(177 days)
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Intended for use in the posterior segment to perform retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: (532nm) proliferative and non-proliferative diabetic retinopathy, macular-edema, choroidal neovascularization associated with wet age-related macular degeneration, age-related macular degeneration, lattice degeneration, retinal tears and detachments. (577nm) proliferative and non-proliferative diabetic retinopathy, macular edema, choroidal neovascularization associated with wet age-related macular degeneration, age-related macular degeneration, lattice degeneration, retinal tears and detachments. Intended for use in the treatment of ocular pathology in the anterior segment including: (532 nm and 577nm) iridotomy, trabeculoplasty.
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System is a stand-alone laser delivery console for use with a slit lamp. LIO or probe delivery. Controls and displays include an I.CD/Touchscreen user interface and a slit lamp connector (SLC). The system is equipped with a three-position key switch that enables laser and controls as well as an emergency off switch. An externally connected wired footswitch activator is provided with a shrouded housing, and contains a set of redundant switches. An external door interlock connection allows the laser to be terminated with an open circuit.
The PASCAL® Synthesis™ Ophthalmic Scanning Laser System, submitted under K123542, is a medical device designed for ophthalmic laser treatments. The acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for novel AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a submission for a laser system, the "acceptance criteria" are primarily related to safety, technical specifications aligning with predicate devices, and demonstrating equivalent performance in a preclinical setting. The document doesn't explicitly state numerical acceptance criteria in terms of accuracy or clinical outcomes for a diagnostic AI. Instead, it relies on the established safety and efficacy of predicate devices and a comparative preclinical study.
| Acceptance Criteria Category | Specific Criteria/Goal | Reported Device Performance (PASCAL® Synthesis™) |
|---|---|---|
| Safety | Compliance with relevant national and international standards (e.g., IEC 60601-1, -2-x; EN ISO14971-C; ASTM 4169-09&6653-01; ASTM D4169-09 for hardware, IEC 60601-1-2, -4, -6 for electromagnetic, EN 60601-1-4, 62304 for software). | All testing was conducted and established that the PASCAL® Synthesis system met or exceeded its design specifications and performed equally or better than the stated performance of the predicate. Conclusion: It is as safe as the predicate device. |
| Technical Equivalence | Substantial equivalence in technical characteristics (e.g., Type of Laser, Output Wavelength, Power output, Duty cycle, Exposure time, Repetition Rate, Pulse Counter, CDRH/European MDD Classification, Electrical Requirements) to predicate devices (K092621, K111108, K121475/K071687). | The technological characteristics of the PASCAL® Synthesis Ophthalmic Scanning Laser System are substantially equivalent to those of the predicate devices. The tables in Section VII list the specifications, and they are largely identical or within acceptable ranges for equivalence. For example, Output Wavelength (532 nm or 577 nm), Power output (0, 30 mW - 2000 mW), Duty cycle (100%), Exposure time (2 ms - 1000 ms), and Repetition Rate are all highly similar or identical to one or more predicate devices. |
| Clinical Performance Equivalence | Appearance and diameter of retinal laser lesions comparable to predicate device in a preclinical setting. | An animal study compared lesions produced by the PASCAL® Synthesis system with the predicate PASCAL Streamline system. When comparing lesions of the same clinical grades, the appearance was similar. The diameter of the lesions was |
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.