(32 days)
The Capillus202 is indicated to promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-II, and with Fitzpatrick Skin Phototypes I-IV.
The Capillus202 consists of 202 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as for the previous version, the helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.
The Capillus202 device is indicated to promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-II, and with Fitzpatrick Skin Phototypes I-IV.
The study presented is a Special 510(k) Summary, which focuses on demonstrating substantial equivalence to a previously cleared device (Capillus272 Pro, K143199) rather than a full de novo clinical trial. The Capillus202 is essentially a modified version of the Capillus272 Pro with fewer laser diodes. Therefore, the "study" demonstrating performance relies heavily on the established performance of the predicate device and the assessment that the change (fewer diodes) does not negatively impact safety and efficacy.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily related to maintaining the safety and equivalence characteristics of the predicate device. The performance is assessed comparatively.
| Acceptance Criterion (Implicit) | Reported Device Performance (Capillus202) |
|---|---|
| Safety: | |
| Conformity to established laser safety standards. | Conforms to IEC-602025-2007-03, establishing a laser class of 3R, with AEL (accessible emission limits) of 5 milliWatts maximum. |
| Charger conformity to relevant electrical safety standards. | Charger conforms to IEC 61959. |
| No new significant risks identified due to design changes (reduction in diodes). | Risk assessment from previous model (Capillus272 Pro) revealed no significant changes or risks for the Capillus202. |
| Operation of safety interlock. | Safety interlock mechanism is the same as Capillus272 Pro (pauses therapy if head is moved outside of zone of radiation). |
Individual laser diode output (SmW). | Individual laser output per diode remains the same (SmW). |
| No adverse events reported for this technology. | "Just as for Capillus272 Pro (K143199) and reference devices, there are no reported adverse events for this technology." |
| Functional/Technical Equivalence: | |
| Same laser wavelength as predicate. | 650nm (same as Capillus272 Pro). |
| Same output power per diode as predicate. | Output power (per diode) remains the same. |
| Same output beam, energy type, laser field, and treatment area as predicate (except total dose). | Exactly the same laser wavelength, output power (per diode), output beam, energy type, laser field, and treatment area. |
| Same overall design and configuration (helmet, protective liner, portable use, rechargeable battery). | Same configuration with 202 diodes (vs. 272 for predicate). |
| Implementation of design controls per 21 CFR 820.30. | Capillus LLC Quality Management System compliant to 21 CFR 820.30. All design control activities documented and followed. |
| Efficacy Equivalence (with consideration for reduced dose): | |
| Expected efficacy commensurate with the number of diodes, acknowledging a potential time difference. | "Total 'dose' - delivered energy over time - (J/cm2) is logically reduced. ... this will likely affect only the time required to witness the same result as achieved with the Capillus272 Pro. The Capillus202 is offered as a lower-cost alternative." "The slower efficacy is accepted, with the understanding that treatment is intended to be indefinite." |
| Same intended use/indications for use. | Same indications for use as Capillus272 Pro. |
| Same dose schedule. | Same dose schedule: maximum 30 minutes, every other day. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a traditional clinical "test set" for this submission. The document doesn't describe a new clinical study with a test set for the Capillus202 itself. Instead, it leverages the established performance of the predicate device (Capillus272 Pro) and reference devices. The "performance data" refers to technical verification and validation activities (e.g., laser output, safety interlock) rather than clinical efficacy data on a "test set" of patients for the Capillus202.
- Data Provenance: The efficacy claims for Low-Level Laser Therapy (LLLT) in general and for the Capillus272 Pro specifically would have been derived from separate studies (not detailed in this document). The current submission relies on the technological equivalence and safety verification of the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as there was no new clinical "test set" with ground truth established by experts for the Capillus202 in this submission. The "ground truth" for efficacy of LLLT for hair growth in the predicate device would have been established through clinical trials, typically involving dermatologists or hair restoration specialists.
- The document does mention "Feedback from hair restoration specialists and consumers indicate that a lower-cost alternative is desired," suggesting experts were consulted on market need and acceptance of potentially slower efficacy.
4. Adjudication Method for the Test Set
- Not applicable, as a new clinical test set requiring adjudication was not part of this Special 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is typically for diagnostic imaging devices where different readers interpret cases. The Capillus202 is a therapeutic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This concept is not applicable. The Capillus202 is a physical medical device, not an algorithm. Its performance is its direct therapeutic effect, which is measured in terms of hair growth, not reader performance.
7. Type of Ground Truth Used
- For the Capillus202 submission itself, the "ground truth" is primarily based on technical specifications, safety standards compliance, and the established clinical efficacy of the predicate device (Capillus272 Pro) and other cleared LLLT devices.
- The original ground truth for LLLT efficacy for the predicate device (Capillus272 Pro) would have been established through clinical outcomes data (e.g., hair count, hair density measurements, photographic assessment) in studies.
8. Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm or a new clinical trial for the Capillus202. The device is a hardware modification.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above.
§ 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.