VIVARING MICROWAVE ABLATION PROBE

K040279 · Vivant Medical, Inc. · GEI · Mar 2, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040279
• Device Name: VIVARING MICROWAVE ABLATION PROBE
• Applicant: Vivant Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The VivaRing Microwave Ablation Probe is a surgical instrument designed for soft tissue coagulation. It features a pre-shaped curved microwave antenna housed within a delivery cannula, attached to a handle mechanism for deployment into target tissue. The device is powered by the Vivant Medical VivaWave Microwave Generator to coagulate tissue within and around the antenna. It includes a saline-cooled shaft for percutaneous and laparoscopic applications. Operated by physicians in clinical settings, the device provides controlled thermal ablation to treat soft tissue, excluding cardiac procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, materials, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Microwave ablation probe with pre-shaped curved antenna and delivery cannula. Features a saline-cooled shaft for percutaneous/laparoscopic use. Powered by external microwave generator. Materials are biocompatible and previously cleared in other devices.

Indications for Use

Indicated for coagulation of soft tissue. Not for use in 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

• LoopTM Microwave Ablation Probe (K023311)
• VivaTipTM Microwave Ablation Probe (K032702)

Submission Summary (Full Text)

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MAR - 2 2004

510(k) Summary 6040279

General Information

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

# Intended Use

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

# Predicate Devices

| LoopTM Microwave Ablation Probe | K023311 |
|------------------------------------|---------|
| VivaTipTM Microwave Ablation Probe | K032702 |

# Device Description

The VivaRing M Microwave Ablation Probe 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. Once deployed, the antenna can be powered by the Vivant Medical VivaWave™ Microwave Generator to coagulate a region of tissue within and around the antenna. VivaRing™ Microwave Ablation Probe also incorporates a saline-cooled shaft for percutaneous and laparoscopic use.

# Materials

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

# Summary of Substantial Equivalence

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

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

Re: K040279

Trade/Device Name: VivaRing™ 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: February 4, 2004 Received: February 5, 2004

Dear Mr. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & now reviewed your been wined 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 cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de noos mat have been 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 r ou may, merce 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 (sec above) into either class II (Special Controls) or class III (PMA), it If your de roo 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, IDA 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 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 Or A rut our of 19 meeting (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) I mis letter witi anow you to cegm maing of substantial equivalence of your device to a legally prematicate 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 If you desire specific advice for Jour a01) 594-4659. Also, please note the regulation entitled, Coniact the Office of Computers as (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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

(6 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 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VivaRing ™ Microwave Ablation Probe and Accessories |
| Indications For Use: | The VivaRing™ Microwave Ablation Probe is intended for<br>coagulation of soft tissue. Not for use in cardiac<br>procedures. |

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 Sign-Off) (Division bigand Neurological Devices

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