CONFOSCAN

K971953 · Tomey Corporation USA · HJO · Aug 14, 1997 · Ophthalmic

Device Facts

• Record ID: K971953
• Device Name: CONFOSCAN
• Applicant: Tomey Corporation USA
• Product Code: HJO · Ophthalmic
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

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.

Device Story

Tomey ConfoScan is a scanning slit confocal microscope for visualizing anterior eye cell layers. Device uses conjugate scanning slits in illumination and viewing paths to restrict apertures, eliminating scattered light to improve contrast and spatial resolution compared to conventional microscopy. System utilizes 100W halogen light source and Achroplan objective lens with floating mount. Operated by clinicians in a clinical setting; requires corneal contact. Output is a visualized image of ocular cell layers, aiding clinicians in diagnostic assessment of anterior eye structures. Benefits include enhanced visualization of ocular tissue layers.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including elution testing per Japanese Ministry of Health and Welfare requirements, and electrical/thermal safety certification by the Japan Quality Assurance Organization (JQA).

Technological Characteristics

Scanning slit confocal microscope; 100W halogen light source; Achroplan objective lens with floating mount; 0-10 mm working distance; 1 micron depth resolution; 10 micron horizontal resolution. Device requires corneal contact. Not pre-sterilized; objective lens disinfected by end-user per manual. Standalone system.

Indications for Use

Indicated for use as a diagnostic tool for visualization of cell layers of the anterior eye. Intended for prescription use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Tandem Scanning Confocal Microscope (K912514)
• Tomey EM-100 Specular Microscope (K944910)
• Tomey Video Vision Analyzer, VRB 100 (K945959)

Submission Summary (Full Text)

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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) [phone] [phone] (FAX)

Correspondent:

Tomey Corporation (USA) 325 Vassar Street, Cambridge, MA 02139 Contact: Dave Maclellan (Engineer)

[phone] [phone] (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

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<br>Side-by-Side Comparison with Predicate Devices | | | | |
|-----------------------------------------------------------|----------------------------------------|---------------------------------------|----------------------------------------|---------------|
| Characteristic | Tomey<br>ConfoScan | Tandem<br>Scanning | Tomey Specular<br>Microscope | Tomey<br>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<br>Halogen | 100 W<br>Hg Arc | IR | IR |
| Objective Lens | Achroplan<br>with<br>Floating<br>Mount | Convex<br>Applanating<br>Dipping Cone | Dipping Cone<br>with Floating<br>Mount | 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Everett Bean
(Division Sign-Off)

Division of Ophthalmic Devices
510(k) Number Y974853