(148 days)
The WS™ THERAPY UNITS, TY-101N and TY-101F, may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The WS™ THERAPY UNIT (Model # TY-101 series), is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3 ~ 25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net or the emitter to prevent fire or direct touch by the user. The entire unit is mounted on base that is easy to move. The device uses 110 Vac as power source. it meets the related requirement of IEC 60601-1 Electrical Safety.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for the WS™ THERAPY UNIT (Model # TY-101 series).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Standards Conformance | Conformance to applicable electrical safety and electromagnetic compatibility standards. | The device conforms to IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) and related standards. The device uses 110 Vac as a power source and meets the related requirements of IEC 60601-1 Electrical Safety. |
| Intended Use Equivalence | Same intended use as a legally marketed predicate device. | The WS™ THERAPY UNIT (Model # TY-101 series) has the same intended use as the predicate device, the TDP CQ-27 Heat Lamp (K003538). Both are for temporary relief of minor muscle and joint pain/stiffness, minor joint pain with arthritis, temporary increase in local circulation, muscle relaxation, muscle spasms, minor sprains/strains, and minor muscular back pain. |
| Technological Characteristics | Similar technological characteristics to a legally marketed predicate device, with no new safety/effectiveness questions raised by differences. | The WS™ THERAPY UNIT has similar technological characteristics to the TDP CQ-27 Heat Lamp. Bench testing demonstrated that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. The device description notes an IR emitter with an emission spectrum from 3 ~ 25 microns. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific "test set" in the context of clinical performance or data analysis. The evaluation relies on:
- Conformance to recognized standards (IEC 60601-1, IEC 60601-1-2) which are typically assessed through bench testing and documentation.
- A comparison to a predicate device based on intended use and technological characteristics, supported by bench testing.
Therefore, there is no mention of a "test set" in terms of patient data, sample size, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or available from the provided text. As noted above, there's no mention of a clinical "test set" and subsequently no need for expert ground truth establishment for such a set.
4. Adjudication Method for the Test Set
This information is not applicable or available from the provided text, as there is no described clinical "test set" that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. The device is evaluated primarily through compliance with standards and substantial equivalence to a predicate device based on its intended use and technological characteristics ("bench testing").
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This is not applicable. The WS™ THERAPY UNIT is an infrared heating device, not an AI/algorithm-driven diagnostic or treatment system. Its performance isn't measured in terms of an algorithm operating "standalone."
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic device evaluation (e.g., pathology, outcomes data) is not applicable here. The device's "truth" or effectiveness is established through its compliance with safety and performance standards relevant to infrared heating lamps, and its substantial equivalence to a predicate device. The performance claims (e.g., "temporary relief of minor muscle and joint pain") are based on the established effectiveness of the device type, not on a specific clinical study with a defined "ground truth" for this particular submission.
8. Sample Size for the Training Set
This information is not applicable or available from the provided text. The device is not an AI/machine learning product that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or available from the provided text, as the device is not an AI/machine learning product requiring a "training set" with ground truth.
§ 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.