MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM

K021211 · Sanarus Medical, Inc. · GEH · Jun 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021211
• Device Name: MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
• Applicant: Sanarus Medical, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Visica™ Treatment System is intended 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 . 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

Visica™ Treatment System is a cryosurgical unit utilizing inert argon gas for cooling and helium for thawing via the Joule-Thompson principle. System comprises a control unit, a single-use disposable cryoprobe, and optional independent T-type needle thermocouples for monitoring surrounding tissue. Operated by physician via console keys or remote foot-pedal. Control unit uses CPLD to manage gas flow and monitor temperatures at probe tip and surrounding tissue. LED screen displays system status. Device destroys target tissue through extreme cold application. Benefits include precise tissue ablation for benign and malignant conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications identical to the predicate device.

Technological Characteristics

Cryosurgical unit; Joule-Thompson cooling principle; argon/helium gas source; CPLD-based control; T-type needle thermocouples for temperature monitoring; 110/230 VAC power; LED display; console and foot-pedal interface.

Indications for Use

Indicated for patients requiring tissue ablation in general surgery (breast fibroadenoma), gynecology (malignant neoplasia or benign dysplasia of female genitalia), and oncology (cancerous/malignant tissue, benign tumors, or 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 (K020605)

Submission Summary (Full Text)

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KOZI211

## JUN 2 6 2002

# Section 2 - Summary of Safety and Effectiveness

#### (1) Contact Information

Vincent Cutarelli Vice President, Regulatory Affairs Telephone: [phone] ext. 105 FAX: [phone]

#### (2) Company Information

Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: [phone] FAX: [phone]

#### (3) Device Name

Sanarus Visica™ Treatment System

#### (4) Device Description

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe. The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates off standard 110/230 VAC wall power and is controlled 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. A remote foot-pedal can be used to start and stop the system.

The cryoprobe overates on the Joule-Thompson principle and the refrigerative canacity is limited only to the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control 2 independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

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Koz1211

#### Indications for Use (ട)

The Sanarus Visica™ Treatment System is intended 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 .
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 ●

#### (6) Name of Predicate or Legally Marketed Device

Sanarus Visica™ Treatment System -

#### Substantial Equivalence (7)

The Sanarus Visica™ Treatment System is substantially equivalent to the Sanarus Visica™ Treatment System that was determined to be substantially equivalent on March 8, 2002 (reference K020605).

#### Technological Characteristics (8)

The Visica™ Treatment System has the same technological characteristics and performance specifications as the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with three heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 6 2002

Mr. Vincent Cutarelli Vice President, Regulatory Affairs Sanarus Medical, Inc. 5880 W. Las Positas Boulevard, Suite 52 Pleasanton, CA 94588

Re: K021211

Trade/Device Name: Sanarus Visica™ Treatment System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: May 20, 2002 Received: May 28, 2002

Dear Mr. Cutarelli:

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. Iisting 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 - Mr. Vincent Cutarelli

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Stypk Rlvods

M. Witten, Ph.D., M.D. Celia Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications For Use

Kozall 510(k) Number: ______________________________________________________________________________________________________________________________________________________________

Device Name: Visica™ Treatment System

Indications for Use: The Visica™ Treatment System is intended 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 .
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

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

Hyatt Hurly

Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021211

Prescription Use: _ X_ (Per 21 CFR 801.109)