(133 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML-powered medical devices. The intended use describes a simple heating device for pain relief.
Yes
The device is intended for the relief of muscle and joint pain, which falls under therapeutic uses.
No
The "Intended Use / Indications for Use" describes therapeutic actions (elevating tissue temperature for pain relief), not diagnostic purposes. There is no mention of identifying or characterizing a disease or condition.
No
The provided 510(k) summary describes a device that provides "topical heating" for pain relief. This function inherently requires a hardware component to generate heat and apply it to the body. A software-only device cannot perform this physical action.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide topical heating for the relief of muscle and joint pain, stiffness, arthritis pain, and muscle spasm. This is a therapeutic application, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided description does not involve any such examination of specimens.
The device's function is to apply heat externally to the body for therapeutic purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Provide topical heating for the purpose of elevating tissue temperature for the relief of muscle and joint pain and stiffness, minor arthritis pain and muscle spasm.
Product codes
ILY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The HHS logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
OCT 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Irradia AB c/o Theo Russo-Larsson President US Medata, LLC 20101 SW Birch Street, #272 Newport Beach, California 92660
Re: K051548
Trade/Device Name: Irradia MID-Laser (S3) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 30, 2005 Received: October 4, 2005
Dear Mr. Russo-Larsson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in 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 r ou may, the Croy isions 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 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- Theo Russo-Larsson
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,
Barbara Prueher
to
Mark N. Melkerson Acting 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): K051548
Irradia MID-Laser (S3) Device Name:
Indications For Use:
Provide topical heating for the purpose of elevating tissue temperature for the r rovide topiour neating for uscle and joint pain and stiffness, minor arthritis pain and muscle spasm
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)
urrence of CDRH, Office of Device Evaluation (ODE) Conc
Harshaw Chelius
Division of General, Restorative, and Neurological Devices
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510(k) Number K051548