The HVR Lamp is an over-the-counter handheld device used for the treatment of chronic pain by emitting energy in the near-infrared spectrum for the temporary relief of minor aches and pains in muscles and joints, arthritis and muscle spasms, relieving stiffness. promoting relaxation of muscle tissue and to temporarily increase local blood circulation where applied.

Device Description

The HVR Lamp is a pain relief device consisting of a hand-held module containing an array of 48 near-infrared (red) LED's, user controls and a power supply. The unit is intended to emit energy in the near-infrared spectrum for the temporary relief of pain in the muscles and joints. The HVR device operates on a continuous frequency providing ninety (90) seconds of treatment time per application. The user powers on the unit by pressing the power button. Once powered on, the LEDs illuminate and the user places the device over the desired treatment area. The unit automatically shuts off at the end of the treatment time.

AI/ML Overview

This 510(k) summary describes a medical device, the HVR Lamp, which is an infrared lamp intended for the temporary relief of pain. The summary indicates that the device's substantial equivalence to a predicate device (Quantum WARP 10) is demonstrated through shared intended use, design, and functional features, and that any minor differences do not raise new safety or efficacy issues.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail metrics with specific thresholds in the provided text. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by comparing design and functional specifications. The "acceptance criteria" are implicitly that the HVR Lamp's performance and specifications are equivalent to or better than the predicate device without raising new safety or efficacy concerns.

Feature/Criteria (Implicit Acceptance)	HVR Lamp Reported Performance	Predicate Device (Quantum WARP 10)
Basic Device Design	Handheld module with circular treatment area	Handheld module with circular treatment area
Target Skin Temperature	Minimum 39° C and maximum 45° C	Minimum 39° C and maximum 45° C
Radiation Safety	Low powered LED diodes are extremely safe as Class II device	Low powered LED diodes are extremely safe as Class II device
Indications for Use	Temporary relief of minor aches and pains in muscles and joints, arthritis and muscle spasms, relieving stiffness, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation.	Same as HVR Lamp
Light Intensity	50 - 80 mW/cm²	50 - 80 mW/cm²
Wavelength	Near Infrared 650nm to 950nm	Near Infrared 650nm to 950nm
Waveform	Constant	Constant
Energy Delivery	Handheld treatment probe; Multi diode dispersed over treatment area	Handheld treatment probe; Multi diode dispersed over treatment area
Effective Treatment Area	1000 mm² (10 cm²)	1000 mm² (10 cm²)
Diodes	48 near-infrared (red)	48 near-infrared (red)
Frequency	One continuous setting	One continuous setting
Automatic Shut-off	90 second automatic shut off	90 second automatic shut off
Electrical Safety	AA disposable batteries and A/C wall plug adaptor, or AA rechargeable batteries	AA disposable batteries and A/C wall plug adaptor, or AA rechargeable batteries
Compliance	Meets all functional and technical specifications per IEC 60601-1-1-2005	(Implied compliance for predicate)
Skin Surface Temperature	Temperature at the skin surface where the device is applied is acceptable	(Implied acceptable for predicate)

2. Sample Size for Test Set and Data Provenance

The document does not specify any sample size for a test set in the context of clinical performance or effectiveness. The testing mentioned appears to be related to electrical safety and temperature, not human subject data for efficacy.

3. Number of Experts and Qualifications for Ground Truth

No information is provided regarding experts or their qualifications for establishing ground truth, as no clinical efficacy study with human subjects requiring such a process is described.

4. Adjudication Method

No adjudication method is mentioned, as there is no human subject data or expert review process described for clinical performance.

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

No MRMC study was conducted or reported. This device is an infrared lamp, not an imaging or diagnostic device that typically involves human reader interpretation. No comparison of human readers with or without AI assistance is relevant or discussed.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm is described. This device is a physical therapeutic device, not an AI or algorithmic medical device.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on the technical specifications, functional performance, and safety profile being equivalent to a legally marketed predicate device. The document mentions "IEC 60601-1-1-2005" for functional and technical specifications, and ensuring "temperature at the skin surface where the device is applied is acceptable." These are engineering and safety standards, not clinical "ground truth" in the traditional sense of disease diagnosis or outcome.

8. Sample Size for Training Set

No training set is mentioned or applicable, as this is not an AI or machine learning device requiring a training phase.

9. How Ground Truth for Training Set Was Established

Not applicable, as no training set is discussed.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the HVR Lamp meets its (implicit) acceptance criteria is a technical and comparative analysis against a predicate device and relevant safety standards, rather than a clinical efficacy trial.

The relevant section, "7. Testing Summary," states:
"Testing for the HVR Lamp has been carried out to verify that the device meets all functional and technical specifications per IEC 60601-1-1-2005 and to ensure the temperature at the skin surface where the device is applied is acceptable."

This indicates that:

The study was a series of technical and safety tests.
The acceptance criteria for these tests were:
- Compliance with IEC 60601-1-1-2005 (a standard for medical electrical equipment).
- Acceptable temperature at the skin surface during device application.
The results of these tests (though not detailed in the snippet) presumably demonstrated compliance with IEC 60601-1-1-2005 and acceptable skin temperatures. This, combined with the detailed comparison of specifications showing substantial equivalence to the Quantum WARP 10 (K032229), forms the basis of the FDA's 510(k) clearance.

In essence, for this type of device and 510(k) submission, the "proof" primarily relies on demonstrating that the new device functions in the same way, produces the same therapeutic output (light intensity, wavelength), and meets the same safety standards as a device already on the market, without raising any new questions of safety or effectiveness. No clinical performance or efficacy studies with human subjects are mentioned.

