NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

K040913 · Bausch & Lomb · MXK · Jul 23, 2004 · Ophthalmic

Device Facts

• Record ID: K040913
• Device Name: NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
• Applicant: Bausch & Lomb
• Product Code: MXK · Ophthalmic
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Indicated use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye. Also a diagnostic instrument indicated for the automated measurement and analysis of optical aberrations of the eye by use of wavefront technology.

Device Story

NGDI Workstation combines two diagnostic systems: Anterior Segment Analyzer and Aberrometer. Anterior Segment Analyzer uses slit scanning technology and Placido disc system to measure corneal elevation, curvature, pachymetry, white-to-white distance, and anterior chamber depth. Aberrometer uses Hartmann-Shack wavefront sensing; 785 nm laser diode beam focuses on retina; reflected light passes through lenslet array to detect wavefront distortion. Device operates in clinical setting; used by eye care professionals to analyze eye's optical system. Output includes corneal maps and wavefront aberration data; assists clinicians in evaluating ocular geometry and optical aberrations to inform clinical decision-making.

Clinical Evidence

Bench testing only. Repeatability study compared NGDI to Orbscan II using test objects. NGDI demonstrated RMS repeatability of 0.05 D (vs 0.04 D for Orbscan). Error statistics showed NGDI mean error of 0.00 D (SD 0.05 D) and RMS error of 0.05 D, compared to Orbscan mean error of 0.05 D (SD 0.09 D) and RMS error of 0.10 D.

Technological Characteristics

Combines slit scanning (660 nm laser) and Placido disc system for anterior segment analysis with Hartmann-Shack wavefront sensing (780 nm laser) for aberration measurement. Features motor-controlled trombone optical path. Dimensions/form factor not specified. Connectivity/software details not provided. Sterilization not applicable.

Indications for Use

Indicated for scanning, mapping, and displaying anterior segment geometry and for automated measurement and analysis of optical aberrations of the eye using wavefront technology.

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 II (K984443)
• Zywave Wavefront Diagnostic System (K010992)

Reference Devices

• Documenting Laser Slit Lamp (K012873)

Submission Summary (Full Text)

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# KO40913

## Section 15

## SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.

#### 1. Submitter's name, address, telephone number, contact person, and date summary prepared

- Bausch & Lomb a. 180 Via Verde Dr. San Dimas, CA 91773 [phone]
- David U, Thomas, M.S., R.A.C. b. Contact Person: Manager, Global Regulatory Affairs
- Date Summary Prepared: December 19, 2003 C.

#### Name of device, including trade name and classification name: 2.

| a. | Trade/Proprietary Name: | NGDI (Next Generation Diagnostic Instrument) |
|----|-------------------------|----------------------------------------------------------------------------------------|
| b. | Classification Name: | Ophthalmic Refractometer, AC Powered Keratascopy and AC Powered SlitLamp Biomicroscope |

#### 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Company: | Ortek, Inc |
|---------------|------------------------------------|
| Device: | Orbscan II |
| 510(k) | K984443 |
| Date Cleared: | March 5, 1999 |
| Company: | Bausch & Lomb, Incorporated |
| Device: | Zywave Wavefront Diagnostic System |

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| 510(k) | K010992 |
|---------------|-----------------------------|
| Date Cleared: | Class I, Exempt |
| Company: | Bausch & Lomb, Incorporated |
| Device: | Documenting Laser Slit Lamp |
| 510(k): | K012873 |
| Date Cleared: | November 19, 2001 |

- A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The NGDI Workstation comprises two individual measuring systems.

The Anterior Segment Analyzer measures elevation and curvature on both the anterior and posterior surfaces of the cornea, full corneal pachymetry, white-towhite, anterior chamber depth and angle kappa.

The Anterior Segment Analyzer in the NGDI Workstation is a diagnostic system that provides a complete analysis of the eye's optical system by utilizing slit scanning technology with an advanced Placido disc system. The slit scan is used to create the pachymetry model in the NGDI Workstation, which gives the thickness of the cornea and the location of the lens.

The Aberrometer is a precision optical instrument which measures the deviation of light beams reflected off the eye's retina to define the wavefront deformation as a function of the position of the pupil. It uses a motor-controlled trombone to set up the optical path for the eye image to return through in complete focus.

The Aberrometer function of the NGDI employs the principles of Hartman-Schack wavefront sensing in which a narrow illumination beam from a 785 mm, low power, laser diode goes into the eye and focuses into a diffraction limited point on the retina. The light reflects off the retina and comes back out the eye. The light exiting the eye is then passed through an array of tiny lenses (the lenslet array) that tak the exiting rays of light and breaks them into small points. With a normal, regular pattern, one can see where there is a plain wavefront with a uniform and symmetric grid and regular spacing between the points. Aberrated wavefronts are characterized by a distortion of the grid pattern after the light passes through the lenslet array.

