(189 days)
The Fotona Dualis KTP (532 nm) Laser System and Accessories is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology :
The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
The Fotona Dualis KTP (532 nm) system is based on Nd:YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
The Dualis KTP system is designed with 3 major sub-systems:
a) An optical delivery system, interfacing the energy from the laser to the patient via an optical fiber arm and a focusing handpiece.
b) An electronic power supply and interface circuitry.
c) An optical chamber containing laser rod and laser cavity optics.
The provided text is a 510(k) premarket notification for the Fotona Dualis KTP (532 nm) Laser System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, and comparative effectiveness studies is not available in this type of regulatory submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria:
- The primary "acceptance criteria" here is meeting the regulatory requirements for substantial equivalence to predicate devices under 21 CFR 878.4810 for "Instrument, Surgical, Powered, Laser." This means demonstrating that the device is as safe and effective as existing legally marketed devices.
- Specific performance characteristics are implicitly compared to predicate devices, but explicit quantitative acceptance criteria with pass/fail thresholds are not detailed in this summary. Instead, the claim is that the output characteristics are "very similar" and risks/benefits are "comparable."
- Reported Device Performance:
- The document states that the Fotona Dualis KTP (532 nm) laser output characteristics are very similar to those of the predicate devices.
- It also states that the risk and benefits for the Fotona Dualis KTP (532 nm) are comparable to the predicate devices when used for similar clinical applications.
- No numerical performance metrics (e.g., specific power output ranges, pulse durations, or ablation rates with associated tolerance limits) are provided in this summary as "reported device performance."
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Coherent VersaPulse, Laserscope Lyra, and other KTP lasers) in terms of: | |
| - Intended Use | Intended use is identical: incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas (skin, cutaneous, subcutaneous, striated/smooth muscle, cartilage, mucous membrane, lymph vessels/nodes, organs, glands). Specific dermatological use for vascular lesions (Angiomas, Hemangiomas, Telangiectasia) also listed. |
| - Technological Characteristics (e.g., laser type, wavelength, delivery system, control system) | Identical characteristics: Nd:YAG laser rod generating 532 nm wavelength; delivered via optical fiber and focusing handpiece; microprocessor controlled; Class I aiming beams; internal closed-loop water-air heat exchanger. |
| - Output Characteristics | "Very similar to those of the predicate devices." (No specific numerical values provided in this document). |
| - Safety and Effectiveness (risks and benefits) | "Comparable to the predicate devices when used for similar clinical applications." "No new questions of Safety or Effectiveness raised." |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This type of 510(k) summary does not typically include clinical test set data from efficacy studies, as the primary path to clearance is substantial equivalence to existing devices, often relying on technological comparisons and bench testing rather than new clinical trials. No clinical "test set" with patient data is mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. As no new clinical test set is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No test set or adjudication method is described.
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 / Not Provided. This device is a laser system for surgical procedures, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This is a physical surgical laser device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. No new clinical ground truth establishment is described in this substantial equivalence summary. The "ground truth" for the clearance is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable / Not Provided. This is a hardware medical device, not a machine learning algorithm that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. As above, the concept of a training set and its ground truth is not applicable to this 510(k) submission for a surgical laser system.
§ 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.