(151 days)
Bashan TDP Heat Lamp is 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 the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Bashan TDP Heat Lamp is used to provide topical heating to the body. It is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 5 to 25 microns, 110 volt power, 250 watts. It includes timer, safety fuses.
The provided text describes a 510(k) summary for the "Bashan TDP Heat Lamp," comparing it to predicate devices. This document focuses on demonstrating substantial equivalence to legally marketed devices, primarily through adherence to recognized standards and comparison of features. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, or reader improvement.
However, based on the provided text, I can extract information related to safety and performance testing that serves as the basis for claiming substantial equivalence.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (e.g., target specificity or sensitivity) that a study would aim to meet for a diagnostic device. Instead, the "acceptance criteria" appear to be met by compliance with recognized electrical safety and electromagnetic compatibility standards, and by showing similar characteristics and intended use to predicate devices. The "reported device performance" is essentially that the device meets these standards and is comparable to the predicate devices.
| Feature/Criterion | Acceptance Criteria (Implied by Standards/Predicate Devices) | Reported Device Performance |
|---|---|---|
| Safety & Essential Performance | Compliance with AAMI/ANSI ES60601-1 | Bashan TDP Heat Lamp meets AAMI/ANSI ES60601-1. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Bashan TDP Heat Lamp meets IEC 60601-1-2. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 (for OTC use) | Bashan TDP Heat Lamp meets IEC 60601-1-11. |
| Output Parameters | Verification of output parameters | Performance test report conducted to verify output parameters. Result indicates "safe and effective." |
| Intended Use/Indications | Comparable to predicate devices | "temporary relief of minor muscle and joint pain and stiffness, ... temporary increase in local circulation ... relaxation of muscles. ... muscle spasms, minor sprains and strains, and minor muscular back pain." (Matches predicate devices). |
| Operating Timer | Predicate devices have various ranges or unspecified | Up to 60 minutes (Difference from predicate's "Up to 95 minutes" noted, but deemed not to affect safety/effectiveness). |
| Skin Temperature | Effective skin temperatures between 40 ~ 45 ℃ at 8" ~ 12" distance | Models TDP-124D & TDP-124F: 20cm: 45°C; 25cm: 42°C; 30cm: 40°C. Models TDP-166D & TDP-166F: 20cm: 45°C; 25cm: 43°C; 30cm: 41°C. (Difference noted, but deemed not to affect safety/effectiveness). |
| Usability | Users' ability to comprehend labeling and operate as intended, with no safety issues. | 500 eligible device users successfully operated the device with no safety issues reported. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions 500 eligible device users for the usability study.
The data provenance is not explicitly stated as "country of origin," but the submitter, Chongqing YUHE Medical Instruments Co., Ltd., is based in Chongqing, China. The study appears to be a prospective usability study where participants interacted with the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For the usability study, the document does not specify "experts" establishing ground truth in the sense of clinical reviewers. Instead, the "ground truth" for usability was likely derived from the successful interaction of the 500 device users with the product and its labeling, and the absence of reported safety issues. There were no clinical experts mentioned in evaluating the usability outcomes.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical adjudication process described for the usability study. The determination of "successfully operated" and "no safety issues" likely came directly from the observed outcomes of the 500 users.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is an infrared heat lamp for pain relief, not a diagnostic imaging device typically associated with MRMC studies to assess reader interpretations. The study conducted was a usability study and performance testing against standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone "algorithm only" performance study was not done. This device is a physical therapeutic device, not an AI or algorithm-based product.
7. The Type of Ground Truth Used
- Usability Study: The "ground truth" was derived from directly observed user performance and self-reported issues (or lack thereof) during the study. Successful operation and absence of safety issues reported by the 500 users served as the "ground truth" for usability.
- Performance Tests: The "ground truth" for performance (e.g., output parameters, skin temperature) was established through measurement against predefined engineering specifications and recognized electrical safety and performance standards.
8. The Sample Size for the Training Set
Not applicable. This device does not use an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.