(95 days)
Ellipse Nordlys system is intended to be used in dermatology, as tabled below:
•Permanent Hair Reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime) (overall 600-950nm).
·Treatment of Telangiectasias (530-750nm or 555-950mm).
· Treatment of Port Wine Stains (530-750nm or 555-950nm).
· Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (ex Diffuse Redness) (530-750nm or 555-950nm).
· Treatment of Rosacea (530-750nm or 555-950mm).
· Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm).
- · Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
· Treatment of Inflammatory Acne Vulgaris (530-750mm).
· Using Nd: Y AG laser, (1064nm) (Ellipse MultiFlex+ system, only):
- · Treatment of Leg vessels (0.1 -3.0mm diameter).
- · Treatment of Benign Vascular Lesions
- •Treatment of Venous Lakes
·Treatment of Port Wine Stains
• Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g.,
dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
· Treatment of benign cutaneous lesions, such as warts.
- •Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including
- Matrixectomy.
- Periungal and subungal warts
- Plantar warts.
Ellipse Nordlys is an Intense Pulsed Light (IPL) and Nd:YAG Laser 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, rosacea, poikiloderma of civatte and inflammatory acne in the area of dermatology.
The systems consist of a console containing power unit and control electronics with control and display panel including software.
IPL Applicators/hand-pieces are connected to the systems 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 Nordlys for treatment of vascular lesions as stated below under Intended Use/Indications for Use.
This document, a 510(k) Summary for the Ellipse Nordlys device, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. In a 510(k) submission, the FDA often receives evidence that a new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics, performance, and intended use.
Here's a breakdown of why the requested information is not present and what the document does provide:
Missing Information (and why it's missing in a 510(k) Summary like this):
- A table of acceptance criteria and the reported device performance: This would be found in a more detailed clinical or performance study report, which is usually part of the full 510(k) submission but not typically summarized in this public-facing document. The 510(k) summary focuses on equivalence to existing devices rather than a direct, quantitative performance validation against novel acceptance criteria.
- Sample sized used for the test set and the data provenance: Not mentioned. This would be part of a specific study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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, not an AI diagnostic tool that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
- The sample size for the training set: Not applicable for a device that is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable for a device that is not an AI/ML algorithm.
What the document does provide regarding "performance standards" and "equivalence" (which is the closest it gets to your request):
The document explicitly states that the Ellipse Nordlys system has been tested according to and complies with a list of regulatory and safety standards. These standards implicitly set "acceptance criteria" for the device's fundamental safety and electrical performance.
Performance Standards (serving as implicit "acceptance criteria" for safety and basic function):
- US FDA 21 CFR 1040.10 and 1040.11: For class IV Laser Products (This relates to laser product performance, safety, and labeling requirements).
- IEC 60601-1 3rd edition, UL 60601-1 and CSA C22.2 No. 601.1: Medical electrical equipment - General requirements for basic safety and essential performance.
- IEC 60601-2-57: Particular requirements for the basic safety and essential performance of laser devices for dermal and aesthetic applications.
- IEC 60825-1 and IEC 60601-2-22: Safety of laser products and particular requirements for surgical, therapeutic and diagnostic laser equipment.
- IEC 60601-1-2: Electromagnetic compatibility.
- Complies with the European Medical Device Directive 93/42/EEC (Annex II): A broad directive for medical devices in Europe.
- Manufactured under ISO 13485 Quality Management System certified by Presafe/DGM and QMI and also complies with the US FDA 21CFR Part 820: Demonstrates a robust quality management system in place.
The "study" or evidence provided to meet these criteria is the compliance with these standards. This means the manufacturer has conducted tests (e.g., electrical safety tests, electromagnetic compatibility tests, laser output parameter tests) and demonstrated that the device meets the specifications and safety requirements outlined in these standards. The specific results of these tests are not detailed in this summary but would be part of the full submission.
Substantial Equivalence Conclusion:
The core "study" mechanism here is the comparative analysis for substantial equivalence. The manufacturer concluded: "The Ellipse Nordlys system are substantially equivalent in terms of technological characteristics, performance, intended use/indications for use to the predicate devices listed on page 1 of this document." This means they presented data (likely including design specifications, output parameters, and sometimes clinical literature for the predicate devices) to convince the FDA that the Nordlys performs comparably to the already approved predicate devices. They explicitly state, "Based on this analysis of the overall performance of the mentioned predicate devices Ellipse A/S believes that no significant differences exist. The Ellipse Nordlys system should not raise new issues of safety or effectiveness."
§ 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.