(45 days)
The Dermatherm 100 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
See Attachment II
The provided document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics. Instead, it is a 510(k) summary and FDA clearance letter for the Dermatherm 100, an infrared heat lamp.
The key points from the document regarding performance and testing are:
- Non-clinical Performance Data: None
- Clinical Performance Data: None
- Conclusion: The Dermatherm 100 is substantially equivalent to other existing Heat Lamps in commercial distribution (specifically, the Warm-Lamp by Olympic Medical, cleared under K932881).
Therefore, based on the provided text, I cannot complete the requested tables and sections. The device's clearance was based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a dedicated performance study as would be described for many AI/ML devices or novel technologies.
§ 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.