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.

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.

AI/ML Overview

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	< 1 micron	NA	NA
Horizontal Resolution	10 microns	6 micron	NA	NA
Pre Sterilized	No	No	No	NA

2. Sample Size for Test Set and Data Provenance

No specific test set or clinical study data is provided in this submission. The "Non-Clinical Testing" section describes tests like elution, sterilization, biocompatibility, and electrical/thermal safety, but these are not performance studies on a "test set" of patient data.
The entire submission relies on comparison to legally marketed predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with a distinct test set.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Since there's no clinical performance study presented that uses a "test set" requiring ground truth establishment by experts, this information is not present. The submission focuses on device characteristics and safety/functionality tests.

4. Adjudication Method for Test Set

Not applicable. No test set requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a microscope for visualization, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No. The Tomey ConfoScan is a physical ophthalmic microscope. It is not an algorithm, and therefore, a standalone algorithm-only performance study is not relevant or included.

7. Type of Ground Truth Used

Not applicable. As no clinical performance study is described, there is no ground truth, expert consensus, pathology, or outcomes data used for this purpose. The "ground" for approval is the demonstration of substantial equivalence to existing devices.

8. Sample Size for Training Set

Not applicable. The Tomey ConfoScan is a hardware device for visualization, not an AI/machine learning system that requires a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable. As the device does not use a training set, the establishment of ground truth for it is irrelevant.

Summary of the Study Proving Device Meets Acceptance Criteria (as per the provided text):

The "study" presented is primarily a non-clinical performance testing and a comparison of characteristics to predicate devices to demonstrate substantial equivalence.

Non-Clinical Testing:
- Elution testing: The ConfoScan "passed the Elution test performed according to the requirements of the Ministry of Health and Welfare in Japan." This indicates it meets safety standards related to leaching of substances.
- Sterilization: The objective lens is intended for disinfection by the end-user following recommended procedures. This implies the device design allows for user-level sterilization.
- Biocompatibility: The biocompatibility issues are stated to be "identical to those of the many other ophthalmic microscopes employing short focal length immersion lenses." This indicates the materials are considered safe based on prior experience with similar devices.
- Electrical and Thermal Safety: The ConfoScan system was "certified for Electrical and Thermal safety by the JQA (Japan Quality Assurance Organization)." This demonstrates compliance with relevant safety standards.
Substantial Equivalence Comparison: The core of the evidence is the "Side-by-Side Comparison with Predicate Devices" (Table 1). This table maps characteristic features, working parameters (e.g., working distance, depth/horizontal resolution), and light sources of the ConfoScan against three predicate devices. The claim is that the device "has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use."

Conclusion: The provided document establishes the device's acceptability not through a traditional clinical study with defined acceptance criteria and performance metrics, but by demonstrating safety (non-clinical testing) and showing its fundamental characteristics and intended use are "substantially equivalent" to devices already legally marketed, thus implying equivalent safety and effectiveness.

Summary

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SECTION VI

AUG 1 4 1997

510(k) Summary

K971953

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

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B. DEVICE DESCRIPTION

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 1Side-by-Side Comparison with Predicate Devices
Characteristic	TomeyConfoScan	TandemScanning	Tomey SpecularMicroscope	TomeyViVA
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 WHalogen	100 WHg Arc	IR	IR
Objective Lens	AchroplanwithFloatingMount	ConvexApplanatingDipping Cone	Dipping Conewith FloatingMount	NA
Depth Resolution	1 micron	< 1 micron	NA	NA
Horizontal Resolution	10 microns	6 micron	NA	NA
Pre Sterilized	No	No	No	NA

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E. NON-CLINICAL TESTING

This section summarizes the performance testing that Tomey Corporation carried out on the Tomey ConfoScan system. This testing addressed the following issues:

1. Elution testing

The ConfoScan passed the Elution test performed according to the requirements of the Ministry of Health and Welfare in Japan.

2. Sterilization

The ConfoScan objective lens is intended to be disinfected by the end user employing procedures recommended in the instruction manual.

Biocompatibility 4.

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 5.

The ConfoScan system has been certified for Electrical and Thermal safety by the JQA (Japan Quality Assurance Organization).

F. CONCLUSIONS

Tomey Corporation has demonstrated that its evaluation of the ConfoScan system and its review of the literature shows equivalent safety and effectiveness with respect to performance, biocompatibility issues, and comfort and corneal surface damage, although no specific claim for these attributes is being made.

ConfoScan, Section VI

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 1997

Mr. Dave MacLellan-Engineer Tomey Corporation USA 325 Vassar Street Cambridge, MA 02139

Re: K971953 ... . Trade Name: Tomey ConfoScan Confocal Microscope Regulatory Class: II Product Code: 86 HJO Dated: April 15, 1997 Received: May 28, 1997

Dear Mr. MacLellan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS)inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Dave MacLellan

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits . your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):	K971953
Device Name:	ConfoScan

ري - Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺳﺎ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Everett Bean
(Division Sign-Off)

Division of Ophthalmic Devices
510(k) Number Y974853

Regulation Number and Section

§ 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.