a 510(k) summary for the Endocare Cryocare CS Surgical System. This document describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices. It does not present any clinical study data or acceptance criteria for a device's performance, as would be found in a study demonstrating the efficacy or safety of a new medical device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided document.

The document indicates that the device has the "same intended use" and "same operating principle and has not altered the fundamental technology" as its predicate devices (K032333 and K043278). This suggests that substantial equivalence was established primarily through comparison to existing devices rather than new clinical performance data.

Summary

{0}------------------------------------------------

Èndocare, Inc. Traditional 510(k): Cryocare CS Surgical System FEB 2 5 2005

Image: logo	endocareextending life everyday
-------------	--------------------------------------------

510(K) SUMMARY

Page ① of ②

K050347

Prepared -- December 12, 2004

TRADE NAME	Cryocare CS Surgical System
COMMON NAME	Cryosurgical unit and accessories
CLASSIFICATION	Class II (21 CFR 878.4350)
SUBMITTED BY	Endocare, Inc.201 TechnologyIrvine, CA 92618	CONTACTEben GordonRegulatory Affairs949.450.5424949.450.5300
PREDICATE DEVICE	K032333 - Endocare Cryocare CS Surgical SystemDecision date: 8/18/2003K043278 - Teratech Model 8IOC4, 8IOL4, 10LAP4 ProbeDecision date: 12/13/2004
DEVICE DESCRIPTION	The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.The Cryocare CS Surgical system unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures.The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views.Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings.The 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows:

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

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

ರ	S	いﺎ	्
	くﮐﺮ

	Frequency	7.0 MHz
	# Elements	128
	Array type	Linear
	Pitch (mm)	0.30
	Elevation width (mm)	5.0
	Geometric focus (mm)	25
	Azimuth radius (mm)	N/A
	Azimuth length (mm)	38.4
The Cryocare CS Surgical System can control up to eight, single-use, disposableCryoProbes and monitor up to eight independent TempProbes. The consoleoperates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argonand helium gas. An IBM compatible microprocessor serves as the host computeroperating in a Windows environment. CryoProbe control can also be achieved viathe remote control keypad. The CryoProbes can be operated manually or using theAutoFreeze mode, which allows users to pre-program specific prostate treatmentparameters.
INDICATIONS FORUSE	The Cryocare CS Surgical System has the same intended use as previouslycleared for the Cryocare CS Surgical System - K032333.
The Cryocare CS Surgical System is intended for use in open, minimally invasiveor endoscopic surgical procedures in the areas in general surgery, urology,gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonarysurgery and thoracic surgery. The system is designed to freeze/ablate tissue by theapplication of extreme cold temperatures including prostate and kidney tissue, livemetastases, tumors, skin lesions, and warts.The intended use of the 10LAP4 probe, when used as a part of the Cryocare CSSurgical System, is for diagnostic ultrasound imaging or fluid flow analysis of thehuman body and is a subset of the uses cleared under K043278, and is documentedin Section 4.3 of this submission.
SUMMARY OFSUBSTANTIALEQUIVALENCE	The Cryocare CS Surgical System has the following similarities to that of thepreviously cleared predicate devices:Has the same intended use; The 10LAP4 ultrasound probe is the same as Teratech's cleared underK043278 and is intended for the same clinical application; Use the same operating principle and has not altered the fundamentaltechnology; Incorporate the same CryoProbe; Incorporate the same system design; Incorporate the same patient contacting materials; Same manufacturing materials; and Packaged and sterilized using the same materials and processes.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endocare, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K050347

Trade/Device Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH, IYN, ITX Dated: February 7, 2005 Received: February 11, 2005

Dear Mr. Job:

This letter corrects our substantially equivalent letter of February 25, 2005.

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.

{3}------------------------------------------------

Page 2 - Mr. Mark Job

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.

elmall

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

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

Page ① of 2

Indications for Use Statement

510(k) Number:

K050347

Device Name:

Cryocare CS Surgical System

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X __ (Per 21 CFR 801.109)

Miriam C. Provost

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

510(k) Number K050347

{5}------------------------------------------------

050347

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

Page ② of 2

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)

PRESCRIPTION USE X X (PER 21 CFR 801.109)

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.