MODIFICATION TO: THERMACOOL IIA

K013034 · Thermage, Inc. · GEI · Oct 4, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013034
• Device Name: MODIFICATION TO: THERMACOOL IIA
• Applicant: Thermage, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 4, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Device Story

ThermaCool IIA is an electrosurgical device for electrocoagulation and hemostasis in dermatologic and general surgery. System components include an RF generator, handpiece connection module, RF cooling module, and RF handpiece assembly. Device generates RF energy in monopolar or bipolar modes; monopolar mode requires a dispersive patient return electrode, while bipolar mode uses the handpiece tip. System continuously monitors output energy, treatment duration, and tissue impedance. Modifications from previous versions include an integrated heating element and a new cryogen metering valve within the handpiece to improve cryogen flow characteristics. Operated by clinicians in a surgical or clinical setting. Output provides controlled thermal energy for tissue coagulation; helps clinicians manage bleeding and perform surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical cutting and coagulation device. Operates via high-frequency RF energy in monopolar or bipolar modes. Includes RF generator, handpiece, cooling module, and connection module. Features integrated cryogen metering valve and heating element for cooling control. Connects via industry-standard BNC connector. Class II device under 21 CFR 878.4400.

Indications for Use

Indicated for patients undergoing dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

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

• ThermaCool II (K000944)
• ThermaCool II (K003183)

Submission Summary (Full Text)

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OCT = 4 2001

# KO13034

## k) Premarket Notification

mmary of Safety and Effectiveness Information

#### ThermaCool IIA Device Name:

RF Unit, coagulator Common Name(s):

Common Name: Electrosurgical cutting and coagulation device and accessories

## Establishment Name & Registration Number:

Thermage Name: Number: 2954746

#### Classification:

Title 21, Code of Federal Regulations,

\$ 878.4400 Electrosurgical cutting and coagulation device and accessories. (a) Identification. An electrosurgical cutting and coagulation device and accessories in a device intended to remove tissue and control bleeding by use of high-frequency electrical current. (b) Classification. Class II.

ProCode: 79GEI

#### Equivalent Device(s):

Equivalent Device(s):
The modified ThermaCool IIA claims substantial equivalence to the ThermaCool II (K000944 & K003183).

#### Description of the Device:

Description of the Device consists of the same four principal components as the ThermaCool and The ThemaCool II as reviewed under the referenced earlier premarket notifications. The four principal components are:

Se Thermage ThermaCool IIA RF Generator

Se Thermage ThermaCool IIA Handpiece Connection Module

Ses Thermage ThermaCool IIA RF Cooling Module

Se Thermage ThermaCool IIA RF Handpiece Assembly

The device generates radio frequency (RF) energy and operates in either monopolar or bipolar mode as selected I ne user. The device continuously monitors output energy, treatment duration, and measured impedance. When used in monopolar mode, a commercially available dispersive patient return electrode is impleance. When used in bipolar mode, a conners viathe handpiece msett tip and no dispersive electrode is needed. The handpiece attaches to the unit via an industry standard BNC type connector. As before, the intended use of the device is for use in dematologic and general surgical procedures for electrocoagulation and hemostasis.

The system has been modified and now includes a heating element and a new cryogen metering valve within the handpiece. The effect of the change is improving cryogen flow characteristics in the clinical setting.

#### Applicant / Sponsor Name / Address:

Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone [phone] fax

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#### Contact Person:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone [phone] fax

#### Submission Correspondent:

Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone [phone] fax

#### Manufacturing Facility:

Manufacturing i actifity .
At the present time, the ThermaCool IIA is contract manufactured according to Thermage specifications.

#### Performance Standards:

Performance Standards.
There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation I hele and accessories. However, voluntary standards such as in-house Standard Operating Procedures and device and accessories. Trowerer, velazary of and utilized in the production of the device.

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a symbol that looks like three stylized lines that resemble a bird in flight.

OCT = 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Pamela Buckman Director, Regulatory and Clinical Affairs Thermage, Inc. 4058 Point Eden Way Hayward, California 94545-3721

Re: K013034

Trade/Device Name: ThermaCool IIA Regulation Number: 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: September 7, 2001 Received: September 10, 2001

Dear Ms. Buckman:

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 - Ms. Pamela Buckman

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mankeing your and equivalence of your device to a legally prematicated 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 and If you desire specific au roo for your witto diagnostic devices), please contact the Office of additionally 21 CF N Fat 607.10 for the raily, for questions on the promotion and advertising of Compliance at [phone] - 122215 Compliance at [phone]. Also, please note the your device, picuse commor and seemes to premarket notification" (21CFR Part 807.97). Tegulation chitica, "Misorananing of responsibilities under the Act may be obtained from the Outler general information on your respational 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,

Susan Walter, MP

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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Page 1 of 1

510(k) NUMBER: k013034

DEVICE NAME : ThermaCool IIA

INDICATIONS FOR USE:

The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) (Division Sigh Oral), Restorative Division of egical Devices

510(k) Number k013034

OR

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

**Prescription Use**
(Per 21 CFR 801.109)

ThermaCool510.doc