(119 days)
The Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers are non-invasive infrared lamps intended to provide topical heating. The Terraquant MQ2000 v.5 and HandyRx Laser MQ2007 Lasers are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The Escada Terraquant MQ2000 Laser Therapy Device has been modified resulting in the Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers. The Terraquant MQ2000 was modified to increase the power level range for the laser from .4 to 1.4 mW to .4 to 7.5 mW and to provide the device in a hand held configuration. The proposed Terraquant MQ2000 v.5 (increased power but same configuration as Terraquant MQ2000) and the HandyRx MQ2007 (increased power level in a hand held configuration) are essentially identical in intended use and fundamental technology to the parent Terraquant MQ2000 Laser Therapy Device described in K043055. As with the original Terraquant MQ2000 system, the Terraquant MQ2000 v.5 and HandyRx MQ2007 System utilize heating lamps consisting of a laser diode, infrared diodes, and a visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.
The parent Terraquant MQ2000 system and the Terraquant MQ2000 v. 5 consist of a desktop control unit, and a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The proposed HandyRx MQ2007 consists of only the handheld emitter from which the laser and other radiances are released. Both the parent and proposed device laser and light therapies release radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
Under its 510(k) summary, Escada International, Inc. describes the acceptance criteria and the study that proves the Terraquant MQ2000 v.5 and HandyRx MQ2007 Lasers meet the acceptance criteria:
- Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Device Performance (HandyRx MQ2007) |
|---|---|
| Minimum skin temperature | Achieved 40°C (104°F) after approximately 6 minutes of exposure. |
| Maintained skin temperature | Maintained a temperature within 40-45°C (104-113°F) for 24 minutes in all anatomic locations. |
| Classification as a heating lamp (FDA 21 CFR 890.5500) | Successfully demonstrated to increase skin temperature to the specified FDA range, thus qualifying as a heating lamp. |
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified beyond "human subjects."
- Data Provenance: The study was conducted on "human subjects," implying prospective, clinical testing. The country of origin is not mentioned.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. The ground truth was based on direct temperature measurement, not expert consensus or interpretation.
-
Adjudication method for the test set: Not applicable. The study involved direct measurement of skin temperature.
-
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 device is a heating lamp, not an AI-powered diagnostic tool requiring human reader studies.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "device performance" described is essentially standalone, demonstrating the device's ability to achieve and maintain target temperatures without human intervention beyond initial setup.
-
The type of ground truth used:
- Ground Truth: Direct measurement of skin surface temperature in human subjects. The target temperature range of 40-45°C (104-113°F) was specified by the FDA.
-
The sample size for the training set: Not applicable. This device's performance was evaluated through direct physical measurements rather than a machine learning model requiring a training set.
-
How the ground truth for the training set was established: Not applicable, as there was no training set for an algorithm.
§ 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.