(257 days)
The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
The Silver Bay Quasar Calypso C50 is a visible light and/or heat source with high spectral purity. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light sources. The device is two-sided with one side emitting narrow band blue light at 405 to 420 nm. The opposite side of the device emits red light at 628 nm +- 10 nm. The device is operated by a momentary switch, which allows the operator to select either the blue or red operation. The device does not allow the operator to select the red and blue light simultaneously.
The Quasar Calypso C50 uses a 12 volt wall mount power supply.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, explicit performance acceptance criteria and corresponding reported device performance for treating acne vulgaris are not provided. The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and safety standards, rather than direct clinical performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit clinical acceptance criteria were stated for acne treatment efficacy. | No clinical performance data related to acne treatment efficacy was presented. |
| Technological Characteristics Equivalence: The device should have the same technological characteristics, design, material, chemical composition, and energy source as the cited predicate devices. | The Quasar Calypso C50 is stated to have the "same technological characteristics, design, material, chemical composition, and energy source as the cited predicate devices." |
| Electrical Safety Standards Compliance: Compliance with performance standards under Section 878 of the Federal Food, Drug, and Cosmetics Act, and IEC/EN 60601-1-2000 and IEC/EN 60601-1-2 Standards. | The device is stated to be "in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act" and "in conformity with IEC/EN 60601-1-2000 and IEC/EN 60601-1-2 Standards." |
| Biocompatibility: Patient contact material (polycarbonate plastic) is well-known and accepted. | The patient contact material is polycarbonate plastic, which is stated to be "the same material used in the cited predicate devices" and its biocompatibility is "well known and accepted." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical studies were conducted or submitted.
- Data Provenance: Not applicable. No clinical data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a test set was required.
4. Adjudication Method for the Test Set
- Not applicable. No clinical studies were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT done.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as no such study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone performance study was NOT done. The device is a physical light therapy device, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable. No clinical efficacy data was submitted, and thus no ground truth for clinical performance was established in the context of this submission. The "ground truth" for the submission's purpose was the established safety and efficacy of the predicate devices and compliance with relevant safety standards.
8. The Sample Size for the Training Set
- Not applicable. This is a medical device (light therapy) submission, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The provided 510(k) summary explicitly states: "No Clinical Data is submitted with this application."
Instead of conducting clinical studies to prove direct efficacy for treating mild to moderate acne vulgaris, the submission relies on demonstrating substantial equivalence to existing predicate devices already on the market. The "proof" that the device meets its implicitly accepted performance (i.e., effectiveness for its intended use) and safety criteria is based on the following:
- Technological Equivalence: The device shares the "same technological characteristics, design, material, chemical composition, and energy source" as the identified predicate devices (K093963 Quasar Blue Light Therapy System, K060792 Illumimed, K083183 Aklarus, K081307 Omnilux Clear-U). This implies that if the predicates are safe and effective, and the new device is technologically similar, it is also assumed to be safe and effective for the same indications.
- Compliance with Recognized Standards: The device's compliance with established performance standards under Section 878 of the Federal Food, Drug, and Cosmetics Act, and electrical and safety standards like IEC/EN 60601-1-2000 and IEC/EN 60601-1-2. This addresses the safety aspect of the device.
- Biocompatibility of Materials: The use of polycarbonate plastic for patient contact, a material already "well known and accepted" and used in predicate devices, addresses biocompatibility concerns.
In essence, the "study" proving the device meets the acceptance criteria is a comparative analysis against predicate devices and adherence to relevant safety and performance engineering standards, rather than a clinical trial demonstrating efficacy in patients.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.