(87 days)
No
The summary describes the use of "algorithms and normative databases" and "automatic/manual image registration features" which are standard image processing techniques, not explicitly AI or ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No
The device is intended to aid healthcare professionals in the detection, monitoring, and management of ocular diseases by processing and displaying image and optical coherence tomography data, but it does not directly treat or provide therapy to patients.
Yes
The Retina Workplace is intended to "aid trained healthcare professionals in the detection, monitoring and management of ocular diseases." Its functionality includes processing and displaying image and optical coherence tomography data, generating reports containing results from OCT and fundus photography, and allowing comparison of macular thickness data to a database of normal subjects. These functions are directly supportive of diagnosing conditions.
Yes
The device is described as a "software application" that processes and displays data from other medical devices (OCT and Fundus photography). It does not appear to include any hardware components itself, relying on the FORUM PACs system (server) and client software.
Based on the provided information, the Retina Workplace is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- Retina Workplace Function: The Retina Workplace processes and displays image and optical coherence tomography data obtained from the ocular anatomical site. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to aid trained healthcare professionals in the detection, monitoring, and management of ocular diseases based on imaging data.
- Device Description: The description clearly states it's a software application that processes and displays OCT and Fundus photography data.
Therefore, the Retina Workplace falls under the category of medical devices that analyze imaging data, not IVD devices that analyze biological specimens.
N/A
Intended Use / Indications for Use
The Retina Workplace is a FORUM® application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography.
The Retina Workplace uses CIRRUS™ algorithms and normative databases as quantitative tool for the comparison of macular thickness data to a database of normal subjects.
The Retina Workplace is intended to aid trained healthcare professionals in the detection, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
The Retina Workplace is a software application to a Class II medical device regulated under 21 CFR §892.2050 and therefore is a Class II medical device. As a software application of the FORUM PACs system (server), the Retina Workplace client is designed to process and display CIRRUSTM HD optical coherence tomography (OCT) data and images provided by Fundus photography.
More specifically, the Retina Workplace processes the retrieved OCT exam data from CIRRUS HD-OCT and CIRRUS Photo images from the FORUM server to display the results of macular thickness analysis (MTA), macular change analysis (MCA), and 5 line raster analysis. The results may be compared against an age-matched population of normal subjects. Analysis and databases comparison is performed by using algorithms and normative databases previously cleared in CIRRUS HD-OCT (K111157) and CIRRUS Photo (K112184) predicate devices. The reports generated by the Retina Workplace can be displayed, printed, and the patient record can be stored back on the FORUM server database.
In addition, Retina Workplace can automatically register images generated by Fundus photography with the OCT cube image when provided in a valid DICOM format, including the necessary pixel spacing. Additionally, the user has the option to register the fundus / OCT images manually. The automatic/manual image registration features (Fovea Finder™ and AutoCenter™) are currently cleared on the CIRRUS™ HD-OCT system (K111157) and CIRRUSTM Photo (K112184) devices.
The Retina Workplace provides the same overlays as included in the currently cleared CIRRUS HD-OCT system such as:
- Fundus image overlay with another fundus image. (Fundus to Fundus registration)
- ILM-RPE overlay on the fundus image. (Inner limiting membrane / retinal ● pigment epithelium)
- ETDRS overlay on the fundus image. (Early Treatment of Diabetic Retinopathy ● Study)
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
optical coherence tomography, Fundus photography
Anatomical Site
Ocular, macula, retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals / 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
Bench testing was conducted, including Unit, System Integration, and System testing, against documented product requirements. Verification and validation testing was performed to evaluate the performance and functionality of the software. Each function/feature was tested via an appropriate test case. As part of verification testing, a direct comparison was made between original OCT test reports generated on CIRRUS HD-OCT and CIRRUS Photo and reports generated by the Retina Workplace using the same test data, to verify equivalence. Software verification and regression testing was performed successfully.
Clinical functionalities were validated by ophthalmologists using a production equivalent Retina Workplace system with verified software, including representative data (sample data that is representative of clinical cases) installed on a segregated computer and used as a non-clinical system. Validation participants executed test cases that simulated device use in a clinical environment and completed questionnaires.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Unit, System Integration, and System testing were conducted to verify performance against documentation. The device was found to perform as intended. Module and integration test phase and system verification were performed. A direct comparison test verified that reports generated by the Retina Workplace using the same test data were equivalent to original OCT test reports generated on the CIRRUS HD-OCT and CIRRUS Photo.
