MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000

K052861 · Sanarus Medical, Inc. · GEH · Nov 15, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052861
• Device Name: MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000
• Applicant: Sanarus Medical, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Nov 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications: General Surgery - Ablation of breast fibroadenoma - Localization of breast lesions . 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 .

Device Story

Cryosurgical system for tissue destruction via extreme cold; utilizes Joule-Thompson principle. Inputs: argon gas for cooling, helium for thawing; temperature data from integrated cryoprobe thermocouple and two optional external T-type needle thermocouples. Control unit manages gas flow and monitors temperatures; CPLD-based logic; LED status display. Operated by clinician in clinical setting. Output: controlled cryoablation of target tissue. Benefits: minimally invasive tissue destruction for benign/malignant tumors and fibroadenomas.

Clinical Evidence

Bench testing only. Performance testing confirmed that modifications to the cryoprobe configuration met applicable specifications and performance standards, demonstrating equivalence to the predicate device.

Technological Characteristics

Cryosurgical unit; Joule-Thompson cooling principle; argon/helium gas-based. Components: control unit, single-use disposable cryoprobe, T-type needle thermocouples. CPLD-based control logic. Power: 120/240 VAC. LED display. Sterilization: not specified (equivalent to predicate).

Indications for Use

Indicated for patients requiring tissue destruction via extreme cold in general surgery, gynecology, and oncology. Specific applications include ablation of breast fibroadenoma, breast lesion localization, ablation of malignant neoplasia or benign dysplasia of female genitalia, ablation of cancerous or benign tumors, and palliative intervention.

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

• Sanarus Visica Treatment System (K022314)

Submission Summary (Full Text)

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K052861

Sanarus Visica Treatment System

Page 1 of 2

# NOV 1 5 2005 Appendix A: 510k Summary of Safety and Effectiveness

## CONTACT INFORMATION

Trena Depel Director, Requlatory and Clinical Affairs Telephone: [phone] FAX: [phone] e-mail: [e-mail]

## COMPANY INFORMATION

Sanarus Medical, Inc. 4696 Willow Road Pleasanton, CA 94588 Telephone: [phone] FAX: [phone]

## DEVICE NAME

## Sanarus Visica™ Treatment System

## DEVICE DESCRIPTION

The Visica Treatment System consists of a control unit that controls one single-use. disposable (Visica Treatment Device or "cryoprobe"). The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself.

The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent temperature probes to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

### INDICATIONS FOR USE

Indications for Use: The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:

General Surgery

Sanarus Medical CONFIDENTIAL

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Premarket Submission: Special 510k

Sanarus Visica Treatment System

2052861

Page 2 of 2

- Ablation of breast fibroadenoma .
- Localization of breast lesions .

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 .

## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

### Sanarus Visica™ Treatment System

## SUBSTANTIAL EQUIVALENCE

The Sanarus Visica Treatment System is substantially equivalent to the Sanarus Visica Treatment System that was determined to be substantially equivalent on Oct 15, 2002 (reference K022314).

The Sanarus Visica Treatment System has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials in both the new and predicate device are the same. The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent.

Based on the indications for use; technological characteristics and performance testing results, the Sanarus Visica Treatment System does not raise significant new questions of safety and effectiveness.

### PERFORMANCE TESTING SUMMARY

Performance testing confirms that modifications to the cryoprobe, resulting in the addition of an additional cryoprobe configuration to Sanarus Visica Treatment System, meet applicable specifications and performance standards and are equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services in the USA. The seal is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized symbol that resembles three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2005

Trena Depel Director, Regulatory and Clinical affairs Sanarus Medical, Inc. 4696 Willow Road Pleasanton, California 94588

Re: K052861

Trade/Device Name: Sanarus Visica™ Treatment System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: November 1, 2005 Received: November 2, 2005

Dear Ms. Depel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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.

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#### Page 2- Trena Depel

This letter will allow you to begin 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/industry/support/index.html.

Sincerely vours.

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kos-2861

## Indications for Use

#### 510(k) Number: K052861

Device Name: Sanarus Visica™ Treatment System

Indications for Use:

The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:

General Surgery

- . Ablation of breast fibroadenoma
- Localization of breast lesions .

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

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
|-------------------------------------------------|---|--------|------------------------------------------------|--|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

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

(Division Sign-Off)

Division of General. Restorative,
and Neurological Devices

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| 510(k) Number | K052861 |