(59 days)
The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to 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.
The provided document describes a 510(k) premarket notification for the "Hair Boom 69" device. The submission asserts substantial equivalence to a predicate device, the "HairMax Laser 80," rather than presenting a new study with acceptance criteria and device performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available because the submission is based on demonstrating substantial equivalence to a predicate device, not on a new clinical study with specific acceptance criteria that the device's performance was measured against.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No new clinical test set was used for the Hair Boom 69 as part of this 510(k) submission. The device's equivalence is based on its technological characteristics and the predicate device's existing clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No new ground truth was established for a test set for the Hair Boom 69 in this submission.
4. Adjudication Method for the Test Set:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC comparative effectiveness study was not done as part of this 510(k) submission.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a hardware product (laser helmet) and does not involve an algorithm with standalone performance.
7. Type of Ground Truth Used:
Not applicable to the Hair Boom 69 itself in this submission. The "ground truth" for its efficacy relies on the prior clearance of the predicate device, HairMax Laser 80, which presumably established its efficacy through its own studies.
8. Sample Size for the Training Set:
Not applicable. No training set was used for this device as it's a hardware device demonstrating equivalence, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the K182562 Submission for Hair Boom 69:
The document focuses on establishing substantial equivalence of the "Hair Boom 69" to the "HairMax Laser 80" (K180885). This means the Hair Boom 69 did not undergo a new clinical trial to define and meet specific acceptance criteria. Instead, its safety and effectiveness are inferred from the predicate device's prior clearance based on similar intended use and technological characteristics.
Key points from the submission regarding "performance":
- No clinical performance data was produced for this submission because the Hair Boom 69 is an equivalent device in optical, electronic, and mechanical function, as well as recommended clinical treatment regime, to the predicate device.
- The Hair Boom 69 was tested to internationally recognized non-clinical standards (IEC, AAMI/ANSI, ISO standards for laser safety, basic safety, EMC, home use, software, risk management, and biological evaluation). These standards demonstrate the device's safety and quality manufacturing, but do not directly assess clinical efficacy in terms of hair growth.
- The submission highlights that both devices use Class IIIa/3R laser systems (by IEC standard) and have similar adverse event profiles.
- The only ergonomic design distinction mentioned is that the Hair Boom 69 is a helmet design, while the HairMax Laser 80 is a cap design, which the sponsor believes does not affect therapeutic value or safety.
- Both devices share the same treatment regime: 30 minutes, every other day, on non-consecutive days, or three times per week for 16 weeks.
In essence, the "study" proving the device meets acceptance criteria (in this context, substantial equivalence to the predicate) is the comparison chart and the assertion that "the Hair Boom 69, is substantially equivalent to the HairMax Laser 80 and based upon the equivalent technological designs of the compared devices." The acceptance criteria for this type of submission are legal and regulatory (meeting the requirements for substantial equivalence to a legally marketed predicate) rather than specific clinical performance metrics for the new 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.