FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Permanent Hair Reduction (defined as teh 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 - 950 nm).
Treatment of Telangiectasias (530-750 nm or 555-950 nm)
Treatment of Port Wine Stains (530-750 nm or 555-950 nm)
Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness) (530-750 nm or 555-950 nm)
Treatment of Rosacea (530-750 nm or 555-950 nm)
Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm)
Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris)(400-720 nm)
Treatment of Inflammatory Acne Vulgaris (530-750 nm)

Ellipse Nordlys + Nd: YAG Laser (1064 nm):
*Treatment of Leg Vessels (0.1-3.0 mm 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, and coagulation of soft tissue), including:

Matrixectomy
Periungal and subungal warts
Plantar warts.

Ellipse Nordlys + Frax 1550 Laser, (1550 nm)

The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Nordlys + Frax 1940 Laser (1940 nm):

The Frax 1940 nm Laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

Ellipse Ydun system is intended to be used in dermatology, as tabled below:
Ellipse Ydun + Frax 1550, (1550 nm):
*The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Ydun + Frax 1940, (1940 nm)
*The Frax 1940 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures

Device Description

The Frax 1940 applicator is used with the Ellipse Nordlys (K150907 and K161162) and Ellipse Ydun (K180406). The Nordlys and Y dun systems consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1940 applicator connects to the system and have built in Laser diodes emitting 1940 nm light in a fractionated pattern. The mode of action is delivering a series of light pulses in a row of up to 10 mm as the applicator is moved across the skin. This leaves a pattern of micro dots (Micro Thermal Zone) of irradiated skin, typically in the order of 100 MTZ/cm2. Due to the area of the damaged skin in each MTZ, a certain percentage of the covered skin is affected, and this is referred to as the Coverage (percentage) of the treatment. The control of pulses as the applicator is moved is by a magnetic motion sensor embedded in the roller that also acts as skin distance controlling device. The motion detection and the control of the laser diodes is done in a micro controller embedded in the handpiece. The materials used are the same as the predicate device Frax 1550 (aluminum and ABS), and the applicator is intended to be in contact with the patient for 15-30 minutes. The system is intended to be used in healthcare facilities and hospital environments.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Ellipse Frax 1940 laser system. It seeks to demonstrate substantial equivalence to a predicate device, the Fraxel Dual 1550/1927 Laser System (K130193). The document focuses on showing that the new device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" in a quantitative table format with specific thresholds for performance metrics. Instead, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device in terms of technological characteristics, performance, and intended use/indications for use.

The reported device performance is primarily focused on safety and histological outcomes, which are compared to expected outcomes for similar devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Technological Equivalence (Beam Specifications)	- Wavelength: Frax 1940 (1940 nm) compared to Fraxel 1927 (1927 nm).

Reported Performance: Theoretical analysis showed negligible difference in chromophore absorption at the two wavelengths, supported by a statement from a Professor of Dermatology. |
| Technological Equivalence (Beam Diameter) | - Beam Diameter: Comparison based on measurements for Frax 1940 and labeling for Fraxel 1927.
Reported Performance: Frax 1940 has a smaller beam diameter than the predicate device. Beams are comparable. |
| Technological Equivalence (Energy Release & Coverage) | - Energy Levels and Coverage: Comparisons to predicate. |
| | - Reported Performance: Energy levels and Coverage are equivalent for the two devices. |
| Clinical Safety/Healing Process | - Tissue Damage and Healing: Evaluate adverse events, healing time, and skin reaction. |
| | - Reported Performance: Complete healing with no significant adverse events.
Healing complete after 7 days for 5 mJ exposure and 34 days for 20 mJ.
Good tolerance to applicator angulation.
Immediate effects: mild to moderate edema and erythema, resolving within 1-7 days.
One instance of Post Inflammatory Hyperpigmentation (PIH) noted with 5 mJ energy setting and unusually high coverage (77.9%), which is significantly higher than recommended settings (20-35% for off-face treatment in Fitzpatrick skin type I-III). |
| Compliance with Regulatory and Safety Standards | - Standards: US FDA 21 CFR 1040.10 and 1040.11, IEC 60601-1, UL 60601-1, CSA C22.2 No. 601.1, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-2, European Medical Device Directive 93/42/EEC (Annex II), ISO13485, US FDA 21CFR Part 820.
Reported Performance: The device has been tested according to and complies with all listed standards. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): 3 subjects for the in-vivo histological healing response study.
Data Provenance: Prospective, controlled, in-vivo study of human abdominal skin. The country of origin for the study is not explicitly stated in the provided text.

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)

The text mentions that "a theoretical analysis has been established showing negligible difference in chromophore absorption at the 2 wavelengths, supported by a statement from a Professor of Dermatology." This indicates one Professor of Dermatology was involved in supporting part of the non-clinical evaluation related to wavelength differences.

For the clinical study, the judgment of "complete healing with no significant adverse events" and observations of edema, erythema, and PIH would have been made by clinical investigators, but their specific number, qualifications, and role in establishing a formal "ground truth" are not detailed beyond being integral to the study's execution.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the clinical outcomes in the test set. Clinical observations and histological assessments would have been made by the study investigators.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
This device is a laser system for dermatological procedures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no mention of human readers or AI assistance in the context of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical laser system, not a software algorithm. The "standalone" performance would refer to the laser system's (Frax 1940) inherent performance specifications, which were assessed through non-clinical beam diameter measurements, wavelength analysis, and clinical histological studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical safety performance (healing process) was primarily established through:

Histology: "in-vivo histological healing response study of human abdominal skin."
Clinical Observation/Outcomes Data: Observations of "complete healing with no significant adverse events," resolution of edema and erythema, and instances of PIH.

For the non-clinical comparison of wavelength absorption, the ground truth was supported by expert opinion (statement from a Professor of Dermatology) on theoretical analysis.

8. The sample size for the training set

The document does not describe a "training set" in the context of a machine learning algorithm. This 510(k) submission is for a physical medical device, not an AI/ML product that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned or implied for this physical medical device.

Summary

Regulation Number and Section

§ 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.