(83 days)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.
IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). 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 (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.
The provided document does not contain information about specific acceptance criteria related to clinical performance metrics (e.g., hair reduction percentage, adverse event rates) or a detailed study demonstrating the device meets such criteria. Instead, it focuses on non-clinical studies for safety and functional equivalence to predicate devices.
Therefore, the following information cannot be extracted from the document:
- A table of acceptance criteria and the reported device performance regarding hair removal efficacy.
- Sample size used for a test set (clinical or performance efficacy).
- Data provenance for a clinical test set.
- Number of experts used to establish ground truth for a clinical test set and their qualifications.
- Adjudication method for a clinical test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
- The sample size for the training set (as no AI/algorithm performance study is described).
- How the ground truth for the training set was established.
However, the document does describe non-clinical studies conducted to demonstrate substantial equivalence, focusing on safety and technical performance.
Here's a summary of the non-clinical studies and their conclusions as presented:
Acceptance Criteria and Reported Device Performance (Non-Clinical):
The document states that non-clinical tests were conducted to verify that the IPL Hair Removal Device meets all design specifications and complies with various safety standards. While specific numerical acceptance criteria for each test are not explicitly detailed (e.g., current limits, specific temperature ranges), compliance with the listed standards serves as the acceptance criterion for these non-clinical aspects.
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-5 (In Vitro Cytotoxicity) | Complies |
| ISO 10993-10 (Irritation & Skin Sensitization) | Complies |
| Electrical Safety and EMC: | |
| IEC 60601-1-2 (EMC) | Passed |
| ANSI AAMI ES60601-1 (Basic Safety & Essential P.) | Passed |
| IEC 60601-1-11 (Home Healthcare Environment) | Passed |
| IEC 60601-2-83 (Home Light Therapy Equipment) | Passed |
| Eye Safety: | |
| IEC 62471 (Photobiological Safety) | Complies |
| Software Verification & Validation: | |
| FDA Guidance: "Software Contained in Medical Devices" | Test according to requirements |
| Usability: | |
| FDA Guidance: "Human Factors & Usability Engineering" | Evaluated and Verified |
Study Details:
The non-clinical studies were conducted to support the conclusion of Substantial Equivalence (SE) to predicate devices. These are laboratory-based tests rather than clinical trials with human subjects for efficacy.
- Sample size used for the test set and the data provenance: Not applicable in the context of clinical efficacy; these were non-clinical, laboratory-based tests on the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as ground truth in this context refers to compliance with established technical and safety standards, not clinical diagnoses or outcomes. The tests were performed by a "reliable third-party lab" for biocompatibility.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical compliance testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No (not an AI/algorithm device in this context).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, the "ground truth" is adherence to the specifications and requirements set forth by the cited international and national standards (e.g., ISO, IEC, ANSI AAMI).
- The sample size for the training set: Not applicable, as no AI/machine learning algorithm requiring a training set is described in relation to clinical efficacy.
- How the ground truth for the training set was established: Not applicable.
§ 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.