(79 days)
The OmniLight VL-3000, PL-3000, DL-3000 and WL-3000 are indicated for emitting 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 pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the OmniLight VL-3000, PL-3000, DL-3000, and WL-3000 devices. It states that these devices are substantially equivalent to legally marketed predicate devices.
However, this letter does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: The letter only indicates the device's intended use (topical heating for pain relief) and its classification as an infrared lamp. It does not provide any specific quantitative performance metrics or acceptance thresholds.
- Sample size and data provenance for a test set: No information regarding a test set, its size, or its origin (e.g., country, retrospective/prospective) is present.
- Number and qualifications of experts for ground truth: There's no mention of expert involvement in establishing ground truth.
- Adjudication method: Not applicable as no ground truth establishment is described.
- MRMC comparative effectiveness study results: This is not a study focused on human reader performance with or without AI, but rather a clearance for a physical therapy device.
- Standalone algorithm performance: This is not an AI algorithm, but a physical therapy device.
- Type of ground truth used: No ground truth data is discussed.
- Training set sample size: Not applicable as it's not an AI/machine learning device.
- Ground truth establishment for the training set: Not applicable.
The letter's purpose is to grant market clearance based on substantial equivalence to existing devices, not to detail the performance study results. To answer your questions, one would need access to the 510(k) submission itself, or related performance studies that would have been part of establishing substantial equivalence for the predicate device, or for the OmniLight device if specific performance claims were being made beyond those of the predicate.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three parallel lines that curve upwards and to the right, resembling a stylized human figure.
Public Health Service
MAY 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rick Murdoch OmniLight, Inc. 45 Dusty Trail Drive Placitas. New Mexico 87043
Re: K040664
Trade/Device Name: OmniLight VL-3000, DL-3000, DL-3000 and WL-3000 Regulation Number: 21 CFR §890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 3, 2004 Received: May 6, 2004
Dear Mr. Murdoch:
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 gencral ccntrols 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 madc 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.
{1}------------------------------------------------
Page 2 - Rick Murdoch
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 premaince 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. Millerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K040664
Device Name: _ OmniLight VL-3000, PL-3000, DL-3000 and WL-3000 Indications for Use: The OmniLight VL-3000, PL-3000, DL-3000 and WL-3000 are indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of clevating tissue temperature for the temporary relief of minor muscle and joint pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood i circulation.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASF. DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkerson
storative, and
510(k) Number K040664
N/A