MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)

K072870 · Foundry Newco X, Inc. · NEY · Jan 14, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K072870
• Device Name: MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
• Applicant: Foundry Newco X, Inc.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Jan 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.

Device Story

The Microwave Tissue Coagulation System (MTCS) is a surgical device used to coagulate soft tissue. The system comprises an applicator, an external microwave generator, a vacuum pump, and a cooling fluid pump with tubing. The operator manually sets the desired power levels and delivery time on the generator's control panel. The generator delivers microwave energy through the applicator, which is applied to the tissue via surface contact. The system is intended for use by clinicians in a surgical setting. By providing controlled microwave energy, the device facilitates tissue coagulation, aiding in hemostasis or tissue management during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes microwave generator, applicator, vacuum pump, and cooling fluid pump. Generator contains electric circuits, control boards, and power supply. Applicator uses surface contact for energy delivery. Materials are biocompatible and previously cleared. No specific software algorithm class or connectivity details provided.

Indications for Use

Indicated for coagulation of soft tissue. Patient population not specified.

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)
• Microsulis MTA System (K052919)
• Radionics Cool-Tip RF System (K984552)
• Medela Vacuum Pump Model 30 (K021368)
• AFX Microwave Generator (K003978)

Submission Summary (Full Text)

{0}------------------------------------------------

72870

Page 1 of 2

### 510(k) Summary

### General Information

# Class II

Microwave Tissue Coagulation System (MTCS) Trade Name

Submitter

Classification

Foundry Newco X, Inc. 199 Jefferson Drive Menlo Park, CA 94045 USA Tel: [phone] Fax: [phone]

Contact

Steven Kim Chief Technology Officer

### Intended Use

The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.

### Predicate Devices

| K011676 | VivaWave Microwave Ablation System |
|---------|------------------------------------|
| K052919 | Microsulis MTA System |
| K984552 | Radionics Cool-Tip RF System |
| K021368 | Medela Vacuum Pump Model 30 |
| K003978 | AFX Microwave Generator |

#### Device Description

The Microwave Tissue Coagulation System (MTCS) is designed to coagulate soft tissue using a surface contact applicator. The system consists of an applicator, external microwave generator, vacuum pump, and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator.

# 【JAN 1 4 2008

{1}------------------------------------------------

K072870

Page 2 of 2

The generator 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 applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator.

### Materials

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

### Testing

Product testing was conducted to evaluate conformance to product specification.

The results showed the system met specification.

### Summary of Substantial Equivalence

The MTCS is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.

Public Health Service

JAN 1 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Foundry Newco X, Inc. % Mr. Steven Kim Chief Technology Officer 199 Jefferson Drive Menlo Park, California 94025

Re: K072870

Trade/Device Name: Microwave Tissue Coagulation System (MTCS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: December 19, 2007 Received: December 20, 2007

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.

{3}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N Mulhern

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

72870

### Indications for Use

Device Name:

Microwave Tissue Coagulation System (MTCS)

510(k) Number (if known):

Indications for Use:

The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.

X OR Prescription Use (Per 21 CFR 801.109)

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

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

> Concurrence of CDRH, Off Bigges Forn Lation (ODE) Division of General, Restorative,

> > and Neurological Devices

12072870 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Page 1 of 1