(60 days)
The Erbium Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The Erbium Fractional Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
Here's an analysis of the provided 510(k) summary regarding the Erbium Fractional Handpiece:
Acceptance Criteria and Device Performance Study for K083900 - Erbium Fractional Handpiece
Based on the provided 510(k) summary, the device's acceptance criteria and performance are established through a claim of substantial equivalence to predicate devices, rather than a new clinical study with specific acceptance criteria metrics.
The document explicitly states:
"The specifications and indications for use of the Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in premarket notification. Thus, it does not result in additional safety or effectiveness information."
And:
"The Erbium Fractional Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this premarket notification demonstrates that the Erbium Fractional Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."
This means that no new, independent study was conducted to demonstrate the device's performance against specific, pre-defined acceptance criteria. Instead, the FDA cleared the device based on its similarity to previously approved devices. Therefore, the following information is largely not applicable or not explicitly detailed in the provided document, as a traditional performance study was not conducted for this specific 510(k) filing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable - Performance established through substantial equivalence to predicate devices. | The device shares the same technological characteristics, mechanism of action, intended use, and physical properties as its predicate devices: |
- Palomar Erbium Fractional Handpiece (K071768)
- Palomar Erbium Handpiece (K071152, K063571)
- Palomar Lux1540 Fractional Handpiece (K080244)
- Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel Re:Pair™) (K080915) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No new test set data was reported for this 510(k) submission. Performance was established via substantial equivalence.
- Data Provenance: Not applicable. The submission relies on data previously reviewed and accepted for the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was conducted.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No new test set was evaluated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done for this submission. The device's clearance is based on substantial equivalence.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it is a laser handpiece for dermatological procedures.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a medical instrument (laser handpiece), not a software algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for this specific 510(k) submission, as performance was demonstrated through substantial equivalence. The predicate devices would have relied on appropriate clinical data (e.g., expert clinical assessment, histopathology) to establish their safety and effectiveness.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a laser handpiece, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. This device is a laser handpiece, not an algorithm that requires a training set.
Summary of K083900's Clearance Basis:
The Erbium Fractional Handpiece (K083900) received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This means the manufacturer successfully argued that their new device shares fundamental technological characteristics, intended use, mechanism of action, and physical properties with devices already on the market that have been deemed safe and effective. Therefore, no new clinical performance studies, test sets, or training sets were required for this specific submission to prove safety and effectiveness beyond what was already established for the predicates.
§ 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.