SELITHERM, MODEL C100

K030382 · Selicor, Inc. · IMJ · Apr 1, 2003 · Physical Medicine

Device Facts

• Record ID: K030382
• Device Name: SELITHERM, MODEL C100
• Applicant: Selicor, Inc.
• Product Code: IMJ · Physical Medicine
• Decision Date: Apr 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Diathermy Component. Indications for Use: To generate deep heating within body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures. Muscle Stimulator Component To increase local blood flow, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, and immediate post surgical stimulation of calves to prevent deep vein thrombosis.

Device Story

SeliTherm C100 is a combination device featuring a shortwave diathermy component and a muscle stimulator component. Diathermy component generates deep tissue heating to treat pain, muscle spasms, and joint contractures. Muscle stimulator component provides electrical stimulation to increase local blood flow, facilitate muscle re-education, relax spasms, prevent disuse atrophy, and provide post-surgical calf stimulation for DVT prevention. Device is intended for clinical use by healthcare professionals. Output effects include thermal tissue modulation and neuromuscular electrical stimulation to support rehabilitation and post-operative recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combination device consisting of a shortwave diathermy unit (21 CFR 890.5290) and a muscle stimulator (21 CFR 890.5850). Product codes IMJ and IPF. Class II device.

Indications for Use

Indicated for patients requiring deep tissue heating for pain relief, muscle spasms, or joint contractures, and patients requiring muscle stimulation for blood flow, re-education, spasm relaxation, atrophy prevention, or post-surgical DVT prophylaxis.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 1 2003

Selicor. Inc. James B. Bingham Manger, Regulatory Affairs 7000 North Mopac, Second Floor Austin, Texas 78731

Re: K030382

Trade/Device Name: SeliTherm Model C100 Regulation Number: 21 CFR 890.5290 and 21 CFR 890.5850 Regulation Name: Shortwave Diathermy Device Regulatory Class: Class II Product Code: IMJ and IPF Dated: January 29, 2003 Received: February 5, 2003

Dear Mr. Bingham:

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.

{1}------------------------------------------------

Page 2 - Mr. James B. Bingham

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 yours,

Mark N. Millman

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

{2}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

Ver/ 3 - 4/24/96

Selicor, Inc. Applicant:____

510(k) Number (if known):_ Unknown

Device Name:_SeliTherm C100

Diathermy Component. Indications for Use: To generate deep heating within body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.

> Muscle Stimulator Component To increase local blood flow, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, and immediate post surgical stimulation of calves to prevent deep vein thrombosis.

Concurrence of CDRH, Office of Device Evaluation (OD)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

R. Mark A. Millican

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

510(k) Number -

Number K030382