MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)

K014044 · Notal Vision, Inc. · HOQ · Mar 4, 2002 · Ophthalmic

Device Facts

• Record ID: K014044
• Device Name: MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
• Applicant: Notal Vision, Inc.
• Product Code: HOQ · Ophthalmic
• Decision Date: Mar 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1330
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for The early detection of central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with macular degeneration.

Device Story

The Macular Computerized Psychophysical Test (MCPT) is a PC-based software device designed to identify central and paracentral macular visual field abnormalities. The device presents a series of images in vertical and horizontal planes on a screen to the user. It analyzes the user's responses to these image presentations to detect irregularities and stores the resulting analysis on a computer server. The device is intended for use by clinicians to assist in the diagnosis of macular degeneration. By providing a computerized, interactive alternative to the traditional Amsler Grid, the MCPT aims to improve the detection of retinal abnormalities, potentially facilitating earlier clinical intervention for patients with macular degeneration.

Clinical Evidence

Prospective, single-blinded, randomized clinical study comparing MCPT to Amsler Grid in patients with age-related macular degeneration (AMD) and healthy controls. Total sample size included multiple investigational sites. Primary endpoint: ability to distinguish AMD stages from healthy eyes. Results: MCPT sensitivity 68.4% vs. Amsler Grid 25.6% (p=0.0000001). MCPT specificity 81.8% vs. Amsler Grid 100%. Study concluded MCPT is significantly more sensitive than the Amsler Grid for detecting AMD-related retinal abnormalities.

Technological Characteristics

Computerized interactive software device housed in a standard PC. Operates by presenting visual images on a screen to assess the central and paracentral macular field. Data is processed and stored on a computer server. No specific materials or energy sources beyond standard PC hardware are specified.

Indications for Use

Indicated for the early detection of central and paracentral visual field irregularities, most commonly associated with macular degeneration, in patients requiring assessment for retinal abnormalities.

Regulatory Classification

Identification

An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

Predicate Devices

• Amsler Grid (21 CFR 886.1330)

Submission Summary (Full Text)

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K014044

# sion Inc.

1 VOLUT - 972-3-6293, ISRAEL. Tel: [phone] Fax: [phone]

MAR 4 2002

# 510(k) Summary Statement

| Submitter: | Company Name: | Notal Vision, Inc. |
|------------|-----------------|---------------------------------------------|
| | Address: | 5 Droyanov Street<br>Tel Aviv, 63143 Israel |
| | Contact Person: | Dr. Zeev Even Chen |
| | Phone: | (972) 3 6293763 Ext. 103 |
| | Fax: | (972) 3 6293764 |
| | Registration : | Pending |

# Manufacturer Information:

| Company Name: | Notal Vision, Inc. |
|-----------------|---------------------------------------------|
| Address: | 5 Droyanov Street<br>Tel Aviv, 63143 Israel |
| Contact Person: | Dr. Zeev Even Chen |
| Phone: | (972) 3 6293763 Ext. 103 |

Registration Number: Pending

| Official Correspondent: | Richard E. Lippman, O.D., F.A.A.O. |
|-------------------------|---------------------------------------------------------------------------------------|
| Address: | C.L. McIntosh, Inc.<br>12300 Twinbrook Parkway Suite 230<br>Rockville, Maryland 20852 |
| Phone : | 301-770-9590 |
| Fax: | 301-770-9584 |

# DEVICE IDENTIFICATION:

| Trade Name: | Macular Computerized Psychophysical Test (MCPT) |
|----------------------|-------------------------------------------------|
| Common Name: | Amsler Grid |
| Classification Name: | Amsler Grid |

CLASSIFICATION Name and Reference:

21 CFR 886.1330 Amsler Grid

REGULATORY CLASS Class I Amsler Grid COMMON NAME: ESTABLISHMENT REGISTRATION: Pending

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## INDICATION for USE:

The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for The early detection of central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with macular degeneration.

## SUBSTANTIALLY EQUIVALENT TO:

The Notal Vision Macular Computerized Psychophysical Test is substantially equivalent to an Amsler Grid, a Class I Exempt medical device (21 CFR 886.1330) that is a chart with grids that is held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

### DEVICE DESCRIPTION:

The device is a computerized interactive software device that provides the user with a series of images oriented in vertical and horizontal planes on a imaging screen that is designed to identify irregularities in the central and paracentral macular field of the human visual system. The device analyzes the image presentation in the process of identifying visual field abnormalities and stores the analysis in a computer server. The device is housed in a PC computer.

