(193 days)
890.5700, 890.5700, 890.5700, 890.5700
Not Found
No
The description focuses on basic infrared heating technology and control electronics, with no mention of AI/ML terms or functionalities.
Yes.
The device's stated intended use is 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," which are therapeutic benefits.
No
Explanation: The device description and intended use clearly state that the SSIR System is for therapeutic purposes (topical heating for pain relief, increased circulation, muscle relaxation) and does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states the system consists of a power supply and a treatment module containing an infrared radiating element, which are hardware components.
Based on the provided information, the SSIR System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, circulation increase, muscle relaxation). This involves direct interaction with the patient's body.
- Device Description: The description details a system that emits infrared energy and is applied externally to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. The SSIR System operates in vivo (on the body).
N/A
Intended Use / 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.
Product codes
ILY
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing of the SSIR System included functional performance testing and electrical safety testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters are 'K014208'. The characters are written in a simple, slightly rough style, suggesting they were written quickly or with a thick marker. The numbers are easily readable.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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