THERMOMED 1.8

K063748 · Thermosurgery Technologies, Inc. · GEI · Feb 1, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063748
• Device Name: THERMOMED 1.8
• Applicant: Thermosurgery Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.

Device Story

ThermoMed Model 1.8 is a battery-operated electrosurgical instrument; delivers localized current field radio frequency (RF) heat to tissue; selectively destroys diseased tissue. Used in clinical settings for dermatological procedures. Physician operates device to treat benign lesions and basal cell carcinoma. Output is thermal energy; effect is tissue destruction. Clinical benefit includes effective treatment of specified dermatological conditions and basal cell carcinoma with high patient satisfaction and low side effects.

Clinical Evidence

Single-center study (n=60) evaluated safety and efficacy for basal cell carcinoma. 85% of patients showed no evidence of tumor cells upon histological examination 3 months post-treatment. Reported side effects: mild infection (n=2), pain (n=1), lightheadedness (n=1). Patient satisfaction scores (1-10 scale): treatment comfort 8.35, convenience 8.97, side effects 9.02.

Technological Characteristics

Battery-operated electrosurgical instrument; delivers localized current field radio frequency energy. Class II device. Product code GEI.

Indications for Use

Indicated for patients with benign superficial dermatological conditions (warts, molluscum contagiosum, angioma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, dermatophytosis) and basal cell carcinoma.

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

• ThermoMed Model 1.8 (K021117)
• Thermosurgery (K894166)
• ConMed Hyfrecator 2000 (K970493)
• Birtcher (K800617)

Submission Summary (Full Text)

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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional

| 5. 510(k) Summary | K063748 | Page 1 of 2 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submission Date | December 7, 2006 | FEB - 1 2007 |
| Submitter's Name<br>and Address | Thermosurgery Technologies Inc.<br>2901 W. Indian School Rd<br>Phoenix, AZ 82017 | |
| Contact Person | Gene R. Hedin<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Name of Medical<br>Device | Trade Name: ThermoMed Model 1.8<br>Common Name: localized current field radio frequency<br>instrument<br>Classification Name: Device, Electrosurgical, Cutting and<br>Coagulation Accessories, Class II<br>Product Code: GEI / 878.4000/Class II | |
| Substantial<br>Equivalence | ThermoMed Model 1.8 (K021117)<br>Thermosurgery (K894166)<br>ConMed Hyfrecator 2000 (K970493)<br>Birtcher (K800617) | |
| Device<br>Classification | Class II | |
| Device Description | The ThermoMed Model 1.8 is a battery-operated device<br>that delivers precisely controlled localized current field radio<br>frequency heat to selectively destroy certain diseased<br>tissue. | |
| Indications for Use | The device is intended to treat benign superficial<br>dermatological indications that includes; warts, molluscum<br>contagiosm, angioma, fibroma, seborrheic keratoses,<br>acrochordon, syringoma, hydrocystoma, calvus, actinic<br>keratoses, keloids, epidermoid cysts, cystic acne,<br>cutaneous leishmaniasis, atypical mycobacteria, and<br>dermatophytosis. In addition, it is intended to treat basal<br>cell carcinoma. | |
| Summary<br>predicate device<br>SE | The ThermoMed Model 1.8 for this submission is the same<br>instrument as the ThermoMed 1.8 (K02117) currently<br>cleared for marketing in the United States and substantially<br>equivalent to the Thermosurgery (K894166), ConMed | |
| | (K970493) and the Bircher (K800617). This submission if<br>for indications statement changes. A summary of the<br>clinical trial performed under IDE G020145 has been<br>included in this submission. | |
| Safety | The device is the same as the predicate device (K02117).<br>Clinical trial performed under IDE G020145 submitted data<br>shows safety and effectiveness of the device. | |
| Clinical trial<br>summary | A single center study of 60 patients was conducted to<br>evaluate the safety and efficacy of the ThermoMed™ Model<br>1.8 device in the treatment of basal cell carcinoma. Eighty<br>five (85) percent of patients showed no evidence of tumor<br>cells upon histological examination 3 months after a single<br>treatment with the ThermoMed™ device. Treatment related<br>side effects were low, with two reports of mild infection at<br>the treatment site, one report of pain after treatment, and<br>one report of light headedness. Patient satisfaction was<br>high, with average patient ratings as follows: treatment<br>comfort at 8.35, treatment convenience at 8.97, and side<br>effects at 9.02, on a 1-10 scale with 10 being most<br>favorable. | |

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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
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and the comments of the comments of

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thermosurgery Technologies, Inc. % Mr. Gene R. Hedin CEO 2901 W. Indian School Road Phoenix, Arizona 85017

FEB - 1 2007

Re: K063748 Trade/Device Name: ThermoMed Model 1.8 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 7, 2006 Received: December 19, 2006

Dear Mr. Hedin:

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 – Mr. Gene R. Hedin

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 ye

Ka Dio Pm

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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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional

## KO63748

4. Indications for Use Statement

## Indications for Use

510 (k) Number:

Device Name:

ThermoMed Model 1.8

Indications for Use:

The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.

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

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)

Olohe

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

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