(64 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 emit the treatment light pulses. The device is for single-person use only.
The IPL Home Use Hair Removal Device includes D-1103, D-1119, D-1129 and D-1130 five models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, LCD display contents, hair removal lamp cartridge's quantity and appearance, as well as lamp tube's placement location; in addition, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) is different; but these differences do not affect or change the intended use of the device.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IPL Home Use Hair Removal Device:
Important Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving them through a clinical study for a novel device. Therefore, much of the requested information (like specific performance metrics for the device's efficacy in hair removal, sample sizes for test/training sets for an AI, and expert ground truthing) is not present in this document. The "performance data" section primarily addresses safety and general performance aspects relative to standards, not direct efficacy claims against predefined criteria.
Description of Acceptance Criteria and Supporting Study
The provided document describes the IPL Home Use Hair Removal Device and its submission for 510(k) clearance by the FDA. The primary objective of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
In this context, specific quantitative "acceptance criteria" for hair removal efficacy are not explicitly defined and measured as the primary outcome for this submission. Instead, the "acceptance criteria" are broad: to establish that the device is as safe and effective as the predicate devices, meeting relevant safety standards and showing similar operational characteristics.
The "study" that proves the device meets these (implicit) acceptance criteria is the collection of performance data, biocompatibility testing, electrical safety, eye safety, and software verification and validation activities performed on the device.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't present explicit quantitative acceptance criteria for hair removal efficacy that the device must meet, nor does it provide specific numerical efficacy performance results in the given tables. Instead, it demonstrates compliance with safety standards and similarity to predicate devices.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|
| Biocompatibility: No unreasonable risk from body-contacting components. | - Biocompatibility evaluation conducted per ISO 10993-1. |
- Passed ISO 10993-5 (In Vitro Cytotoxicity).
- Passed ISO 10993-10 (Irritation and Skin Sensitization). |
| Electrical Safety: Compliance with relevant electrical safety standards. | - Passed IEC 60601-1-2 (EMC). - Passed IEC 60601-1 (Basic safety & essential performance).
- Passed IEC 60601-1-11 (Home healthcare use).
- Passed IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use). |
| Eye Safety: Compliance with standards for photobiological safety. | - Passed IEC 62471 (Photobiological safety of lamps and lamp systems). |
| Software Functionality: Software operates as intended and hazards are mitigated. | - Software documentation consistent with a moderate level of concern. - System validation testing demonstrated all software requirement specifications are met and hazards mitigated. |
| Functional Equivalence: Same intended use & similar operational characteristics as predicates. | - Same intended use (removal of unwanted body/facial hair). - Similar mode of action (IPL technology).
- Similar operational characteristics (e.g., energy medium, pulsing control, delivery device).
- Differences in wavelength, energy density, spot size, and pulse duration are considered minor and not affecting safety or efficacy in achieving substantial equivalence. |
2. Sample Size for the Test Set and Data Provenance
This information is not provided in the document. The term "test set" in the context of device performance usually refers to clinical data for efficacy, which is absent as a specific clinical trial outcome here. The performance data presented are primarily safety and engineering tests, not clinical efficacy trials with patient sample sizes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/provided. The submission is not based on an AI algorithm where ground truth would be established by experts. The "ground truth" for the safety tests is derived from adhering to international standards and passing defined metrics within those standards.
4. Adjudication Method for the Test Set
This information is not applicable/provided. There is no "test set" in the sense of clinical data requiring expert adjudication for this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable/provided. This is not an AI device or an imaging device where an MRMC study would typically be conducted to compare human reader performance with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical IPL hair removal device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the safety and general performance data is adherence to recognized international standards (e.g., ISO 10993, IEC 60601 series, IEC 62471). For substantial equivalence, the "ground truth" is also the characteristics and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided. As above, no training set for an AI algorithm is involved.
§ 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.