(151 days)
The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
The 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 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 activation 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 and fully applied to the skin of the treatment area, the device will not emit light pulses.
This document describes the regulatory approval for a home-use hair removal device (models T4, T5, T8, T4-01, T5-01, T8-01, T7) based on Intense Pulsed Light (IPL) technology. The FDA's 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for de novo devices. Therefore, the "acceptance criteria" and "study" described below are within the context of a 510(k) submission, primarily focusing on non-clinical performance and comparison to a predicate, rather than a clinical efficacy study with human participants.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) are implicitly met by demonstrating substantial equivalence to a predicate device through various tests. The direct "performance data" presented in this document primarily relates to the safety and engineering aspects of the device, rather than its efficacy in hair removal (which is generally inferred from the predicate).
| Acceptance Criteria Category (Implicit 510(k)) | Specific Test/Evaluation | Reported Device Performance/Outcome |
|---|---|---|
| Biocompatibility | Evaluation of body-contacting components according to ISO 10993-1. Specific tests: | Passed: |
| - ISO 10993-5: Tests for In Vitro Cytotoxicity | - Tests passed, indicating no significant cytotoxic effects. | |
| - ISO 10993-10: Tests for Irritation and Skin Sensitization | - Tests passed, indicating no significant irritation or skin sensitization. | |
| Electrical Safety | Testing according to relevant IEC 60601 series standards (e.g., IEC 60601-1, IEC 60601-1-2 EMC, IEC 60601-1-6 Usability, IEC 60601-1-11 Home Healthcare, IEC 60601-2-57 Non-laser source for cosmetic use, IEC 60601-2-83 Home Light Therapy). | Passed: |
| - Device meets general requirements for basic safety and essential performance. | ||
| - Complies with electromagnetic compatibility (EMC) requirements. | ||
| - Meets usability requirements. | ||
| - Complies with standards for home healthcare and home light therapy equipment. | ||
| Eye Safety | Testing according to IEC 62471: Photobiological safety of lamps and lamp systems. | Passed: |
| - Device meets photobiological safety standards for its light emission. (This is critical for a device using IPL, as misuse or faulty operation could cause eye damage.) | ||
| Software Verification & Validation | Documentation and testing for a moderate level of concern software. | Passed: |
| - All software requirement specifications are met. | ||
| - All software hazards have been mitigated to acceptable risk levels. | ||
| Functional Equivalence | Comparison of technological characteristics (Wavelength range, Energy medium, Energy density, Spot size, Pulse duration, Pulsing control, Delivery device, Indications for use, Location for use) to the predicate device (K210311). | "Same intended use, mode of action and similar operational characteristics." Minor differences in spot size, pulse duration, and display are noted but deemed not to "affect or change the intended use of the device" or raise safety/efficacy issues. (Specific numerical comparisons are in the document's comparison table). The device also includes a skin sensor to detect appropriate skin contact for light emission, similar to predicate devices. |
| Safety and Effectiveness Profile | Based on all performance data. | "Safety and effectiveness profile that is similar to the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not specify sample sizes for human subjects for efficacy testing. The tests conducted (biocompatibility, electrical safety, eye safety, software V&V) are typically in vitro or engineering tests and do not involve "test sets" in the clinical trial sense with human participants. For functional equivalence, the "samples" are the device models themselves (T4, T5, T8, etc.) and a comparison is made to the predicate device's specifications.
- Data Provenance: The document does not explicitly state the country of origin for the data itself, but the applicant (Shenzhen Mareal Tech Co., Ltd) is based in China. The data would have been generated from laboratory and engineering tests, likely conducted at the manufacturer's facility or certified testing labs. The data is retrospective in the sense that it supports a pre-market notification for a device that has already been developed and tested. There is no mention of prospective clinical trials in this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable in the context of this 510(k) submission. "Ground truth" for medical device performance (like hair removal efficacy) is typically established through clinical data, often involving expert assessments (e.g., dermatologists or image analysis). However, for a 510(k) of a device like this, the "ground truth" for the safety and basic functionality is established by adherence to recognized international consensus standards (like IEC and ISO standards) and engineering principles, which represent the collective expertise in device design, safety, and testing. There's no mention of expert radiologists or similar clinical experts establishing ground truth for efficacy in this document, as the submission relies on substantial equivalence to a predicate.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies involving human readers or evaluators where there might be subjective interpretations of results. This 510(k) relies on objective engineering and performance data against set standards, not subjective assessments requiring adjudication.
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 direct-to-consumer home-use hair removal device. It does not involve "human readers" or "AI assistance" for interpretation of medical images or data. Therefore, an MRMC study is not relevant to proving its substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is primarily based on:
- Compliance with recognized international consensus standards: For electrical safety (IEC 60601 series), biocompatibility (ISO 10993 series), and photobiological safety (IEC 62471). These standards represent established scientific and engineering principles for safety.
- Software verification and validation outputs: Demonstrating the software meets specifications and mitigates hazards.
- Comparison to the predicate device's specifications: The predicate device, having already been cleared, serves as a benchmark for acceptable performance characteristics (energy density, pulse duration, wavelength, etc.) for a home-use IPL hair removal device.
- Functional testing: Implied by the successful completion of the safety tests and the comparison to the predicate, ensuring the device operates as intended.
There is no mention of "expert consensus" on hair removal efficacy, pathology, or outcomes data from a clinical trial, as those are typically not primary requirements for a 510(k) where substantial equivalence to a cleared predicate is claimed.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI algorithm.
§ 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.