(14 days)
The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.
The Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is intended to emit energy in the infrared spectrum to provide topical heating. The acceptance criteria and the study proving the device meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance: Ability to elevate tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; temporary increase in local blood circulation; and/or temporary relaxation of muscle (demonstrated by reaching an effective therapy temperature range). | Subject Device (FIR 51, SN-51): Skin temperature can rise to 40°C within 5 minutes and maintain skin temperature for at least 10 minutes within a 15-minute treatment time when tested at distances of 30cm, 35cm, and 40cm. |
| Comparison with Predicate Device: Both the subject device and the predicate device (Xinfeng CQ-27, CQ-36, CQ-55A) achieved a temperature range of 41-45°C, which is considered an effective therapy temperature range. Testing was conducted at 30cm, 35cm, 40cm, and 45cm for the subject device (15 min treatment) and 8", 10", 12" for the predicate device (60 min treatment) in a 25°C ambient environment. The report states the new device is "as effective as" the predicate. | |
| Electrical Safety: Compliance with relevant international standards. | Complies with IEC 60601-1 (1988 with amendments 1991, 1995), IEC 60601-1-2 (2001 with amendment 2004), and UL 60601-1 (2003). |
| Risk Management: All identified risks are under control. | A risk management report was submitted, showing "all the risk are under control." The device uses 600-2000 nm infrared (Near-infrared and Short-wavelength infrared), which is visible when working, implying a lower burn risk compared to the predicate device which uses 5-25 microns and is not visible. |
| Substantial Equivalence: The device is substantially equivalent to a legally marketed predicate device. | Compared to the Xinfeng Heating Lamp (K043558), the FIR 51, SN-51 has the same intended use. Differences in infrared wavelength (600-2000 nm vs 5-25 microns) are noted but are deemed not to affect effectiveness and imply a potentially lower burn risk for the subject device. The product passed safety testing and its risk management report showed all risks under control. Thus, the differences "do not raise new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document describes "a performance testing with the subject device" and "a comparison testing with the subject device and predicate device." However, specific sample sizes (e.g., number of units tested, number of measurement points per unit) are not explicitly stated. Instead, it refers to conducting tests on "the subject device" at various distances.
- Data Provenance: The tests were conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. The data appears to be retrospective relative to the 510(k) submission date, as the testing reports are cited within the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This section is not applicable as the evaluation primarily involved performance and safety testing against objective physical parameters (temperature measurements, compliance with electrical standards), not diagnostic interpretations requiring expert consensus. The "ground truth" for efficacy was established through demonstrating the ability to raise tissue temperature to a known therapeutic range.
4. Adjudication Method for the Test Set:
This section is not applicable as there was no expert review or adjudication of diagnostic findings. The tests involved direct physical measurements.
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:
This section is not applicable. The device is an infrared lamp for therapeutic heating, not a diagnostic imaging device involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical therapeutic device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used was based on objective physical measurements (temperature readings) and established scientific understanding that a specific temperature range (41-45°C) is effective for the stated therapeutic purposes. Compliance with international electrical safety standards also served as a "ground truth" for safety.
8. The Sample Size for the Training Set:
This section is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as above.
§ 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.