(11 days)
The HairMax LaserComb is indicated to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.
Similar to the HairMax LaserComb K060305, the modified HairMax LaserComb consists of a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The predicate unit operates from solely on a class 2, UL and CUL rated wall transformer. The modified unit adds a Lithium ion battery power supply option. In addition, cosmetic changes are being made to the device color and exterior plastic housing. Changes do not alter form fit or function as compared to the predicate device.
Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and study information:
The document (K093499) describes a modified HairMax LaserComb (version 5.2) and seeks substantial equivalence to a previously cleared device (K060305). Crucially, this 510(k) pertains to modifications (adding a Li-ion battery, cosmetic changes) to an already cleared device, not a new device requiring a full de novo clinical study to prove efficacy. The submission explicitly states that the changes "do not alter form fit or function as compared to the predicate device" and "do not affect the safety or performance of the device and do not change the intended use of the HairMax LaserComb."
Therefore, the document does not contain information about a clinical study proving the modified device's performance against acceptance criteria in terms of hair growth promotion. Instead, it relies on the predicate device's existing clearance and demonstrates that the modifications do not negatively impact safety or effectiveness.
Based on the provided text, the following information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this 510(k) is for a modified device and not a new device requiring efficacy trials for hair growth, there are no specific performance acceptance criteria for hair growth or reported device performance for this particular submission. The focus is on demonstrating that the modifications do not affect safety or performance compared to the predicate.
The document mentions: "Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10." However, Section 10 is not included in the provided text. These tests would typically be related to electrical safety, mechanical integrity, battery performance, and electromagnetic compatibility to ensure the modified device is as safe as the predicate, rather than clinical efficacy.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable for a hair growth efficacy study in this submission. The document refers to "verification and validation tests" in Section 10, which would have their own sample sizes for engineering/safety tests, but these are not specified.
- Data Provenance: Not applicable for a hair growth efficacy study in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical efficacy test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical efficacy test set is described.
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 low-level laser therapy device for hair growth, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical therapeutic device, not a standalone algorithm.
7. The type of ground truth used:
- Not applicable for hair growth efficacy in this submission. For the safety and performance of the modified device, the "ground truth" would be compliance with internal design specifications and relevant industry standards (e.g., electrical safety standards).
8. The sample size for the training set:
- Not applicable. No AI/machine learning model is being trained here.
9. How the ground truth for the training set was established:
- Not applicable. No AI/machine learning model is being trained here.
Summary of what the document does provide regarding acceptance/equivalence:
- Predicate Device: HairMax LaserComb K060305. The current device (K093499) is considered substantially equivalent to this predicate.
- Basis for Equivalence:
- Same indicated use: "to promote hair growth in males, 30-60 years of age with androgenetic alopecia who have Norwood Hamilton Classifications IIa -V patterns of hair loss and Fitzpatrick Skin Types I to IV."
- Same operating principle.
- Same basic device design and physical properties.
- Same materials.
- Same technological characteristics (laser power, wavelength, laser delivery method, comb component, instructions for use, audible timer).
- Modifications: Adding a Lithium ion battery power supply option and cosmetic changes (device color and exterior plastic housing dimensions).
- Verification of Modifications: The submission states these modifications "do not alter form fit or function as compared to the predicate device" and "do not affect the safety or performance of the device and do not change the intended use." Performance testing was conducted "to confirm compliance to design specifications; all functions were verified to operate as designed." (Details of these tests and their acceptance criteria are in a section not provided).
§ 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.