(261 days)
The Varava Sport Model 200 is indicated/intended 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.
The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs 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 a 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/adapter.
The provided 510(k) summary for the Varaya Sport Model 200 does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics through clinical trials. Instead, it relies on substantial equivalence to predicate devices and presents summary safety testing.
Here's a breakdown based on the information provided, highlighting the absence of the requested study details:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the submission. The submission states, "Formal clinical trials were not deemed necessary as device is using same or similar technology and intended use as predicate devices." Therefore, no specific acceptance criteria for clinical performance (e.g., pain reduction scores, circulation improvement percentages) are outlined, nor is there any reported device performance data against such criteria.
The submission does mention:
- "The Varaya Sport Model 200 meets the required tissue heating requirements (tests provided)." - However, the specific requirements and results are not detailed in this summary.
- "Information regarding testing safety and effectiveness in accordance with IEC 60601-1, IEC 60601-1-2 and ISO 10993 were provided." - These are safety and electromagnetic compatibility standards, not clinical performance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Since no clinical performance study was conducted, there is no test set sample size or data provenance (country of origin, retrospective/prospective) for device performance against clinical acceptance criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the absence of a clinical performance study, there were no experts used to establish ground truth for a test set regarding the device's clinical efficacy.
4. Adjudication Method for the Test Set
As no clinical performance test set was used, there was no adjudication method for such a set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was conducted or reported. The submission explicitly states that formal clinical trials were not deemed necessary. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone Study Was Done
No standalone study (i.e., algorithm only without human-in-the-loop performance) was conducted or reported, as this is a medical device for direct patient use, not an AI algorithm for diagnostic interpretation.
7. The Type of Ground Truth Used
For the purpose of substantial equivalence, the "ground truth" implicitly used is the established safety and efficacy profiles of the predicate devices. For safety testing (e.g., tissue heating, IEC standards), the ground truth would be adherence to specified engineering and safety standards. There is no clinical ground truth established through expert consensus, pathology, or outcomes data for this specific device's clinical performance.
8. The Sample Size for the Training Set
Since no clinical performance study was conducted, and the device is not an AI/ML algorithm that requires training data in the conventional sense, there is no training set sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, there is no method described for establishing its ground truth.
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510 (k) Summary of Safety and Effectiveness
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 112494
1. General Information:
| Submitter: | Varaya Photoceuticals, LLC |
|---|---|
| Address: | 16511 Scientific Way, Suite 200 |
| Irvine, CA 92618 | |
| P: 949.753.1482 | |
| F: 949.753.1485 | |
| mykl@ldallc.com |
| Contact Person: | Frances Beckman, Owner |
|---|---|
| C: 949.233.6156 | |
| fbeckman2@cox.net |
Date Prepared:
March 19, 2012
- Names:
Varaya Sport Device Name: Device Model No.: 200
Classification Name: Lamp, Infrared Common Name: LED Light System
Physical Medicine Review Panel:
ILY Product Code:
890.5500 Regulation No.:
3. Predicate Devices:
Warp 10 (K032229), Tanda Pro Restore (K090008), Diomedics PainX 2000 Model 900 (K982546), RXLight (K100213).
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4. Device Description:
The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs 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 a 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/adapter.
5. Indications for Use:
For the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
6. Performance Data:
Based upon analysis, Varaya Photoceuticals, LLC believes there are no significant differences from the predicate devices.
7. Comparison to Predicate Devices:
The intended use and technological characteristics are similar or equivalent to the listed predicates.
8. Summary of Testing:
The Varaya Sport Model 200 meets the required tissue heating requirements (tests provided).
Formal clinical trials were not deemed necessary as device is using same or similar technology and intended use as predicate devices.
Information regarding testing safety and effectiveness in accordance with IEC 60601-1, IEC 60601-1-2 and ISO 10993 were provided.
9. Conclusion:
The Varaya Sport Model 200 meets the safety and efficacy requirements necessary for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 6 2012
Varaya Photoceuticals, LLC % Myk Lum 16511 Scientific Way, Suite 200 Irvine, California 92618
Re: K112494
Trade/Device Name: Varaya AR, Varaya Sport Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: May 09, 2012 Received: May 14, 2012
Dear Myk 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
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Page 2 - Myk Lum
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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INDICATIONS FOR USE
K112494 510(K) NUMBER:
Varaya Sport Model 200 DEVICE NAME:
INDICATIONS FOR USE:
The Varava Sport Model 200 is indicated/intended 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.
Prescription Use: X (Part 21 CFR 801 Subpart D) and/or
Over-the Counter Use: ____ (21CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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NylRP Admn for mxm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112494
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§ 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.