DERMATOLOGIC TREATMENT SYSTEM (DTS) G2

K082819 · Miramar Labs, Inc. · NEY · Mar 20, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082819
• Device Name: DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
• Applicant: Miramar Labs, Inc.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Mar 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DTS G2 System is indicated for use for coagulation of soft tissue.

Device Story

DTS G2 System is a microwave-based soft tissue coagulation device. It consists of an external microwave generator with an integrated vacuum pump, a cooling fluid pump, tubing, and a surface contact applicator. The operator manually sets the desired power and delivery time. The generator includes electric circuits, cooling fans, power supply, and control boards. The applicator delivers microwave energy to the patient via a sterile, disposable distal head. The system is used in a clinical setting to coagulate soft tissue, providing a controlled thermal effect. The device is operated by a clinician who monitors the manual settings to achieve the desired therapeutic outcome.

Clinical Evidence

Product and animal testing was conducted to evaluate conformance to product specifications and equivalence to the predicate device. Results demonstrated that the system met all specifications.

Technological Characteristics

Microwave-based tissue coagulation system. Components include microwave generator, vacuum pump, cooling fluid pump, and surface contact applicator. Energy source is microwave energy. Materials are standard medical-grade materials used in previously cleared devices. System is manually controlled by the operator for power and time settings.

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

• Foundry Newco X Microwave Tissue Coagulation System (K072870)

Submission Summary (Full Text)

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Ko82819

## 510(k) Summary

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General Information

| Classification | Class II | MAR 20 2005 |
|----------------|--------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name | DTS G2 System | |
| Submitter | Miramar Labs, Inc.<br>199 Jefferson Drive<br>Menlo Park, CA 94025<br>USA<br>Tel: [phone]<br>Fax: [phone] | |
| Contact | Kathy O'Shaughnessy, PhD<br>VP Clinical and Regulatory Affairs | |

#### Intended Use

The DTS G2 System is indicated for use for coagulation of soft tissue.

Predicate Devices

K072870 Foundry Newco X Microwave Tissue Coagulation System

#### Device Description

The DTS G2 System is designed to interact-using a surface contact applicator. The system consists of an applicator; external microwave generator with integrated vacuum pump; and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator.

The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, integrated vacuum pump, 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. The distal end has a sterile, disposable applicator head that contacts the patient.

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K082819

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### Materials

All materials used in the manufacture of the DTS G2 System are suitable for this use and have been used in numerous previously cleared products.

### Testing

Product and animal testing was conducted to evaluate conformance to product specification and equivalence to predicate devices.

The results showed the system met specification.

## Summary of Substantial Equivalence

The DTS G2 System is equivalent to the predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Miramar Labs, Inc. % Kathy O'Shaughnessy, PhD VP, Clinical and Regulatory Affairs 199 Jefferson Drive Menlo Park, California 94025

MAR 2 0 2009

Re: K082819

Trade/Device Name: DTS G2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: February 27, 2009 Received: March 2, 2009

Dear Dr. O'Shaughnessy:

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.

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#### Page 2 - Kathy O'Shaughnessy, PhD

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 yours.

fmhi, m.D. for

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

Enclosure

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6082819

# Indications for Use

510(k) Number (if known):

K082819

DTS G2 System

Device Name:

Indications for Use:

The DTS G2 System is indicated for use for coagulation of soft tissue.

X

Prescription Use (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use (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)

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

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Number K082819