ORBSCAN

K984443 · Technolas Perfect Vision GmbH · MXK · Mar 5, 1999 · Ophthalmic

Device Facts

• Record ID: K984443
• Device Name: ORBSCAN
• Applicant: Technolas Perfect Vision GmbH
• Product Code: MXK · Ophthalmic
• Decision Date: Mar 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Orbscan II intended use is for scanning, mapping and displaying the geometry of the anterior segment of the eye.

Device Story

Orbscan II is a non-invasive diagnostic system for anterior segment geometry measurement. Input: video images of slit-shaped light projections on the eye; optional placido pattern provides surface slope data. Operation: optical head projects slits at equi-distant angles; video camera records images; CPU uses edge detection algorithms and triangulation to calculate elevation, curvature, corneal thickness, anterior chamber depth, and iris/lens elevation. Output: graphical colored maps displaying height/thickness variations. Used in clinical settings by eye care professionals. Enhanced computing (Pentium-based) reduces processing time compared to predecessor. Placido pattern integration improves reproducibility to +/- 0.003 mm. Benefits: provides detailed topographic data for clinical decision-making regarding anterior segment health.

Clinical Evidence

Internal company and independent clinical studies conducted on human subjects and test objects. Results demonstrated improved reproducibility of +/- 0.003 mm with the optional placido pattern compared to +/- 0.005 mm without it. Processing time for anterior segment information reduced to less than 1.5 minutes.

Technological Characteristics

Optical head with scanning slit apertures, video CCD camera, and optional back-illuminated LED placido pattern. CPU: Intel Pentium technology (400 MHz, 128MB RAM). Connectivity: Windows-based interface, standard PC peripherals. Safety: medically approved power supply, isolated patient contact (chin/forehead rest). Measurement principle: triangulation and edge detection.

Indications for Use

Indicated for scanning, mapping, and displaying anterior segment geometry of the eye in patients requiring corneal or anterior chamber evaluation.

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

• Orbscan (K940647)

Submission Summary (Full Text)

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3/5/99

## Summary of Safety and Efficacy

K984443

| Date of Summary | March 3, 1999 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Orbtek, Inc.<br>1977 W. North Temple<br>Salt Lake City, UT 84106, USA<br>801-320-9700 |
| Contact Person | Pier Calacino<br>Quality Assurance Manager |
| Name of Device | Orbscan IITM Keratometer |
| Class | Class II |
| Classification Name | AC Powered Keratoscope<br>AC Powered SlitLamp Biomicroscope (886.1850) |
| Product Code | MXK Anterior Segment Analysis Device |
| Predicate Device | The predicate device is the original Orbscan manufactured<br>by Orbtek, Inc., and cleared for marketing by FDA on<br>07/06/94 with premarket notification number K940647. |
| Intended Use | The Orbscan II Keratometer is intended to scan, map and<br>display the geometry of the anterior segment of the eye. |

## Device Description

The Orbscan II is a non-invasive, diagnostic system that measures and displays the anterior segment geometry of the eye. The system consists of an optical head, power supply and CPU. The optical head projects light through moving slit shaped apertures, The slit images are projected onto the eye at equi-distant angles from a central optical axis. A video camera placed on the optical axis records the images of the slits as they pass over the eye. The location of each slit at each position is determined during the system calibration.

During an examination, the slits are stepped across the cornea and an image of the cornea at each slit location is recorded, The CPU processes the images by using edge detection algorithms to determine the location of all of the edges the light strikes during the exam. Through direct triangulation, the elevation and curvature for the various surfaces is determined. Corneal thickness, anterior chamber depth and clevation of the iris and lens can then be determined by subtracting the surfaces.

This anterior segment information is displayed graphically to a user in the form of colored maps. These maps display variations in height and thickness numerically as well as with gradations in color. The graded colors allow for easier visualization of true

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measurements and how they relate to elevation and thickness of the eye geometry. The maps can be displayed individually or in several combinations. They can also be customized by the user for their specific examination needs. The Orbscan operates on a Windows™ based user interface and operating system that allows for ease of operation and system control. The CPU used with the Orbscan is a standard, high-speed PC type computer. Other peripherals may include a display monitor, a mouse pointing device and a printer for hard copies of the maps, should the user desire them.

To enhance repeatability, an optional placido pattern can be attached to the Orbscan. The placido pattern provides slope data for the anterior surface of the eye. The slope data obtained from using the placido pattern is combined with the elevation data as measured with triangulation. Tests on both test objects and human subjects have shown that the reproducibility has been enhanced from +/- . 005mm without the placido to +/-.003 mm with the placido pattern.

The device is non-invasive and only contacts the patient on his/her chin and forehead. The other concerns for safety are the light output and electrical safety. The light output is of an evesafe intensity and wavelength. Electrical safety is provided by packaging which is compliant to accepted safety standards, and mcdically safe power sources which isolate the patient from hazardous voltages and current.

The device is proven effective in incasuring the anterior geometry of the eve through internal company and independent clinical studies.

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## Product Comparison

| Feature | Orbscan | Orbscan II |
|---------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Field of view | 10 x 14 mm | same |
| Axis range | 0 to 360 degrees | same |
| Dioptric range | 9 to 99 Diopters | same |
| Resolution | 0.10 Diopters | same |
| Reproducibility | +/- 0.025 mm | +/- 0.003 mm1 |
| Acquisition head | scanning slit<br>HiRes video CCD camera<br>Fully coated optics<br>Coaxially fixation light<br>Optical Positioning Aid | same |
| Additional Hardware | | Backlit placido pattern2<br>Relocation of Power supply to Self<br>contained box3 |
| Power Requirements | 110/120 volt AC, 50/60 Hz<br>220/240 volt AC, 50/60 Hz | same |
| Dimensions | 24" x 34" footprint | same |
| Cpu4 | 80486 33 MHz<br>4 Mb Ram | Intel Pentium technology<br>400 MHz or greater<br>typ 128Mb Ram |

¹ Surfaccs measured with Placido pattern attached.

² The Placido Pattern provides slope data, which, when integrated with true elevation data yields better surface curvature calculations. The pattern is back illuminated with highly diffused LED light sources and is attached to the front of the Orbscan II without modification. The pattern does not come in contact with the patient and is electrically isolated for safety.

³ The power supply was originally located in the cabinet that contained the CPU. The previous location was determined to not be as safe due to the fact that computer housings are frequently accessed by nontechnical individuals. The new location allows more room for a medically approved power supply and it isolates the device from uncontrolled grounding. This arrangement also prevents un-authorized access to the device.

⁴ Increased computing capability allowed the ability to process the increased amount of data points. Orbscan took approximately 3-5 min to process the anterior corneal surface only. Orbscan II processes all information in less than 1 1/2 min.

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Anterior surface topography Posterior Surface topography Full Corneal Pachymetry Elevation of the iris Elevation of the Lens Depth of the Anterior Chamber

S The term Topography is used to include the two terms of Elevation and curvature.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Mr. Pier Calacino Quality Assurance Manager ORBTEK, Inc. 1977 West North Temple Salt Lake City, UT 84116

Re: K984443

> Trade Name: AC-powered Slitlamp Biomicroscope Regulatory Class: II Product Code: MXK Dated: January 22, 1999 Received: January 25, 1999

Dear Mr. Calacino:

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 (for the indications for use stated in the enclosure) 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 OS 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. Pier Calacino

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. Ralph 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): __ K984443__________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The Orbscan II intended use is for scanning, mapping and displaying the geometry of the anterior segment of the eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carl Callaway

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. k984443

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)