CRYOCARE CS SURGICAL SYSTEM

K101333 · Endocare, Inc. · GEH · Jun 14, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101333
• Device Name: CRYOCARE CS SURGICAL SYSTEM
• Applicant: Endocare, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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, 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.

Device Story

Cryocare CS Surgical System is a cryosurgical unit utilizing Argon gas to deliver extreme cold temperatures to targeted tissue via the Joule-Thomson principle. The system includes the CRYOcare V-probe, a single-use sterile disposable accessory. Used in open, minimally invasive, or endoscopic procedures by surgeons to freeze/ablate tissue, including prostate, kidney, liver metastases, tumors, skin lesions, and warts. The system provides controlled cryoablation, allowing clinicians to destroy diseased tissue or provide palliative care. Benefits include precise tissue destruction for various oncological and dermatological conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Cryosurgical unit using Argon gas and Joule-Thomson effect for cooling. Includes single-use sterile disposable V-probe. System design, materials, and sterilization processes are identical to the predicate. Class II device (21 CFR 878.4350).

Indications for Use

Indicated for patients requiring tissue ablation or freezing across general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Specific conditions include prostate cancer, BPH, skin cancers, warts, tumors, and nerve tissue for pain management.

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

• Endocare Cryocare CS Surgical System (K060279)

Reference Devices

• Teratech 10LAP4 ultrasound probe (K043278)

Submission Summary (Full Text)

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K1013333

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510(k) Summary

Prepared – December 12, 2004

JUN 1 4 2010

"

| TRADE NAME | Cryocare CS Surgical System |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON NAME | Cryosurgical unit and accessories |
| CLASSIFICATION | Class II (21 CFR 878.4350) |
| SUBMITTED BY | Endocare, Inc. as wholly own subsidiary of Healthtronics, Inc.<br>9825 Spectrum Drive<br>Building 2<br>Austin, TX 78717<br><br>Contact: Cheryl Blake<br>949-285-3517<br>e-mail: [e-mail] |
| PREDICATE<br>DEVICE | K060279 - Endocare Cryocare CS Surgical System<br>Decision date: February 26, 2006 |
| DEVICE<br>DESCRIPTION | The CRYOcare V-probe is a CRYOprobe accessory to be<br>used in conjunction with the CRYOcare CS Surgical System.<br>The indications for use have not changed. The V-Probe<br>delivers cold temperatures via Argon gas utilizing the Joules<br>Thompson principle to targeted tissue. The patient contact V-<br>Probe (an accessory item to the CRYOcare CRYOsurgical CS<br>System) is supplied as a single use Sterile Disposable item. |

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## INDICATIONS FOR USE

The CRYOcare CS Surgical System has the same intended use as previously cleared for the Cryocare CS Surgical System - K060279 Decision Date February 28, 2006.

The Cryocare CS Surgical system has the same intended use as previously cleared. The CRYOsurgical CS Surgical System and accessories 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 cvsts, 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

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| | Dermatology<br>Ablation or freezing of skin cancers and other<br>cutaneous disorders Proctology<br>Ablation of benign or malignant growths of the anus or<br>rectum<br>Ablation of hemorrhoids Thoracic surgery<br>Ablation of arrhythmic cardiac tissue<br>Ablation of cancerous lesions |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY OF<br>SUBSTANTIAL<br>EQUIVALENCE | The Cryocare CS Surgical System has the following<br>similarities to that of the previously cleared predicate devices:<br>Has the same intended use; The 10LAP4 ultrasound probe is the same as<br>Teratech's cleared under K043278and is intended for<br>the same clinical application; Uses the same operating principle and has not altered<br>the fundamental technology; Incorporates the same system design; Incorporates the same patient contacting materials; Same manufacturing materials; and Packaged and sterilized using the same materials and<br>processes. In summary, the modified Cryocare CS Surgical System<br>described in this submission is substantially equivalent to the<br>predicate devices. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 4 2010

Endocare. Inc. % Underwriters Laboratories, Inc. Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062

Re: K101333

Trade/Device Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cyrosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 29, 2010 Received: June 02, 2010

Dear Mr. Devine:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Mr. Ned Devine

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A Milkersan

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement

510(k) Number:

K101333

Cryocare CS Surgical System Device Name:

#### Indications for 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, 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 t
- Palliation of tumors of the oral cavity, rectum and skin 0
- 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 _ (Per 21 CFR 801.109) ×

Michael P. Allen for mam
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101333

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Indications for Use Statement (Continued)

#### Urology

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

- o Ablation of malignant neoplasia or benign dysplasia of the female genitalia
### Oncology

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

#### 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 .
- t Ablation of hemorrhoids

#### Thoracic Surgery

- Ablation of arrhythmic cardiac tissue t
- Ablation of cancerous lesions a

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Prescription Use 510(k) Number ...

> PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(k))