(216 days)
The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter (OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
This document is an FDA 510(k) premarket notification for the NuBrilliance Light Pain Therapy device. As such, it primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the way one might expect for a novel device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, type of ground truth) are not applicable because the submission explicitly states that no clinical performance data was required or submitted to establish substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated in terms of performance metrics, but implied by 510(k) process) | Reported Device Performance (as demonstrated by non-clinical testing and substantial equivalence) |
|---|---|---|
| Safety | Compliance with applicable safety standards, biocompatibility, electrical safety. | * Complies with applicable voluntary standards for biocompatibility. * Meets all requirements for overall design, biocompatibility, and electrical safety. * Passed all testing to confirm output meets design inputs and specifications. |
| Effectiveness (via Substantial Equivalence) | Same intended use and similar technological characteristics as predicate device (K081570). | * Utilizes the same technological characteristics (LEDs emitting light energy). * Has the same intended use (relaxation of muscles, relief of muscle spasms, temporary relief of minor muscle/joint aches/pains/stiffness, temporary relief of minor pain/stiffness associated with arthritis, temporarily increase local blood circulation). * Emits energy from LEDs with wavelengths of 625 nm and 940 nm (vs. 660 nm and 880 nm for predicate). * Provides similar irradiance output to the treatment area. * Desired therapeutic effects from both devices are generated by their emissions creating a local increased temperature. * Differences do not raise new types of questions regarding safety and effectiveness. |
| Regulatory Compliance | Adherence to FDA regulations (e.g., general controls provisions). | FDA has determined the device is substantially equivalent, allowing marketing subject to general controls. |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A). The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device."
- Therefore, no specific clinical test set data from humans was generated for this 510(k) submission. Non-clinical (bench) testing was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A). As no clinical test set data was required, no experts were needed to establish ground truth for a clinical comparison.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable (N/A). No clinical test set.
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
- Not Applicable (N/A). This device is a light pain therapy system, not an AI-assisted diagnostic or imaging device used by human readers. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This is a therapeutic device, not an algorithm, and its performance is assessed against its indicated use and comparison to a predicate device, not as a standalone algorithm.
7. The type of ground truth used
- For demonstrating substantial equivalence and safety: The "ground truth" essentially relies on the established safety and efficacy of the legally marketed predicate device (LED Technologies, LLC DPL™ Therapy System, K081570) and non-clinical testing of the NuBrilliance device itself against engineering specifications and industry standards.
- No clinical ground truth (e.g., pathology, outcomes data) was generated for this submission.
8. The sample size for the training set
- Not Applicable (N/A). This device did not involve machine learning or AI, and therefore no "training set" in that context was used.
9. How the ground truth for the training set was established
- Not Applicable (N/A). No training set was used.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2015
Wellquest International Incorporated % Ms. Carrie Hetrick Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K150554
Trade/Device Name: NuBrilliance Light Pain Therapy Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Dated: August 27, 2015 Received: August 28, 2015
Dear Ms. Hetrick:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)
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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" (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 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.
Sincerelv vours.
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For 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) K150554
Device Name NuBrilliance Light Pain Therapy
Indications for Use (Describe)
The Nu Brilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
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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FOR FDA USE ONLY
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510(k) Summary for NuBrilliance Light Pain Therapy K150554
1. Submission Sponsor
Wellquest International, Inc. 230 Fifth Ave. Suite 808 New York, NY 10001 USA Phone: (212) 689.9094 Fax: (212) 213.1599 Contact: Ms. Yveth Kan
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com
3. Date Prepared
October 5, 2015
4. Device Identification
| Trade/Proprietary Name: | NuBrilliance Light Pain Therapy |
|---|---|
| Common/Usual Name: | Infrared lamp |
| Classification Name: | Infrared lamp |
| Classification Regulation: | 21 CFR § 890.5500 |
| Product Code: | ILY |
| Device Class: | Class II |
| Classification Panel: | Physical Medicine |
5. Legally Marketed Predicate Device(s)
LED Technologies, LLC DPL™ Therapy System (K081570)
6. Device Description
The NuBrilliance Light Pain Therapy device is a lightweight, light emitting diode (LED) device that emits light energy. The NuBrilliance Light Pain Therapy device is an Over-The-Counter
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(OTC), hand held, ergonomically designed pain relief device that uses the infrared lamp for therapeutic heating. The head consists of four (#4) visible diodes (red lights) in the 625 nm (±5%) spectrum, and (#56) fifty-six infrared diodes (purple lights) in the 940 nm (±5%) spectrum that are used in combination for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature. Treatment is controlled by the operator. There are no user settings or adjustments.
7. Indication for Use Statement
The NuBrilliance Light Pain Therapy system is an Over-The-Counter handheld device intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
8. Substantial Equivalence Discussion
The Wellquest NuBrilliance Light Pain Therapy device utilizes the same technological characteristics and has the same intended use as the K081570 predicate device. The K081570 device emits energy from light-emitting diodes (LED)s with wavelengths of 660 nm and 880 nm. The NuBrilliance Light Pain Therapy device emit energy from light-emitting diodes (LED)s with wavelengths of 625 nm and 940 nm. Both devices provide similar irradiance output to the treatment area. The desired therapeutic effects from both devices are generated by their emissions creating a local increased temperature in the area being treated. Differences between the NuBrilliance Light Pain Therapy device and the predicate do not raise new types of questions regarding the safety and effectiveness when used for the above indications for use.
9. Non-Clinical Performance Data
The device has been tested for applicable safety requirements. The NuBrilliance Light Pain Therapy complies with the applicable voluntary standards for biocompatibility. As part of demonstrating safety and effectiveness of NuBrilliance Light Pain Therapy and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Wellquest International, Inc. completed a number of tests. The NuBrilliance Light Pain Therapy meets all the requirements for the overall design, biocompatibility, and electrical safety confirm that the output meets the design inputs and specifications. The NuBrilliance Light Pain Therapy passed all testing stated above as shown by the acceptable results obtained.
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10. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the differences, between the NuBrilliance Light Pain Therapy device and the predicate device listed above, do not raise new types of questions regarding safety and effectiveness. Further, the NuBrilliance Light Pain Therapy device utilizes the same type of technology as the predicate device. The NuBrilliance Light Pain Therapy, as designed and manufactured, is determined to be substantially equivalent to the above-listed predicate device.
§ 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.