(72 days)
The Palomar Lux2940 handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications:
- Skin resurfacing .
- Treatment of wrinkles .
- Epidermal nevi .
- Telangiectasia .
- Spider veins ●
- Actinic chelitis .
- Keloids .
- Verrucae .
- Skin tags .
- Anal tags .
- Keratoses .
- Scar revision (including acne scars) .
- Debulking benign tumors .
- Debulking cysts .
- Superficial skin lesions
The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.
The provided 510(k) summary for the Palomar Lux2940 Handpiece indicates that the device's performance was not evaluated through a dedicated study with specific acceptance criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not applicable | "The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No dedicated test set was used for performance evaluation as per the provided summary. The device's performance was established by demonstrating substantial equivalence to predicate devices, implying that its performance aligns with those already marketed and deemed safe and effective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth was established for a test set, as no dedicated performance study was conducted.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, [they] do not result in additional safety or effectiveness information." This indicates that a comparative effectiveness study, such as an MRMC study, was not conducted to assess the device's performance or improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
No. The device is a "Handpiece" for an Er: YAG laser system, implying it's a hardware component, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Not applicable. No ground truth was established for a direct performance assessment of the Lux2940 Handpiece. Its equivalence was based on technological characteristics and intended use compared to legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. The device is a hardware component (laser handpiece), not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set was used.
Summary of Acceptance Criteria and Study Approach:
The regulatory submission for the Palomar Lux2940 Handpiece primarily relies on demonstrating substantial equivalence to already approved predicate devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results. The core argument is that the Lux2940 Handpiece shares sufficiently similar technological characteristics and intended uses with existing devices (Friendly Light, Contour Profile, Harmony Lovely II, Dermablate) that its safety and effectiveness can be inferred. This approach is common for Class II medical devices seeking 510(k) clearance, where a de novo approval or a Premarket Approval (PMA) requiring extensive clinical trials is not deemed necessary.
§ 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.