(90 days)
The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as : Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea
And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.
The NLite System is a flashlamp pumped, pulsed dye laser consisting of the following:
- Main laser console incorporating the laser resonator and external optics, high . voltage delivery system, internal cooler, fluid circulation system, control unit and user interface;
- Flexible fibre optic delivery device and optical handpiece; .
- Footswitch for pulsing control. .
The provided text is a 510(k) summary for the ICN Photonics Ltd., Nlite System, a laser device. It specifically states that no additional efficacy information was required because the device was found to be substantially equivalent to predicate devices. This means a direct study demonstrating clinical acceptance criteria for the Nlite System itself was not performed or provided within this document.
Therefore, many of the requested sections regarding a specific study proving device performance against acceptance criteria cannot be directly answered from the given text.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (NLite System) |
|---|---|
| Equivalence to Predicate Devices: Key laser parameters (wavelength, pulse duration, energy density, delivery mechanism) | Equivalent to predicate devices (Candela Clearbeam Pulse Dye Laser System K013043 and Cynosure. Photogenica V Pulsed Dye Laser K921842) |
| Identical Indications for Use: | Identical to predicate devices for Vascular lesions (Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea) and benign cutaneous lesions (Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts). |
| Identical Interaction with Vasculature: Permanent damage to vasculature within the dermal region of the skin. | Identical to predicate devices in targeting and producing permanent damage to the vasculature. |
| Technological Design Principles: Method of producing laser output. | Same design principles as predicate devices. |
| Compliance with Standards: Design and manufacture in accordance with relevant international standards. | Stated to be in accordance with relevant international standards. |
| Minimized Risk to Operator and Patient: | Stated that potential risk has been minimized. |
| Safety and Efficacy Information: Required if not substantially equivalent. | None required due to substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: The substantial equivalence determination negated the need for an independent clinical study with a test set for the Nlite System's efficacy. The "test" was a comparison against the specifications and performance of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: No clinical test set requiring expert-established ground truth was part of this 510(k) submission for efficacy. The ground truth was based on the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable: No clinical test set requiring adjudication was performed as part of this 510(k) submission for efficacy.
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
- Not Applicable: This device is a laser system for medical treatment, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a laser system, not an algorithm. Its performance is directly tied to the physical output of the laser and its application by a human operator in a clinical setting.
7. The Type of Ground Truth Used
- Predicate Device Performance (Established Safety and Efficacy): The primary "ground truth" used for this submission was the established safety and efficacy of the legally marketed predicate devices. The NLite System demonstrated that its parameters and indications for use were equivalent to these already-approved devices, implying similar performance and outcomes.
8. The Sample Size for the Training Set
- Not Applicable: There is no mention of a "training set" in the context of this 510(k) submission, as it relates to a physical device rather than a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
§ 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.