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, 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 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 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.

Associated accessories include the following:

I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures.

Helium gas is used after the freezing process to thaw tissue. 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 patient contact CryoProbe (an accessory item to the Cryocare System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare System.

2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples.
3.) A warming system for use in urological applications.

AI/ML Overview

The provided text describes the Cryocare CS Surgical System, a cryosurgical unit designed to ablate tissue using extreme cold temperatures. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria and performance metrics.

Here's a breakdown based on the provided information, noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) is a submission for substantial equivalence, which means it compares the new device to a legally marketed predicate device rather than establishing new performance criteria or conducting a clinical trial that measures device performance against predefined acceptance criteria.

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

This information is not provided. As no new clinical study (with a "test set" of patients or cases) was conducted for this 510(k) submission to demonstrate performance, there is no sample size or data provenance to report. The submission relies on the established safety and effectiveness of the predicate device.

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

This information is not provided. Since no new clinical study requiring ground truth establishment was conducted, there are no experts or qualifications to specify.

4. Adjudication Method for the Test Set

This information is not provided. As no new clinical study was conducted, there was no test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with or without AI assistance, or assessing human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/not provided. The Cryocare CS Surgical System is a physical medical device (cryosurgical unit), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

This information is not applicable. Since no new clinical performance study was conducted to generate specific performance data requiring ground truth, there is no type of ground truth to report for this 510(k) submission. The basis for safety and effectiveness is through comparison to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. As the Cryocare CS Surgical System is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.

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

This information is not applicable/not provided. For the same reasons as above, there is no training set or ground truth establishment method to describe for this device.

Summary of the Study (Basis for Substantial Equivalence):

The "study" in this context is the submission of information to the FDA to demonstrate substantial equivalence to a previously cleared predicate device, the Cryocare CST Surgical System (K050347) marketed by Endocare, Inc.

The rationale for substantial equivalence is based on the following claims:

Similarity of Design: The Cryocare CS Surgical System patient interface accessory CryoProbe and Cryo-Hose design are "very similar" to the predicate device.
Identical Intended Uses and Operating Principles: The new device shares the exact same intended uses and operating principles (effectiveness) as the predicate device.
Identical Operational and Safety Features: The new device's operational features and safety features are the same as those offered by the predicate device.
Compliance with Standards: The Cryocare CS Surgical System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-82 (reapproved 2002)].

Conclusion of the Submission:

The submission concludes that the data demonstrates the CryoProbe and Cryo-Hose accessory items are substantially equivalent with respect to indications for use, operating principles, operational features, and safety features. No new issues of safety, effectiveness, or performance were identified compared to the predicate device. This led to the FDA's "Substantial Equivalence" decision.

Summary

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Cryocare Surgical System

510(k) SPECIAL PREMARKET NOTIFICATION SUMMARY

• Device Trade or Proprietary Name: Cryocare CS Surgical System · Common / Classification Name: Impedance Cryosurgical unit and accessories · Class: Class II Regulation Number: . 878.4350

Product Code: GEH
· Labeling:

Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional.

· Predicate Device for Substantial Equivalence Comparison:

The Cryocare CS Surgical System CryoProbe accessory is claimed to be substantially equivalent to the following currently marketed Predicate Device and currently being marketed by Endocare:

Manufacturer	Device Name	510-K Number	Decision Date
Endocare, Inc.	Cryocare CSTM	K050347	February 05, 2005

· Device Description:

Associated accessories include the following:

I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate

KO60279

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on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures.

2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples.
3.) A warming system for use in urological applications.

• Indications for Use Statement:

The Cryocare CS Surgical System has the same intended use as previously cleared for the Cryocare CS Surgical System - K050347

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

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· 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
Contraindications for Use ●
- There are no specific contraindications for the use of this device. .
· Rationale for Substantial Equivalence
- 1. The Cryocare CS Surgical System patient interface accessory CryoProbe and Cryo-Hose design is very similar to the predicate device [Cryocare CS Surgical System accessory item already approved by the FDA and currently being marketed by Endocare, Inc.].
- 1. The INTENDED USES and the OPERATING PRINCIPLES (i.e. Effectiveness) of the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are the SAME as the predicate device.
- 1. The OPERATIONAL FEATURES of the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are the SAME to those offered by the predicate device
- 1. The SAFETY FEATURES of the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are the SAME to those offered by the predicate device.

Therefore, in summary, the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are substantially equivalent to the identified predicate device accessory items that have previously been allowed for commercial distribution in the United States.

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• Safety and Effectiveness

The Cryocare CS Surgical System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-82 (reapproved 2002)] which reasonably assures the device is safe when used as directed for its prescribed intended use.

The Cryocare CS Surgical System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device,

· Conclusions

The data submitted in this 510(k) Premarket Notification, for the Cryocare CS Surgical System demonstrates that this CryoProbe and Cryo-Hose accessory item is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to the identified legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the 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 representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endocare, Inc. c/o Mr. Alden Kay Senior Director, Quality and Regulatory 201 Technology Drive Irvine, CA 92618

Re: K060279

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 Dated: January 27, 2006 Received: February 2, 2006

Dear Mr. Kay:

This letter corrects our substantially equivalent letter of February 28, 2006.

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. Alden Kay

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

elgmall

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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Indications for use

Indications for Use Statement

Device Name: Cryocare CS Surgical System

Indications for Use:

The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic The Cryoure Do builgion in the areas in general surgery, urology, oncology, neurology, surgiour procedures proctology, pulmonary surgery and thoracic surgery. The system is designed definatology; ENT', provices }) Firstion 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, nerianal 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)

510(k) Number: K0 60279

el.gm@l

Division of General, Restorative, and Neurological Devices

KO60279 510(k) Number_

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.