ULTRATHERM (908)

K964083 · Sie-Med, Inc. · IMJ · Apr 3, 1997 · Physical Medicine

Device Facts

• Record ID: K964083
• Device Name: ULTRATHERM (908)
• Applicant: Sie-Med, Inc.
• Product Code: IMJ · Physical Medicine
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.

Device Story

Shortwave diathermy device; generates deep heat in body tissues. Input: electrical power; Output: electromagnetic energy for therapeutic heating. Operated by clinicians in clinical settings. Replaces tube generator with compact transistor generator; reduces operating voltage and leakage. Features LED display and luminous band for output monitoring; touch-sensitive contacts for mode/intensity selection. Electrodes include non-flammable silicon rubber field electrodes and sheltered coil field electrodes. Enhances safety via reduced impulse peak (400W) and maximal effective output (200W). Assists in pain relief, muscle spasm reduction, and joint contracture management.

Clinical Evidence

No clinical data. Safety and effectiveness established via manufacturer's successful marketing history of similar device in Europe and Canada without recalls or significant adverse experience reports.

Technological Characteristics

Shortwave diathermy; transistor generator; maximal output 200W; impulse peak 400W. Components: non-flammable silicon rubber field electrodes, sheltered coil field electrodes, touch-sensitive contacts, LED control/display. Symmetrical and asymmetrical output sockets.

Indications for Use

Indicated for patients requiring deep tissue heating for the treatment of pain, muscle spasms, and joint contractures.

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

• Ultratherm 808i (K862589)

Submission Summary (Full Text)

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K964083
APR - 3 1997

# 510(k) Summary for Ultratherm 908i

Applicant: SIE-MED Incorporated
991 Aviation Parkway - Suite 100
Morrisville, North Carolina 27560
Contact: Mr. Karl Harbauer, President
Phone: [phone]

Date: October 5, 1996

## Predicate Device: Ultratherm 808i

**Device Description:** The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.

**Changes:** The labeling for the Ultratherm 908i limits its intended uses to those accepted by FDA for class II shortwave diathermy devices. Operating voltage and leakage are significantly reduced by replacing the tube generator with a compact transistor generator. The maximal effective output does not exceed 200 watts. The selected output is kept constantly in the scope of the patient’s coupling conditions and is electronically indicated by the addition of a LED display and luminous band. Safety is enhanced by symmetrical and asymmetrical output sockets for the electrodes, the use of non-flammable silicon rubber field electrodes and sheltered coil field electrodes, and the reduction of impulse peak to 400 watts. Mechanical switches and a small light with a yes/no function have been replaced by touch sensitive contacts with LED control for the selection of operating mode and LED display of output intensity.

The foreign manufacturer of the Ultratherm 908i has independently marketed a similar device in Europe for 4 to 5 years and in Canada for 1 year. The same firm also manufactures the Ultratherm 808i which the present applicant distributes under a premarket notification (K862589) cleared by FDA on August 1, 1986. The safety, effectiveness, and reliability of the Ultratherm 908i have been established by the manufacturer’s successful marketing of a similar device without the need for recall or receipt of significant adverse experience reports. The revised indications and changes in technological characteristics described in this present 510(k) submission enhance the safety and effectiveness of this device.