Who is the manufacturer of Retina Workplace?

Carl Zeiss Meditec, AG filed the 510(k) submission for Retina Workplace (K150467).

What is the FDA product code for Retina Workplace?

NFJ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Retina Workplace?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Retina Workplace?

FORUM (K122938); CIRRUS HD-OCT (K111157); CIRRUS Photo (K112184); FORUM Glaucoma Workplace (K141297).

Who can help prepare an FDA 510(k) submission like Retina Workplace?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Retina Workplace

K150467 · Carl Zeiss Meditec, AG · NFJ · May 21, 2015 · Radiology

Device Facts

Record ID	K150467
Device Name	Retina Workplace
Applicant	Carl Zeiss Meditec, AG
Product Code	NFJ · Radiology
Decision Date	May 21, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

Retina Workplace is a software application client for the FORUM PACS server; processes/displays OCT data and fundus images. Inputs: OCT exam data and fundus images from CIRRUS HD-OCT/Photo systems. Processing: utilizes previously cleared CIRRUS algorithms/normative databases for macular thickness analysis (MTA), macular change analysis (MCA), and 5-line raster analysis; performs automatic/manual image registration (Fovea Finder/AutoCenter). Outputs: processed images, quantitative analysis results, and clinical reports. Used in clinical settings by ophthalmologists/optometrists to review patient records. Output aids clinicians in detecting/monitoring ocular diseases by comparing patient data against age-matched normative populations. Benefits: facilitates efficient clinical workflow, standardized reporting, and longitudinal monitoring of retinal conditions.

Clinical Evidence

Bench testing only. Verification included unit, system integration, and system testing against product requirements. Direct comparison testing confirmed that reports generated by Retina Workplace were equivalent to those from CIRRUS HD-OCT and CIRRUS Photo using identical test data. Non-clinical validation involved ophthalmologists using production-equivalent systems with representative clinical data to confirm workflow functionality.

Technological Characteristics

Software application for FORUM PACS server. Connectivity: DICOM compliant. Operating systems: Windows 7/8, Windows Server 2008, OS X 10.8. Analysis: Rule-based algorithms and normative databases for macular thickness/change analysis. Features: Image registration (Fovea Finder, AutoCenter), report generation, and overlays (ILM-RPE, ETDRS).

Indications for Use

Indicated for trained healthcare professionals to aid in detection, monitoring, and management of ocular diseases (e.g., macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration) in patients requiring optical coherence tomography (OCT) and fundus photography analysis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

FORUM (K122938)
CIRRUS HD-OCT (K111157)
CIRRUS Photo (K112184)
FORUM Glaucoma Workplace (K141297)

Related Devices

K170638 — Retina Workplace · Carl Zeiss Meditec, AG · Jun 21, 2017
K182318 — Retina Workplace · Carl Zeiss Meditec, Inc. · Oct 24, 2018
K211715 — RetinAI Discovery · Retinai Medical AG · Apr 28, 2022
K141297 — FORUM GLAUCOMA WORKPLACE · Carl Zeiss Meditec, AG · Oct 3, 2014
K181501 — Afina · Neurovision Imaging, LLC · Nov 2, 2018

Submission Summary (Full Text)

{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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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.