(374 days)
Electro-Light Therapy System is used to provide topical heating for:
- Temporary increases in local blood flow and circulation .
- . Temporary relief of minor muscle and joint aches
- . Temporary relief of pain and stiffness
- . Relaxation of muscles
- . Temporary relief (or relaxation) of muscle spasms
- . Temporary relief of minor pain and stiffness associated with arthritis
The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.
The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256. The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist. Both the predicate devices and the new device are intended to be used on a cart. The new device has a maximum time setting of 99 minutes.
1. Table of acceptance criteria and the reported device performance
This 510(k) summary does not provide specific acceptance criteria or quantitative performance metrics in the format of a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly K072256 (HF 54 with Optional Hands-free operation) and K071445 (Terraquant Mq2000 V.5 With The Tq-1 Tens).
The primary performance aspects discussed the document relate to safety and intended use:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety - Temperature in Tissues | |
| (Maximum temperature in tissues below 45°C to prevent new safety issues compared to predicate) | "From Measurement, it was shown that the maximum temperature was 45 ℃ there is no new safety issue when compared with the K072256 predicate." |
| Safety - Patient Supervision | |
| (Prevention of patient falling asleep during treatment) | "The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep." |
| Effectiveness/Functionality - Infrared Therapy Output | |
| (Similar IR therapy intensity to predicate K072256 for a single light head) | "The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256." |
| Effectiveness/Functionality - Combined Electrotherapy and IR Therapy | |
| (Ability to be used with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy through a transparent electrode, similar to K071445 for combined use.) | "The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode... The Electro-Light Therapy also has same characteristics of combined electrotherapy and IR therapy as the K071445 predicate." |
| Electrical Safety Standards | |
| (Compliance with relevant electrical safety standards, e.g., IEC 60601-1) | "The new device is in compliance to the same standards [as the predicate device]." |
2. Sample size used for the test set and the data provenance
The document does not describe a formal study with a "test set" in the context of clinical performance or diagnostic accuracy. The evaluation appears to be based on:
- Engineering/Bench Testing: The "Measurement" for tissue temperature (maximum temperature was 45 ℃) strongly suggests bench testing. There is no specified sample size for this test.
- Comparison to Predicate Devices: The primary method of demonstrating substantial equivalence is by comparing the technological characteristics, performance capabilities (like light intensity and compatibility with electrodes), and safety features to legally marketed predicate devices.
Data Provenance: Not applicable as it's not a clinical study with patient data. The safety assessment relies on engineering measurements and a comparison of features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an infrared therapy lamp. The 510(k) summary does not involve a "ground truth" derived from expert interpretation (e.g., radiologists interpreting images) for a test set. The evaluation focuses on physical characteristics, safety, and equivalence to existing devices.
4. Adjudication method for the test set
Not applicable. As there are no expert interpretations or clinical data in a formal test set described, there is no adjudication method mentioned.
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 an infrared therapy lamp, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an infrared therapy lamp, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Temperatures in Tissues" section, the "ground truth" is established through physical measurement of temperature, likely using thermal sensors or similar instrumentation during testing. This is an objective physical measurement, not an expert consensus, pathology, or outcomes data.
For other aspects, substantial equivalence relies on:
- Engineering specifications and design comparisons.
- Compliance with recognized standards (e.g., IEC 60601-1).
- Functional comparison to predicate devices, demonstrating similar intended use and performance.
8. The sample size for the training set
Not applicable. This device is an infrared therapy lamp and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is an infrared therapy lamp and does not have a training set.
§ 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.