Non-Clinical Validation: Validation of clinical functionalities (Use Case) was completed by ophthalmologists using a production equivalent Retina Workplace system with verified software including representative data (sample data that is representative of clinical cases) installed on a segregated computer and used as a non-clinical system. The validation participants used the Retina Workplace system, executed test cases that simulated the use of the device in a clinical environment and completed questionnaires rating the various aspects of the software. Verification and validation activities met their acceptance criteria successfully and proved that the product, the Retina Workplace, meets its requirements and intended uses.
All testing deemed necessary was conducted to ensure that the device is as safe and effective as the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines extending from the bottom profile. The profiles are arranged in a way that suggests unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2015
Carl Zeiss Meditec, Inc. % Ms. Christine Dunbar Manager, Regulatory Submission 5160 Hacienda Drive Dublin, CA 94568
Re: K150467
Trade/Device Name: Retina Workplace Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ Dated: February 18, 2015 Received: February 23, 2015
Dear Ms. Dunbar:
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.
1
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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150467
Device Name Retina Workplace
Indications for Use (Describe)
The Retina Workplace is a FORUM® application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography.
The Retina Workplace uses CIRRUS™ algorithms and normative databases as quantitative tool for the comparison of macular thickness data to a database of normal subjects.
The Retina Workplace is intended to aid trained healthcare professionals in the detection, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
5. 510(K) SUMMARY
510(k) SUMMARY ( as per 21 CFR §807.92)
The Retina Workplace
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany
+49 3641220-667 (phone)
+49 3641220-282 (fax)
Establishment Registration Number: 9615030 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christine Dunbar
Manager, Regulatory Affairs, Submissions
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
(925) 560-5139 Phone
(925) 557-4259 Fax
E-mail: christine.dunbar@zeiss.com |
| Date prepared: | February 18, 2015 |
| Device | System, Image Management, Ophthalmic |
| Classification: | 21 CFR 892.2050 |
| Device Class: | II |
| Product Code: | NFJ |
| Common Name: | Picture Archiving and Communications System |
| Trade/Proprietary Name: | Retina Workplace |
Page 0017 of 2194
4
'Zhe Retina Workplace is intended to be a clinically focused accessory to the FORUM
Workplace. The Retina Workplace as described in this premarket notification has a similar intended use, indications for use (specific for the device), and is based on the same fundamental scientific technical characteristics as the predicate devices listed below.
| Predicate Devices and
Clearances | Clearance
Date | Substantially
Equivalent To: | Company |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| FORUM® is a server
based PACs workplace
supporting generic post-
processing tools (display,
pan, zoom, generating
reports, etc.) and interfaces
with DICOM based
ophthalmic devices. | K122938 /
November 2,
2012 | The Retina Workplace
accessory client for the
FORUM® PACS
system providing
clinically focused
applications. | Carl Zeiss
Meditec AG |
| CIRRUS™ HD-OCT
containing algorithms for
the detection and analysis
of ophthalmic anatomy,
including Retinal Nerve
Fiber Layer (RNFL),
Macular, Optic Nerve
Head and Ganglion Cell
Normative Databases | K11157 /
January 19,
2012 | The Retina Workplace
as a clinically focused
accessory to the
FORUM® PACs
workplace containing
algorithms and
databases for the
analysis of ocular
diseases including
macular edema, and
degeneration and other
retinopathies. | Carl Zeiss
Meditec AG |
| CIRRUS™ Photo
Combined fundus camera
and OCT system for the
imaging, display, storage,
and report generation of
the fundus images and
OCT images. | K112184 /
June 18, 2012 | The Retina Workplace
as a clinically focused
accessory to the
FORUM® PACS
workplace imports
OCT data and Fundus
images for display,
storage, and report
generation. | Carl Zeiss
Meditec AG |
| FORUM® Glaucoma
Workplace
As a clinically focused
accessory to the FORUM | K141297 /
October 3,
2014 | The Retina Workplace
as a clinically focused
accessory to the
FORUM® PACS | Carl Zeiss
Meditec AG |
| Predicate Devices and
Clearances | Clearance
Date | Substantially
Equivalent To: | Company |
| PACs and is a client of the
FORUM server | Reference
Predicate | workplace and is a
client of the FORUM
server. | |
Substantial Equivalence Claimed To (21 CFR §807.92(a)(3))
Carl Zeiss Meditec AG
Page O
5
510(K) SUMMARY
INTENDED USE (21 CFR §807.92(a)(5))
The Retina Workplace is a FORUM® application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography.