## CLINICAL INVESTIGATION

A prospective single blinded randomized clinical investigation was conducted at multiple investigational sites to evaluate the presence of central and paracentral visual field defects in the diagnosis of macular degeneration. The test device was the interactive software driven Macular Computerized Psychophysical Test (MCPT). The Amsler Grid chart was used as a comparison tool in two separate sets of subjects. Test subjects were those individuals with defined age-related macular degeneration (AMD) at different stages, and the control subjects were those with normal healthy eyes. Only one eye was tested in either the test group or the control group.

The primary objective of the study was to evaluate the ability of each technique to distinguish between patients with AMD at different stages and healthy controls without retinal abnormality.

The statistical tests, which was used for analyzing the results of this study, include comparative analysis to demonstrate the hypothesis that the MCPT is equal to or better than the Amsler grid in the detection of AMD-related retinal abnormalities, i.e., to

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reject the null hypothesis which states: "The Amsler grid is better then the MCPT in detecting abnormalities in the macular area".

# CLINICAL OUTCOMES AND CONCLUSIONS

#### Efficacy:

The MCPT indicated the presence of AMD significantly more often than the Amsler grid. The overall sensitivity of MCPT was 68.4%, compared with 25.6% of the Amsler grid. This difference is statistically significant. However, MCPT was also inclined to diagnose more Category 1 subjects (healthy subjects-false positives) as having AMD. The specificity of MCPT was 81.8%, compared to 100% for the Amsler grid.

| Category | MCPT | | | Amsler Grid | | | | P-Value¹ | |
|----------|------|----|-------|-------------|----|----|-------|----------|-----------|
| | - | + | Sens | Spec | - | + | Sens | Spec | |
| 1 | 27 | 6 | | 0.818 | 33 | 0 | | 1.0 | 0.0312500 |
| 2 | 30 | 21 | 0.412 | | 47 | 4 | 0.078 | | 0.0000763 |
| 3 | 6 | 14 | 0.70 | | 16 | 4 | 0.20 | | 0.0019531 |
| 4 | 1 | 26 | 0.963 | | 15 | 12 | 0.444 | | 0.0001221 |
| 5 | 0 | 19 | 1.0 | | 9 | 10 | 0.526 | | 0.0039063 |
| TOTAL² | 37 | 80 | 0.684 | | 87 | 30 | 0.256 | | 0.0000001 |

## MCPT and Amsler Grid Results per Category

= = Positive results; - = Negative results; Sens. = Sensitivity' Spec. = Specificity

1 Calculated according to mcNemar Test for two related dichotomous variables.

2 Categories 2 to 5.

The MCPT sensitivity analysis was calculated as follows: Sensitivity = (21+14 +26 + 19)[(21 +14 +26 +19) + 30 +6 +1 +0)] = 0.684 Specificity = 27/(27 +6) = 0.818

The Amsler Grid sensitivity analvsis was calculated as follows: Sensitivity = (4 +4 +12 + 10)[(4 +4 +12 +10) + (47 +16 +15 +9)] = 0.256 Specificity = 33/(33) = 1

#### Safety:

No adverse events were observed or reported by the subjects throughout the study. It is concluded that both the MCPT and the Amsler grid are safe.

#### LABELING

The Notal Vision Macular Computerized Psychophysical Test (MCPT) is provided with a User Manual for the Practitioner. The information is available from the company:

Notal Vision, Inc. 5 Droyanov Street Tel Aviv 63143. Israel (972) 3 6293763

0000312

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, one behind the other. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2002 MAR

Notal Vision, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. C.L. McIntosh, Inc. 12300 Twinbrook Parkway Suite 230 Rockville, Maryland 20852

Re: K014044

Trade Name: Macular Computerized Psychophysical Test (MCPT) Regulation Number: CFR 886.1330 Regulation Name: Amsler Grid Regulatory Class: Class I Product Code: HOQ Dated: December 1, 2001 Received: December 7, 2001

#### Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to 10gails and the Medical Device Amendments, or to Conimeres proc to may 20, 1976, are excordance with the provisions of the Federal Food, DDIg. de noos that have been that do not require approval of a premarket approval application (PMA). and Cosmette Act (110t) that do not requent to the general controls provisions of the Act. The r ou may , are every missas of the Act include requirements for annual registration, listing of general volusion profiteruring 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 I load or how love 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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## Page 2 - Richard E. Lippman, O.D., F.A.A.O.

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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Copy

#### Indications Statement

510(k) Number (if known)

The Notal Vision Macular Computerized Psychophysical Test (MCPT) Device Name:

#### Indications for Use:

The Notal Vision Macular Computerized Psychophysical Test (MCPT) is indicated for the eatly dection of central The Notal Vision Macqual Computerized in the visual field, most commonly associated with macular degeneration.

Additional Claims:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Presription Use

OR

Dennis L. McCarthy

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Ti

510(k) Number

Over -The-Counter Use _

(Oprtional Format 1-2-96)

000015