MICROSULIS TISSUE ABLATION SYSTEM

K052919 · Microsulis Americas, Inc. · NEY · Jan 13, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052919
• Device Name: MICROSULIS TISSUE ABLATION SYSTEM
• Applicant: Microsulis Americas, Inc.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.

Device Story

MTA System consists of Sulis V generator, surgical applicator, and temperature probes; used for intraoperative soft tissue coagulation. Operator inserts applicator into soft tissue; generator delivers energy to coagulate tissue volume surrounding applicator tip. Temperature probes monitor tissue temperature at applicator periphery; operator manually sets power levels. Used in clinical/surgical settings by physicians. System provides thermal coagulation to achieve hemostasis or tissue destruction; benefits patient through controlled soft tissue ablation.

Clinical Evidence

Bench testing only. Performance testing included electrical safety (IEC 60601-1), electromagnetic compatibility (EN 60601-1-2, EN 55011), biocompatibility (ISO 10993), sterilization validation (EN 550, ISO 11135), and shelf-life/distribution simulation (ASTM D4169, ASTM F88, ISTA Procedure 2A). No clinical data provided.

Technological Characteristics

System comprises microwave generator, applicator, and temperature probes. Patient contact materials are biocompatible per ISO 10993. Electrical safety per IEC 60601-1; EMC per EN 60601-1-2. Sterilization per EN 550 and ISO 11135. Packaging/shelf-life validated per ASTM D4169, ASTM F88, and ISTA 2A.

Indications for Use

Indicated for intraoperative coagulation of soft tissue. Prescription use only.

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

• Tyco/Radionics Cool-Tip RF System (K984552)
• Vivant Medical VivaWave Microwave System (K011676)
• Vivant VivaTherm Temperature Measurement System (K031552)
• Vivant VivaTip Microwave Ablation Probe and Accessories (K032702)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the text "Ko52919" in a handwritten style. The text is written in black ink on a white background. The numbers are slightly larger than the letters, and the text is slightly slanted to the right.

## 510(k) Summary of Safety and Effectiveness

## JAN 1 3 2006

| General Information | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II |
| Trade Name | Microsulis Tissue Ablation (MTA) System is comprised of<br>o MTA Sulis™ V Generator<br>o Applicator and Temperature probes |
| Submitter | Microsulis Americas, Inc.<br>275 Wyman Street, Suite 12<br>Waltham, MA 02451<br>1-781-547-7710 |
| Contact | Timothy Y Cowart<br>Executive Vice President, Chief Regulatory Officer |

#### Intended Use

intended Use
The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.

#### Predicate Devices

| • Tyco/Radionics Cool-TipTM RF System | K984552 |
|-----------------------------------------------------------|---------|
| • Vivant Medical VivaWaveTM Microwave System | K011676 |
| • Vivant VivaThermTM Temperature Measurement System | K031556 |
| • Vivant VivaTip Microwave Ablation Probe and Accessories | K032702 |

#### Device Description

Device Describution
The MTA surgical applicator is inserted into soft tissue and coagulates a volume of tissue surrounding the active The MTA Suglicator tip. Temperature probes are included in the applicator kits to determine the temperature at area of the applicator up. Temperature probos are included in the applicator is to be used with the MTA Sulis™ V the penpher you the obegalate manually set at the desired power levels by the operator.

#### Materials

illiatient contact materials used in the manufacture of the MTA System are suitable for this use and have been used in numerous previously cleared products.

#### Performance Data

Performance testing was undertaken to ensure that the MTA System functions as intended and meets design Penomance lessing was andonente to oneans that the device is substantially equivalent to the specifications. Junicient add were safety and effectiveness criteria. In addition, the testing aloromonitorial problem complies with the following standards.

- that the MTA Cyclem Somple 1:2003 Medical Electrical Equipment. Part 1: General . requirements for safety .
- Tequirements for Salety
Electromagnetic compatibility Meets EN 60601-1-2, EN55011, & IEC60601-1-2.2001 .
- Biocompatibility ISO 10993, Biological Evaluation of Medical Devices .
- Sterility Sterilization validation requirements of EN550 and ISO 11135 .
- Stelf Life Distribution Vallation Per ASTM D4169, Seal Strength Evaluation per ASTM F88 .
- Oncir Life Dictional Safe Transit Association (ISTA) Procedure 2A 2004, Package . Distribution Simulation per ASTM D4169

### Summary of Substantial Equivalence

Summary of Substantial Equivaler
The MTA System is equivalent to the predicate products. The indications for use, basic overall function, methods The MTA System is equivalient to the productions in the microsulis believes that the MTA system is substantially equivalent to existing legally marketed devices.

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

JAN 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Timothy Y. Cowart, Esq., P.E. Executive Vice President of Regulatory Affairs Chief Regulatory Officer Microsulis Americas, Inc. 275 Wyman Street, Ste. 12 Waltham, Massachusetts 02451

Re: K052919

Trade/Device Name: Microsulis Tissue Ablation (MTA) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: December 12, 2005 Received: December 14, 2005

Dear Mr. Cowart:

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

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

Page 2 - Mr. Cowart

Federal agencies. You must comply with all the Act's requirements, including, but not rcueral agencies: "Fourmals: compy" (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation mandiacturing practice requiredble, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 11ns letter will and if you to organ - The FDA finding of substantial equivalence of your J rotty promation nowleted 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 If you desire openite the Office of Compliance at [phone]. Also, please note the oo 1), prease other . "Misbranding by reference to premarket notification" (21CFR Part 16 guildion onlined, "Min other general information on your responsibilities under the 807.97). Tod may obtain only general 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 Volpe


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

Enclosure

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

K052919

# Indications for Use

510(k) Number (if known):

K052919

Device Name:

Indications For Use:

.

Microsulis Tissue Ablation System and Accessories

The Microsulis Tissue Ablation (MTA) System is indicated The Microsullo Hoose ative coagulation of soft tissue.

Prescription Use પછડ (21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use _ No (21 CFR 801 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-

2

Page 1 of _ 1 __

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

510(k) Number k052919