(25 days)
The Hair Boom 69 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 of Ila- V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this document is a 510(k) summary for a minor modification to an already cleared device ("Hair Boom 69"). Therefore, it primarily focuses on demonstrating substantial equivalence to the predicate device rather than establishing new performance criteria through de novo clinical studies.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Safety: Meets international safety standards for laser devices. | The Hair Boom 69 (proposed) was tested to internationally recognized standards including IEC 60825-1 (Laser Safety & Classification), IEC 60601-1 (Basic Safety and Essential Performance), IEC 60601-1-2 (EMC), IEC 60601-1-11 (Home Use), IEC 62304 (Software and Life Cycle Processes), ISO 14971 (Application of Risk Management to Medical Devices), ISO 10993-5 (In Vitro Cytotoxicity), and ISO 10993-10 (Irritation and Skin Sensitization). The submission states these tests are "consistent with the current recommendations adopted by the FDA." The device is classified as a Class IIIa/3R laser system by IEC, and its adverse event profile is expected to be the same as the predicate. |
| Effectiveness: Promotes hair growth in specified populations with androgenetic alopecia (Ludwig-Savin I-II for females, Norwood-Hamilton IIa-V for males) and Fitzpatrick Skin Phototypes I-IV. | No new clinical performance data was produced for this submission. The document explicitly states: "No clinical performance data was produced for this submission because the Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69." The effectiveness is inferred from the established effectiveness of the predicate device (Hair Boom 69, K191154) due to substantial equivalence. The proposed device has the same intended use, technological characteristics (laser diodes, wavelength), and treatment protocol as the predicate. |
| Technological Characteristics: Low-level laser therapy (LLLT) with 69 Class 3R laser diodes, wavelength 650 +/- 5 nm, helmet design (with minor physical modifications), passive use (hands-free). | The proposed device is stated to have the "identical device in optical, electronic and mechanical function" with the predicate. The comparison chart confirms all these characteristics are the same, with the only changes being "removed ear pads and enclosures/Color of helmet enclosure" and a changed storage base design, which were deemed not to affect electrical safety or performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No new clinical performance data or test set was generated for this submission. The study relies on establishing substantial equivalence to a previously cleared predicate device.
- Data Provenance: Not applicable for a new clinical test set. The safety data provenance is from compliance with international standards (IEC, ISO) and the established safety/effectiveness profile of the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. As no new clinical study with a test set was performed, there was no need for experts to establish ground truth for a test set. The regulatory determination relies on demonstrating equivalence to a device whose safety and efficacy were previously established.
4. Adjudication Method for the Test Set
- Not applicable. No new clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and safety testing, not on comparative clinical efficacy between human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- No, a standalone algorithm-only performance study was not done. This device is a physical LLLT device, not an AI/software algorithm that would require standalone performance evaluation.
7. The Type of Ground Truth Used
- Implied Ground Truth: The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (Hair Boom 69, K191154). Since the proposed device is technologically identical in function and intended use, its safety and effectiveness are deemed equivalent. The safety ground truth is also established through compliance with international standards (e.g., laser safety, electrical safety, biocompatibility).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no training set for this device.
§ 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.