(78 days)
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No
The summary describes a standard confocal microscope and its performance testing, with no mention of AI or ML capabilities.
No
The device is described as a diagnostic tool for visualization of cell layers in the eye, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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."
No
The device description clearly describes a physical microscope system with optical components (scanning slits, viewing and illuminating light paths, objective lens) and mentions electrical and thermal safety testing, indicating it is a hardware device with potentially integrated software.
Based on the provided information, the Tomey "ConfoScan" Confocal Microscope is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use as a diagnostic tool for looking at the cell layers of the anterior parts of the eye." This directly aligns with the definition of an IVD, which is used to diagnose conditions.
- Device Description: While it describes the technology, it reinforces its purpose of visualizing cell layers for diagnostic purposes.
- Anatomical Site: It focuses on the "anterior parts of the eye," which is a specific anatomical site relevant to diagnosis.
While the device description focuses on the imaging technology, the stated intended use as a "diagnostic tool" is the key factor in classifying it as an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
86 HJO
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
anterior parts of the eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
This section summarizes the performance testing that Tomey Corporation carried out on the Tomey ConfoScan system. This testing addressed the following issues:
- Elution testing: The ConfoScan passed the Elution test performed according to the requirements of the Ministry of Health and Welfare in Japan.
- Sterilization: The ConfoScan objective lens is intended to be disinfected by the end user employing procedures recommended in the instruction manual.
- Biocompatibility: The biocompatibility issues for the ConfoScan system are identical to those of the many other ophthalmic microscopes employing short focal length immersion lenses.
- Electrical and Thermal Safety: The ConfoScan system has been certified for Electrical and Thermal safety by the JQA (Japan Quality Assurance Organization).
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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SECTION VI
AUG 1 4 1997
510(k) Summary
Tomey ConfoScan Confocal Microscope
Common/Classification Name: Microscope, Ophthalmic, 21 CFR 886.1850
Applicant:
Tomey Corporation 2-11-33 Noritakeshinnmachi Nishi ku, Nagoya 451 Japan Attn: Mr. Susumu Nozawa (Manager / Regulatory) (052) 565-1601 (052) 561-4735 (FAX)
Correspondent:
Tomey Corporation (USA) 325 Vassar Street, Cambridge, MA 02139 Contact: Dave Maclellan (Engineer)
(617) 864-6488 (617) 864-6897 (FAX)
April 1, 1996 Prepared:
LEGALLY MARKETED PREDICATE DEVICES A.
Tandem Scanning Confocal Microscope as manufactured by Tandem Scanning Corporation, Reston VA (as cleared in K912514)
Tomey EM-100 Specular Microscope by Tomey Corporation, Cambridge, MA (as cleared in K944910).
Tomey Video Vision Analyzer, VRB 100 by Tomey Corporation, Cambridge, MA (as cleared in K945959).
ConfoScan, Section VI
1
B. DEVICE DESCRIPTION
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.
C. INTENDED USE
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.
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D. SUBSTANTIAL EQUIVALENCE SUMMARY
The Tomey Corporation device has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use. A table of comparison of the ConfoScan system to the predicate devices is presented in Table 1.
| TABLE 1
| Side-by-Side Comparison with Predicate Devices | ||||
|---|---|---|---|---|
| Characteristic | Tomey | |||
| ConfoScan | Tandem | |||
| Scanning | Tomey Specular | |||
| Microscope | Tomey | |||
| ViVA | ||||
| Ophthalmonic 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 |