(63 days)
The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device named PAIN-X-2000. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information about sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics based on this document.
The document only states the device's indications for use: "to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature." It then confirms its regulatory classification and allows it to be marketed.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 22 1998
Mr. Randall Everett President Diomedics, Inc. 3817 S.W. 15th Street Gainesville, Florida 32608
Re: K982546 Trade Name: Pain-X-2000 Models: 300, 600, 900, 1600, 2500 and 5700 Regulatory Class: II Product Codc: IL Y Dated: July 16, 1998 Received: July 21, 1998
Dear Mr. Everett:
We have reviewed your Section 510(k) notification of intent to market the device referenced ahove and we 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). You may, therefore, market the device, subject to the general control: 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Randall Everett
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 (301) 594-4595. 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"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
f coole
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Officc of Devicc Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
510(k) Number: _K982546
Device Name _PAIN-X-2000
Indications for Use:
The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
(Please do not write below this line - Coutinue on another page if needed)
Concurrence of CDRH Office of Device Evaluation (ODE)
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510kj Num
Prescription Use (per 21 CFR 801.109)
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Over-the Counter Use
§ 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.