(168 days)
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
OmniProbe Infrared Lamp, OmniProbe 500 Infrared Lamp Control Unit
The provided FDA letter for K060191 describes the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. However, it is a 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device. This type of regulatory submission typically does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, or ground truth establishment in the way that would be found in a De Novo or PMA submission for novel devices or higher-risk devices.
Therefore, many of the requested details about acceptance criteria and study particulars are not present in the provided text. The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and general controls.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The 510(k) clearance is based on substantial equivalence to a predicate device, not on specific acceptance criteria and performance metrics for the new device as would be detailed in a PMA or De Novo.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document does not describe any specific clinical or performance studies with test sets, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available in the provided text. A 510(k) clearance, especially for an infrared lamp, typically does not involve establishing ground truth by a panel of experts in the way an AI/CAD device would. The safety and effectiveness are inferred from the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available in the provided text. No adjudication method for a test set is mentioned as no such study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not available in the provided text. The device is an infrared lamp, not an AI/CAD system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available in the provided text. The device is not an algorithm; it's a physical medical device (an infrared lamp).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not available in the provided text. Ground truth in the context of diagnostic or AI devices is not relevant to an infrared lamp's 510(k) submission.
8. The sample size for the training set
- Not applicable/Not available in the provided text. This device does not involve a training set as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable/Not available in the provided text. As there is no training set, there is no ground truth establishment for one.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for the OmniProbe Infrared Lamp and OmniProbe 500 Infrared Lamp Control Unit. Its purpose is to state that the device is "substantially equivalent" to legally marketed predicate devices. This regulatory pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and similar safety and effectiveness profile as a previously cleared device. It does not typically require or describe the detailed performance studies, specific acceptance criteria, sample sizes, or ground truth establishment that would be associated with novel or higher-risk devices, especially those incorporating AI or complex diagnostic algorithms.
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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
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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 LampOmniProbe 500 Infrared Lamp Control Unit |
| LED Pad Model Numbers: | 200LED-P2, 200LED-LE, 200LED-S, 200LED-K,200LED-N, and 200LED-EFor use with the OmniProbe 500 Control Unitand/or any external medical grade powersource providing an isolated 5 to 12VDC powersource. |
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
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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.
§ 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.