(199 days)
The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.
The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system. The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit. The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500. The two laser applicator heads produce an output power of
Here's an analysis of the provided text regarding the Quantum Light Therapy System, focusing on acceptance criteria and the study (or lack thereof) proving its performance.
It's important to note that this document is a 510(k) summary for a medical device. 510(k) clearances typically establish substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the information provided focuses more on demonstrating equivalence and compliance with standards than on a detailed clinical study demonstrating specific performance metrics.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds for clinical performance (e.g., minimum sensitivity, specificity, accuracy, or reduction in a pain score). Instead, the "acceptance criteria" for a 510(k) device like this are primarily related to substantial equivalence to predicate devices, safety, and compliance with relevant technical standards.
The "reported device performance" is framed in terms of its intended use, similarity to predicate devices, and adherence to various electromagnetic and safety standards.
Here's a table summarizing what can be inferred as "acceptance criteria" from the document and the corresponding "performance" as stated:
| Acceptance Criterion (Inferred from 510(k) Process) | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices. | "The Quantum Light Therapy System has the same intended use... It combines the clinically accepted therapeutic uses of previously FDA 510(k) approved light therapy systems... into one complete, compact, and cost-effective system." |
"Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin..." (same as predicate indications). |
| Technological Characteristics Equivalence: Similar technological characteristics (wavelengths, power output) to predicate devices. | "The technological equivalence to the predicate devices is substantiated by the wavelengths and power outputs generated by the individual Quantum System applicator heads."
The two laser applicator heads produce an output power of "
§ 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.