Summary

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K 101716

510(k) SUMMARY HVR Lamp

JAN 1 1 201

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

1. Submitter's Information

Name: HVR. LLC

Address: 7821 Orion Avenue, Suite 200 Van Nuys, CA 91406 Phone: (818) 217-2556 Fax: (818) 217-3556
Contact: Jessany Garrett Director of Legal Affairs

Date Prepared: November 6. 2010

2. Device Information

Trade/Proprietary Name:	HVR Pain Relief Device
Common/Usual Name:	Infrared Lamp
Classification Name:	Infrared Lamp, Therapeutic Heating(21 CFR 890.5500)
Product Code:	ILY

3. Predicate Device

. Quantum WARP 10 (K032229. November 3. 2003)

4. Intended Use

న. Device Description

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K101716

ninety (90) seconds of treatment time per application. The user powers on the unit by pressing the power button. Once powered on, the LEDs illuminate and the user places the device over the desired treatment area. The unit automatically shuts off at the end of the treatment time. Details are provided in the Device Description Section of this submission.

6. Substantial Equivalence

The HVR Lamp is substantially equivalent to its predicate device when intended for use for the treatment of chronic pain by emitting energy in the near-infrared spectrum for the temporary relief of minor aches and pains in muscles and joints, arthritis and muscle spasms, relieving stiffness, promoting relaxation of muscle tissue and to temporarily increase local blood circulation where applied. The data in this 510(k) notification demonstrates that the HVR device shares the same intended use, design features and functional features and is therefore substantially equivalent to its predicate devices. There are very minor differences between the HVR Lamp and the predicate device including a more ergonomic design and larger overall unit size; however the treatment area, number and type of LEDs, light intensity and wavelength, frequency setting options and electrical safety features are the same in both devices. The minor differences between the HVR Lamp and the predicate device do not raise any new issues of safety or efficacy. A comparison of the HVR Lamp and the Quantum WARP 10 device is presented in the table below:

HVR	Quantum WARP 10
Basic Device Design: Handheld module	Basic Device Design: Handheld module
with circular treatment area	with circular treatment area
Target Skin Temperature: Minimum 39° C	Target Skin Temperature: Minimum 39° C
and maximum 45° C	and maximum 45° C
Radiation: Low powered LED diodes areextremely safe as Class II device	Radiation: Low powered LED diodes areextremely safe as Class II device
Indications for use:	Indications for use:
The HVR Lamp is an over-the-counter	The Quantum WARP 10 Light Delivery
handheld device used for the treatment of	System is a handheld device used for the
chronic pain by emitting energy in thenear-infrared spectrum for the temporary	treatment of chronic pain by emitting
relief of minor aches and pains in muscles	energy in the near-infrared spectrum forthe temporary relief of minor muscles and
and joints, arthritis and muscle spasms,	joint pain, arthritis and muscle spasms.
relieving stiffness, promoting relaxation	relieving stiffness, promoting relaxation
of muscle tissue and to temporarily	of muscle tissue and to temporarily
increase local blood circulation whereapplied.	increase local blood circulation whereapplied.

Light Intensity: 50 - 80 mW/cm²	Light Intensity: 50 - 80 mW/cm²

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K101716

Wavelength: Near Infrared 650nm to950nm	Wavelength: Near Infrared 650nm to950nm
Waveform: Constant	Waveform: Constant
Energy Delivery: Handheld treatmentprobe; Multi diode dispersed overtreatment area	Energy Delivery: Handheld treatmentprobe; Multi diode dispersed overtreatment area
Dimension: 69.85 mm x 164.3 mm x77.72 mm	Dimensions: 67 mm x 141 mm x 51 mm
Materials: Rigid ABS	Materials: Rigid ABS
Effective treatment area: 1000 mm² (10cm²)	Effective treatment area: 1000 mm² (10cm²)
Diodes: 48 near-infrared (red)	Diodes: 48 near-infrared (red)
Frequency: One continuous setting	Frequency: One continuous setting
Additional safety option: 90 secondautomatic shut off	Additional safety option: 90 secondautomatic shut off
Electrical safety options: AA disposablebatteries and A/C wall plug adaptor, orAA rechargeable batteries	Electrical safety options: AA disposablebatteries and A/C wall plug adaptor, orAA rechargeable batteries

7. Testing Summary

Testing for the HVR Lamp has been carried out to verify that the device meets all functional and technical specifications per 1EC 60601-1-1-2005 and to ensure the temperature at the skin surface where the device is applied is acceptable.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. The bird is positioned within a circular border. Encircling the bird are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

HVR, LLC % Mr. Jessany Garrett Director of Legal Affairs 7821 Orion Avenue, Suite 200 Van Nuys, California 91406

JAN 1 1 2011

Re: K101716

Trade/Device Name: HVR Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: IL Y Dated: November 05, 2010 Received: November 08, 2010

Dear Mr. Garrett:

. . . . . . .

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

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Page 2 - Mr. Jessany Garrett

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson 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 Statement

JAN 1 1 2011

510(k) Number (if known): K (6) 716

Device Name: HVR Infrared Lamp

Indications for Use:

The HVR device is an over-the-counter handheld device used for the treatment of chronic pain by emitting energy in the near-infrared spectrum for the temporary relief of minor aches and pains in muscles and joints, arthritis and muscle spasms, relieving stiffness, promoting relaxation of muscle tissue and to temporarily increase local blood circulation where applied.

Prescription Use (Parı 21 CFR 801 Subparı D)

AND/OR

Over-the-Counter Use メ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Polen for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101716

(Division Sign-Off) Division of General Restorative Devices

510(k) Number

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.