(91 days)
The LUMIX CPS Series IR Lamp Systems are intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
The LUMIX CPS Series IR Lamp Systems are intended for use as therapeutic heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The LUMIX CPS Series IR Lamp Systems deliver visible and invisible laser light beams at wavelengths between 650 and 1064 nm using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser guide light with 3 mW of power. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable. The control consoles are made of standard medical PVC material and are designed to be placed on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display. The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiber optic cables. The probes contain a protective lens at the aperture, which is made of glass suitable for medical applications.
This document is a 510(k) premarket notification for the LUMIX CPS Series IR Lamp Systems. It does not describe a study involving an algorithm or artificial intelligence, so many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on what is applicable to this medical device submission:
1. Acceptance criteria and reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a numerical threshold for a study. Instead, it demonstrates compliance with recognized medical device standards and establishes "substantial equivalence" to predicate devices. The reported device performance is primarily described through its intended therapeutic action and compliance with safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1:2006 (General Safety) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60825-1:2014 (Laser Safety) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60601-1-2:2010 (EMC) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60601-1-6:2013 (Usability) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 60601-2-22:2012 (Laser Equipment Specific) | Systems are manufactured to comply with this standard. |
| Compliance with IEC 62304:2006 (Software Life Cycle) | Systems are manufactured to comply with this standard. |
| Compliance with ISO 14971:2012 (Risk Management) | Systems are manufactured to comply with this standard. |
| Functional performance as a therapeutic heat lamp | Non-invasive, emits light energy for topical heating to elevate tissue temperature. |
| Delivers visible and invisible laser light at 650-1064 nm | Specifies use of gallium arsenide (GaAs) diode sources. |
| Achieves therapeutic elevation of tissue temperature | Stated purpose for temporary relief of various pains/spasms, and temporary increase in local blood circulation/muscle relaxation. |
| Substantial equivalence to predicate devices | Determined by FDA to be substantially equivalent. |
| Does not raise new safety or efficacy issues | Explicitly stated in conclusions. |
2. Sample size used for the test set and the data provenance
Not Applicable. This submission focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison to predicate devices, rather than a clinical trial with a "test set" of patient data. The "testing" mentioned refers to engineering and performance testing of the device itself (functional, electrical safety).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. As there was no clinical test set of patient data, there was no need for expert adjudication of ground truth for medical conditions.
4. Adjudication method for the test set
Not Applicable. No test set requiring adjudication was used.
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. This device is an infrared lamp, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical infrared lamp system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. The "ground truth" for this submission revolves around engineering specifications, safety standards, and the established therapeutic principles of infrared heating, rather than clinical outcome "ground truth" in an AI context. The document states that "The use of light energy to generate heat for therapeutic use has been well documented and is a generally accepted alternative treatment modality for the temporary relief of pain," implying reliance on existing medical literature and accepted practices.
8. The sample size for the training set
Not Applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. No training set was used.
§ 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.