(59 days)
The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (630mm 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 Photodynamic Therapy (PDT) Equipment HM-PDT 900 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 (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Five sets of LEDs panels are available for the device.
This document describes a 510(k) premarket notification for a Photodynamic Therapy (PDT) Equipment. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, clinical study specifics, and expert involvement is not available in this document.
Here's a breakdown of the information that can be extracted and what is explicitly stated as not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with numerical performance goals and achieved results for clinical effectiveness. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards.
The "performance comparison" in Table 7-2 highlights similarities and differences between the proposed device and the predicate. The "acceptance criteria" here is effectively "substantially equivalent to the predicate device."
| Feature/Parameter | Acceptance Criteria (Substantially Equivalent to Predicate K190938) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Intended Use | Same as Predicate | The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. | SAME |
| Blue Light (415nm) Indication | Treat dermatological conditions and specifically moderate inflammatory acne vulgaris. | Treat dermatological conditions and specifically moderate inflammatory acne vulgaris. | SAME |
| Red Light (630nm) Indication | Treatment of superficial, benign vascular, and pigmented lesions. | Treatment of superficial, benign vascular, and pigmented lesions. | SAME |
| Infrared Light (835nm) Indication | 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. | 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. | SAME |
| Wavelength (nm) | Red light 630±15nm; Blue light 415±5nm; NIR light 835±10nm | Red light 630nm±15nm; Blue light 415nm±15nm; Infrared light 835nm±15nm | SAME (Note: Blue light wavelength tolerance slightly different for predicate, but declared "SAME") |
| Light frequency | 200Hz | 200Hz | SAME |
| LED power (per diode) | 3W | 3W | SAME |
| Max Power Density (Red) | 115mW/cm2 (242J/cm2) | 115mW/cm2 (242J/cm2) | SAME |
| Max Power Density (Blue) | 120mW/cm2 (180J/cm2) | 120mW/cm2 (180J/cm2) | SAME |
| Max Power Density (IR) | 70mW/cm2 (147J/cm2) | 70mW/cm2 (147J/cm2) | SAME |
| Treatment time | 20 minutes (recommended) | 20 minutes (recommended) | SAME |
| Working distance | 10~15cm | 10~15cm | SAME |
| Power supply | AC 100-240V 50/60Hz 10A | AC 100-240V 50/60Hz 500VA (Note: 10A vs 500VA; implies similar power draw) | SAME |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-1-2 | Comply with IEC 60601-1 and IEC 60601-1-2 | SAME |
| Radiation Safety | Comply with IEC 60601-2-57 | Comply with IEC 60601-2-57 | SAME |
| Photobiological safety | Comply with IEC 62471 | Comply with IEC 62471 | SAME |
| Panels Type | 3panel: 180EA LEDS; 4 Panel: 240 EALEDs. Panels may emit three lights (red, blue, infrared). | 5panel: 300 EALEDs. Panels may emit the three light (red, blue, infrared). | Analysis (Differences in panel/LED count, but deemed not to affect output energy) |
| Treatment area | 756cm2 and 1008cm2 | 1410cm2 | Analysis (Difference, but deemed not to affect output energy) |
| Numbers of LEDs | 3 panels: 180EA; 4 panels: 240EA. | 5 panels: 300EA. | Analysis (Difference, but deemed not to affect output energy) |
| Dimension | 500mm[H]× 500[W]× 1350[D] | 638mm×243mm×1560mm (Host); 494mm×346mm×69 (LEDs Panels) | Analysis (Difference, but deemed not to affect output energy) |
Analysis from document regarding "differences": "The proposed device has different panel number, diode number of each LED, LED number, and treatment area than predicate device, but the difference does not affect the output energy for treatment. Therefore, the slight difference is considered to have no effectiveness and safe."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical test set.
- Data Provenance: Not applicable. The submission relies on non-clinical bench testing and adherence to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth derived from expert consensus for clinical performance. The "ground truth" for non-clinical tests would be the established specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
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 light therapy equipment, not an AI diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. The device's performance is measured by its output parameters (wavelength, power density, etc.) as confirmed by bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (bench testing): The "ground truth" would be the engineering specifications and established performance limits defined by international standards (e.g., IEC 60601 series, IEC 62471).
8. The sample size for the training set:
- Not applicable. No training set was used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary from the document regarding studies:
- Clinical Test Conclusion: "No clinical study is included in this submission." (Page 5)
- Non-Clinical Test Conclusion: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1-2:2014 (EMC)
- IEC 60601-1:2005/A1:2012 (Basic safety and essential performance)
- IEC 60601-2-57:2011 (Non-laser light source equipment safety)
- IEC 62471:2006 (Photobiological safety)
- Software Verification and Validation Testing
- Bench Testing (Energy density output accuracy, Wavelength accuracy)" (Page 5-6)
In essence, the acceptance criteria for this device's 510(k) clearance was its ability to demonstrate substantial equivalence to a previously cleared predicate device through non-clinical testing verifying its physical and electrical performance parameters, and by adhering to relevant safety and performance standards. No clinical efficacy or performance studies with human subjects were conducted or required for this submission.
§ 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.