(59 days)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The IPL 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal 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 its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance，size，and operation are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.
This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L). The request asks to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance beyond basic safety and electrical testing.
However, the provided 510(k) clearance letter and summary primarily focus on establishing substantial equivalence to predicate devices through comparisons of technical specifications and robust safety testing (biocompatibility, electrical safety, eye safety, and software verification).
There is no detailed information provided in this document regarding a clinical performance study (e.g., patient trials, or studies that measure the actual effectiveness of hair removal) beyond the statement that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." The "Performance Data" section specifically lists only safety and software V&V, not clinical efficacy.
Therefore, I cannot fully complete all sections of your request as the provided text does not contain the specific clinical performance study details you are asking for. The clearance is based on the device being "substantially equivalent" to predicate devices that are already cleared for the specified indications for use, and a demonstration that the new device meets relevant safety standards and its software functions as intended.
Here's what can be extracted and inferred based on the provided document:
Acceptance Criteria and Device Performance (Based on Provided Document)
While the document doesn't detail specific clinical efficacy acceptance criteria for the hair removal function, it does outline acceptance criteria for safety and technical performance, which are crucial for FDA clearance. The "study" proving these are met refers to the various engineering and safety tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Stated) | Reported Device Performance / Study Results |
|---|---|---|
| Safety - Biocompatibility | Compliance with ISO 10993 standards for skin-contacting components (cytotoxicity, skin sensitization, skin irritation). | Passed: ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Skin sensitization), ISO 10993-23 (Skin irritation). |
| Safety - Electrical & EMC | Compliance with IEC 60601-1 series standards for general safety, electromagnetic disturbances, home healthcare, and light therapy equipment. | Passed: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83. |
| Safety - Eye Safety | Compliance with IEC 62471 for photobiological safety. | Passed: IEC 62471. |
| Software Functionality | Software requirement specifications met, hazards mitigated to acceptable risk levels. Consistent with moderate level of concern. | Passed: System validation testing demonstrated all software requirements met and hazards mitigated. |
| Substantial Equivalence | Device features, intended use, mode of action, and operational characteristics are similar to legally marketed predicate devices, and any differences do not raise new questions of safety or efficacy. | Determined: Subject device is substantially equivalent to predicate and reference devices in intended use, mode of action, and operational characteristics. Minor differences (size, weight, specific wavelengths, energy density, pulse duration, materials, environmental conditions) were assessed and deemed not to affect safety or effectiveness, with compliance to relevant IEC standards cited. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Performance Test Set: Not applicable / Not specified in this document for a clinical efficacy study. The document focuses on bench testing and safety compliance.
- Safety Testing (Biocompatibility, Electrical, Eye): The "sample size" for these tests would typically refer to the number of devices or material samples tested. This information is not detailed in the provided 510(k) summary (e.g., how many units underwent electrical safety testing).
- Data Provenance: Implied to be from the manufacturer's own testing conducted in China (where the manufacturer is located). The nature of these tests (e.g., bench testing) makes the "retrospective or prospective" classification less applicable than for clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable for this type of submission. This 510(k) relies on standardized engineering and safety tests, and establishing "ground truth" for these types of tests is typically based on adherence to the specified international standards (e.g., IEC, ISO) and laboratory procedures, rather than expert consensus on observational data.
4. Adjudication Method for the Test Set
- Not applicable for this type of submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert readers or evaluators independently assess data (e.g., medical images). The tests described here are compliance tests against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is a specific type of clinical study used primarily for medical imaging devices to evaluate human reader performance with and without an AI algorithm. This document describes a physical hair removal device, not an imaging device, and does not mention any clinical comparative effectiveness study, especially not one involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable for this type of device. This device is a direct-use consumer product. While it has "Software Verification and Validation," this refers to the embedded software controlling the device's functions (e.g., light emission, skin sensor), not a standalone diagnostic algorithm whose performance would be measured independently.
7. The Type of Ground Truth Used
- For safety and electrical performance: Ground truth is established by the requirements and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device's performance is measured against the specifications and limits defined by these standards.
- For substantial equivalence: The ground truth is the performance and safety data of the legally marketed predicate devices, against which the subject device is compared. The argument is that the subject device's technical characteristics and tested safety performance are "substantially equivalent" to these predicates.
8. The Sample Size for the Training Set
- Not applicable. This document describes the clearance of a physical medical device, not a machine learning or AI model that requires a "training set" of data. The software verification mentioned refers to traditional software testing methodologies.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
§ 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.