GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES

K093213 · Carl Zeiss Meditec, Inc. · HPT · Mar 12, 2010 · Ophthalmic

Device Facts

• Record ID: K093213
• Device Name: GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: HPT · Ophthalmic
• Decision Date: Mar 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1605
• Device Class: Class 1
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K093213 · Mar 12, 2010	GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES	Carl Zeiss Meditec, Inc.	Sponsor-sponsored multi-site clinical study of glaucoma patients; Published clinical literature (Amalish-Montel et al., Casas-Llera et al.)	The sponsor used a multi-site study of 363 glaucoma patients to establish test-retest variability limits for the software's progression analysis. Published literature was used to support the clinical performance and substantial equivalence of the device in glaucoma populations.	Glaucoma; Test-retest variability; Visual field progression; Clinical literature review

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Sponsor-sponsored perimetric test-retest variability study; Multi-site clinical study; Follow-up/Duration: Four tests within one month	363 qualified glaucoma subjects; Sample Size: 363; Number of Sites: 9	Not applicable for this study	Quantification of perimetric test-retest variability; establishment of limits for change

Indications for Use

The Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series is a software analysis module that is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma. It is also intended to compare change over time and determine if statistically significant change has occurred.

Device Story

GPA is a software module for Humphrey Field Analyzer II/II-i series perimeters; processes visual field test results from up to 14 follow-up tests compared to an established baseline. Identifies progressive visual field loss in glaucoma patients; highlights changes exceeding clinical variability; provides plain-language alerts (e.g., 'Possible Progression'). Calculates Visual Field Index (VFI) as a percentage of remaining useful vision; generates VFI Rate of Progression plots with 3-5 year trend projections. Used by clinicians in eye care settings to monitor disease progression; output informs clinical decision-making regarding glaucoma management and treatment adjustments. Benefits patients by providing objective, longitudinal tracking of visual field status.

Clinical Evidence

Bench testing and clinical literature review. Sponsored study of 363 glaucoma subjects across nine sites quantified perimetric test-retest variability using SITA Standard, SITA Fast, and Full Threshold algorithms. Results established significance levels for change detection. Literature review confirms GPA performance in glaucoma populations and validates the Visual Field Index (VFI) methodology.

Technological Characteristics

Software analysis module for Humphrey Field Analyzer II/II-i series. Utilizes linear regression analysis for VFI trend projection. Implements statistical thresholds based on perimetric test-retest variability. Operates on existing HFA hardware platforms.

Indications for Use

Indicated for practitioners to assist in the detection, measurement, and management of visual field loss progression in patients with ocular diseases, including glaucoma. Aids in assessing change over time, including change from baseline and rate of change.

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 II (K954167)
• Cirrus™ HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Databases (K083291)

Submission Summary (Full Text)

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K69.3213

MAR 1 2 2010

## 5. 510(K) SUMMARY

# 510(k) SUMMARY Guided Progression Analysis (GPA) for the Humphrey® Fleld Analyzer II and II - i series

## GENERAL INFORMATION

Manufacturer:

Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 [phone] (phone) [phone] (fax) ----Est. Reg. No. 2918630

Contact Person:

Judith A. Brimacombe, MA Director, Regulatory/Clinical Affairs Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 [phone] (phone) [phone] (fax)

Classification name:

Classification:

Perimeter

HPT

Class I (according to 21 CFR 886.1605)

Product Code:

Trade/Proprietary name: Guided Progression Analysis (GPA) for the Humphrey® Field Analyzer II and Humphrey® Field Analyzer II - i series

### PREDICATE DEVICES

Company: Device:

Carl Zeiss Meditec, Inc. Humphrey® Field Analyzer II (K954167)

Company: Device:

Carl Zeiss Meditec, Inc. Cirrus™ HD-OCT with Retinal Nerve Fiber Layer and Macular Normative Databases (K083291)

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## INTENDED USE

The Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series is a software analysis module that is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma. It is also intended to compare change over time and determine if statistically significant change has occurred.

## INDICATIONS FOR USE

The Carl Zeiss Meditec, Inc. Guided Progression Analysis is a software analysis module for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II - i series (HFA II - i) that assists practitioners with the detection, measurement, and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma.

# DEVICE DESCRIPTION

The Carl Zeiss Meditec, Inc. Guided Progression Analysis (GPA) is a software package for the Humphrey Field Analyzer II and II - i series that is designed to help practitioners identify progressive visual field loss in glaucoma patients. GPA compares the visual field test results of up to 14 follow-up tests to an established baseline over time and determines if there is statistically significant change. The GPA printout highlights any changes from baseline that represent larger than expected clinical variability, and it provides simple plain-language messages such as "Possible Progression" or "Likely Progression" whenever changes show consistent and statistically significant loss. The GPA printout also presents the Visual Field Index (VFI), a global index which reports a measure of the patient's remaining useful vision in the form of a percentage, as well as the VFI Rate of Progression plot which provides a trend analysis of the patient's overall visual field history and indicates a 3-5 year projection of the VFI regression line if the current trend continued.

