(183 days)
iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
The provided text is a 510(k) summary for the iHelmet Hair Growth System (Model: LTD200S). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical outcomes.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies are not explicitly provided in this regulatory document. This document primarily addresses safety and performance through bench testing and comparison to a predicate device.
Here's a breakdown of the information that can be extracted or inferred from the provided text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not present clinical acceptance criteria for hair growth or efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards. The "acceptance criteria" here are compliance with recognized safety standards and similarity to the predicate device.
| Acceptance Criteria (Inferred from compliance) | Reported Device Performance (from "Test Summary" and "Comparison") |
|---|---|
| Safety Standards Compliance | |
| IEC 60601-1 (General Safety) | Complied with IEC 60601-1 |
| IEC 60601-1-2 (EMC) | Complied with IEC 60601-1-2 |
| IEC 60825-1 (Laser Safety) | Class 3R (device classification per standard) |
| IEC 60601-1-11 (Home Healthcare Environment) | Complied with IEC 60601-1-11 |
| ISO 10993-5 (Cytotoxicity) | Complied with ISO 10993-5 (Patient contacting materials) |
| ISO 10993-10 (Sensitization/Irritation) | Complied with ISO 10993-10 (Patient contacting materials) |
| Temperature between device & scalp | Highest temperature between iHelmet and scalp would not exceed 43°C during operation, meeting IEC 60601-1 requirement. |
| Functional/Technical Equivalence | |
| Intended Use / Indications for Use | "Substantially Equivalent" to predicate device, indicated for promoting hair growth in females with Ludwig-Savin Class I - II and males with Norwood Hamilton Classifications IIa - V, both with Fitzpatrick Skin Phototypes I - IV. |
| Waveform | Visible red laser (identical to predicate) |
| Wavelength | 650nm ± 10nm (very similar to predicate's 650nm) |
| Energy of per Laser Lamp | 4~5mW (similar to predicate's |
§ 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.