(207 days)
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.
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.
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.
§ 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.