(207 days)
Nd:YAG Laser (1064 nm): The Fotona Dualis Nd:YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Er:YAG Laser (2940 nm): The Fotona Dualis® Er:YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, muscle, mucous membrane, lymph vessels and nodes, organs and glands.
The Fotona Dualis 8 laser system is based on the Nd:YAG (1064 nm) and Er:YAG (2940 nm) laser technology. It is modification to combine two lasers into one housing. The unmodified devices are the Fotona Fidelis Er:YAG laser and the Fotona Dualis' " Nd:YAG laser system. There are two optical cavities containing the Nd:YAG and Er:YAG crystals. Both are activated by means of the use of flashlamps. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided:
- . In case of the Nd: YAG laser through an optical fiber delivery system to a focusing handpiece.
- In case of the Er: Y AG laser through articulated arm to a focusing handpiece. ●
Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the Nd:YAG laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fotona Dualis® Nd:YAG/Er:YAG Laser System:
It's important to note that the provided text is a 510(k) Premarket Notification summary, not a detailed clinical study report. Therefore, it focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting primary clinical trial data with specific acceptance criteria and performance metrics for the new device as a standalone entity.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" for this 510(k) submission are fundamentally based on substantial equivalence to predicate devices. There are no explicit quantitative performance metrics or acceptance criteria for the new device itself outlined in the document, outside of its operational characteristics being the same as the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | Met: |
| - Same Intended Use as Predicate (Fotona Dualis Nd:YAG and | - "They therefore have the same Intended Use as the Fotona Dualised laser system." |
| Fotona Fidelis Er:YAG). | - "The Fotona Dualis® Nd:YAG laser is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through selective targeting of melanin in hair follicles..." |
| - "The Fotona Dualis® Er:YAG laser is indicated for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas." | |
| - Shares same design features (wavelength, active medium, etc.) | - "The Dualis Nd:YAG/Er:YAG laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices." |
| - Output characteristics are the same. | - "The output characteristics are the same as those of the predicate devices." |
| - Comparable risks and benefits. | - "The risk and benefits for the Dualis 9 laser system are comparable to the predicate devices when used for similar clinical applications." |
| - No new questions of Safety or Effectiveness. | - "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Dualis 80 Nd:YAG/Er:YAG laser system." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document describes a substantial equivalence (510(k)) submission, not a clinical study with a "test set" in the traditional sense of evaluating patient outcomes with the new device. The "test" here is a comparison of the new device's specifications and intended use against existing predicate devices.
- Data Provenance: Not applicable for a primary clinical test set of the new device. The data provenance referenced is the prior clearance of the predicate devices (Fotona Dualis Long Pulse Nd:YAG and Fotona Fidelis Er:YAG laser systems). This indicates historical data and regulatory decisions, not new clinical studies on the Dualis® Nd:YAG/Er:YAG Laser System.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a substantial equivalence submission, there isn't a "ground truth" derived from expert consensus on patient outcomes for this specific new device. The "ground truth" for the comparison is the established safety and effectiveness of the predicate devices, as determined by prior FDA clearances.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set involving adjudication of outcomes exists for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. An MRMC comparative effectiveness study was not done or reported in this document. This type of study is typically associated with diagnostic devices, where multiple readers interpret cases with and without AI assistance to measure improvements in diagnostic accuracy. This document is for a therapeutic laser system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, in a way, the entire 510(k) submission is assessing the "standalone" performance of the new device against its predicates. The device itself is the standalone "algorithm" (laser system) in this context. The claim is that its operational characteristics and output are equivalent to the previously cleared devices. There's no "human-in-the-loop" concept applicable here as it's a direct therapeutic device.
7. The Type of Ground Truth Used
The "ground truth" used is the documented safety and effectiveness of the predicate devices as established during their prior FDA clearance processes. This relies on the regulatory history and body of evidence supporting those previously cleared devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The device is a medical laser system. The "training" for the substantial equivalence claim comes from the existing safety and effectiveness data and regulatory clearances of the predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The "ground truth" for proving substantial equivalence relies on the historical regulatory evaluations and approvals of the predicate devices by the FDA. This would have involved the predicate devices themselves meeting their own specific performance criteria and demonstrating safety and effectiveness for their intended uses.
§ 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.