(53 days)
The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a specific medical device (Rich-Mar AutoPrism Infrared Lamp). It contains information about the regulatory classification, indications for use, and substantial equivalence to predicate devices.
However, it does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, ground truth establishment, or any kind of AI or algorithm performance study. The document is a regulatory communication, not a technical study report.
Therefore, I cannot fulfill your request with the input provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Mr. David Richards Vice President and Director of Regulatory Affairs -Rich-Mar Corporation 15499 East 590th Road PO Box 879 Inola, Oklahoma 74036-0879
Re: K040679
Trade/Device Name: Rich-Mar AutoPrism Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Codc: ILY Dated: March 11, 2004 Received: March 15, 2004
Dear Mr. Richards:
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 mcan 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 – Mr. David Richards
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melleman
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Rich-Mar AutoPrism
Indications For Use:
The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provirle topical heating for the temporary increase in local blood circulation, tempora y relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore me itioned conditions
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS L NE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offic : of Device E.valuation (ODE)
Mark N. Milleesen
- Restorative, and Neurological Devices
K040679
510(k) Number
N/A