CONFOSCAN 2 CONFOCAL MICROSCOPE

K012416 · Nidek Technologies Srl · HJO · Oct 26, 2001 · Ophthalmic

Device Facts

• Record ID: K012416
• Device Name: CONFOSCAN 2 CONFOCAL MICROSCOPE
• Applicant: Nidek Technologies Srl
• Product Code: HJO · Ophthalmic
• Decision Date: Oct 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma.

Device Story

Fully digital corneal confocal microscope; utilizes quartz halogen light source and scanning slit to illuminate tissue; second slit filters reflected light from unfocused layers. Captures 350 images per examination; images stored in PC RAM and saved to hard drive. Features automatic sensing to detect corneal contact; objective reverses if contact occurs. Used in clinical settings by eye care professionals. NAVIS software provides automated endothelial cell analysis (cell density calculation) and optical pachymetry. Enables visualization of corneal layers and components (endothelium, stroma, nerve fibers, etc.) for diagnosis of dystrophies, keratoconus, keratitis, and trauma. Benefits include precise display, digital storage, and quantitative analysis of corneal structures.

Clinical Evidence

Bench testing only. Electrical safety and EMC tested per EN 60601-1 and EN 60601-1-2. Ophthalmic instrument requirements tested per ISO 15004. Light energy levels found negligible. Endothelial cell analysis software validated using 134 samples extracted from corneal images, compared against results from two other commercially available specular microscopes.

Technological Characteristics

Confocal microscope; 100W internal halogen light source; water immersion Achroplan 40x objective lens; 10-micron depth resolution; 1-micron horizontal resolution; 0.75 numerical aperture. Integrated lift table, PC, and optical head. CCD camera (monochrome, 5 milliLux sensitivity). Connectivity: PC-based image storage. Software: NAVIS. Z-scan principle uses CCD camera to record scattered light for profile curve generation. Sterilization: lens disinfected per instructions.

Indications for Use

Indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye in patients requiring corneal examination.

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

• ConfoScan Confocal Microscope (K972953)

Submission Summary (Full Text)

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K012416

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CONFOSCAN 2 CONFOCAL MICROSCOPE

# SUBMITTER INFORMATION

| A. | Company Name: | Nidek Technologies Srl |
|----|--------------------------------|--------------------------------------------------------------------|
| B. | Company Address: | Via Regina, 88<br>Vigonza (Padova), Italy 35010 |
| C. | Company Phone:<br>Company Fax: | 39 49 89 35 191<br>39 49 62 55 84 |
| D. | Contact Person: | Mr. Aldo Cocchiglia<br>Managing Director<br>Nidek Technologies Srl |
| E. | Date Summary Prepared: | October 24, 2001 |

#### DEVICE IDENTI

| A. | Classification Name: | AC-Powered Slit-Lamp Biomicroscope |
|----|-------------------------|------------------------------------|
| B. | Trade/Proprietary Name: | ConfoScan 2 Confocal Microscope |
| C. | Device Classification: | Class II (886.1850) |
| D. | Product Code: | HJO |

#### DEVICE DESCRIPTION

The Nidek Technologies Srl ConfoScan 2 Confocal Microscope is a fully digital, corneal confocal microscope that allows a user to view and image human corneal layers in vivo. The confocal arrangement consists of one slit that illuminates the tissue and a second slit that filters the reflected light from unfocused layers. The user can view, magnify, measure, and photograph scparate layers of the transparent structures and tissues of the cornea. One examination records 350 different images.

10-24-01

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The ConfoScan 2 microscope is supplied with a Quartz Halogen light source and a scauning slit, suitable for performing ophthalmic examination. The system includes a 15-inch LCD S-VGA Monitor and a Personal Computer, which incorporates the dedicated NAVIS software.

#### INTENDED USE

The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma.

#### SUBSTANTIAL EQUIVALENCE

The ConfoScan 2 Confocal Microscope device has the same intended use and the same fundamental scientific technology as the following predicate device:

| Predicate Device | 510(k) Holder | 510(k) No. | Date Cleared |
|----------------------------------|-------------------|------------|--------------------|
| ConfoScan Confocal<br>Microscope | Tomey Corporation | K972953 | August 14,<br>1997 |

## TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the ConfoScan 2 Confocal Microscope and the predicate device has been performed, and the results are summarized in the table below. The results of this comparison demonstrate that the ConfoScan 2 Confocal

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Microscope device has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device.

