(87 days)
The DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
DUO, Model: IPL-HH380-IT,a small over-the-counter,is a home-use device for the permanent reduction of hair growth based on 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.A personal Light-Based Hair Removal System.Emission activation is by finger switch.Device includes a treatment window head,a facial adaptor and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.The device contains a Quartz Xenon Lamp,a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.
The provided text describes a 510(k) submission for the DUO, Model: IPL-HH380-IT, an Intense Pulsed Light (IPL) device for hair removal. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance data for the DUO device itself.
Therefore, the requested information, particularly regarding specific acceptance criteria with reported device performance results for a clinical study on the DUO device, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is largely not available in this document.
The document details safety and performance testing through lab bench testing for electrical safety, electromagnetic compatibility, and software verification, as well as biocompatibility tests on materials. These are internal validation tests, not clinical performance studies against specific hair reduction efficacy criteria.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines "acceptance criteria" through compliance with various standards and by demonstrating substantial equivalence to predicate devices for its intended use. However, it does not present a table of specific clinical performance acceptance criteria (e.g., percentage of hair reduction) for the DUO device, nor does it report the DUO's clinical performance against such criteria.
The "Indications for Use" section defines permanent hair reduction as "the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen." This is a definition of the intended outcome, not a quantified acceptance criterion for this specific device's performance.
The document largely focuses on safety and technical specification compliance.
| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Reported DUO Device Performance / Compliance |
|---|---|---|
| Intended Use | The device is an over-the-counter device intended for the removal of unwanted body and/or facial hair in adults, and for permanent reduction in unwanted hair (defined as long-term stable reduction in hair number at 6, 9, and 12 months post-treatment). | The DUO's stated intended use matches this definition. The document asserts 'substantial equivalence' to predicate devices for this intended use, implying that the DUO is expected to achieve similar results, though no direct performance data is presented for the DUO against this criterion. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-57 standards. | "Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards" was performed. Results state "Comply with IEC60601-1 and IEC60601-2-57". |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 standard. | "Electromagnetic compatibility test according to IEC 60601-1-2 standard" was performed. Result implicitly passes by inclusion in "Test Summary" and statement of "Comply with IEC 60601-1 and IEC 60601-1-2". |
| Software Verification & Validation | Compliance with FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" requirements. | "Software verification and validation test according to the requirements of the FDA 'Guidance for PreMarket Submissions and for Software Contained in Medical Devices'" was performed. Result implicitly passes by inclusion in "Test Summary" and statement that the device has Software/Firmware/Microprocessor Control. |
| Biocompatibility (Housing & Output Contacts) | Cytotoxicity: No more than Grade 2 according to United States Pharmacopoeia (for limited skin contacting). | |
| Skin Sensitization: Grade 0 according to United States Pharmacopoeia (for limited skin contacting). | ||
| Skin Irritation: 0-0.4 for Irritation Index according to United States Pharmacopoeia (for limited skin contacting). | Cytotoxicity: "The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria." | |
| Sensitization: "The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria." | ||
| Irritation: "The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria." | ||
| (All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.) | ||
| Physical Characteristics (e.g., Weight, Dimensions, Wavelength, Fluence, Spot Size) | Compliance with relevant standards (e.g., IEC 60601-1, IEC 60601-2-57). Differences from predicates should not raise new safety or effectiveness issues. | Specific values are provided in the "Physical characteristics" table and "Comparison to predicate device" table. The document claims "Although the 'Wavelength (nm)', 'Max. Fluence (J/cm2)', and 'Spot Size (cm2)' of subject device are a little different from the predicate devices, they all comply with IEC 60601-2-57 requirement. So the differences of function specification will not raise any safety or effectiveness issue." |
| Device Life (Lamp) | Lamp life up to 300,000 pulses, with an indicator light flashing at 2Hz when end of life is reached and device stops working. | Device description states: "When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz, it means that the device life has reached the end, the device stops working." This describes the feature, implying its performance meets the design. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not mentioned in terms of clinical performance. The only "test set" mentioned are for bench testing (electrical, EMC, software) and biocompatibility (e.g., L929 cells for cytotoxicity, Guinea Pig for sensitization/irritation).
- Data Provenance: Not applicable for a clinical study as no such study is presented for the DUO's clinical efficacy. For the referenced predicate devices, data provenance is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical efficacy test set is described. The ground truth for the biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) is based on standardized biological assay results, not expert consensus in a clinical setting.
4. Adjudication method for the test set:
- Not applicable as no clinical efficacy test set or corresponding 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 system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A "standalone" performance in terms of clinical efficacy of hair reduction for the DUO device is not explicitly described or quantified with data in this document. The document primarily focuses on demonstrating that the DUO device meets safety and technical specifications and is substantially equivalent to predicate devices, which are themselves "standalone" (non-human-in-the-loop) devices designed for direct user application.
7. The type of ground truth used:
- For Biocompatibility: Standardized biological tests (e.g., L929 cell response for cytotoxicity, Guinea Pig skin reaction for sensitization/irritation) as per ISO 10993 standards.
- For Electrical Safety, EMC, Software: Compliance with recognized international standards (IEC 60601 series) and FDA guidance for software. The "ground truth" here is adherence to these engineering and regulatory standards.
- For Clinical Efficacy (implied by Intended Use): The general understanding of "permanent hair reduction" as defined in the indications for use. However, no specific clinical "ground truth" (e.g., pathology reports of hair follicle counts, high-resolution imaging by a dermatologist, outcomes data) resulting from a study of this device is provided. The reliance is on the substantial equivalence to predicate devices that presumably did have such data for their original clearances.
8. The sample size for the training set:
- Not applicable as no machine learning model or "training set" for AI is part of this device or its reported evaluation within this document.
9. How the ground truth for the training set was established:
- Not applicable as no training set is relevant to this submission.
In summary, this 510(k) submission for the DUO, Model: IPL-HH380-IT, is based on demonstrating substantial equivalence to previously cleared predicate devices and compliance with relevant safety and performance standards rather than presenting new clinical efficacy data generated from a direct study of the DUO device against explicit clinical acceptance criteria.
§ 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.