(78 days)
The Tomey "ConfoScan" Confocal Microscope is intended for use in carrying out a visualization of the cell layers of the anterior parts of the eye.
The Tomey "ConfoScan" Confocal Microscope is intended for use as a diagnostic tool for looking at the cell layers of the anterior parts of the eye.
The Tomey "ConfoScan" Confocal Microscope is a scanning slit microscope system that is used to carry out a visualization of the cell layers of the anterior parts of the eye. The prime attributes of a Confocal Microscope include both improved contrast and spatial resolution over more conventional microscopy. The improved image rendition is accomplished in the Tomey "ConfoScan" Confocal Microscope by the introduction conjugate scanning slits into the viewing and illuminating light paths of the microscope. By illuminating and viewing an object through restricted apertures, it is possible to eliminate the contributions of scattered light from other regions in the object plane that can degrade contrast and spatial resolution.
The provided text describes the Tomey ConfoScan Confocal Microscope, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria are provided in terms of performance metrics (e.g., sensitivity, specificity, accuracy, resolution targets). The document highlights characteristics of the ConfoScan and compares them to predicate devices, implying these characteristics are accepted by virtue of being similar or equivalent to already approved devices.
| Characteristic | Tomey ConfoScan | Predicate Tandem Scanning Confocal Microscope (for performance comparison) | Predicate Tomey Specular Microscope | Predicate Tomey ViVA |
|---|---|---|---|---|
| Ophthalmic Microscope | Yes | Yes | Yes | No |
| Cornea Contact | Yes | Yes | Yes | No |
| Floating Objective Lens | Yes | Unknown | No | NA |
| Working distance | 0-10 mm | 0-8 mm | 0-1.3 mm | 100+ cm |
| Type Scanning Aperture | Slit | Nipkow Disk | NA | NA |
| Aperture Light Budget | 3% | 0.25-1% | NA | NA |
| Light Source | 100 W Halogen | 100 W Hg Arc | IR | IR |
| Objective Lens | Achroplan with Floating Mount | Convex Applanating Dipping Cone | Dipping Cone with Floating Mount | NA |
| Depth Resolution | 1 micron |
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.