FibroLux by Multi Radiance Medical

This is a 510(k) clearance letter for a medical device called FibroLux, an infrared lamp indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia. This document does not contain the kind of detailed performance study information typically provided for AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot provide answers to most of your requested points because the information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on a detailed performance study with acceptance criteria and ground truth analysis.

Here's what I can extract and state based on the provided text, and where I must indicate that the information is "Not Available in the provided text":

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not Available in the provided text.
- Reported Device Performance: Not Available in the provided text. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on specific performance metrics outlined in this document.
Sample size used for the test set and the data provenance: Not Available in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Available in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Available in the provided text.
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 Available in the provided text. This is not an AI-based device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Available in the provided text. This is not an AI-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Available in the provided text.
The sample size for the training set: Not Available in the provided text.
How the ground truth for the training set was established: Not Available in the provided text.

Summary of what is available:

Device Name: FibroLux
Indication for Use: "The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia."
Regulatory Clearance: 510(k) clearance (K212189) based on substantial equivalence to a predicate device.
Device Type: Infrared Lamp (Product Code: NHN)
Regulatory Class: Class II
Type of Use: Prescription Use

The provided document is a regulatory communication, not a clinical study report. To get the requested information, you would need to consult detailed clinical study reports or 510(k) summary documents if they contain such information. However, for a device cleared via substantial equivalence, often detailed performance studies with explicit acceptance criteria and ground truth establishment in the manner described are not a primary component of the 510(k) submission itself, but rather rely on the safety and effectiveness of the predicate device.

Summary

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September 2, 2022

Multi Radiance Medical % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K212189

Trade/Device Name: FibroLux Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: August 10, 2022 Received: August 10, 2022

Dear Kevin Walls:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212189

Device Name FibroLux

Indications for Use (Describe)

The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

N/A