INDICATIONS FOR USE (21 CFR §807.92(a)(5))
The Retina Workplace is a FORUM® application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography.
The Retina Workplace uses CIRRUS™ algorithms and normative databases as quantitative tool for the comparison of macular thickness data to a database of normal subjects.
The Retina Workplace is intended to aid trained healthcare professionals in the detection, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.
DEVICE DESCRIPTION(21 CFR §807.92(a)(4))
The Retina Workplace is a software application to a Class II medical device regulated under 21 CFR §892.2050 and therefore is a Class II medical device. As a software application of the FORUM PACs system (server), the Retina Workplace client is designed to process and display CIRRUSTM HD optical coherence tomography (OCT) data and images provided by Fundus photography.
More specifically, the Retina Workplace processes the retrieved OCT exam data from CIRRUS HD-OCT and CIRRUS Photo images from the FORUM server to display the results of macular thickness analysis (MTA), macular change analysis (MCA), and 5 line raster analysis. The results may be compared against an age-matched population of normal subjects. Analysis and databases comparison is performed by using algorithms and normative databases previously cleared in CIRRUS HD-OCT (K111157) and CIRRUS Photo (K112184) predicate devices. The reports generated by the Retina
6
510(K) SUMMARY
Workplace can be displayed, printed, and the patient record can be stored back on the FORUM server database.
In addition, Retina Workplace can automatically register images generated by Fundus photography with the OCT cube image when provided in a valid DICOM format, including the necessary pixel spacing. Additionally, the user has the option to register the fundus / OCT images manually. The automatic/manual image registration features (Fovea Finder™ and AutoCenter™) are currently cleared on the CIRRUS™ HD-OCT system (K111157) and CIRRUSTM Photo (K112184) devices.
The Retina Workplace provides the same overlays as included in the currently cleared CIRRUS HD-OCT system such as:
- Fundus image overlay with another fundus image. (Fundus to Fundus registration)
- ILM-RPE overlay on the fundus image. (Inner limiting membrane / retinal ● pigment epithelium)
- ETDRS overlay on the fundus image. (Early Treatment of Diabetic Retinopathy ● Study)
RISK MANAGEMENT AND GENERAL SAFETY AND EFFECTIVENESS
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements, and validation of the clinical workflow to ensure that the product meets its intended uses. ZEISS adheres to recognized and established industry practice and relevant international standards where indicated.
Refer to Sections 16 and 21 for the Risk Management documentation.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a) (6)):
The Substantial Equivalence comparison chart (Section 12) demonstrates the comparison of the technological characteristics of the Retina Workplace to the currently cleared predicate devices. The reference predicate, FORUM Glaucoma Workplace is the first clinically focused client accessory to the FORUM PACS server. The design of the FORUM PACS server is to support clinically focused client workplaces to aid the optometric and ophthalmology clinicians with the processing, display, review, management, and storage of digital data contained in patient records.
The Retina Workplace is substantially equivalent to the predicate devices with regard to the indications for use statement and is functionally equivalent to the predicate devices as follows:
Carl Zeiss Meditec AG
7
- . The Retina Workplace and the predicate device. FORUM (K122938), supports the generation of reports which contain the results from optical coherence tomography data and Fundus photography and a variety of overlays.
- . The Retina Workplace and the predicate device FORUM (K122938) are software devices, whereas the predicate devices, CIRRUS HD-OCT (K111157) and CIRRUS Photo (K112184) are ophthalmic devices which have both software and hardware functionalities. The primary software functionalities to support clinically focused analysis of the retina in the predicate devices are implemented in the Retina Workplace.
- . The Retina Workplace and the predicate devices, CIRRUS HD-OCT [with Retinal Nerve Fiber Layer (RNFL), Macular, Optic Nerve Head and Ganglion Cell Normative Databases (K111157)] and CIRRUS photo (K112184), process OCT exam results and display these results in relation to a normative database.