| | CONFOCAL MICROSCOPE TECHNOLOGICAL COMPARISON | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nidek Technologies Srl<br>ConfoScan 2 Confocal Microscope | Tomey ConfoScan Confocal<br>Microscope<br>Predicate Device - K971953 |
| Indications For Use | The Nidek Technologies Srl<br>Confoscan 2 Confocal Microscope is<br>indicated for use as a diagnostic tool<br>for observation of the cell layers of<br>the anterior parts of the eye. | The Tomey Confoscan Confocal<br>Microscope is indicated for use as a<br>diagnostic tool for looking at the cell<br>layers of the anterior parts of the eye. |
| Corneal Contact | In normal use the front surface of the<br>eye does not contact the objective<br>lens; however, corneal contact can<br>occur. The ConfoScan 2 has an<br>automatic sensing feature which<br>detects if the cornea has been<br>touched (a warning is sounded and<br>the objective reverses direction). | In normal use the front surface of the eye<br>does not contact the objective lens;<br>however, corneal contact can occur. |
| Floating Objective Lens | Yes | Yes |
| Working Distance Between<br>Cornea and Objective | 1.98 mm | 0 to 10 mm (depending on lens) |
| Focus | Fixed | Fixed |
| Adjustment Direction | The examination device is<br>horizontally adjusted while the<br>patient is sitting straight in front of<br>the device (automatic or manual<br>adjustment option). | The examination device is horizontally<br>adjusted while the patient is sitting<br>straight in front of the device (manual<br>adjustment only). |
| Front Lens Area | 16.61mm2 | 16.61mm2 |
| | Nidek Technologies Srl<br>ConfoScan 2 Confocal Microscope | Tomey ConfoScan Confocal<br>Microscope<br>Predicate Device - K971953 |
| Type Scanning Aperture | Slit | Slit |
| Light Source | 100W Halogen, Internal | 100W Halogen, External |
| Objective Lens | Water Immersion Lens Achroplan<br>40x | Water Immersion Lens Achroplan 40x |
| Depth Resolution | 10 microns | 10 microns |
| Horizontal Resolution | 1 micron | 1 micron |
| Pre Sterilized Lens | No. Lens disinfected according to<br>instructions for use. | No. Lens disinfected according to<br>instructions for use. |
| Working Position | Horizontal | Horizontal |
| Standard Magnification | 40x | 40x |
| Mean Magnification | 500x on 15" display (1024 x 768<br>pixels). | 500x on 15" display (1024 x 768 pixels). |
| Numerical Aperture (na) | 0.75 | 0.75 |
| CCD Camera | Yes, (monochrome, 5 milliLux<br>sensitivity) | Yes, (monochrome, 5 milliLux<br>sensitivity) |
| Image Storage | Image directly stored in PC RAM,<br>then saved to a PC hard drive | Image stored on VCR tape, then<br>transferred to a PC |
| Automated Endothelial Cell<br>Analysis Software | Yes, the program provides the user<br>with a cell density (cells/mm²) | Yes, the program provides the user with a<br>cell density (cells/mm²). |
| Optical Pathway | Typical confocal microscope optical<br>path with IR and UV filters. Slit<br>oscillation is controlled by a stepper<br>motor. | Typical confocal microscope optical path<br>with IR and UV filters. Conjugate<br>Scanning slits with Galvin meter controls<br>slit movement. |
| Physical Layout | The lift table, PC, and Optical head<br>are integrated into one piece | The lift table, PC, and Optical head are<br>three separate modules |
| Operating Software | NAVIS | Confo-Commander |
| Z-Scan Principle (Cornea<br>Profile Measurement) | A CCD camera is used instead of the<br>photo multiplier to record the<br>scattered light from each corneal<br>image. This value is calculated<br>directly from the recorded image and<br>placed within a profile curve. There<br>is now an image correlated to each<br>point on the curve. | An intensity profile is taken via the photo<br>multiplier as a standing slit is scanned<br>through the cornea. The Photo multiplier<br>records scattered light profiles of the<br>cornea. The values are then placed on a<br>graph that provides the user with a profile<br>curve of the cornea without a correlated<br>image. |

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## PERFORMANCE EVALUATION

The following testing was performed on the ConfoScan 2 Confocal Microscope to demonstrate that it meets all specified requirements and is equivalent to the predicate device:

- Electrical Safety Testing & Electromagnetic Compatibility A.
The ConfoScan 2 Confocal Microscope was tested in accordance with EN 60601-1 and EN 60601-1-2, and was found to meet all requirements of both standards.

- Programmable Electrical Medical Systems B.
The ConfoScan 2 Confocal Microscope was tested in accordance with EN 60601-1-4 and was found to meet all requirements of the standard.

- Fundamental Test Requirements and Test Methods for Ophthalmic Instruments C.
The ConfoScan 2 Confocal Microscope was tested in accordance with ISO 15004 and was found to meet all requirements of the standard.

#### Light Energy Levels D.

The amount of light energy transferred to the patient during the normal examination time of one to two minutes was found to be negligible.

- Endothelial Cell Analysis Software Validation E.
A total of 134 samples (extracted from corneal images) were analyzed by the ConfoScan 2 Confocal Microscope to validate the resulting automatic cell density

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values via comparison to the results of two other commercially available specular microscopes.

## CONCLUSIONS

Nidek Technologies Srl has demonstrated through its evaluation of the ConfoScan 2 Confocal Microscope that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing people or families, in a flowing, interconnected design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2001

NIDEK TECHNOLOGIES SRL c/o Ms. Carol L. Patterson Patterson Consulting Group, Inc. 21911 Erie Lane, Lake Forest, CA 92630

Re: K012416

Trade/Device Name: ConfoScan 2 Confocal Microscope Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered Slip-Lamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: July 27, 2001 Received: July 30, 2001

Dear Ms. Patterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

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

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# INDICATIONS FOR USE

| 510(k) Number: | K012416 (To Be Assigned By FDA) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | ConfoScan 2 Confocal Microscope |
| Indications For Use: | The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of 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)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Tharsha L. Burke Nichols

(Division Sign-Off) Division of Ophthalmic Devices 24110 K, 01 510(k) Number .

OR

Confidential

07/23/01