(43 days)
The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:
532nm
- . macular edema
- age-related macular degeneration .
- . lattice degeneration
- . retinal tears and detachments
577nm
- proliferative and nonproliferative diabetic retinopathy .
- macular edema .
- choroidal neovascularization .
- . branch and central retinal vein occlusion
- . age-related macular degeneration
- . lattice degeneration
- retinal tears and detachments .
- retinopathy of prematurity .
Intended for use in the treatment of ocular pathology in the anterior segment including:
577nm
- iridotomv .
- trabeculoplasty .
The PASCAL Laser Indirect Ophthalmoscope (LIO) with eye safety filter is a non-sterile, multiple use, delivery device that is worn on the physician's head and is used in conjunction with a compatible hand held ophthalmoscopic examination lens to view and treat the patient's retina. LIOs are used to treat patients in a supine position or who could not otherwise be treated using a slit lamp delivery system.
This document is a 510(k) Pre-market Notification for a medical device called the PASCAL® Laser Indirect Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the typical sense for AI/software devices.
Therefore, many of the requested sections regarding acceptance criteria and performance against those criteria, especially those pertaining to AI/software performance assessment like MRMC studies, standalone performance, and ground truth establishment, are not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" in this 510(k) is framed around substantial equivalence to predicate devices rather than quantitative performance metrics for a novel functionality. The primary acceptance criteria for a 510(k) submission are that the new device has the same intended use and technological characteristics as a legally marketed device (predicate device) and does not raise new questions of safety and effectiveness.
| Acceptance Criteria Category | Specific Criteria (from text) | PASCAL® Laser Indirect Ophthalmoscope Performance (from text) |
|---|---|---|
| Intended Use | Same as predicate devices | "The PASCAL® Laser Indirect Ophthalmoscope shares the same indications for use..." (Section VII) |
| Technological | Similar design features and functional capabilities as predicate devices | "The technological characteristics of the PASCAL® Laser Indirect Ophthalmoscope are substantially equivalent to those of the predicate devices." (Section VI) |
| Characteristics | Treatment Wavelength: 577 ±2 nm or 532 ±2 nm | |
| Aiming Wavelength: 635 +10 nm | ||
| Eye Filter OD: > 5 @ 532 nm or > 5 @ 577 nm | ||
| Working Distance: 280 mm | ||
| Fiber Length: 5 meters | ||
| Aerial Spot Size: 1060 µm | ||
| Illumination Source: LED and DC Battery | ||
| Cooling System: Convection Cooled Air | ||
| Weight: 5 @ 532 mm or > 5 @ 577 nm (Matches both predicates) | ||
| Working Distance: 280 mm (Matches both predicates) | ||
| Fiber Length: 5 meters (Matches both predicates) | ||
| Aerial Spot Size: 1060 µm (Matches both predicates) | ||
| Illumination Source: LED and DC Battery (Different from predicates, but considered "similar" functionality) | ||
| Cooling System: Convection Cooled Air (Matches both predicates) | ||
| Weight: |
§ 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.