(77 days)
Not Found
No
The description focuses on traditional perimetry techniques and hyperacuity principles, with no mention of AI or ML.
No.
The device is intended for detection and monitoring of a disease, not for treatment.
Yes
Explanation: The device is intended for "detection and monitoring the progression of Age-related Macular Degeneration (AMD)" and "detection and characterization of central and paracentral metamorphopsia (visual distortion)". These are diagnostic functions, as it identifies the presence and characteristics of a disease. Furthermore, the device's "Key Metrics" section provides sensitivity and specificity, which are common performance measures for diagnostic devices.
Yes
The device is described as an "interactive software driven device" that is designed for use with "standard off-the-shelf PC units." While it relies on a PC for operation, the core medical device functionality is explicitly stated to be software-driven, and there is no mention of specialized hardware components included as part of the device itself.
Based on the provided information, the PreView PHP™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- PreView PHP™ Function: The PreView PHP™ is a device that interacts directly with the patient's eye to assess visual function (specifically, central and paracentral visual fields and metamorphopsia). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "detection and monitoring the progression of Age-related Macular Degeneration (AMD)" by assessing visual perception and distortion, not by analyzing biological samples.
- Device Description: The description details a software-driven device that presents visual stimuli to the eye and detects changes in visual function. This is a functional assessment, not an in vitro test.
Therefore, the PreView PHP™ falls under the category of a medical device used for functional assessment and monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
HPT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
macular region of the eye, central and paracentral visual field
Indicated Patient Age Range
Not Found
Intended User / Care Setting
office of a licensed eye care practitioner
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 AMD.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity to detect recent onset of CNV was 82% (95% confidence interval [CI]: 72% to 92%).
Specificity to differentiate recent onset of CNV from the intermediate stage of AMD was 88% (95% CI: 81% to 96%).
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.
K954167, K841099, K971671, K014044
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.
Not Found
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
§ 886.1605 Perimeter.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
| 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.
5 Droyanov Street
Tel Aviv 93143
Israel |
|------------|-----------------------------------------------------------|--------------------------------------------------------------------------------|
| | Phone:
FAX:
Contact Person:
Registration Number: | (011) 972 3 6293763 Ext. 103
(011) 972 3 6293764
Ori Lubin
3004103096 |
Manufacturer Information:
| | Company Name:
Address: | Notal Vision, Inc.
5 Droyanov Street
Tel Aviv 93143
Israel |
|--|--------------------------------|---------------------------------------------------------------------|
| | Phone:
Registration Number: | (011) 972 3 6293763
9058077 |
Official Correspondent:
| | Address: | Richard E. Lippman, O.D., F.A.A.O.
R.P. Chiacchierini & Associates, LLC
15825 Shady Grove Road Suite 30
Rockville, MD 20850 |
|--|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Phone:
FAX: | (240) 683-3738
(240) 683-9236 |
DEVICE IDENTIFICATION:
| | Trade Name:
Common Name:
Classification Name: | PreView Hyperacuity Perimeter
(Preview PHP™)
Perimeter
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:
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. .
- 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
. ....
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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 (301) 827-8910. 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/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:
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(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)