(72 days)
The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery of light and an on/off button to activate and deactivate the infrared emission.
The provided documentation for the K-Laser Heat Lamp (K050070) does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices.
Here's an breakdown based on the provided text, addressing your points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Standards: Conforms to 21 CFR section 1010.10 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products). | "Klaser conforms to the applicable requirements of 21 CFR section 1010.10 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products)." (From Section E, Part 3) |
| Intended Use/Indications For Use: - Temporary increase in local blood circulation - Temporary relief of minor muscles and joint aches, pains and stiffness - Relaxation of muscles - Muscle spasms - Minor pain and stiffness associated with arthritis | "The intended Use/Indications For Use stated herein are identical to the cleared indications for the predicate device." (From Section E, Part 5) The K-Laser generates infrared therapy for treatment and shares the same or similar basic characteristics and the same intended use as predicate devices. (From Section E, Part 6) |
| Safety and Effectiveness: No substantive differences between K-Laser and predicate devices or other similar medical devices. Developed and documented under Eltech's mature Quality Management System (21 CFR Part 820), under design/change control, and verified/validated to applicable standards/guidance documents. Certified by CERMET (notified body n. CE 0476) according to Annex II of 93/42 EEC Directive. | "There are no substantive differences between the products defined in SHE EPT This 2011 - 1 in other similar medical devices. They were developed and documented under Eltech's mature Quality Management System, under The Quality System Regulation, 21 CFR Part 820, under design/change control, and verified/validated to applicable standards/guidance documents. Besides, Eltech's Quality Assurance System is certified by CERMET, notified body n. CE 0476, according to Annex II of 93/42 EEC Directive, transposed in Italy by Digs. n. 46 of 24 February 1997. Klaser is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program." (From Section E, Part 7) |
Summary of Device Performance: The primary claim of performance is that the K-Laser functions identically to established predicate devices (ALT Laser, Model VTR 75; Vectra Genisys Laser System; Solaris D890) for the specified indications for use, and it adheres to relevant electrical and light-emitting product performance standards and quality system regulations. There is no specific performance data presented in terms of efficacy metrics (e.g., how much pain reduction, how much blood circulation increase). The "performance" is implicitly deemed acceptable because it directly mirrors that of already cleared devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None provided. The document does not describe a clinical study with a test set of patients or data. The submission relies on substantial equivalence to predicate devices, not de novo clinical testing for performance.
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. No test set or ground truth establishment by experts is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method 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. This document is for an infrared therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device. Its "performance" is its ability to emit infrared radiation for therapeutic purposes, which is demonstrated by its technical specifications and compliance with standards, and its similarity to predicate devices already cleared for similar applications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly defined as "ground truth" in the context of a new study. The "ground truth" for the K-Laser's safety and effectiveness relies on the prior clearance of its predicate devices and its adherence to established performance standards for electronic and light-emitting products. The manufacturer also highlights their robust Quality Management System.
8. The sample size for the training set
- Not applicable. This device is not developed using machine learning or AI models with training sets.
9. How the ground truth for the training set was established
- Not applicable. This device is not developed using machine learning or AI models with training sets.
§ 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.