(168 days)
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No
The summary describes a simple infrared lamp for topical heating and pain relief, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "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," which are therapeutic purposes.
No
The device is described as emitting infrared energy for topical heating to relieve pain, stiffness, and increase blood circulation. These are therapeutic uses, not diagnostic. A diagnostic device would be used to identify or determine the nature of a disease or condition.
No
The device description explicitly mentions "OmniProbe Infrared Lamp" and "OmniProbe 500 Infrared Lamp Control Unit," indicating physical hardware components that emit infrared energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies energy to the body for therapeutic purposes (heating tissue, relieving pain, increasing circulation). This is a therapeutic device, not a diagnostic one.
- Device Description: The description mentions an "Infrared Lamp" and "Control Unit," which are consistent with a device that emits infrared energy for heating.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis or monitoring of a disease or condition based on sample analysis.
Therefore, this device falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to for use to emit 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
Product codes
ILY
Device Description
OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit.
LED Pad Model Numbers: 200LED-P2, 200LED-LE, 200LED-S, 200LED-K, 200LED-N, and 200LED-E.
For use with the OmniProbe 500 Control Unit and/or any external medical grade power source providing an isolated 5 to 12VDC power source.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Accelerated Care Plus Corp. % Intertek Testing Services Mr. Neil E. Devine, Jr. Senior Staff Engineer 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K060191
Trade/Device Name: OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: IL Y Dated: June 27, 2006 Received: June 28, 2006
Dear Mr. Devine:
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, Jrug, 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, TDA moral 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 not 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
1
Page 2 - Mr. Neil E. Devine, Jr.
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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Herber Semenias
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for use
| 510(k) Number (if known): | K060191 |
|---|---|
| Device Name: | OmniProbe Infrared Lamp |
| OmniProbe 500 Infrared Lamp Control Unit | |
| LED Pad Model Numbers: | 200LED-P2, 200LED-LE, 200LED-S, 200LED-K, |
| 200LED-N, and 200LED-E | |
| For use with the OmniProbe 500 Control Unit | |
| and/or any external medical grade power | |
| source providing an isolated 5 to 12VDC power | |
| source. |
Indications for Use:
This device is intended to for use to emit 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
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
AND/OR
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulud Lumer
Division of General, Restorative, and Neurological Devices
510(k) Number K060191
This document is the property of Accelerated Care Plus and must be accounted for. Information here in is considered confidential. Do not reproduce it, reveal it to an unauthorized person or send it outside of Accelerated Care Plus without written authorization from Accelerated Care Plus.