LOOP MICROWAVE ABLATION PROBE

K023311 · Vivant Medical, Inc. · GEI · Apr 9, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023311
• Device Name: LOOP MICROWAVE ABLATION PROBE
• Applicant: Vivant Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

Device Story

Loop™ Microwave Ablation Probe consists of pre-shaped curved microwave antenna housed in delivery cannula. Physician deploys antenna into targeted soft tissue using handle mechanism. Device utilizes RF electrosurgical generator connector for initial deployment; subsequently, microwave cable connects to Vivant VivaWave™ Microwave Generator. Microwave energy transmitted to antenna heats tissue within and around antenna to achieve coagulation. Used in clinical settings for soft tissue ablation; excludes cardiac procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Pre-shaped curved microwave antenna; delivery cannula; handle deployment mechanism; RF electrosurgical generator connector; microwave cable interface. Materials are biocompatible and consistent with previously cleared devices. Energy source: microwave generator.

Indications for Use

Indicated for coagulation of soft tissue. Contraindicated for cardiac procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• VivaWave™ Microwave System - Vivant Medical, Inc. (K011676)
• Bovie Hand Control - Sybron Corp. (K790187)

Submission Summary (Full Text)

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### 510(k) Summary

KO23311

General Information

| Classification | Class II |
|----------------|-------------------------------------------------------------------------------|
| Trade Name | Loop™ Microwave Ablation Probe |
| Submitter | Vivant Medical, Inc.<br>1916-A Old Middlefield Way<br>Mountain View, CA 94043 |
| | 650-694-2900 |
| Contact | Steven Kim<br>Director of Research and Development |

#### Intended Use

The Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

#### Predicate Devices

| VivaWave™ Microwave System - Vivant Medical, Inc. | K011676 |
|---------------------------------------------------|---------|
| Bovie Hand Control - Sybron Corp. | K790187 |

#### Device Description

The device consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. The electrode comes with a connector that can be attached to a standard RF electrosurgical generator to assist in deployment of the curved microwave antenna into tissue. Once the curved antenna is fully deployed, the RF connector can be removed and the remaining microwave cable is connected to the Vivant VivaWave™ Microwave Generator. The microwave energy is then transmitted to the curved antenna which heats the tissue within and around the antenna.

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## Materials

All patient contact materials used in the manufacture of the Loop™ Microwave Ablation Probe are suitable for this use and have been used in numerous previously cleared products.

## Summary of Substantial Equivalence

The Loop™ Microwave Ablation Probe is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Vivant Medical believes the Loop™ Microwave Ablation Probe is substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

APR 0 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Kim Director of Research and Development Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, California 94043

Re: K023311

Trade/Device Name: Loop™ Microwave Ablation Probe Regulation Number: 21 CFR 878.4400 Regulation Names: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Codes: GEI Dated: January 9, 2003 Received: January 10, 2003

Dear Mr. Kim:

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 - Mr. Steven Kim

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]. 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) you may obtain. 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,

Muriam C. Provost

40 Celia M. Witten, Ph.D., M.D. 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

| 510(k) Number (if known): | This application | K023311 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name: | Loop™ Microwave Ablation Probe | |
| Indications for Use: | The Loop™ Microwave Ablation Probe is<br>intended for coagulation of soft tissue<br>Not for use in cardiac procedures. | |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number
K023311