The Varaya Sport Mode 200 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Description

The Varaya Sport (Model 200) is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs in the device are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Varaya Sport (Model 200), an infrared lamp. It details the device's characteristics, intended use, and a summary of safety and effectiveness testing. However, the document does not contain specific acceptance criteria, tabulated device performance data, detailed information about study designs (like sample sizes for test/training sets, data provenance), expert qualifications, ground truth establishment methods, or effect sizes of human reader improvements with AI assistance.

The document mainly focuses on establishing substantial equivalence to a predicate device (K112494, which is the same device) and confirming compliance with general safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, ISO 10993). It also mentions an "Over-the Counter Use Study" but provides only a high-level summary of its findings, not the detailed methodology or results needed to answer your questions.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from the provided text, nor can I provide the detailed study parameters you've asked for beyond what's explicitly stated.

Based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document beyond a general statement of compliance with safety standards. No specific performance metrics or thresholds are listed.

2. Sample sizes used for the test set and the data provenance:

For the "Over-the Counter Use Study," the document states, "Study participants were recruited solely from the general population, not specifically from a group of intended consumers. This was done to ensure an unbiased, naive sample representative of the general US population." However, no specific sample size is mentioned.
The provenance (country of origin) is implied to be the US since the study aimed for a "representative of the general US population."
The study appears to be a prospective user study focused on usability and label comprehension for over-the-counter use, rather than a clinical effectiveness study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable or not provided. The "Over-the Counter Use Study" was a user study about self-selection, usability, and label comprehension, not a diagnostic or AI performance study requiring expert ground truth in the traditional sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable or not provided. This was a user study, not an imaging diagnostic study requiring adjudication.

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:

No. The document describes a traditional medical device (infrared lamp) and a user study, not an AI-based diagnostic device. Therefore, no MRMC study or AI assistance effect size is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI algorithm. The device is an infrared lamp.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "Over-the Counter Use Study," the "ground truth" was participant behavior and responses regarding self-selection, understanding of instructions for use, and potential risks of misuse. It was evaluated to confirm "a person was able to appropriately self-select themselves into using or rejecting the device" and that the "device design essentially mitigates anticipated risks of misuse and misunderstanding of the instruction for use." This is user behavior and comprehension, not medical diagnosis ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI device trained on data.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI device.

In summary, the provided document is a regulatory submission for an infrared lamp, focusing on demonstrating substantial equivalence and general safety/usability rather than the detailed performance metrics and study designs typically associated with AI/diagnostic device approvals.

Summary

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Image /page/0/Picture/1 description: The image contains the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three overlapping human profiles facing to the right, with flowing lines extending from the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Varaya Photoceuticals, LLC Mr. Myk Lum Co-owner 16511 Scientific Way, Suite 200 Irvine, California 92618

December 8, 2015

Re: K150716 Trade/Device Name: Varaya Sport (Model 200) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: October 20, 2015 Received: November 2, 2015

Dear Mr. Lum,

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

For

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150716

Device Name Varaya Sport Model 200

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the logo for Varaya Pharmaceuticals. The logo features an orange, four-petal flower-like design above the word "varaya" in lowercase, followed by the word "photoceuticals" in a smaller font size. The overall design is clean and modern.

entific Way, Suite 200

PHOTOCEUTICALS, LLC

510(k) Summary of Safety and Effectiveness

This traditional 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Owner's Name:	Varaya Photoceuticals, LLC
Address:	16511 Scientific Way, Suite 200
	Irvine, CA 92618
Telephone:	(949) 753-1482
Fax:	(949) 753-1485

Contact Person:	Frances Beckman, Co-Owner16511 Scientific Way, Suite 200Irvine, CA 92618
Telephone:	(949) 743-1482
Fax:	(949) 753-1485
Cell:	(949) 233-6156
Email:	fbeckman2@cox.net

510(k) preparation date: March 11, 2015

Device Name and Classification:

Trade and Proprietary name:	Varaya Sport (Model 200)
Common Name:	Infrared Lamp
Classification Name:	Lamp Infrared, Therapeutic Heating
Product Code:	ILY
Regulation Number:	21 CFR 890.5500
Class:	II

Predicate Device:

The legally marketed predicate for the Varaya Sport (Model 200) is: K112494, Varaya Sport (Model 200).

Device Description:

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has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.

Intended Use:

The Varaya Sport Model 200 is indicated/intended for the temporary relief of minor muscle and join pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Technological Characteristics:

This submitted device is the same device as in K112494 (predicate) with no technological changes. The Varaya Sport (Model 200) device utilizes two highpowered LEDs: one Red and one nearInfrared in a handheld unit. The device is held .25" above the desired treatment area and operated when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor.

Nonclinical and Clinical Testing:

The subject device has been tested to confirm compliance in accordance with IEC 60601-1 (200 Edition), IEC 60601-1-2 and ISO 10993 standards. The subject device has been tested to confirm compliance per FDA required tissue temperature heating requirement. The subject software has been fully validated per FDA requirement for software validation. These test results serve to confirm that the Varava Sport (Model 200) does not raise any new issues of safety or effectiveness.

Over-the Counter Use Study:

Varaya Photoceuticals, LLC has performed the OTC Use Study (self-selection, usability and label comprehension) to ensure the understanding of the proper use as well as any risks of misuse of the Varaya Sport (Model 200) as an over-thecounter medical device product. Study participants were recruited solely from the general population, not specifically from a group of intended consumers. This was done to ensure an unbiased, naive sample representative of the general US population. The study data shows that the device design essentially mitigates anticipated risks of misuse and misunderstanding of the instruction for use. The self-selection protocol and results confirmed a person was able to appropriately self-select themselves into using or rejecting the device.

End of 510(k) Summary

Regulation Number and Section

§ 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.