AUTO*THERM 395, MODEL ME 395

K022458 · Mettler Electronics Corp. · IMJ · Sep 26, 2002 · Physical Medicine

Device Facts

• Record ID: K022458
• Device Name: AUTO*THERM 395, MODEL ME 395
• Applicant: Mettler Electronics Corp.
• Product Code: IMJ · Physical Medicine
• Decision Date: Sep 26, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.

Device Story

Auto*Therm 395 is a shortwave diathermy device operating at 27.12 MHz for deep tissue heating. It utilizes condenser and electromagnetic coil fields in continuous or pulsed modes. The device is a mobile, cabinet-mounted unit with wheels, operated by clinicians in clinics or medical practices. It features a membrane control panel, intensity potentiometer, and digital LED displays for power output (watts) and timer settings. A patient-operated emergency-OFF ripcord is included for safety. The device delivers energy to body tissues to induce therapeutic heating, which clinicians use to manage pain, muscle spasms, blood flow, and joint mobility. It does not incorporate complex software or AI algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Shortwave diathermy device operating at 27.12 MHz (±0.6%). Modes: Inductive and capacitive. Power: 200W (rms) continuous, 30W (rms)/400W (peak) pulsed. Safety: Class II, Type BF. Interface: Membrane control panel, LED bar graph, 7-segment digital display. Configuration: Cabinet-mounted with wheels. Power supply: 115/230 VAC, 50/60 Hz.

Indications for Use

Indicated for patients requiring deep tissue heating for pain relief, reduction of muscle spasms, localized increase in blood flow, and increased range of motion for contracted joints.

Regulatory Classification

Identification

A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.

Special Controls

*Classification: Class II (special controls).* The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. (ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined: (A) Peak output power; (B) Pulse width; (C) Pulse frequency; (D) Duty cycle; (E) Characteristics of other types of modulation that may be used; (F) Average measured output powered into the RF antenna/applicator; (G) Specific absorption rates in saline gel test load or other appropriate model; (H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and (I) Characterization of the deposited energy density in saline gel test load or other appropriate model. (iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use. (v) Labeling must include the following: (A) Output characteristics of the device; (B) Recommended treatment regimes, including duration of use; and (C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications. (vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.

Predicate Devices

• Curapuls 419 (K861248)

Submission Summary (Full Text)

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# AUTO*THERM ® 395, MODEL ME 395 510(K) SUMMARY

K022458

| Submitter's Name: | Mettler Electronics Corp. |
|-------------------|-------------------------------------------------|
| Address: | 1333 South Claudina Street<br>Anaheim, CA 92805 |

SEP 2 6 2002

Telephone: [phone]

Contact: Robert E. Fleming Director, QA/RA

Date Prepared: July 26, 2002

### Device Name:

- a. TRADE NAME:
- b. CLASSIFICATION NAME:
- c. COMMON NAME:

Auto*Therm® 395, Model ME 395 Shortwave diathermy Shortwave diathermy

#### Predicate Device:

- a. TRADE NAME: Curapuls 419
- b. 510(k) Number: K861248

### Description of Device:

The Auto*Therm 395 is a shortwave diathermy device that operates at 27.12 MHz. It provides traditional shortwave diathermy therapy using condenser and electromagnetic coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and the medical practice.

The ME 395 has four wheels for easy transportation between treatment rooms. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 395.

The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting the cables for the condenser and coll applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.

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# AUTO*THERM ® 395, MODEL ME 395 510(K) SUMMARY

#### Device Intended Use Statement:

510(k) Number: TBD

Device Name: Auto*Therm® 395, Model ME 395

Indications for use:

- 1. Pain relief
- 2. Reduction of muscle spasm
- 3. Localized increase in blood flow
- 4. Increase range of motion of contracted joints.

### Comparison of Technological Characteristics Between Auto*Therm® 395, Model ME 395 and Predicate Devices: (see following page)

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# AUTO*THERM ® 395, MODEL ME 395 510(K) SUMMARY

### Comparison of Technological Characteristics Between Auto*Therm® 395, Model ME 395 and Predicate Devices:

| FEATURE | AUTO*THERM 395 | CURAPULS 419 |
|-------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Mains Supply | 115 VAC, ±10%, 50/60 Hz<br>230 VAC, ±10%, 50/60 Hz | 110, 127, 220 or 240 VAC<br>50/60 Hz |
| FDA Class | II | II |
| Safety<br>Classification | 1 Type BF | 1 Type BF |
| Frequency | 27.12 MHz, ±0.6% | 27.12 MHz, ±0.6% |
| Pulse Repetition<br>Frequency (PRF) | 70 Hz/350 Hz | 15-200 Hz in 10 steps |
| Pulse Duration<br>(PD) | 2 mSec/0.4 mSec | ± 400 µSec |
| HF out continuous | 200 W (rms) @ 50 Ω | 450 W (rms) @ 70 Ω |
| HF out pulsed | 30 W (rms)<br>400 W (peak) @ 50 Ω | 1000 W (peak) @ 70 Ω |
| Modes | Inductive & Capacitive | Inductive & Capacitive |
| Timer | Membrane switch pads<br>Digital Indication (min) | Rocker switch<br>Digital indication (min) |
| Maximum Time | 30 minutes | 30 minutes |
| Output Control | Intensity potentiometer | Intensity potentiometer |
| Output Display | LED bar graph reflects %<br>contact + 3-digit, 7-segment<br>display of watts | Bar display intensity meter with<br>silk-screened numerals (1-10)<br>around intensity control |
| Inductive coil<br>electrodes | Yes | Yes |
| Flexible Induction<br>electrode | Yes | Yes |
| Capacitive plate<br>electrodes | Yes | Yes |
| Soft rubber<br>electrodes | Yes | Yes |
| Configuration | Cabinet-mounted with wheels | Cabinet-mounted with wheels |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2002

Mettler Electronics Corp. Robert E. Fleming Director, QA/RA 1333 South Claudina Street Anaheim, California 92805

Re: K022458

Trade/Device Name: Auto*Therm 395, Model ME 395 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Device Regulatory Class: Class II Product Code: IMJ Dated: July 26, 2002 Received: July 26, 2002

Dear Mr. Fleming:

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. Robert E. Fleming

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 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mack n Mellever

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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# INDICATIONS FOR USE STATEMENT AUTO*THERM® 395, ME 395

Indications for use -

Shortwave diathermy delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

- 1. Relieving pain;
- 2. Reducing muscle spasm;

3. Increasing range of motion of contracted joints using heat and stretch techniques; and

4. Increasing blood flow to tissues in the treatment area.

Mark H. Millikan

vision of General, Restorative and Neurological Devices 510(k) Number