CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20

K023757 · Endocare, Inc. · GEH · Dec 5, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023757
• Device Name: CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
• Applicant: Endocare, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Dec 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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 Surgical System is a console-based cryosurgical unit for tissue ablation. System uses inert Argon gas to deliver extreme cold to targeted tissue via disposable CryoProbes operating on the Joule-Thompson principle; Helium gas is used for warming. Console monitors up to eight CryoProbes and eight independent T-type needle thermocouples (TempProbes) for real-time temperature feedback. Operated by physicians in clinical settings; system features manual control or an 'AutoFreeze' mode for pre-programmed treatment parameters. IBM-compatible microprocessor manages system control via remote keypad. Output allows clinicians to visualize and monitor tissue freezing/thawing cycles, enabling precise ablation of tumors, prostate tissue, and other lesions. Benefits include minimally invasive tissue destruction and controlled cryoanalgesia.

Clinical Evidence

Bench testing only. Included in-vitro time and temperature performance testing under simulated use conditions. Software validation performed per IEC 60601-1-4 and FDA guidance.

Technological Characteristics

Console-based cryosurgical unit; utilizes inert Argon (freezing) and Helium (warming) gases. Joule-Thompson principle for cooling at distal probe tips. T-type needle thermocouples for temperature monitoring. IBM-compatible microprocessor control. System supports up to eight disposable CryoProbes and eight TempProbes. Software validation per IEC 60601-1-4.

Indications for Use

Indicated for patients requiring tissue ablation or freezing in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Specific conditions include prostate cancer, BPH, tumors, skin lesions, warts, hemorrhoids, and arrhythmic cardiac tissue.

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 Surgical System (K011074)

Submission Summary (Full Text)

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DEC 0 5 2002

| 04 7

endocare.

# Attachment 5

| 510(k) Summary<br>Prepared November 7, 2002 | | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------------------------------------------------|
| TRADE NAME | Cryocare Surgical System | | |
| CLASSIFICATION | Class II (21 CFR 878.4350) | | |
| SUBMITTED BY | Endocare, Inc.<br>201 Technology<br>Irvine, CA 92618 | CONTACT | Eben Gordon<br>Regulatory Affairs<br>949.450.5424<br>949.450.5300 |
| PREDICATE DEVICE | K011074 Cryocare Surgical System<br>Decision date: January 25, 2002 | | |
| DEVICE DESCRIPTION | The Cryocare Surgical System consists of a compact, easy-to-operate<br>console and associated accessories that include CryoProbes to deliver cold<br>temperatures to the targeted tissue and TempProbes to monitor<br>temperatures in the surrounding tissue.<br>The control console operates off standard 120/230 VAC (60/50 Hz) wall<br>power and utilizes inert Argon gas. The console can control up to eight,<br>single-use, disposable CryoProbes.<br>The CryoProbes operate on the Joule-Thompson Principle and the<br>refrigerative capacity is limited to the distal tip of the probes. Each<br>CryoProbe incorporates a thermocouple to monitor probe temperature.<br>Helium gas is used after the freezing process. As the gas passes through<br>the J-T port, there is a significant pressure drop which conversely results in<br>an increase in the gas temperature.<br>The console can also monitor up to eight independent TempProbes. The<br>TempProbes are standard T-type needle thermocouples.<br>An IBM-compatible microprocessor serves as the host computer. System<br>control is accomplished through a remote control keypad.<br>The system can be operated manually or using the AutoFreeze option,<br>which allows users to pre-program specific treatment parameters. | | |

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| INDICATIONS FOR<br>USE | The Cryocare Surgical System has the same intended use as previously<br>cleared for the Cryocare Surgical System - K011074. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cryocare Surgical System is intended for use in open, minimally<br>invasive or endoscopic surgical procedures in the areas in general surgery,<br>urology, gynecology, oncology, neurology, dermatology, ENT, proctology,<br>pulmonary surgery and thoracic surgery. The system is designed to<br>freeze/ablate tissue by the application of extreme cold temperatures<br>including prostate and kidney tissue, liver metastases, tumors, skin lesions,<br>and warts. |
| TESTING | In-vitro testing of the Cryocare Surgical System included time and temperature<br>performance under simulated use conditions. Software validation was<br>performed in accordance with IEC 60601-1-4 and the General Principles of<br>Software Validation; Final Guidance for Industry and FDA Staff (January 11,<br>2002).<br>All testing of the product yielded acceptable results. |
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The modified Cryocare Surgical System is substantially equivalent to the<br>predicate 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 [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,

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:

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

# 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