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#### Statement of intended use: 5.

Indicated use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye. Also a diagnostic instrument indicated for the automated measurement and analysis of optical aberrations of the eye by use of wavefront technology.

#### 6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

| CHARACTERISTICS | Bausch & Lomb<br>NGDI | ORBSCANIE | ZAWAVE |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Indications for use | Indicated use is for<br>scanning, mapping, and<br>displaying the geometry<br>of the anterior segment<br>of the eye. Also a<br>diagnostic instrument<br>indicated for the<br>automated measurement<br>and analysis of optical<br>aberrations of the eye by<br>use of wavefront<br>technology. | Indicated use is for<br>scanning, mapping, and<br>displaying the geometry<br>of the anterior segment of<br>the eye. | Automated measurement<br>and analysis of optical<br>aberrations of the eye by<br>use of wavefront<br>technology. |
| Operating principle | Hartmann-Schack | N/A | Same |
| Measurement range | Sphere -12 to +6 diopters<br>Cylinder 0 to 6 diopters<br>Axis 0-180 degrees | | Sphere -8 to +6 diopters<br>Cylinder 0 to -6 diopters<br>Axis 0-180 degrees |
| Acquisition Head | Same except for light<br>source (see below). | Scanning slit<br>HiRes video CCD camera<br>Fully coated optics<br>Coaxially fixation light<br>Optical Positioning Aid | |
| Light Source | Laser slit technology (red,<br>660 nanometer) | Incandescent Light source<br>using mechanical aperture to<br>generate slits. | |
| | Trombone Laser Injection<br>780 nanometers 1<br>millimeter off axis. | | Direct Laser Injection 780<br>nanometers 1 millimeter of<br>axis. |

## Table A - Comparative Technological Characteristics

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#### Brief summary of nonclinical tests and results: 7.

Repeatability data was collected for a number of test objects. This was done for the NGDI and Orbscan. The comparisons were made in terms of average Keratometric Power (referred to as Diopters and abbreviated as D in this document), which is related to the Radius of Curvature by the formula

Px = 337.5/ Rc(mm)

Presented in Table B are the Power results of the repeatability study for test objects.

| | RMS Repeatability of Average<br>Power, Diopters | |
|-----------------------------------|-------------------------------------------------|------|
| | Orbscan | NGDI |
| Root Mean Square<br>Repeatability | 0.04 | 0.05 |

Table B - Overall Repeatability of Keratometric Power (Test Objects)

Instrument repeatability represents only a portion of the total error. Systematic errors can occur for a variety of reasons, and as a result, the variances for absolute error are generally larger than the Root Mean Square repeatability. Because the curvatures of the test objects are known, the error statistics can be computed. The results are presented in Table C.

## Table C - Error Statistics (Test Objects)

| Statistic | Error, Diopters | |
|--------------------|-----------------|------|
| | Orbscan | NGDI |
| Mean | 0.05 | 0.00 |
| Standard Deviation | 0.09 | 0.05 |
| Root Mean Square | 0.10 | 0.05 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Bausch & Lomb c/o Intertek Testing Services Daniel W. Lehtonen, Staff Engineer 70 Codman Hill Rd. Boxborough, MA 01779

Re: K040913

Trade/Device Name: NGDI (Next Generation Diagnostic Instrument) Regulation Number: 21 CFR 886.1850 Regulation Name: Biomicroscopes Regulatory Class: Class II Product Code: MXK; HJO; NCF Dated: July 9, 2004 Received: July 13, 2004

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have roviewed your betermined the device is substantially equivalent (for the indications ferenced about and sure) to legally marketed predicate devices marketed in interstate for use bared in the enactment date of the enactment date of the Medical Device Amendments, or to conniner that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been rotation of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ateres, missions 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 or ury 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Kalipi 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

Enclosure

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## 47913

## Indications for Use

510(k) Number (if known):

Device Name: NEXT GENERATION DIAGNOSTIC INSTRUMENT (NGDI) Indications For Use:

> Indicated Use is for scanning, mapping, and displaying the geometry of the anterior segment of the eye.

Also indicated for the measurement and analysis of optical aberrations of the eye by use of wavefront technology.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

> Concurrent ffice of Device Evaluation (ODE)

Elmon R. Rees

(Division Sign-om)
Divisien ef Ophthalmic Ear,
Nese and Threat Devises

**510(k) Number** KD40913

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