(103 days)
The HW-1000 Infrared Therapy System is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.
The HW-1000 Infrared Therapy System is an effective, drug-free and non-invasive device which can deliver 850-950nm infrared energy through light emitting diodes (LED) mounted in the therapy pads (the same as light panels, but different expressions). Each pad has 66 diodes.
The device consists of mainframe, which contains the user interface panel, the power supply, and the output jack used to connect pad to provide output. and therapeutic pads. When working, the plug of therapeutic pads is connected with the output jack of mainframe and the therapy pads are fixed on the surface of skin directly with matched bandages to provide heating.
This document is a 510(k) premarket notification for the "Infrared Therapy System (Model: HW-1000)". It focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device performance against them is not provided in this regulatory submission.
However, based on the provided text, we can infer some "acceptance criteria" through comparison with the predicate device and the results of a clinical test for effectiveness and non-clinical tests for safety.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
As specific, quantified acceptance criteria for performance are not explicitly stated (e.g., "device must achieve X% pain relief in Y% of patients"), this table will present the comparative characteristics and the conclusions drawn from the tests.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Clinical Effectiveness: Achieve temporary relief of minor muscle/joint pain/stiffness, minor arthritis pain, muscle spasm; temporary increase in local blood circulation; temporary relaxation of muscles. (Aligned with intended use of predicate device) | Clinical test (test group with power output vs. control group without power output) showed "far better curative effect" in the test group, ensuring "effectiveness and safety." While specific quantitative metrics (e.g., pain score reduction) are not provided in this summary, the conclusion is that the device is effective for its intended use. The device also shares the same therapeutic temperature range (40-45°C) with the predicate device, which is "accepted by FDA" and implies similar therapeutic effects. |
| Device Temperature Range: Maintain a therapeutic device temperature range. | Device temperature: 40-45°C. This range is stated as being "accepted by the FDA" and is "the same" as the predicate device. |
| Skin Surface Temperature Range: Achieve a therapeutic skin surface temperature range. | Skin surface temperature: 40-45°C. This range is confirmed by self-inspection tests and is "accepted by the FDA" and is "the same" as the predicate device. |
| Biocompatibility: Materials in patient contact are biocompatible. | Tested according to "relevant ISO 10993 Standard" (specifically ISO 10993-5:2009/(R) 2014 for in vitro cytotoxicity and ISO 10993-10:2010 for irritation and skin sensitization). This demonstrates compliance with recognized standards. |
| Electrical Safety: Comply with electrical safety standards. | Tested according to AAMI / ANSI ES60601-1:2005/(R)2012 and its amendments (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod). This demonstrates compliance with recognized standards. |
| Electromagnetic Compatibility (EMC): Comply with EMC standards. | Tested according to IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. This demonstrates compliance with recognized standards. |
| Photobiological Safety: Comply with photobiological safety standards. | Tested according to IEC 62471 First edition 2006-07, Photobiological Safety Of Lamps And Lamp Systems. This demonstrates compliance with recognized standards. |
| Risk Management: Application of risk management processes. | Tested according to ISO 14971 Second Edition 2007-03-01, Medical Devices - Application Of Risk Management To Medical Devices. This demonstrates compliance with recognized standards. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for the clinical test mentioned in "Attachment O Clinical Evaluation Report". The summary only refers to "test group" and "control group".
- Data Provenance: The company is Beijing Huatai Healthcare Technology Co., Ltd. located in P.R. China. The clinical test was "sponsored" by this company. The specific country of origin for the clinical data is not mentioned, but it can be inferred to be China. It is a prospective clinical test as it was done to evaluate the effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the summary. The clinical test evaluated "curative effect," but the methodology for assessing this effect (e.g., patient questionnaires, physician assessment, imaging) and the number/qualifications of experts involved in determining "ground truth" are not detailed.
4. Adjudication method for the test set
- This information is not provided in the summary.
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
- No, an MRMC comparative effectiveness study was not performed. This is an infrared therapy device, not an imaging or diagnostic AI device. The clinical study mentioned compared a treatment group with the device (power output) to a control group without the device (no power output). It did not involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a direct therapeutic device, not an algorithm. Its performance is measured by its direct therapeutic effect, not by an algorithm's output. The clinical test described is essentially a standalone performance evaluation of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the clinical test, the "ground truth" was the "curative effect" observed in patients. While not explicitly defined, this would typically involve patient-reported outcomes (e.g., pain scores, stiffness levels) and potentially clinician assessments. More specific details (e.g., a validated pain scale) are not provided in the summary.
8. The sample size for the training set
- This question is not applicable. The device is not an AI/ML algorithm that requires a training set. The clinical test described served as a validation of the device's therapeutic effect.
9. How the ground truth for the training set was established
- This question is 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.