(38 days)
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
The IPL Home Use Hair Removal Device includes D-1198, D-1186, D-1189, D-1197 five models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains PCB layout, product appearance and internal construction, but these differences do not affect or change the intended use of the device.
This document is a 510(k) Pre-market Notification for an IPL Home Use Hair Removal Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics for the subject device's clinical effectiveness.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for proving clinical effectiveness cannot be fully provided from the given text. This document primarily addresses safety and technical aspects through comparisons and compliance with standards.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: No specific numerical acceptance criteria for clinical effectiveness (e.g., percentage hair reduction, safety endpoints with thresholds) are explicitly stated for the subject device in this document. The document refers to "similar safety and effectiveness profile" and "performance data supports that the device is safe and as effective."
- Reported Device Performance:
- Clinical Effectiveness: The document states the device "works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain." However, no quantitative data on hair reduction percentage, pain scores, or other effectiveness metrics are provided for the subject device. The safety is "similar to the predicate device."
- Technical Performance (derived from comparison table in Section VI):
- Wavelength range: 550-1100nm
- Energy medium: Xenon Arc Flashlamp
- Energy density: 2.0-4.3 J/cm²
- Spot size: D-1198: 2.7cm², D-1185: 2.7cm², D-1186: 3.0cm², D-1189: 3.0cm², D-1197: 3.4cm²
- Pulse duration: 5-12ms
- Pulsing control: Finger switch
- Delivery device: Direct illumination to tissue
- Safety Performance (as per Section VII - Performance Data):
- Biocompatibility: Materials are identical to the predicate device (K211185), thus deemed safe.
- Electrical Safety & Eye Safety: Passed IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, and IEC 62471 standards.
- Software Verification and Validation: Passed, meeting all software requirement specifications and mitigating hazards to acceptable risk levels.
2. Sample size used for the test set and the data provenance:
- Not provided. This document does not describe a clinical test set with specific sample sizes for evaluating hair reduction or other clinical efficacy outcomes. The safety and effectiveness claims are based on comparison to a predicate device and compliance with technical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Since no specific clinical test set for efficacy is described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set involving human judgment and adjudication 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 an IPL hair removal device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of clinical efficacy. While the device itself operates standalone for hair removal, the performance data presented primarily pertains to safety (electrical, eye, biocompatibility) and technical specifications, not a clinical "algorithm only" performance for diagnosis/treatment in the typical sense of AI devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided for clinical efficacy. For safety, the "ground truth" is established by compliance with international standards (IEC standards) and prior FDA clearance of similar materials (for biocompatibility).
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a "training set" in the context of an IPL hair removal device's clinical efficacy or safety. The device does contain software, and "Software Verification and Validation" was performed, but details about a "training set" for software development are not included.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As with point 8, no training set for clinical efficacy is mentioned.
Summary of what is present:
This 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed predicate device (Bosidin IPL Home Use Hair Removal Device/D-1171, K211185). The key arguments for equivalence are:
- Identical Indications for Use: "removal of unwanted body and/or facial hair." (Section V, VI)
- Similar Mode of Action and Operational Characteristics: Uses Intense Pulsed Light (IPL) technology. (Section VI)
- Comparable Technical Specifications: Wavelength range, energy medium, energy density, spot size, pulse duration, pulsing control, delivery method are similar or within acceptable ranges. (Section VI table)
- Safety Compliance: The device components are biocompatible (identical to predicate materials), and it has passed multiple electrical and eye safety standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 62471). Software has also undergone verification and validation. (Section VII)
The document concludes that "the IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device" and is "substantially equivalent." This type of submission usually implies that extensive new clinical efficacy trials for the subject device were not deemed necessary by the FDA because of the strong similarity to an already cleared device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.