(15 days)
The infrared lamp is 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) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating. Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display. The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.
The provided 510(k) summary describes a therapeutic heating device (Infrared Lamp) and its equivalency to existing predicate devices. The "acceptance criteria" in this context are not explicitly defined as specific numerical targets for performance metrics (like sensitivity/specificity for a diagnostic device). Instead, the acceptance criteria are implicitly that the device's performance, particularly its heating capability, is similar to or better than a legally marketed predicate device and that it meets relevant safety standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device delivers topical heating adequate to elevate tissue temperature for therapeutic purposes. | Subject Device (FIR 51, SN-51): Skin temperature can rise to 40°C within 5 minutes and maintain this temperature for at least 10 minutes in a 15-minute treatment session (at 30cm, 35cm, and 40cm distances). When compared against the predicate device (TDP CQ-27 Heat Lamp), both devices achieved a temperature range of 41-45°C, which is stated as an "effective therapy temperature range." |
| Device complies with relevant electrical safety and electromagnetic compatibility (EMC) standards. | Device is manufactured to comply with: |
- IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995)
- IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests; Edition 2.1)
- UL 60601-1, first edition, 2003, deviations to IEC 60601-1. |
| The difference in intended use (prescription vs. OTC) for the FIR 51, SN-51 model (K110721 vs K102149) does not raise new questions of safety and effectiveness. | The labeling of the subject device (K110721) is "readable and understandable for over-the-counter use." The difference does not raise new questions of safety and effectiveness, leading to a substantial equivalence determination. |
| The differences in technological characteristics (e.g., wavelength) between the FIR 51, SN-51 and the TDP CQ-27 Heat Lamp do not raise new questions of safety and effectiveness. | The subject device uses 600 nm - 2000 nm infrared (Near-infrared and Short-wavelength infrared), while the predicate uses 2 to 25 microns (Long-wavelength infrared and Far infrared). The submission claims that "The different wavelength will not affect the effectiveness of device." It also argues the subject device might have "less" burn risk due to visible heating. A comparison test showed both devices achieve the therapeutic temperature range of 41-45°C. Risk management report shows all risks are under control. |
| The device maintains safety when used by layperson users (for OTC use). | "As identical predicates of these devices have been in safe and effective applications by layperson users. Over-The-Counter variance is requested." (Refers to the prior model K102149.) The new device passes safety testing and the risk management report indicates controlled risks. |
2. Sample size used for the test set and the data provenance
- Test Set (Performance Testing): The description refers to "a person" for the performance testing of the subject device. This implies a very limited sample size, possibly n=1, or at most a very small convenience sample. It does not specify a statistically significant sample size.
- Data Provenance: The testing was conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. It appears to be prospective testing specifically for this submission, not retrospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a therapeutic heating device, not a diagnostic device that requires expert consensus for "ground truth" on medical findings. The "ground truth" for its performance is objective physical measurement (temperature increase).
- No experts are mentioned as establishing ground truth in the traditional sense for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The performance testing involved direct temperature measurement using an electronic thermometer, not subjective interpretation requiring adjudication.
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. This is a therapeutic physical device, not an AI-assisted diagnostic tool involving human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a therapeutic physical device, not an algorithm. Its performance is inherent to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the device's performance is objective physical measurement:
- Skin temperature increase measured by an electronic thermometer.
- Compliance with international electrical safety and EMC standards.
- Comparison of heating efficacy against a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. As a physical therapeutic device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and standards, not data training.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of 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.