THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

K050350 · Notal Vision, Inc. · HPT · Apr 29, 2005 · Ophthalmic

Device Facts

• Record ID: K050350
• Device Name: THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
• Applicant: Notal Vision, Inc.
• Product Code: HPT · Ophthalmic
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1605
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The PreView Preferential Hyperacuity Perimeter (PreView PHP™) is intended for use in The detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration , as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to progression of choroidal neovascularization (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

Device Story

PreView PHP is an interactive, software-driven perimeter used in eye care practitioner offices to detect and monitor AMD progression. The device presents horizontal and vertical linear images to the patient's macular region; it utilizes hyperacuity—the ability to perceive fine differences in relative spatial localization—to map central and paracentral visual field distortions (metamorphopsia). Patients interact with the system to identify misalignments; the device records these inputs to detect intermediate and advancing macular changes. By identifying these distortions, the device assists clinicians in detecting choroidal neovascularization (CNV) and monitoring disease progression, facilitating earlier clinical intervention. The system operates on standard off-the-shelf PCs.

Clinical Evidence

Prospective, comparative, multicenter study of subjects with intermediate AMD or recent-onset CNV (n not specified). Primary endpoints were sensitivity and specificity for detecting recent-onset CNV. Results: Sensitivity 82% (95% CI: 72%–92%); Specificity 88% (95% CI: 81%–96%). Data supports the device's ability to differentiate recent-onset CNV from intermediate AMD.

Technological Characteristics

Software-driven automated perimeter; utilizes hyperacuity-based psychophysical testing. Operates on standard off-the-shelf PC hardware. No specific materials or energy sources beyond standard computing equipment described. Class I device; no FDA performance standards issued.

Indications for Use

Indicated for patients with age-related macular degeneration (AMD) and stable fixation to detect and characterize central/paracentral metamorphopsia and monitor progression of disease factors, including choroidal neovascularization (CNV).

Regulatory Classification

Identification

A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

Predicate Devices

• Humphrey Field Analyzer (K954167)
• Octopus 500/500e (K841099)

Reference Devices

• Heidelberg Retina Angiograph FA/ICGA (K971671)
• Macular Computerized Psychophysical Test (MCPT) (K014044)
• Amsler Grid

Submission Summary (Full Text)

{0}------------------------------------------------

K050350

| | | APR 29 2005 |
|--------------------|--|-------------------|
| Notal Vision, Inc. | | Original 510(k) |
| | | |
| PreView PHP™ | | SUMMARY STATEMENT |

510(k) Summary of Safety and Substantial Equivalance

| Submitter: | Company Name: | Notal Vision, Inc.<br>5 Droyanov Street<br>Tel Aviv 93143<br>Israel |
|------------|-----------------------------------------------------------|--------------------------------------------------------------------------------|
| | Phone:<br>FAX:<br>Contact Person:<br>Registration Number: | (011) 972 3 6293763 Ext. 103<br>(011) 972 3 6293764<br>Ori Lubin<br>3004103096 |

Manufacturer Information:

| | Company Name:<br>Address: | Notal Vision, Inc.<br>5 Droyanov Street<br>Tel Aviv 93143<br>Israel |
|--|--------------------------------|---------------------------------------------------------------------|
| | Phone:<br>Registration Number: | (011) 972 3 6293763<br>9058077 |

Official Correspondent:

| | Address: | Richard E. Lippman, O.D., F.A.A.O.<br>R.P. Chiacchierini & Associates, LLC<br>15825 Shady Grove Road Suite 30<br>Rockville, MD 20850 |
|--|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Phone:<br>FAX: | [phone]<br>[phone] |

DEVICE IDENTIFICATION:

| | Trade Name:<br>Common Name:<br>Classification Name: | PreView Hyperacuity Perimeter<br>(Preview PHP™)<br>Perimeter<br>Automated Perimeter |
|--|-----------------------------------------------------|-------------------------------------------------------------------------------------|
|--|-----------------------------------------------------|-------------------------------------------------------------------------------------|

CLASSIFICATION NAME AND REFERENCE: 21 CFR Part 886.1605

| | REGULATORY CLASS: | Class I |
|--|--------------------------------|-----------------------------------------------------------------------|
| | DEVICE PANEL AND PRODUCT CODE: | Ophthalmic: 86 HPT |
| | STANDARDS: | US FDA has not issued performance standards for automated perimeters. |

/

{1}------------------------------------------------

| Notal Vision, Inc. | Original 510(k) |
|--------------------|-------------------|
| PreView PHP | SUMMARY STATEMENT |

## INDICATIONS FOR USE:

The PreView PHP™ is intended for use in the detection and monitoring the progression of Agerelated Macular Degeneration (AMD) including, but not limited to, the detection of choroidal neovascularization (CNV).

## SUBSTANTIAL EQUIVALENCE:

1. 1. 1. 1. 1. 1.

The Notal Vision Ltd. PreView Preferential Hyperacuity Perimeter (PreView PHP™) is substantially equivalent to the following combination of predicate medical devices:

- Humphrey Field Analyzer: Perimeter, Automatic, AC-Powered, a class I Exempt medical . device (21 CFR 886.1605); (K954167) Product Code HPT
- Octopus 500/500e (21CFR 886.1605); (K841099) Product Code HPT. .

1. 1. 1. 1. 1. 1. 1.

