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The indicated use of the Nanobeam 940 is to emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

DavaRay's Nanobeam 940 is a near-infrared light device used for therapeutic purposes. The proposed classification for the new device is Class II. The Nanobeam 940 falls within the definition of a "Sec. 890.5500 Infrared Lamp" Class II device.

This 510(k) premarket notification for the Nanobeam 940 device does not include detailed information about specific acceptance criteria, a study that proves the device meets those criteria, or a data analysis of performance metrics. The submission focuses on demonstrating substantial equivalence to predicate devices, which is a common pathway for Class II medical devices like the Nanobeam 940 (an Infrared Lamp).

The documentation does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for a performance study.

Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices. This means that the device's safety and effectiveness are established by showing it is as safe and effective as, and performs similar functions to, existing devices already on the market.

Based on the provided text, here's what can be inferred:

1. Acceptance Criteria and Reported Device Performance:

• No explicit acceptance criteria or reported device performance metrics are provided in the document.
• The implicit "acceptance criteria" for the 510(k) pathway is that the new device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety/effectiveness profile.
• The "reported device performance" is essentially that the Nanobeam 940 emits energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, etc., similar to its predicates.

2. Sample Size and Data Provenance:

• Not applicable / Not provided. The submission does not detail a clinical or performance study with a test set. Substantial equivalence is often demonstrated through comparison of device specifications, materials, and intended use, rather than a de novo clinical trial for every 510(k) submission.

3. Number of Experts and Qualifications:

• Not applicable / Not provided. No ground truth establishment is described for a performance study.

4. Adjudication Method:

• Not applicable / Not provided.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• Not applicable / Not provided. This type of study would be relevant for devices involving image interpretation or diagnostic aid, which the Nanobeam 940 is not.

6. Standalone Performance Study:

• Not applicable / Not provided. While the device operates "standalone" in the sense that it functions without human-in-the-loop interpretation, a formal "standalone performance study" (as typically understood in AI/software medical devices) was not conducted or described. The performance is assessed in comparison to its predicates.

7. Type of Ground Truth Used:

• Not applicable / Not provided.

8. Sample Size for the Training Set:

• Not applicable / Not provided. This device is hardware for therapeutic purposes, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not provided.

Summary of the Study (or lack thereof) Proving Acceptance Criteria:

The "study" proving the Nanobeam 940 meets acceptance criteria, in the context of this 510(k) submission, is the assessment of substantial equivalence to predicate devices.

• Predicate Devices Identified:

  • BioBeam 940 (K042813)
  • MedLight 630 Pro (K042813)
  • LumiWave 1X4 (K051816)

• Basis for Equivalence: The Nanobeam 940 is considered substantially equivalent because its intended use (temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation where heat is indicated) is the same as the predicate devices, and it operates by emitting Near-IR spectrum energy, similar to its predicates, which were approved through the 510(k) exemption process. The regulatory classification for all these devices is Class II, "Infrared Lamp."

In essence, the "proof" is that the device is technologically and functionally similar to devices already found safe and effective by the FDA. No de novo performance study with specific metrics, test sets, or ground truth establishment is described within this 510(k) summary.

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