VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER

K050223 · Vivant Medical, Inc. · GEI · Feb 24, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050223
• Device Name: VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER
• Applicant: Vivant Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

Device Story

Coaxial Introducer functions as accessory to VivaWave Microwave Ablation System; aids insertion of microwave energy applicator into soft tissue. System utilizes microwave power generator to coagulate tissue volume surrounding probe active area. Used in clinical settings by physicians. Output is physical guidance for applicator placement; facilitates precise tissue coagulation. Benefits include improved access and placement of ablation probe for soft tissue treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Coaxial design; patient-contact materials previously cleared in other devices. Mechanical accessory for probe insertion. No electronic or software components.

Indications for Use

Indicated for coagulation of soft tissue using the VivaWave Microwave Ablation System. The Coaxial Introducer aids insertion of the microwave energy applicator. 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)

Submission Summary (Full Text)

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## 510(k) Summary

# FEB 2 4 2005

| General Information | K050223 |
|---------------------|-------------------------------------------------------------------|
| Classification | Class II |
| Trade Name | Coaxial Introducer |
| Submitter | Vivant Medical, Inc. |
| | 1916-A Old Middlefield Way<br>Mountain View, CA 94043 |
| | [phone] |
| Contact | Kristine Foss<br>Vice President, Regulatory, Quality and Clinical |

## Intended Use

The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

#### Predicate Devices

VivaWave™ Microwave Ablation System

K011676

## Device Description

The VivaWave™ Microwave Ablation System consists of a microwave power generator and a disposable probe that is the microwave energy applicator. The disposable probe is inserted into soft tissue to coagulate a volume of tissue surrounding the active area of the probe. The Coaxial Introducer may be used to aid insertion of the microwave energy applicator.

#### Materials

All patient contact materials used in the manufacture of the Coaxial Introducer are suitable for this use and have been used in numerous previously cleared products.

#### Summary of Substantial Equivalence

The VivaWave Microwave Ablation System with the addition of the Coaxial Introducer 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 Coaxial Introducer is substantially equivalent to existing legally marketed devices.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

FEB 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristine Foss Vice President, Regulatory, Quality and Clinical Vivant Medical, Inc. 1916-A Old Middlefield Way Mountain View, California 94043

Re: K050223

Trade/Device Name: Coaxial Introducer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 28, 2005 Received: February 9, 2005

Dear Ms. Foss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalled by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure to regars the Medical Device Amendments, or to commerce phor to may 20, 1970, accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costicule Hot (110) that the device, subject to the general controls provisions of the Act. The r out may, mercerere, manel at the Act include requirements for annual registration, listing of general controlo provisive, 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 rr your device is elabilition (overal controls. Existing major regulations affecting your device can may be subject to back added to begulations, 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 r 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 or any I 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 rendrun radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kristine Foss

This letter will allow you to begin marketing your device as described in your Section 510(k) The lotel watification. The FDA finding of substantial equivalence of your device to a legally premated 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 yours,

Miriam C. Provost

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

050223

Device Name:

Coaxial Introducer

Indications for Use:

The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

**510(k) Number** K050223