SSIR SYSTEM

K014208 · Russian-American Technology Associates, Inc. · ILY · Jul 2, 2002 · Physical Medicine

Device Facts

• Record ID: K014208
• Device Name: SSIR SYSTEM
• Applicant: Russian-American Technology Associates, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for: - the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; - the temporary increase in local circulation; and / or - the temporary relaxation of muscle.

Device Story

SSIR System is an infrared lamp providing continuous heat therapy. Device consists of a power supply unit with controls and a treatment module (Velcro Strap Model). Treatment module contains a silicon diode housed in black anodized aluminum, covered with black cotton felt for skin contact. Device is placed directly on the skin to emit infrared energy. Power supply includes a green LED indicator for active status. Used to elevate tissue temperature for pain relief, increased circulation, and muscle relaxation. Operates via electrical power supply.

Clinical Evidence

Bench testing only. Functional performance and electrical safety testing were conducted to verify that the device produces tissue temperatures consistent with literature and FDA-accepted therapeutic heat performance specifications.

Technological Characteristics

Infrared lamp utilizing silicon diodes as the energy source. Treatment module features black anodized aluminum housing and black cotton felt contact surface. Power supply housed in plastic. Device is intended for direct skin contact. No software or complex algorithms described.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, increased local circulation, or muscle relaxation.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Photonic Stimulator (Bales Scientific, Inc.)
• Super Nova / Acubeam systems (Light Force Technology, Inc.)
• Light Patch (BioScan, Inc.)
• Nu Photonics Pain Therapist system (Nu Photonics, Inc.)

Submission Summary (Full Text)

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# 510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

# SSIR SYSTEM

## I. Applicant:

Russian-American Technology Associates, Inc. 23667 Patterson Road Robertsdale, AL 36567 USA

Key Contact: Floyd T. Neth, Ph. D. President

Date Revised: June 30, 2002

## II. Device Name

| Proprietary Name: | SSIR System |
|----------------------|--------------------------------|
| Common / Usual Name: | Infrared Lamp |
| Classification Name: | Infrared Lamp (21 CFR 890.555) |
| Product Code: | ILY |

## III. Predicate Device

The SSIR System is substantially equivalent to other infrared lamps currently in commercial distribution such as the Photonic Stimulator manufactured by Bales Scientific, Inc., the Super Nova / Acubeam systems manufactured by Light Force Technology, Inc., Light Patch manufactured by BioScan, Inc., and Nu Photonics Pain Therapist system manufactured by Nu Photonics, Inc.

## IV. Intended Use of the Device

The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:

- the temporary relief of minor muscle and joint pain and stiffness, minor p arthritis pain, or muscle spasm;
- > the temporary increase in local circulation; and / or
- the temporary relaxation of muscle. や

## V. Description of the Device

The SSIR System is a modern, safe, and easy-to-use devices, which provide continuous heat therapy. The SSIR System consists of a power supply that houses the electronics and controls and treatment module (Velcro Strap Model) that contain the infrared radiating element. The power supply is manufactured from a plastic material that is used in similar products currently in commercial

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distribution by various medical device companies. The power supply houses a green LED light to indicate when the unit is active.

The Velcro Strap Model is a treatment module comprised of a silicon diode in a black anodized aluminum housing with attached velcro straos. The area of this module that comes in contact with the treatment site is covered with black cotton feit.

## VI. Summary of the technical characteristics of the SSIR System to the referenced predicate devices.

The SSIR System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. The device utilizes infrared diodes to generate topical heating for the purpose of elevating tissue temperatures for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or musde spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The System is intended to be placed directly on the skin to provide heating.

#### VII. Testing

Testing of the SSIR System included functional performance testing and electrical safety testing.

# VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the SSIR System has the same intended uses, with similar functional and performance characteristics. The SSIR System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature1 and accepted by the Federal Food and Drug Administration.

The SSIR System performs as intended and does not raise any new safety or efficacy issues.

ર્ભ

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Image /page/2/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 to the right, resembling a bird-like shape.

JUL = 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Russian-American Technology Association, Inc. c/o Ms. M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 8303 S.W. Freeway, Suite 835 Houston, Texas 77074-1601

Re: K014208

Trade/Device Name: SSIR System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: April 18, 2002 Received: April 19, 2002

Dear Ms. Heinrich:

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. Iisting 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 - Ms. Joyce Heinrich

.. . . . . .

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

510(k) Number (if known):

Device Name: SSIR System

# Indications for Use:

The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:

- the temporary relief of minor muscle and joint pain and stiffness, minor > arthritis pain, or muscle spasm;
- > the temporary increase in local circulation; and / or
- the temporary relaxation of muscle. >

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use:** OR
(Per 21 CFR 801.109)

Over the Counter Use: (Optional Format 1-2-96)

(Division Sign-Off)

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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