VIVATIP MICROWAVE ABLATION PROBE

K032702 · Vivant Medical, Inc. · GEI · Oct 3, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032702
• Device Name: VIVATIP MICROWAVE ABLATION PROBE
• Applicant: Vivant Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VivaTip Microwave Ablation Probe is a needle-like device for soft tissue coagulation. Device is inserted into tissue to coagulate a surrounding volume via microwave energy. Used in conjunction with VivaWave microwave power generator. Includes accessories for shaft cooling and multi-probe positioning. Operated by clinicians in a clinical setting. Output is thermal coagulation of target tissue; assists in surgical or interventional procedures. Benefits include localized tissue destruction.

Technological Characteristics

Needle-like microwave ablation probe; microwave energy source; includes shaft cooling and multi-probe positioning accessories. Patient-contact materials are biocompatible and previously cleared.

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 Ablation System (K011676)
• Tri-Loop™ Microwave Ablation Probe (K032047)

Submission Summary (Full Text)

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# - 3 2003

510(k) Summary

General Information

K032702 (pg 1 of 1)

| Classification | Class II |
|----------------|-------------------------------------------------------------------------------|
| Trade Name | VivaTipTM Microwave Ablation Probe and Accessories |
| Submitter | Vivant Medical, Inc.<br>1916-A Old Middlefield Way<br>Mountain View, CA 94043 |
| | [phone] |
| Contact | Steven Kim<br>Vice President of Research and Development |

#### Intended Use

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

#### Predicate Devices

| VivaWave™ Microwave Ablation System | K011676 |
|-------------------------------------|---------|
| Tri-Loop™ Microwave Ablation Probe | K032047 |

#### Device Description

The VivaTip Microwave Ablation Probe is a needle-like device that is inserted into soft tissue and coagulates a volume of tissue surrounding the active area of the probe. The probe is to be used with the VivaWave™ microwave power generator. Accessories to assist in cooling the shaft of the probe and to hold multiple probes together for simultaneous ablation are included.

#### Materials

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

#### Summary of Substantial Equivalence

The VivaTip™ 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 VivaTip™ Microwave Ablation Probe is substantially equivalent to existing legally marketed devices.

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Image /page/1/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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

OCT - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032702

Trade/Device Name: VivaTip™ Microwave Ablation Probe and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 29, 2003 Received: September 3, 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. Stephen Kim

Enclosure

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,

Mark A. Millman

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

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### Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

This application KO32702

VivaTip™ Microwave Ablation Probe and Accessories

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use __

(Per 21 CFR 801.109) (Optional Format 1-2-96)

for Mark N Millman
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K032702

Confidential