(57 days)
The IR Pro 250 is intended for use in 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 help muscle spasms, minor sprains and strains, and minor back pain.
The IR Pro 250 lamp can be used for topical heating of the body. It is designed to emit light between 700 to 50,000 nanometers in wavelength. The lamp uses 120 volts AC power at 250 watts. It is mounted on a swivel stand with 5 casters. An automatic timer controls exposure time.
The provided 510(k) summary for the IR Pro 250 Infrared Heating Lamp does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or effectiveness.
This submission is for an infrared heating lamp, which falls under a general controls class II device. For such devices, substantial equivalence is often demonstrated through comparison to a legally marketed predicate device and adherence to recognized safety standards, rather than extensive clinical studies with specific performance metrics and ground truth establishment.
Here's an analysis based on your requested information, highlighting what is present and what is absent in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance: Not specified for therapeutic effectiveness. | Intended Use: "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 help muscle spasms, minor sprains and strains, and minor back pain." (Stated intent, not performance against a metric.) |
| Safety Standard Compliance: Must meet UL 482, 9th Edition Standard for Safety for Portable Sun/Heat Lamp. | Compliance: "A sample of the device was tested in accordance with the Standard for Safety for Portable Sun/Heat Lamp, UL-482, 9th Edition, September 2, 2005: UL 482/21, UL 482/22, UL 482/24, UL 482/26, UL 482/27, UL 482/29" (Implies successful testing, but does not provide specific test results or pass/fail thresholds for each section). |
| Technological Characteristics: To be substantially equivalent to predicate device (TDP CQ-27 Lamp). | Comparison: Both use 120 volts, AC 60 Hz power and emit infrared heat. The IR Pro 250 uses a 250-watt infrared bulb, while the TDP lamp uses an emission plate. (This is a description of shared and differing characteristics, not a performance metric.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical performance data. For safety testing, it states "A sample of the device was tested," implying at least one device was subjected to UL 482 tests, but the exact number isn't quantified.
- Data Provenance: Not applicable for clinical performance. The UL 482 testing is likely an internal or third-party laboratory test, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as no clinical or diagnostic "ground truth" test set is described. The predicate device's established use history and accepted safety standards serve as the basis for equivalence.
4. Adjudication Method for the Test Set
- Not applicable as no clinical or diagnostic test set requiring adjudication is described.
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 MRMC study was conducted. This device is an infrared heating lamp, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a physical heating lamp, not an algorithm.
7. The Type of Ground Truth Used
- For demonstrating substantial equivalence:
- Predicate Device History: The regulatory history and accepted intended use of the legally marketed predicate device (TDP CQ-27 Lamp, K003538) serves as the primary "ground truth" for demonstrating similar safety and effectiveness.
- Safety Standards: Compliance with UL 482 acts as "ground truth" for electrical and heating safety.
- No clinical "ground truth" (expert consensus, pathology, outcomes data) involving patient data was used for a de novo assessment of efficacy.
8. The Sample Size for the Training Set
- Not applicable. There is no training set for an algorithm as this is a physical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no training set.
Summary of Device Acceptance:
The device's "acceptance" by the FDA, as indicated by the 510(k) clearance letter, is based on a demonstration of substantial equivalence to an existing legally marketed predicate device (the TDP CQ-27 Lamp). This means the FDA determined that the IR Pro 250 has the same intended use, and the same technological characteristics as the predicate device (or different characteristics that do not raise new questions of safety and effectiveness).
The primary evidence presented to support this claim includes:
- Identical Intended Use: The intended use of the IR Pro 250 is precisely the same as the predicate device.
- Similar Technological Characteristics: Both devices operate on similar power, emit infrared heat, and serve the same purpose.
- Compliance with Recognized Safety Standard: Testing against UL 482 (Standard for Safety for Portable Sun/Heat Lamp) ensures the device meets established safety requirements for its type.
For this type of device, a clinical study demonstrating therapeutic efficacy against specific acceptance criteria (like a reduction in pain score by X%) is typically not required for 510(k) clearance if substantial equivalence to a well-established predicate can be shown. The "study" here is the safety testing according to UL 482 and the regulatory comparison to the predicate.
§ 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.