ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM

K980110 · Endocare, Inc. · GEH · Apr 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980110
• Device Name: ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
• Applicant: Endocare, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Apr 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy 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: Urology - Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia . Oncology - . Ablation of cancerous or malignant lissue - Ablation of benign tumors . - . Palliative intervention Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders . Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia . 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 arca, 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 Thoracic Surgery - Ablation of arrhythmic cardiac tissue . - Ablation of cancerous lesions . Prociology - Ablation of benign or malignant growths of the anus or rectum ● - Ablation of hemorrhoids ●

Device Story

Cryosurgical system console controls 1-8 disposable CRYOprobes; monitors temperatures via T-type needle thermocouples. Operates on 110 VAC power. Used in clinical settings by physicians to destroy targeted tissue (prostate, kidney, liver, skin, etc.) via extreme cold application. System provides real-time temperature monitoring to guide cryoablation; enables precise tissue destruction for oncology, urology, and general surgery applications. Benefits include minimally invasive tissue ablation and palliative tumor management.

Clinical Evidence

No clinical data provided; bench testing only. Sterilization validation performed per AAMI guidelines for industrial ethylene oxide sterilization, achieving a Sterility Assurance Level (SAL) of 10^-6.

Technological Characteristics

Console-based cryosurgical system; 1-8 independent channels for CRYOprobes and T-type needle thermocouples. 110 VAC power. CRYOprobes sterilized via ethylene oxide (EtO) per AAMI guidelines. Sterile barrier packaging: Tyvek/Polyester pouch.

Indications for Use

Indicated for patients requiring tissue destruction via extreme cold in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. Specific conditions include prostate cancer, BPH, malignant/benign tumors, skin cancers, warts, gynecological dysplasia, cardiac arrhythmias, and various cutaneous/rectal lesions.

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

• Cryomedical Sciences, Inc. AccuProbe® (K973190)
• ENDOcare cryosurgical system (K973686)

Submission Summary (Full Text)

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

APR 1 0 1998

980110

# Section II - SMDA 1990 Requirements

# Safety and Effectiveness Summary

# Device Description

The ENDOcare CRYOcare™ Cryosuryical System consists of a console which can control one to eight single-use, disposable CR YOprobes™ and one to eight independent inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.

The system is available in 1, 4 and 8-CRYOprobetM configurations. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (c.g., 1-8) and the size of the outer casc.

# Indications for Use

The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy 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:

#### Urology

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

- . Ablation of cancerous or malignant tissue
- Ablation of benign tumors .
- . Palliative intervention

# Dermatology

- . Ablation or freezing of skin cancers and other cutaneous disorders
# Gynecology

- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .

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

$$\mathbb{X}^{\bullet} \otimes_{\mathbb{A}} \mathcal{O} \upharpoonright_{\mathcal{O}} \mathbb{Y}^{\bullet}$$

# General Surgery

- Destruction of warts or lesions .
- Palliation of tumors of the oral cavity, rectum and skin .
- Ablation of leukoplakia of the mouth, angjomas, sebaceous hyperplasia, basal cell . turnors 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

# Thoracic Surgery

- Ablation of arrhythmic cardiac lissue .
- Ablation of cancerous lesions t

# Prociology

- Ablation of benign or malignant growths of the anus or rectum .
- Ablation of hemorrhoids .

#### Substantial Equivalence

The F.NDOcare CRYOcare™ CRYOsurgical System is substantially equivalent to the Cryomedical Sciences. Inc. AccuProbe® models which were found to be substantially equivalent on November 21, 1997 (reference K973190) and the ENDOcare cryosurgical system which was determined to be substantially equivalent on December 22, 1997 (K973686).

#### Sterilization Methodology

The following sterilization information is applicable to the CRYOprobes™ only. Sterilization validation was based on the recommendations in the current AAMI (American Association for the Advancement of Medical Instrumentation) Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices A minimum Sterility Assurance Level (SAL) of $10^{-6}$ was achieved. Sterile barrier packaging consists of standard disposable medical device packaging containing a plastic film and a coated paper side. The packaging consists of a 16" x 28", straight seal, 10-59B Tyvek/Polyester (48 ga. /Polyethylene pouch. Maximum levels of EtO residuals did not exceed.

25 ppm for ethylene oxide 25 ppm for ethylene chlorohydrin 250 ppm for ethylene glycol

{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 & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endocare, Incorporated c/o Mr. Vin Cutarelli Vice President Regulatroy Affairs & Quality Assurance 7 Studebaker Irvine, CA 92618

Re: K980110 Trade Name: ENDOcare CRYOcare™ Cryosurgical System Regulatory Class: II (two) Product Code: OCL. GEH Dated: January 9, 1998 Received: January 12, 1998

Dear Mr. Cutarelli:

This letter corrects our substantially equivalent letter of November 29, 2004.

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. Vin Cutarelli

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 (OS) 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,
El.mee

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

Enclosure

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

# Indication For Use Statement

510(k) Number:

Device Name: ENDOcare CRYOcare™ Cryosurgical System

9801 D

The ENDOcare CR YOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy 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:

Urology

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

- . Ablation of cancerous or malignant lissue
- Ablation of benign tumors .
- . Palliative intervention

#### Dermatology

- Ablation or freezing of skin cancers and other cutaneous disorders .
Gynecology

- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Concurrence of CDRH, Office of Device Evaluation (ODE):

Mark N. Melkus

for (Division Sign-Off)
mw Division of General Restorative Devices
510(k) Number
PAGE 1OF 2
K98 0110

Prescription Usc: X (Per 21 CFR 801 109)

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

Indications for Use (continued):

#### 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 arca, 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

# Thoracic Surgery

- Ablation of arrhythmic cardiac tissue .
- Ablation of cancerous lesions .

#### Prociology

- Ablation of benign or malignant growths of the anus or rectum ●
- Ablation of hemorrhoids ●

Concurrence of CDRH, Office of Device Evaluation (ODE):

Prescription Use: X (Per 21 CFR 801.109)

Murk A. Milberser

(Division Sign-Off)
for
mw Division of General Restorative Devices
510(k) Number K980110