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510(k) Data Aggregation
(139 days)
NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980
The Nexus XPulse IR Lamp Systems are intended to emit energy in the 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 Nexus XPulse 805 and the Nexus XPulse 980 IR Lamp Systems are intended for use as infrared heat lamps. The Systems are noninvasive devices that emit light energy to the skin-surface of human body for the purpose of causing the therapeutic elevation of tissue temperature. The Nexus XPulse Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 805 nm and 980 nm using a gallium aluminum arsenide (GaAlAs) source. 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 quide light. The Systems consist of 2 main hardware sub-systems: 1) he control console and 2) he treatment handpiece probe with its connecting cable. The control console is made of standard medical PVC material and is designed to be place 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 probe is made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probe contains a focusing lens at the aperture, which is made of glass suitable for medical applications.
This document describes the Nexus XPulse 805 and Nexus XPulse 980 IR Lamp Systems, intended for use as infrared heat lamps for therapeutic elevation of tissue temperature.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with EN 60601-1:2001 (Medical Electrical Equipment, Part 1, General Requirements for Safety) | Tested and Compliant: "The Systems are manufactured to comply with the following international standards: EN 60601-1:2001 Medical Electrical Equipment, Part 1, General . Requirements for Safety" |
| Compliance with EN 60601-1-2:2001 (Medical Electrical Equipment, General Requirement for Safety. Electromagnetic Compatibility) | Tested and Compliant: "The Systems are manufactured to comply with the following international standards: . EN 60601-1-2:2001 Medical Electrical Equipment, General Requirement for Safety. Electromagnetic Compatibility" |
| Compliance with ISO 14971 (Medical Devices: Application of Risk Management) | Tested and Compliant: "The Systems are manufactured to comply with the following international standards: ISO 14971 Medical Devices: Application of Risk Management ." |
| Intended uses are substantially equivalent to predicate devices | Determined Substantially Equivalent: "The Nexus XPulse IR Lamp Systems have the same intended uses, with similar functional and performance characteristics." and "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
| Functional performance is similar to predicate devices | Determined Substantially Equivalent: "...similar functional and performance characteristics." |
| Performance characteristics are similar to predicate devices | Determined Substantially Equivalent: "...similar functional and performance characteristics." |
| No new safety issues | Determined No New Safety Issues: "The Systems perform as intended and do not raise any new safety or efficacv issues." |
| No new efficacy issues | Determined No New Efficacy Issues: "The Systems perform as intended and do not raise any new safety or efficacv issues." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes testing as "functional performance testing and electrical safety testing" against international standards and comparison to predicate devices. It does not mention a specific "test set" in terms of patient data or clinical trials. The evaluation is based on engineering and regulatory compliance rather than clinical performance data from a specific study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The document describes compliance with technical standards and comparison to predicate devices, not clinical studies requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or image-based evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for an infrared lamp, and the evaluation focuses on electrical safety, functional performance, and substantial equivalence to existing predicate devices, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an infrared lamp, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- International Standards Compliance: Verification that the device meets the safety and performance requirements outlined in EN 60601-1, EN 60601-1-2, and ISO 14971.
- Comparison to Predicate Devices: Assessment that the device's intended uses, functional, and performance characteristics are "substantially equivalent" to already legally marketed infrared lamps (e.g., USA Laser Biotech, Inc. LUMINA 1600, Avicenna Laser Technology, Inc. ALT Laser, Model VTR 75).
8. The Sample Size for the Training Set:
Not applicable. This document pertains to an infrared lamp device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is relevant to the information provided.
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