(151 days)
Ellipse MultiFlex is intended for use in dermatology.
Ellipse MultiFlex used with IPL applicators (9APP7133, 7116, 7114, 7134, 7212, 7377, 7213):
- Hair removal (permanent hair reduction).
- Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne.
Ellipse MultiFlex used with Nd: YAG applicator (9APP7472):
- Treatment of leg vessels (0.1 3.0 mm diameter).
Ellipse Multiflex is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains and inflammatory acne in the area of dermatology, The system consists of a console containing power unit and control electronics with control and display panel including software.
IPL Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 400 nm - 950 nm.
Additionally a Nd:YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex for treatment of vascular lesions as stated under Intended Use.
The provided text is a 510(k) summary for the Ellipse MultiFlex device and does not contain detailed information about specific acceptance criteria, study methodologies, or performance results in the way typically expected for a clinical study proving device effectiveness. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards.
Therefore, many of the requested sections cannot be fully answered from the text. Here's what can be extracted and what is not available:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table comparing criteria to reported performance for the Ellipse MultiFlex with Nd:YAG handpiece as a new submission.
Instead, it relies on demonstrating substantial equivalence to predicate devices for its intended uses. The "Performance Standards" section lists compliance with various regulatory and international standards, which implicitly serve as acceptance criteria for safety and general performance, but not for specific clinical efficacy metrics.
Table of Acceptance Criteria and Reported Device Performance (as inferred or not stated):
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety | Compliance with US FDA 21 CFR 1040.10 and 1040.11 for class IV Laser Products. | Complies |
| Compliance with IEC 60601-1, UL 60601-1, CSA C22.2 No. 601.1 (Medical electrical equipment safety). | Complies | |
| Compliance with IEC 60825-1 and IEC 60601-2-22 (Laser safety). | Complies | |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility). | Complies | |
| Compliance with European Medical Device Directive 93/42/EEC (Annex II). | Complies | |
| Quality Management | Manufactured under ISO13485 Quality Management System. | Certified by DGM and QM1. |
| Clinical Efficacy | Ability to treat leg vessels (0.1 - 3.0 mm diameter). (This is the intended use, but no specific efficacy metrics are provided in the text). | Stated as intended use, implying equivalence to predicate devices for this function. |
Study Information
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting novel clinical study data for new claims.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified. The submission primarily refers to substantial equivalence to predicate devices, implying that their previously established performance supports the new device's claims. There is no mention of a new clinical test set for the Nd:YAG handpiece.
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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 as no specific new clinical trial data is presented for the Nd:YAG handpiece in this summary. The ground truth for the predicate devices' performance would have been established previously, but details are not provided here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new test set is described.
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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. This device is a laser/IPL system for dermatological treatment, not an AI-assisted diagnostic device that uses human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device for direct patient treatment, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the Nd:YAG handpiece, the "Intended Use" states "Treatment of leg vessels (0.1 - 3.0 mm diameter)". The implicit ground truth for efficacy would be successful treatment and reduction/elimination of these vessels, as demonstrated by the predicate devices. However, no specific ground truth methodology for this submission is detailed.
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The sample size for the training set:
- Not applicable. The document does not describe a machine learning model or a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is described.
§ 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.