(106 days)
No
The description focuses on established optical measurement techniques (slit scanning, Placido disc, Hartmann-Shack) and standard data analysis (repeatability, error statistics). There is no mention of AI, ML, or related concepts like training/test sets for algorithmic development.
No
The device is described as a diagnostic system for scanning, mapping, displaying geometry, and measuring optical aberrations of the eye, which are functions for diagnosis, not therapy.
Yes
The "Device Description" explicitly states, "The Anterior Segment Analyzer in the NGDI Workstation is a diagnostic system..." and the "Intended Use / Indications for Use" describes functions like "scanning, mapping, and displaying the geometry" and "measurement and analysis of optical aberrations," which are characteristic of diagnostic devices.
No
The device description clearly outlines multiple hardware components, including a slit scanning system, Placido disc system, Aberrometer with a motor-controlled trombone, laser diode, and lenslet array. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is used for scanning, mapping, and analyzing the geometry and optical properties of the anterior segment of the eye and the retina. It uses optical methods (slit scanning, Placido disc, wavefront sensing) to measure physical characteristics of the eye.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient. The measurements are taken directly from the eye itself.
Therefore, while it is a diagnostic device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MXK; HJO; NCF
Device Description
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-to-white, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Slit scanning technology, Hartman-Schack wavefront sensing
Anatomical Site
Eye / Anterior segment of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Overall Repeatability of Keratometric Power (Test Objects): Orbscan RMS Repeatability of Average Power, Diopters = 0.04; NGDI RMS Repeatability of Average Power, Diopters = 0.05.
Error Statistics (Test Objects):
Orbscan: Mean Error, Diopters = 0.05; Standard Deviation Error, Diopters = 0.09; Root Mean Square Error, Diopters = 0.10.
NGDI: Mean Error, Diopters = 0.00; Standard Deviation Error, Diopters = 0.05; Root Mean Square Error, Diopters = 0.05.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability, Error (Mean, Standard Deviation, Root Mean Square)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 (909) 971-5104
- 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 |
1
| 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.
2
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
NGDI | ORBSCANIE | ZAWAVE |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Indications for 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. | Indicated use is for
scanning, mapping, and
displaying the geometry
of the anterior segment of
the eye. | Automated measurement
and analysis of optical
aberrations of the eye by
use of wavefront
technology. |
| Operating principle | Hartmann-Schack | N/A | Same |
| Measurement range | Sphere -12 to +6 diopters
Cylinder 0 to 6 diopters
Axis 0-180 degrees | | Sphere -8 to +6 diopters
Cylinder 0 to -6 diopters
Axis 0-180 degrees |
| Acquisition Head | Same except for light
source (see below). | Scanning slit
HiRes video CCD camera
Fully coated optics
Coaxially fixation light
Optical Positioning Aid | |
| Light Source | Laser slit technology (red,
660 nanometer) | Incandescent Light source
using mechanical aperture to
generate slits. | |
| | Trombone Laser Injection
780 nanometers 1
millimeter off axis. | | Direct Laser Injection 780
nanometers 1 millimeter of
axis. |
Table A - Comparative Technological Characteristics
3
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
Power, Diopters | |
|-----------------------------------|-------------------------------------------------|------|
| | Orbscan | NGDI |
| Root Mean Square
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 |
4
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling human figures or birds in flight, stacked on top of each other.
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.
5
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
6
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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