### SUBSTANTIAL EQUIVALENCE

The Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey Field Analyzer II- i series is substantially equivalent to the Humphrey® Field Analyzer II and Guided Progression Analysis for the Cirrus HD-OCT with Retinal Nerve Fiber Layer (RNFL) and Macular Normative Databases. The

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indications for use for the Guided Progression Analysis for the Humphrey® Field Analyzer II and Humphrey® Field Analyzer II- i series are similar to the indications for the predicate devices cited in this application. A technological comparison demonstrates that the Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series is functionally equivalent to the predicate devices.

Evaluation of published literature on Guided Progression Analysis for the Humphrey® Field Analyzer II and Humphrey® Field Analyzer II- i series supports the indications for use statement, and demonstrates that the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.

#### CLINICAL EVALUATION

Clinical data on GPA has been collected by various researchers and is reported in the clinical literature.12 A review of the clinical literature that discusses the relevant studies related to the development of GPA for analysis of visual field progression has been included in this Premarket Notification. GPA incorporated the visual field progression metrics successfully used in the Early Manifest Glaucoma Trial (EMGT), 34 in which pattern deviation maps were used to identify statistically significant visual field progression.

Carl Zeiss Meditec. Inc. sponsored a study to quantify perimetric test-retest variability in glaucoma subjects having a wide range of visual field loss. A total of 363 qualified glaucoma subjects were enrolled across a worldwide nine-site study. Each subject was tested four times within one month. The results of this study, which used the three threshold testing algorithms available on the Humphrey Field Analyzer (SITA Standard, SITA Fast, and Full Threshold), established the limits for change at different significance levels based on test-retest variability in glaucomatous visual fields. The results allow HFA GPA to indicate when the change for a given patient at a given test location exceeds the test-retest variability for the region.

¹ Amalish-Montel F, Casas-Llera P, Mudoz-Negrete FJ, Rebolleda G. Performance of glaucoma progression analysis software in a glaucoma population. Graefes Arch Clin Exp Ophthalmol 2009;247:391-397.

² Casas-Llera P, Rebolleda G, Muñoz-Negree FJ, Amalich-Montiel F, Pérez-López M, Femández-Buenaga R. Visual field index rate and event-based glaucoma progression analysis: Companison in a glaucoma population. Br. J. Ophthalmol. published online 16 June 2009.

³ Leske CM, Heijl A, Hyman L, Bengtson B for the Early Manifest Glaucoma Trial Croup. Early Manifest Glaucoma Trial - Design and baseline data. Ophthalmology 1999; 106:2144-2153.

⁴ Heil A, Leske CM, Bengtson B, Hussen B, Hussein M for the Early Manifest Glaucoma Trial Group. Reduction of intraccular pressure and glaucona progression - results from the Early Manifest Glaucoma Trial. Arch Ophhalmol. 2002; 120: 268-1279.

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GPA was further refined to include the visual field index (VFI) described by Bengtsson and Heijl.5 This index utilizes data from the pattern deviation probability maps and is incorporated into the new VFI graphical analysis in the GPA software. Linear regression analysis was used to determine the rate of change in VFI. For a visual field series with sufficient follow-up data, the linear regression line is extended into the future to aid the clinician in estimating a patient's future visual status, should previously observed progression rates continue into the future.

### SUMMARY

As described in this 510(k) Summary, all testing deemed necessary was conducted on the Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series to ensure that the device is substantially equivalent to the predicate devices, and safe and effective when used in accordance with its Instructions for Use.

5 B. Beagsson and A. Heiji. A visual field index for cakulation of glaucoma rate of progression; Am J Ophthalmol, Feb 2002; 145(2): 343-53.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

# MAR 1 2 2010

Carl Zeiss Meditec, Inc. c/o Ms. Judith A. Brimacombe, M.A. Director, Clinical and Regulatory Affairs 5160 Hacienda Drive Dublin, CA 94568

Re: K093213

Trade/Device Name: Guided Progression Analysis (GPA) for the Humphrey® Field Analyser II and Humphrey® Field Analyser II - i series

Regulation Number: 21 CFR 886.1605 Regulation Name: Perimeter Regulatory Class: Class II Product Code: HPT Dated: February 5, 2010 Received: February 12, 2010

Dear Ms. Brimacombe:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Judith A. Brimacombe, M.A.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K093213

Device Name:

Guided Progression Analysis (GPA) for the Humphrey® Field Analyzer II and Humphrey® Field Analyzer II ~ i series

Indications for Use:

The Carl Zeiss Meditec, Inc. Guided Progression Analysis is a software analysis module for the Humphrey Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series (HFA II - i) that assists practitioners with the detection, measurement, and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma,

Prescription Use _x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Bruce Drum

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat De nees

510(k) Number K093213