(75 days)
Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.
The Intense Pulse Light Therapeutic Apparatus 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 Intense Pulse Light Therapeutic Apparatus 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 IPL-1 PRO, IPL-1, IPL-12, and IPL-17 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.
The provided FDA 510(k) summary does not contain information on the acceptance criteria and study proving device performance as typically understood for AI/ML-driven medical devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and standard safety and performance testing.
Here's a breakdown of why the requested information is absent and what is provided:
No AI/ML Performance Study Details:
The document does not describe an AI/ML component, nor does it detail a study proving specific performance metrics (like accuracy, sensitivity, specificity) against a clinical ground truth, which would typically involve acceptance criteria, test sets, expert adjudication, or MRMC studies.
The device, "Intense Pulse Light Therapeutic Apparatus," is a physical device for hair removal and does not appear to incorporate AI or machine learning. The section titled "Software Verification and Validation" primarily addresses the software aspect within the context of electrical safety and general device functionality, classifying it as "moderate level of concern" software, which is typical for embedded control systems in medical devices, not necessarily AI.
What the Document Does Provide Regarding Performance and Equivalence:
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Acceptance Criteria (Implicit via Substantial Equivalence):
- The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices (K230097 and K220669). This means the device must have the same intended use, fundamental technological characteristics, and be as safe and effective as the predicate device(s).
- Specific parameters compared (and found to be similar or within acceptable ranges) are listed in the tables. These implicitly act as performance criteria for demonstrating substantial equivalence. For example, energy density (Max 4.92 J/cm² for the subject vs. Max 5.0 J/cm² for predicate K230097), wavelength range, spot size, and output energy levels are compared.
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Study Proving Device Meets Criteria (Safety and Performance Testing):
The document outlines the following standard safety and performance tests performed to demonstrate safety and effectiveness, supporting the claim of substantial equivalence:-
Biocompatibility Safety:
- Tests performed: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Irritation).
- Result: Passed.
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Electrical Safety and EMC:
- Tests performed: IEC 60601-1-2 (EMC), IEC 60601-1 (Basic Safety and Essential Performance), IEC 60601-1-11 (Home Healthcare Environment), IEC 60601-2-83 (Home Light Therapy Equipment).
- Result: Passed.
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Eye Safety:
- Test performed: IEC 62471 (Photobiological safety of lamps and lamp systems).
- Result: Not explicitly stated as "passed" but grouped with other passed tests under "Performance Data."
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Software Verification and Validation:
- Description: "Software documentation consistent with moderate level of concern was submitted... System validation testing... demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This suggests internal V&V activities rather than a clinical performance study.
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Addressing the Specific Questions (where information is available or can be inferred):
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A table of acceptance criteria and the reported device performance:
Acceptance Criterion (Implicit for SE) Reported Device Performance (Subject Device) Predicate Device K230097 Intended Use Removal of unwanted body hair (OTC) Same Mode of Action IPL Same Applicable Skin Type Fitzpatrick Skin Type I-V Same Wavelength range 510~1200nm 470~1200nm Energy density Max 4.92 J/cm² Max 5.0J/cm² Spot size 3.3 +/- 0.25 cm² 3.0 cm² +/- 0.5 cm² Output energy Level 1: 6.0J to Level 5: 12.5J (±20%) Range in 5~12.5J (±20%) Output energy level 1 to 5 level 5 level Pulse duration 5.84~9.24ms 4~10ms Biocompatibility Met ISO 10993-5, -10, -23 Not explicitly detailed but implied similar for SE Electrical Safety/EMC Met IEC 60601-1-2, -1, -11, -2-83 Not explicitly detailed but implied similar for SE Eye Safety Met IEC 62471 Not explicitly detailed but implied similar for SE -
Sample size used for the test set and the data provenance: Not applicable. This refers to a clinical or AI/ML performance test set, which is not detailed here. The tests mentioned are laboratory safety and performance tests for the physical device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth or expert review is described.
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Adjudication method for the test set: Not applicable.
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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. The device is not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and performance tests against recognized standards are used, not clinical ground truth in the AI/ML sense.
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The sample size for the training set: Not applicable. There is no mention of an AI/ML training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) clearance letter and summary for a physical Intense Pulse Light device, not an AI/ML medical device. Therefore, the detailed AI/ML performance study criteria requested are not present in this submission. The "performance data" section refers to standard electrical, biocompatibility, and eye safety testing necessary for the physical device's regulatory clearance.
§ 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.