(260 days)
The Energex® system is intended to be used as an adjunct to medical therapy for the temporary symptomatic relief of mild to moderate chronic anterior knee pain which is not caused by meniscal, ligament, or cartilage injury.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or specific studies proving a device meets them. The document is an FDA 510(k) clearance letter for the Energex System®, which primarily confirms its substantial equivalence to a predicate device for marketing purposes.
It outlines the device's name, regulation number, regulatory class, product code, and indications for use. However, it does not detail:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about test sets.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Details on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set or how ground truth for training was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Energex Systems, Inc. c/o Marie Marlow M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002
DEC 2 1 2005
Re: K042686
Trade/Device Name: Energex System® Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: NHH Dated: October 3, 2005 Received: October 7, 2005
Dear Ms. Marlow:
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
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Page 2 - Ms. Marie Marlow
systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Muotem MD for
Donna-Bea Tillman, Ph.D., M.P.A., Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042686
Device Name: Energex®
Indications For Use: The Energex® system is intended to be used as an adjunct to medical therapy for the temporary symptomatic relief of mild to moderate chronic anterior knee pain which is not caused by meniscal, ligament, or cartilage injury.
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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.