VIVAWAVE MICROWAVE SYSTEM

K011676 · Vivant Medical, Inc. · NEY · Jun 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K011676
• Device Name: VIVAWAVE MICROWAVE SYSTEM
• Applicant: Vivant Medical, Inc.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Jun 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VivaWave™ Microwave System is intended for coagulation of soft tissue

Device Story

VivaWave™ Microwave System is an electrosurgical device for soft tissue coagulation. System comprises an external microwave generator and a probe. Operator manually sets power levels and procedure time on the generator control panel. Generator delivers microwave energy through a cable to the probe, which acts as an antenna. Probe is coated with Teflon (PTFE). Device is used in clinical settings to achieve tissue coagulation. Benefits include controlled thermal energy delivery for surgical applications.

Clinical Evidence

Bench testing only. The device underwent product specification testing to evaluate performance and compliance with electrical safety (EN60601-1) and electromagnetic compatibility (EN60601-1-2) standards. Biocompatibility testing was conducted in accordance with ISO 10993.

Technological Characteristics

System consists of an external microwave generator (aluminum/plastic housing) and a Teflon (PTFE)-coated antenna probe. Energy source is microwave. Dimensions: 13"H x 17"W x 3.5"D. Complies with EN60601-1 (electrical safety) and EN60601-1-2 (EMC). Patient-contact materials are biocompatible per ISO 10993.

Indications for Use

Indicated for coagulation of soft tissue.

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

• HSE-5M Microtaze - Cooper Lasersonics, Inc. (K864413)
• HHS-15M Microtaze - Cooper Lasersonics, Inc. (K861904)
• RF-2000 RF Generator - RadioTherapeutics Corp (K981672)
• LeVeen Needle Electrode - RadioTherapeutics Corp (K962313)
• Model 30-6 Multielectrode Array Probe - Zomed Intl (K962692)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2004

Vivant Medical, Inc. c/o Mr. Steven Kim Director, Research and Development 1916-A Old Middlefield Way Mountain View, CA 94043

Re: K011676

Trade Name: VivaWave™ Microwave System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II (two) Product Code: NEY and GEI Dated: May 8, 2002 Received: May 9, 2002

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of June 18, 2002 regarding the regulation name and number for your device. The regulation number for product code NEY has been changed from 878.4350 to 878.4400.

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 (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 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.

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Page 2 - Mr. Steven Kim

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 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.

B. Zimmerman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular 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

K011676

Device Name:

VivaWave™ Microwave System

Indications for Use:

The VivaWave™ Microwave System is intended for coagulation of soft tissue

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

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

Hypt. Rhode

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

OR

. ·

510(k) Number_1 KD/1676

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### 510(k) Summary

K011676

General Information

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

# Intended Use

The VivaWave™ Microwave System is intended for coagulation of soft tissue

#### Predicate Devices

| HSE-5M Microtaze - Cooper Lasersonics, Inc. | K864413 |
|----------------------------------------------------|---------|
| HHS-15M Microtaze - Cooper Lasersonics, Inc. | K861904 |
| RF-2000 RF Generator - RadioTherapeutics Corp | K981672 |
| LeVeen Needle Electrode - RadioTherapeutics Corp | K962313 |
| Model 30-6 Multielectrode Array Probe - Zomed Intl | K962692 |

# Device Description

The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector.

The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic.

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The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.

The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.

## Materials

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

### Testing

The generator is designed to comply with electrical safety (EN60601-1) and electromagnetic compatibility (EN60601-1-2). Product testing was conducted to evaluate conformance to product specification. Biocompatibility testing was conducted in accordance with ISO 10993. All materials used in the VivaWave™ Microwave System are biocompatible and suitable for use.

### Summary of Substantial Equivalence

The VivaWave™ Microwave System 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 VivaWave™ Microwave System is substantially equivalent to existing legally marketed devices.