(48 days)
The Light Relief Infrared Lamp is an over-the-counter device intended for use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints.
This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
- Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness.
- Provides temporary relief of minor aches and pains in muscles and joints.
- Aids in the relaxation of muscles.
- Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief.
- Provides a temporary increase in local blood circulation.
The Light Relief Infrared Lamp is a pain relief device consisting of a hand-held module with a flexible pad, containing an array of 59 colored and infrared LED's, and a power supply. Minor design changes have been made to the device, including: an increase in the pad size and number of LEDs; addition of rechargeable battery option, automatic shut off feature, internal heating element and frequency options; and changes to the pad material, pad attachment method and body strap closure method.
This is a 510(k) summary for the Light Relief Infrared Lamp, which is a therapeutic heating device. The document states that the device is substantially equivalent to a predicate device (Light Relief, K993686) and that no clinical studies or specific performance acceptance criteria are mentioned for the 510(k) clearance process beyond substantial equivalence to the predicate device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical performance criteria. The basis for clearance is "Substantial Equivalence" to the predicate device (Light Relief, K993686). | The modified Light Relief Infrared Lamp is stated to "share the same intended use, and similar design features and functional features" as the unmodified (predicate) device. The device modifications (increase in pad size and number of LEDs, addition of rechargeable battery option, automatic shut off feature, internal heating element and frequency options, and changes to the pad material, pad attachment method, and body strap closure method) are stated to "not change the indications for use or raise any new issues of safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned in this 510(k) summary for the purpose of demonstrating performance against acceptance criteria. The clearance is based on a comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. As no specific 'test set' for performance evaluation against acceptance criteria is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned in this document. The submission focuses on substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is an infrared lamp, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device itself is intended for direct user application.
7. The Type of Ground Truth Used:
Not applicable in the context of a "ground truth" for an algorithm's performance. The basis for clearance is demonstrating that the device itself is substantially equivalent to a legally marketed predicate device for its intended use of providing temporary relief of minor aches and pains through heat.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device (infrared lamp), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved for this device.
§ 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.