CRYOCARE CS SURGICAL SYSTEM

K060279 · Endocare, Inc. · GEH · Feb 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060279
• Device Name: CRYOCARE CS SURGICAL SYSTEM
• Applicant: Endocare, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Feb 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 Story

Cryocare CS Surgical System is a console-based cryosurgical unit for tissue ablation. System utilizes inert argon gas for freezing (Joule-Thompson principle) and helium gas for thawing. Console connects to up to eight single-use disposable CryoProbes and eight T-type thermocouple TempProbes for real-time tissue temperature monitoring. Operated by physicians in clinical/surgical settings. Features 19-inch LCD display, video printer, and data storage. Supports manual operation or 'AutoFreeze' mode for pre-programmed prostate treatment parameters. Host computer runs in Windows environment. Provides visual feedback of temperature data to clinicians to guide ablation procedures, enabling precise destruction of targeted malignant or benign tissues while sparing surrounding structures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and compliance with ASTM F 882-82 (reapproved 2002) standard for cryosurgical medical instruments.

Technological Characteristics

Console-based cryosurgical unit; utilizes argon/helium gas for Joule-Thompson cooling/thawing. Includes 19" LCD, alphanumeric/remote keypads, CD-R/W drive. Disposable CryoProbes with integrated thermocouples; T-type thermocouple TempProbes. Power: 120/230 VAC. Software: Windows-based host computer. Complies with ASTM F 882-82 (reapproved 2002).

Indications for Use

Indicated for patients requiring tissue ablation or freezing across general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, and thoracic surgery. Includes treatment of prostate cancer, BPH, skin lesions, warts, tumors, and nerve tissue for pain management. No specific contraindications.

Regulatory Classification

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.

Predicate Devices

• Cryocare CSTM (K050347)

Submission Summary (Full Text)

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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:

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

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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.

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.

### • Indications for Use Statement:

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

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

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## 4060279

- · 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.].
- 2. 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.
- 3. 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
- 4. 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 [phone]. 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 [phone] or [phone] 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_