SW-180 SHORTWAVE THERAPY UNIT

K022846 · Ito Co., Ltd. · IMJ · Jan 28, 2003 · Physical Medicine

Device Facts

• Record ID: K022846
• Device Name: SW-180 SHORTWAVE THERAPY UNIT
• Applicant: Ito Co., Ltd.
• Product Code: IMJ · Physical Medicine
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

Device Story

SW-180 Shortwave Therapy Unit provides therapeutic deep heat to body tissues. Device operates at 27.12 MHz with 80 W output power; supports continuous or pulsed modes. System includes main unit and standard applicator; optional applicators available. User interface features LED screen for parameter selection and status messaging. Operated by healthcare professionals in clinical settings. Output heat facilitates treatment of pain, muscle spasms, and joint contractures.

Clinical Evidence

Bench testing only. Performance testing addressed electrical safety, electromagnetic compatibility, heating patterns, and device integrity checks.

Technological Characteristics

Shortwave diathermy device; 27.12 MHz operating frequency; 80 W output power; continuous and pulsed modes; LED user interface; standard and optional applicators.

Indications for Use

Indicated for patients requiring therapeutic deep heat for relief of pain, muscle spasms, and joint contractures. Prescription use only.

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

• Megapulse II (K973732)

Submission Summary (Full Text)

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K072846

JAN 2 8 2003

# 510(k) Summary

# SW-180 Shortwave Therapy Unit

Common/Classification Name: Shortwave Diathermy Device, 21 CFR 890.5290

Ito Company, Ltd. 3-3-3 Toyotama-Minami Nerima-Ku Tokyo 176-8605, Japan

Contact: H. Okazaki, Prepared: August 26, 2002

### LEGALLY MARKETED PREDICATE DEVICES A.

The SW-180 Shortwave Therapy Unit is substantially equivalent to the Megapulse II (K973732) manufactured by Electro-Medical, Ltd.

#### B. DEVICE DESCRIPTION

The SW-180 Shortwave Therapy Unit consists of a main unit and a standard applicator. Several other types of applicators are available as options. The device may be operated in continuous or pulsed modes. The SW-180 has an output power of 80 W and operates at 27.12 ± .16 MHz.

The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters.

The SW-180 Shortwave Therapy Unit device is a prescription device and the prescription statement is contained in the labeling as required.

#### INTENDED USE ்.

The SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

#### D. SUBSTANTIAL EQUIVALENCE SUMMARY

The SW-180 Shortwave Therapy Unit is a medical device, and it has very similar indications for use as the legally marketed predicate device. The differences do not change the intended therapeutic effect. The SW-180 Shortwave Therapy Unit has the same technological characteristics

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technological characteristics as the predicate device. This premarket notification has described the characteristics of the SW-180 Shortwave Therapy Unit in sufficient detail to assure substantial equivalence except for a few of the characteristics where performance testing was carried out (e.g., electrical safety, EMC).

### TECHNOLOGICAL CHARACTERISTICS E.

The technological characteristics are the same as those of the predicate device and other shortwave diathermy devices.

## F. TESTING

Performance testing carried out by Ito Co, Ltd. on the SW-180 addressed the following issues:

- Electrical Safety; (1)
- (2) Electromagnetic Compatibility;
- Heating Patterns (3)
- Various Integrity Checks (4)

# G. CONCLUSIONS

This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in uppercase letters and is evenly spaced around the circle.

JAN 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ITO Co., Ltd. C/o T. Whit Athey, Ph.D. Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 Brookeville, MD 20833-2233

Re: K022846

Trade/Device Name: SW-180 Shortwave Therapy Unit Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: II Product Code: IMJ Dated: December 28, 2002 Received: December 30, 2002

Dear Dr. Athey:

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 -- Dr. T. Whit Athey

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Sincerely yours,

Mark A. Milliken

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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# STATEMENT OF INDICATIONS FOR USE

K022846 510(k) Number (if known): _

SW-180 Shortwave Therapy Unit Device Name:

Indications For Use:

The SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Mark N. Milburn
Division Sign-on

Engtomative Neurological Devices

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