MEGAPULSE II

K973732 · Pti · IMJ · Jan 23, 1998 · Physical Medicine

Device Facts

• Record ID: K973732
• Device Name: MEGAPULSE II
• Applicant: Pti
• Product Code: IMJ · Physical Medicine
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects: - Increases the extensibility of collagen tissues 1. - 2. Decreases joint stiffness - 3. Relieves pain - 4. Relieves muscle spasm - 5. Increases blood flow The Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications: - Disorders of the musculoskeletal system: 1. muscle spasm joint stiffness, contractures - 2. Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases

Device Story

Megapulse II (Model 3029) is a shortwave diathermy system; delivers therapeutic heat to tissues. Principle of operation: electromagnetic energy application to increase tissue temperature. Clinical application: treatment of musculoskeletal disorders (spasms, stiffness, contractures) and chronic inflammatory conditions (tenosynovitis, bursitis, synovitis, pelvic inflammatory disease). Used in clinical settings by healthcare professionals. Output: controlled thermal energy; intended to increase collagen extensibility, decrease joint stiffness, relieve pain/spasms, and increase blood flow. Prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Shortwave diathermy system; electromagnetic energy source; clinical form factor. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for patients requiring therapeutic tissue heating for musculoskeletal disorders including muscle spasm, joint stiffness, and contractures, and for chronic inflammatory or infective conditions including tenosynovitis, bursitis, synovitis, and chronic inflammatory pelvic diseases.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

Mr. Chris Castel CEO PTI. Incorporated 6700 SW Topeka Boulevard Forbes Field, Building 140 Topeka, Kansas 66619

Re: K973732

> Trade Name: Megapulse II, Model 3029 Regulatory Class: II Product Code: IMJ Dated: January 7, 1998 Received: January 12, 1998

Dear Mr. Castel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Castel

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

focollf

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973732

Device Name: MEGAPULSE II

## INDICATIONS FOR USE:

Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

- Increases the extensibility of collagen tissues 1.
- 2. Decreases joint stiffness
- 3. Relieves pain
- 4. Relieves muscle spasm
- న. Increases blood flow

The Megapulse Shortwave Diathermy system is indicated for use in the following con-Ditions or applications:

- Disorders of the musculoskeletal system: 1. muscle spasm
joint stiffness, contractures ----------

- 2. Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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ral Restorative Devices 2473732
E Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)