- The Heidelberg Retina Angiograph FA/ICGA (HRA/C), (Heidelberg Engineering, . Germany) cleared under K971671; Product Code HLI
- The Macular Computerized Psychophysical Test (MCPT), (Notal Vision, Inc.) cleared . under K014044: Product Code HOQ
- Amsler Grid, a Class I Exempt Preamendments Medical Device (21 CFR 886.1330): . Product Code HOQ 10- 14-2

## DEVICE DESCRIPTION:

The PreView PHP™ system is an interactive software driven device that provides a series of horizontal and vertical linear images to the macular region of the eye to detect abnormalities of the central and paracentral visual field that will detect and monitor progression of age related macular degeneration including detection of choroidal neovascularization. The changes in macular and near macular function are identified by the device thus enabling the reader to detect intermediate and advancing changes in macular degeneration and associated diseases to provide the capability for earlier intervention.

The PreView PHP™ is a specialized perimeter, and applies the concept of the static and automated permeter in the detection of visual field defects. The device incorporates the theory of hyperacuity to address more highly specific central and paracentral visual fields. Because of hyperacuity, perception of more finite relative spatial localization. Hyperacuity is defined as the ability to perceive a difference in the relative spatial localization of points on the central field, more specific distortions or misalignments within the central and paracentral field can be mapped with greater accuracy. The device monitors and manages the progressive changes associated with advancing macular degeneration and differentiates the different stages of AMD including but not limited to choroidal neovascularization.

The PreView PHP™ system is designed for use with standard off-the-shelf PC units in the office of the practitioner. It is aimed to detect advancing changes of AMD-related lesions including but not limited to choroidal neovascularlization.

# clinical investigation

ﺑ

11:11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The purpose of the clinical investigation was to assess the ability of the Preferential Hyperacuity Perimeter (PreView PHP™) to detect the recent onset of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) and differentiate it from an intermediate stage of

. ....

ਿੰਗ ਦੇ ਦੇ ਕਾਰ ਸਿੰਘ ਸੀ। ਇਸ ਦੀ ਸੀ। ਇਸ ਦੀ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸਾਰੇ ਦੇ ਸੰ
ਦੀ ਹੈ ਅਤੇ ਇਸ ਦੀ ਸੰਗਰ ਸੀ। ਇਸ ਦੇ ਸੰਸਕ ਸੀ। ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਵੱ Section 2011 11 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 A FREE BREAD POST AND A

{2}------------------------------------------------

| Notal Vision, Inc. | Original 510(k) |
|---------------------------|-------------------|
| PreView PHP ^TM | SUMMARY STATEMENT |

AMD. The study design was a prospective, comparative, concurrent, non-randomized multicenter study

Eligible subjects had in their study eye a corrected visual acuity of 20/160 or better as well as either untreated CNV from AMD diagnosed within the last 60 days or an intermediate stage of AMD (at least 1 large druse or at least 20 medium-size drusen) with no evidence of geographic atrophy of the retinal pigment epithelium or other macular diseases.

A successful outcome was defined a priori as a sensitivity of at least 80% and a specificity of at least 80%.

The results demonstrated that the sensitivity to detect recent onset of CNV was 82% (95% confidence interval [CI]: 72% to 92%). The specificity to differentiate recent onset of CNV from the intermediate stage of AMD was 88% (95% CI: 81% to 96%).

In conclusion, the PreView PHP™ testing can detect recent onset of CNV due to AMD and differentiate it from an intermediate stage of AMD with high sensitivity and specificity. These data suggest that monitoring with PHP should detect most CNV of recent onset with few false positives at a stage when treatment usually would be beneficial so that this monitoring should be considered in the management of the intermediate stage of AMD.

#### LABELING

The Notal Vision PreView PHP™ system 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

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the head and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

APR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Notal Vision, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Vice President, Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15835 Shady Grove Road, Suite 30 Rockville, MD 20850

K050350 Re:

Trade/Device Name: PreView Preferential Hyperacuity Perimeter (PreView PHP™) Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter Regulatory Class: Class I Product Code: HPT Dated: February 9, 2005 Received: February 11, 2005

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encreations) it togens and ment date of the Medical Device Amendments. or to commerce provision to May 20, 1978, and excordance with the provisions of the Federal Food. Drug. devices may have been reculire approval of a premarket approval application (PMA). allia Cosmette Act (1107 market the device, subject to the general controls provisions of the Act. The T ou may, therefore, mance of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classinod 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 ov round in the over ents concerning your device in the Federal Register

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc acvisou that i Dr wation that your device complies with other requirements of the Act that I Drives made a and regulations administered by other Federal agencies. You must of any Federal batiates the requirements, including, but not limited to: registration and listing Comply whil an the Heeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 801), accemes (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

# 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), 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications Statement

510(k) Number (if known): K020350

Device Name: The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHPTM)

### Indications for Use:

The PreView Preferential Hyperacuity Perimeter (PreView PHP™) is intended for use in The detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration , as an aid in monitoring distorion) in patients from ago
progression of disease factors causing metamorphopsia including but not limited to progression of assouse ration (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

#### Additional Claims:

Image /page/5/Figure/6 description: The image contains a collection of text snippets, seemingly extracted from a document. The phrases "comparent of the comments of the comments of" and "and the country of the comment" appear, suggesting a discussion or analysis of comments within a specific country. The repetition of "and the comments of the count" and "and the country of the count" further emphasizes the focus on comment analysis and geographical context. The overall impression is that the image represents a fragment of text related to comment analysis, possibly within a research or analytical context.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Presription Use __

OR

M.L.B. Nicholas

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

i l

510(k) Number K050350

Over -The-Counter Use

(Oprtional Format 1-2-96)