(73 days)
The Neurolase™ devices are an infrared lamp per 21 CFR 890.5500 that emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature to provide temporary relief of minor muscles and joint pain and stiffness, minor pain and stiffness associated with arthritis, or muscle spasm. These devices may temporarily increase blood circulation, and may be used to promote relaxation of muscle tissue.
The Neurolase™ devices consist of a control unit and a handpiece The control unit houses the power supply, control electronics, calibration port, and infrared radiation source. The source is coupled to a fiber optic cable that delivers the energy to the patient through the handpiece.
The provided text does not describe acceptance criteria, nor does it detail a study performed to prove a device meets acceptance criteria for the Neurolase™ Series device.
Instead, this document is a 510(k) pre-market notification summary for the Neurolase™ Series device, outlining its substantial equivalence to previously marketed infrared lamps.
Here's a breakdown of what the document does state regarding testing and performance, and why it doesn't fit the requested criteria:
Performance Data Section (Section 6, Page 1 of 2):
- "The differences in the specifications of the Neurolase™ devices and the predicate devices result in enhanced performance for the Neurolase™ devices and do not raise new questions of safety or efficacy."
- Comment: This statement claims enhanced performance but provides no specific metrics, acceptance criteria, or study results to back this up. It's a general assertion rather than a demonstration of meeting predefined criteria.
Testing Section (Section 7, Page 2 of 2):
- "Prototype units have undergone preliminary testing to ensure compliance with UL2601 and FCC Part 15 requirements."
- Comment: This refers to preliminary testing for electrical safety and electromagnetic compatibility standards, not performance or clinical efficacy against specific acceptance criteria for its intended use (pain relief, increased blood circulation).
- "Once marketing clearance is granted, safety and emissions testing will take place at a registered body."
- Comment: This indicates future testing for safety and emissions, again not performance against acceptance criteria for its therapeutic claims.
- "Production units will each be run through an Acceptance Test Procedure to ensure compliance with the System Specification."
- Comment: This mentions an "Acceptance Test Procedure" and "System Specification" for production units, implying internal quality control checks. However, the document does not provide the specific acceptance criteria defined in this System Specification, nor does it present the results of such a procedure or a study proving compliance.
- "All components have been chosen to ensure compliance with the aforementioned standards."
- Comment: This is a statement about component selection, not a study or performance data.
Conclusion:
The submission focuses entirely on establishing substantial equivalence to predicate devices based on intended use and general device characteristics. It explicitly states that "The differences in the specifications...do not raise new questions of safety or efficacy," implying that extensive new performance studies beyond basic safety/emissions compliance were not deemed necessary for this 510(k) clearance.
Therefore, since the document does not contain the requested information, the table and other points cannot be filled out as requested.
§ 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.