TTI THERMOMED MODEL 1.8 INSTRUMENT

K021117 · Thermosurgery Technologies, Inc. · GEI · May 2, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021117
• Device Name: TTI THERMOMED MODEL 1.8 INSTRUMENT
• Applicant: Thermosurgery Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, svringoma, hydrocystoma, clavus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis.

Device Story

TTI ThermoMed Model 1.8 delivers localized current field (LCF) radio frequency (RF) heat to destroy diseased tissue. Device consists of handheld wand with autoclaveable energy applicator. Operator selects target temperature; device provides audial/visual signals at 30-second intervals once target is reached. Used by clinicians for superficial dermatological conditions. Modification updates temperature controller from analog to digital. Output heat facilitates tissue destruction; clinical benefit is removal of benign lesions.

Clinical Evidence

No clinical data provided. Device modification evaluated via risk analysis and mitigation processes.

Technological Characteristics

Localized current field (LCF) radio frequency (RF) instrument. Features autoclaveable energy applicator. Modification includes digital temperature controller (previously analog).

Indications for Use

Indicated for treatment of benign superficial dermatological conditions including warts, molluscum contagiosum, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, clavus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. Contraindicated for patients with implanted electronic devices, metallic implants, or pregnancy.

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

• RDM Thermosurgery™ Localized Current Field RF Instrument (K894166)

Submission Summary (Full Text)

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# MAY 0 2 2002

### KO21117

#### 510(k) Summary

- 1. Submitter name and address:
Thermosurgery Technologies Inc. (formerly RDM International, Inc.) 2901 West Indian School Road Phoenix, AZ 85017-4162

Establishment registration:

Phone:

Contact person:

Date summary was prepared:

- 2. Trade name:
Common name:

Classification name:

Product code / Regulation no .:

- 3. Predicate device:
Product code / Regulation no.:

- 4. Description of device:
- 5. Intended Use:
- Technological comparison: 6.
urgery
(formerly RDM International, Inc.)
2901 West Indian School Road
Phoenix, AZ 85017-4162

2027460

602-264-7300

Gene R. Hedin, CEO

March 15, 2002

TTI ThermoMed™ Model 1.8 Instrument

Localized current field radio frequency instrument

Device, Electrosurgical, Cutting and Coagulation Accessories, Class II GEI / 878.4400

K894166 - RDM Thermosurgery™ Localized Current Field RF Instrument GEI / 878.4400/ClassII

The TTI ThermoMed device delivers controlled localized current field (LCF) radio frequency (RF) heat to selectively destroy certain diseased tissue. RF energy is delivered to the dermal surface via a hand held wand with an autoclaveable energy applicator. For convenience, an audial and visual signal indicates the elapsed treatment time in 30-second intervals after the selected target temperature is reached.

The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, svringoma, hydrocystoma, clavus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis.

Treatment of patients with implanted electronic devices, patients with metallic implants and pregnant women is contraindicated.

This Special 510(k) device modification is submitted to provide notification of a change in the temperature controller from analog to digital control. No negative effects on safety or effectiveness have been found after the risk analysis and risk mitigation process. This change is rated as a "minor level of concern" per the May 1998 software quidance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

ood and Drug Administration 0 Corporate Boulevard Rockville MD 20850

Mr. Gene R. He

**MAY 02 2002**

Mr. Gene R. Hedin President and CEO. Thermosurgery Technologies, Inc. 2901 West Indian School Road Phoenix, AZ 85017-4162

Re: K021117

Trade/Device Name: TTI ThermoMed™ Model 1.8 Instrument Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 5, 2002 Received: April 8, 2002

Dear Mr. Hedin:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreativent of the enactment date of the Medical Device Amendments, or to conniner or proc to The) 2017 - 11:55 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 I ou may) are se or visions 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 If your de rior is oldsined tontrols. 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 r head be a note 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 Of It Fat 607); accember (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 i 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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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Special 510(k): Device Modification TTI ThermoMed™ Model 1.8 Instrument

# PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

(As required by ODE for all 510(k) received after Jan. 1, 1996.)

510(k) Number:

### Kozilly

Device Name:

TTI ThermoMed™ Model 1.8 Instrument

#### Indications For Use:

The TTI ThermoMed™ Model 1.8 Instrument provides the therapeutic modality to treat the following benign diseases and conditions:

- Warts 1.
- Molluscum Contagiosum 2.
- Anqioma 3.
- Fibroma 4.
- Seborrheic Keratoses ട.
- Acrochordon 6.
- Syringoma 7.
- Hydrocystoma 8.
- Clavus த.
- Actinic Keratoses 10.
- Keloids 11.
- Epidermoid Cysts 12.
- Cystic Acne 13.
- Cutaneous Leishmaniasis 14.
- Atypical Mycobacteria 15.
- Dermatophytosis 16.

(Do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

/510(k) Number K021117

Prescription Use _ (Per 21 CFR 801.109) ਾ

Over-The-Counter Use