(53 days)
The IPL treatment system is intended for medical use in the treatment of the following dermatologic conditions:
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Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
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Moderate inflammatory acne vulgaris;
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Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
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Cutaneous lesions including scars;
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Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.
The IPL Treatment Systems utilizes an intense, visible, broad-spectrum pulse of light that when used with interchangeable filters, allowing it to selectively heat the target for different indications. The optical component is intended to drive the IPL energy to concentrate where the optical energy has selectively heated the target.
The Intense pulsed light (IPL) is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. The light-based component delivers optical energy that is absorbed by specific chromophores in the skin, which is converted to heat, according to the principle of selective photothermolysis.
The proposed device consists of the main unit, control panel and the treatment handpiece(s).
This document is a 510(k) premarket notification for an IPL Treatment System (K200746). It describes the device and claims substantial equivalence to a predicate device (iPulseLight IPL System, K093627). However, the document explicitly states:
VIII Clinical Testing: It is not applicable.
Therefore, there is no study conducted to prove the device meets acceptance criteria through clinical testing. The submission relies solely on non-clinical testing and comparison to the predicate device to establish substantial equivalence.
Given this, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such clinical study was performed or documented in the provided text.
Here is what can be inferred about acceptance criteria and device performance based on the non-clinical information provided:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was performed for performance, the acceptance criteria are implicitly met by the device demonstrating similar specifications and safety profiles to the predicate device through non-clinical testing.
| Acceptance Criteria (Implied from predicate device comparison and non-clinical testing) | Reported Device Performance (as presented in comparison table) |
|---|---|
| Indications for Use: Must be identical or covered by the predicate device's indications. | Proposed device indications: Permanent hair reduction, moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides), cutaneous lesions (scars), benign cutaneous vascular lesions (port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations). |
| Product Code: ONF | ONF |
| Regulation No.: 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class: Class II | Class II |
| Light source: Intense pulsed light (Xenon Flash Lamp) | Intense pulsed light (Xenon Flash Lamp) |
| Wavelength range: 420 – 1200 nm | 420 – 1200 nm |
| Energy output: Equivalent to predicate (10-50 J/cm²) | 4.1-50.8 J/cm² (Equivalent to predicate given similar energy levels for each filter) |
| Pulse width: Equivalent to predicate (2-20 ms) | 5-20 ms (Equivalent to predicate) |
| Pulse duration: Identical to predicate (5-50 ms) | 5-50 ms |
| Spot size: Identical to predicate (1235mm, 1550mm) | 1235mm, 1550mm |
| Filters: Identical to predicate | Identical filter ranges available |
| Fluences (per filter): Equivalent to predicate | Fluences for each filter are at similar energy level, considered equivalent to predicate. |
| Output mode: Pulse mode | Pulse mode |
| Deliver materials: Direct sapphire Coupling | Direct sapphire Coupling |
| Cooling method: Equivalent to predicate (TEC and circulating water & air) | Water cooling, forced-air cooling, copper and TEC (for vertical models) and Water cooling and forced-air cooling (for table top models); considered equivalent. |
| Electrical safety and essential performance: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57. | Device complies with specified IEC standards. |
| Biocompatibility: Demonstrated through Cytotoxicity, Skin irritation, Skin Sensitization tests for contact materials. | Tests performed show compliance with ISO 10993-1. |
Regarding the other points, as no clinical study was performed:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
N/A - No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
N/A - No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A - No clinical test set.
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:
N/A - This device is not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A - This is a physical IPL treatment system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
N/A - No clinical ground truth was established for performance claims.
8. The sample size for the training set:
N/A - This is a physical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
N/A - Not applicable.
§ 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.