Note: The Retina Workplace, Release 1, supports the currently cleared macular thickness analysis (MTA), macular change analysis (MCA), and 5 line raster analysis only. The results may be compared against an age-matched normative population database of normal subjects which has been previously cleared in the CIRRUS HD-OCT system (K111157) and the CIRRUS Photo (K112184) devices. The MTA, MCA, and 5 line raster analysis software applications and normative databases remain unchanged from the currently cleared versions in the CIRRUS HD-OCT and CIRRUS Photo products.
- The Retina Workplace and the reference FORUM Glaucoma Workplace ● (K141297) are similar workplaces in design as they are both clients of the FORUM server, each a clinically focused workplace to support the work flow of the optometric and ophthalmic clinicians and their staff.
PERFORMANCE DATA & SUMMARY OF VERIFICATION AND VALIDATION ACTIVITY (21 CFR §807.92(B)):
Bench Testing (21 CFR §807.92(b) (1))
Performance testing, in the form of software bench testing, was conducted on the Retina Workplace in the form of Unit. System Integration, and System testing against the documented product requirements. Verification and validation testing was performed to evaluate the performance and functionality of the software and the device has been found to perform as intended. Each function and/or feature was tested by means of an appropriate test case for the test specification. The verification testing demonstrates that the device performance complies with specifications and requirements identified for the Retina Workplace.
8
510(K) SUMMARY
The software verification activities were divided into three phases:
- Tests accompanying development (including code inspections)
- . Module and integration test phase - stabilization phase
- . System verification
As part of the verification testing, in a direct comparison test, the original OCT test reports generated on the CIRRUS HD-OCT and CIRRUS photo were compared to the reports generated by the Retina Workplace using the same test data, to verify that the results contained in both reports were equivalent.
The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Plan.
Testing Environment:
The client and server operating systems were also evaluated during verification. The results determined that client, the Retina Workplace, is suitable for the same operating systems for which the respective server, FORUM, is released and that it is suitable under the following operating systems:
Operating Systems (server):
- . Microsoft Windows 7 (64 bit) with Service Pack 1
- . Microsoft Windows 8 (64 bit)
- . Microsoft Windows Server 2008 R2 with Service Pack 1
Operating Systems (client):
- . Windows XP (32 bit) with Service Pack 3
- Windows 7 (32 or 64 bit) with Service Pack 1
- . Windows 8 (64 Bit)
- . Windows Server 2008 R2 with Service Pack 1
- Windows Server 2008 (TS) R2 (64 bit) with Service Pack 1
- . OS X 10.8 (Mountain Lion)
Non-Clinical Validation Test Results (21 CFR §807.92(b) (2))
Validation of clinical functionalities (Use Case) was completed by ophthalmologists using a production equivalent Retina Workplace system with verified software including representative data (sample data that is representative of clinical cases) installed on a segregated computer and used as a non-clinical system. The validation participants used the Retina Workplace system, executed test cases that simulated the use of the device in a clinical environment and completed questionnaires rating the various aspects of the
9
510(K) SUMMARY
software.
Verification and validation activities met their acceptance criteria successfully and proved that the product, the Retina Workplace, meets its requirements and intended uses.
Testing to Consensus Standards (21 CFR §807.92(b)(1))
The Retina Workplace has been tested to meet the requirements for conformity (where applicable) to multiple industry standards. The R&D evaluation of the relevant testing to consensus standards is documented. The Retina Workplace, is an accessory application to the FORUM Workplace.
The Retina Workplace is DICOM compliant according to the FORUM DICOM compliance statement, Doc ID: LEH-CS-044, Rev. 3.3.
Refer to Section 9 for this documentation.
SUBSTANTIAL EQUIVALENCE TO PREDICATES (21 CFR §807.92(B)(1):
As previously indicated, the Retina Workplace has been tested to meet the product requirements (PRS) and software requirements (SRS) and is considered to be substantially equivalent to the predicate and reference predicate devices as indicated above.
510(K) SUMMARY (21 CFR §807.92(C)):
In summary, based on the successful verification and validation testing to the software acceptance criteria, it is ZEISS' opinion that the Retina Workplace client, as an accessory to the FORUM PACs server system, does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate and reference devices.
Additionally, all testing deemed necessary was conducted on the Retina Workplace to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate and reference devices.