(189 days)
The Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (469mm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (633nm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Phototherapy System OL-PDT950 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions.
The device produces light in the red light region of the spectrum (633±15nm), in the blue light regions of the light spectrum (469±15nm) and infrared light region of light spectrum (835±15nm).
Five sets of LEDs panels are available for the device.
Based on the provided FDA 510(k) summary for the Phototherapy System (OL-PDT950) (K230342), here's an analysis of the acceptance criteria and the study proving the device meets them:
Important Note: This document is a 510(k) summary for a premarket notification, which demonstrates substantial equivalence to existing devices. It is not a clinical study report that would typically detail the comprehensive acceptance criteria and performance data for a novel device or a device requiring de novo classification. Therefore, the information related to clinical performance is limited, and many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, ground truth establishment) are generally not part of a 510(k) submission for this type of device.
Acceptance Criteria and Device Performance for Phototherapy System (OL-PDT950)
The device, a Phototherapy System, is intended to emit energy to treat dermatological conditions using red, blue, and infrared light. For a 510(k) submission of this nature, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through a comparison of technological characteristics and performance specifications. Clinical efficacy is typically established through a combination of the predicate device's history of safe and effective use and non-clinical performance testing of the new device.
The study proving the device meets acceptance criteria is primarily composed of non-clinical tests and a comparison of technical specifications to predicate devices. Clinical testing was not performed for this specific submission as stated in Section 6.1.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence based on non-clinical data, the "acceptance criteria" are the demonstration of comparable technical specifications and compliance with relevant safety and performance standards. The "reported device performance" are the results of these non-clinical tests and the listed specifications of the subject device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Subject Device (OL-PDT950) Reported Performance/Specifications | Reference Predicate Devices (K200751, K2227551, K200104) |
|---|---|---|
| Compliance with Electrical Safety Standard | Comply with IEC 60601-1 and IEC 60601-1-2 | Predicates also comply with IEC 60601-1 and IEC 60601-1-2 |
| Compliance with Non-Laser Light Source Equipment Safety Standard | Comply with IEC 60601-2-57 | Predicates also comply with IEC 60601-2-57 |
| Compliance with Photobiological Safety Standard | Comply with IEC 62471 | Predicates also comply with IEC 62471 |
| Software Verification and Validation (if applicable) | Software testing conducted in accordance with FDA guidance. | (Implicit in general controls for all medical devices with software) |
| Wavelengths | Red light: 633nm ± 15nm | |
| Blue light: 469nm ± 15nm | ||
| Infrared light: 835nm ± 15nm | Predicate 1: Red 630±15nm, Blue 415±15nm, IR 835±15nm | |
| Predicate 2: Red 633±15nm, Blue 417±15nm, IR 835±15nm | ||
| Predicate 3: Red 625nm±5nm, Blue 465nm±5nm, Yellow 590nm±5nm (note: Yellow not on subject device) | ||
| Maximum Power Density (Irradiance) | Red light: 75 mW/cm² | |
| Blue light: 35 mW/cm² | ||
| IR: 120 mW/cm² | Predicate 1: Red 115 mW/cm², Blue 120 mW/cm², IR 70 mW/cm² | |
| Predicate 2: Red 20-96 mW/cm², Blue 10-120 mW/cm², IR ≤ 70 mW/cm² | ||
| Predicate 3: Red 100 mW/cm², Blue 45 mW/cm², Yellow 35 mW/cm² | ||
| Treatment Area | 1228 cm² | Predicate 1: 1410 cm² |
| Predicate 2: 900 cm² ± 10% | ||
| Predicate 3: 500cm² and 860cm² | ||
| Recommended Treatment Time | 20 minutes | Predicates all list 20 minutes |
| Working Distance | 10-15cm | Predicate 1: 10-15cm |
| Predicate 2 & 3: Unknown |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for clinical data, as stated in Section 6.1: "Clinical testing was not performed for the subject device as part of the submission."
- Data Provenance: The reported performance data for the subject device comes from non-clinical tests (e.g., electrical safety, electromagnetic compatibility, photobiological safety, and performance specifications adherence). The location of these tests is not explicitly stated but can be inferred to be China, given the manufacturer's location (Shanghai, China). The data is inherently prospective in terms of the specific device's specifications and test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As clinical testing was not performed, there was no "ground truth" derived from expert consensus on medical conditions for a test set. Normative data for device specifications and compliance with standards are established through engineering and testing professionals, not medical experts.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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 device is a phototherapy system, not an AI-powered diagnostic or assistive tool for human readers (like radiologists interpreting images). Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithmic device. Its performance is based on its physical light emission characteristics.
7. The type of ground truth used
- For the non-clinical tests and technical specifications, the "ground truth" is established through objective measurements (e.g., power meters for irradiance, spectrophotometers for wavelength verification) and compliance with internationally recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471). There is no "pathology" or "outcomes data" ground truth used for this type of 510(k) submission.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this device.
§ 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.