(103 days)
Fotona XP Nd:YAG Laser System Family and its accessories are intended for use in the following procedures:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy ー
- Radical nail excision -
- Periungual and subungual warts ー
- Plantar warts l
- Neuromas -
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes ー Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
The Fotona XP Nd:YAG Laser System Family is based on thè Nd:YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial bcam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end and bare fiber on distal end. The user activates laser emission by means of a footswitch.
The Nd: YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 20 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a QCW (Quasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.
The provided text describes a 510(k) premarket notification for the Fotona XP Nd:YAG Laser System Family. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a de novo submission that would typically involve a detailed clinical study with specific acceptance criteria and performance data.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (Cutera GenesisPlus and PinPointe FootLaser) based on:
- Identical technological and similar design characteristics.
- Similar indications for use.
- Comparable technical characteristics (e.g., laser source, wavelength, output mode, energy per pulse, pulse width, repetition rate, output power, beam delivery, spot sizes).
The table provided in the document is a comparison table of technical characteristics between the Fotona XP Nd:YAG Laser System Family and its predicate devices, not a table of acceptance criteria and reported device performance against those criteria.
To directly answer your request based on the provided text, the following information is NOT available:
- 1. A table of acceptance criteria and the reported device performance: This is not present. The document compares technical specifications to predicate devices.
- 2. Sample size used for the test set and the data provenance: Not applicable to this type of submission.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical laser, not an AI algorithm.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The submission aims to show that the new device operates similarly and for the same intended uses as previously cleared devices, hence "substantially equivalent," without needing a new clinical trial to establish safety and effectiveness from scratch.
§ 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.