TRI-LOOP MICROWAVE ABLATION PROBE

K032047 · Vivant Medical, Inc. · GEI · Aug 6, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032047
• Device Name: TRI-LOOP MICROWAVE ABLATION PROBE
• Applicant: Vivant Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Device consists of 3 pre-shaped curved microwave antennas housed within 3 delivery cannulas; attached to handle mechanism for deployment into targeted tissue. RF energy facilitates antenna deployment. Microwave energy delivered via Vivant VivaWave™ Microwave Generator (K011676) to heat tissue within and around antennas. Used by clinicians for soft tissue coagulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Microwave ablation probe featuring 3 pre-shaped curved antennas and delivery cannulas. Energy source: microwave energy via external generator. Materials are biocompatible and previously cleared in other devices.

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

• Vivant Medical Loop™ Microwave Ablation Probe (K023311)

Reference Devices

• Vivant VivaWave™ Microwave Generator (K011676)

Submission Summary (Full Text)

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AUG - 6 2003

### 510(k) Summary

General Information

K032047

page 1 of 1

Classification Class II

Trade Name

Submitter

Tri-Loop™ Microwave Ablation Probe

Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, CA 94043

[phone]

Steven Kim Contact Vice President of Research and Development

# Intended Use

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

K023311

# Predicate Device

Vivant Medical Loop™ Microwave Ablation Probe

### Device Description

The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.

# Materials

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

# Summary of Substantial Equivalence

The Tri-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 Tri-Loop™ Microwave Ablation Probe is substantially equivalent to existing legally marketed devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular and contains the department's name around the perimeter. In the center of the logo is a stylized symbol that resembles three overlapping waves or stripes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2003

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

Re: K032047

Trade/Device Name: Tri-Loop™ Microwave Ablation Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 1, 2003 Received: July 7, 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]. 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,

Miriam C. Provost

for 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):

Device Name:

Indications for Use:

KO32047 This application TRI-Loop " Hickowave Ablation Prole
TRI-Loop " Hickowave Ablation Prolet Deviee name

Tri-Laser™ Microwave Able

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

Barbara Bammuma for CMU
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K032047

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Ja

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)