Who is the manufacturer of RetinAI Discovery?

Retinai Medical AG filed the 510(k) submission for RetinAI Discovery (K211715).

What is the FDA product code for RetinAI Discovery?

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

What is the regulatory pathway for RetinAI Discovery?

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

Who can help prepare an FDA 510(k) submission like RetinAI Discovery?

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.

RetinAI Discovery

K211715 · Retinai Medical AG · NFJ · Apr 28, 2022 · Radiology

Device Facts

Record ID	K211715
Device Name	RetinAI Discovery
Applicant	Retinai Medical AG
Product Code	NFJ · Radiology
Decision Date	Apr 28, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

Device Story

Standalone, browser-based software platform; imports/stores/displays DICOM-compliant ophthalmic diagnostic data (OCT scans, fundus images). User manually segments retinal layers/volumes; platform calculates layer thickness/volume; presents progression graphs; measures ocular anatomy/lesion distances. Used in clinical settings by healthcare professionals to assist in diagnosis and monitoring of disease progression. Output viewed via web browser; supports clinical decision-making by providing quantitative measurements and visualization of eye anatomy.

Clinical Evidence

Bench testing only. Verification and validation included static code analysis, unit, integration, and system testing per IEC 62304/82304. Comparison testing performed against reference devices (Heidelberg Spectralis, Topcon DRI OCT Triton) using identical images to validate manual segmentation and measurement accuracy. Results confirmed computed values from Discovery are substantially equivalent to reference devices.

Technological Characteristics

Standalone, browser-based software application. Compatible with Google Chrome, Mozilla Firefox, Microsoft Edge. Supports DICOM (PS 3.1-3.20) standards. Features manual segmentation and measurement tools for retinal OCT and fundus images. Software lifecycle follows IEC 62304 and IEC 82304-1.

Indications for Use

Indicated for healthcare professionals to manage, display, analyze, and measure ophthalmic diagnostic data (including OCT and fundus images) and perform manual labeling/annotation of retinal OCT scans.

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

OptosAdvance (K162039)

Reference Devices

Topcon DRI OCT Triton (K173119)
Heidelberg Engineering Spectralis (K173648)

Related Devices

K232088 — Altris IMS · Altris, Inc. · Jul 31, 2023
K150467 — Retina Workplace · Carl Zeiss Meditec, AG · May 21, 2015
K162039 — OptosAdvance 4.0 Software · Optos Plc. · Feb 8, 2017
K170638 — Retina Workplace · Carl Zeiss Meditec, AG · Jun 21, 2017
K093313 — SYNERGY · Topcon Medical Systems, Inc. · Dec 2, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ April 28, 2022 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. RetinAI Medical AG Enisa Dresevic Head of Quality and Regulatory Affairs Freiburgstrasse, 3 Bern. 3010 Switzerland # Re: K211715 Trade/Device Name: RetinAI Discovery Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: March 25, 2022 Received: March 25, 2022 # Dear Enisa Dresevic: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. 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 {1}------------------------------------------------ 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K211715 Device Name RetinAl Discovery Indications for Use (Describe) The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans. Type of Use (Select one or both, as applicable) 区 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 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 #### RetinAl Discovery Submitter: RetinAl Medical AG Freiburgstrasse 3 3010 Bern Switzerland Phone: +33 6 29 39 55 25 Contact Person: Enisa Dresevic Date Prepared: April 27, 2022 510(k) number: K211715 Name of Device: RetinAl Discovery Classification Name: Medical image management and processing system Requlatory Class: II Product Code: NFJ Predicate Device Optos PLC's OptosAdvance (K162039) Reference Devices Topcon DRI OCT Triton (K173119) Heidelberg Engineering Spectralis (K173648) #### Intended Use / Indications for Use The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans. #### Device description The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression. {4}------------------------------------------------ ### Summary of Technological Characteristics Both the subject and predicate device are standalone software devices intended to display and analyze previously-acquired images of the eye in order to streamline review of such images by healthcare professionals. Both devices are browser-based platforms that can be used on a variety of web browsers (i.e., Google Chrome, Mozilla Firefox, Microsoft Edge) and feature similar capabilities. The principal difference between the products relates to the availability in Discovery of a wider range of viewing layouts compared to the predicate device. A table comparing the key features of the subject and predicate devices is provided below. The validation of RetinAl Discovery performance is supported by comparison testing with two Reference Devices, Heidelberg Engineering SPECTRALIS HRA+OCT (K173648) and Topcon DRI OCT Triton (K173119). While Discovery is a standalone, browser-based software application, the cleared devices selected as Reference Devices are imaging devices which include ophthalmic image management and data analysis software. The Heidelberg Engineering SPECTRALIS HRA+OCT (K173648) and Topcon DRI OCT Triton (K173119) offer automatic segmentation of retinal layers and measurement features, but also a manual segmentation tool, similar to the one included in the Discovery platform. | RetinAl Discovery | OptosAdvance (K162039) Primary Predicate Device | Topcon DRI OCT Triton (K173119) Reference Device 1 | Heidelberg Engineering Spectralis (K173648) Reference Device 2 | | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device | OptosAdvance 4.0 is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, diagnostic data, clinical images and information, reports, videos, and measurement of DICOM-compliant images. | The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions. The DRI OCT Triton is indicated for in vivo viewing, axial cross sectional, and | The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for: • viewing the posterior segment of the eye, including two- and three-dimensional imaging • cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) • fundus imaging • fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, | {5}------------------------------------------------ {6}------------------------------------------------ | | | | | subjects • a reference database for retinal nerve fiber thickness and optic nerve head neuroretinal rim parameter measurements, which is used to quantitatively compare the retinal nerve fiber layer and neuroretinal rim in the human retina to values of normal subjects of different races and ethnicities representing the population mix of the USA (Glaucoma Module Premium Edition) | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | NFJ | Same | OBO, HKI | OBO, MYC | | User Population | Healthcare Professionals | Same | Same | Same | | Technological Characteristics | Standalone software | Same | OCT device used in combination with Triton data analysis software | OCT device used in combination with Heyex data analysis software | | Operating System | Browser-based | Same | Local installation of the software | Local installation of the software | | Data and Supported Formats | DICOM-compliant files from an ophthalmic device, such as Fundus photographs, Optical Coherence Tomography (OCT) scans | DICOM-compliant files from an ophthalmic device (Scanning Laser Ophthalmoscope, Fundus Camera, Optical Coherence Tomography unit, etc.) | Images acquired from the Topcon OCT device | Images acquired from the Spectralis OCT device and DICOM-compliant files from an ophthalmic device | {7}------------------------------------------------ | Supported Machines | DICOM-compliant devices | Integration with eyecare diagnostic devices via DICOM | Topcon | Spectralis and DICOM-compliant devices | |----------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Image Annotation and Measurement | Yes | Same | Data is automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC. It allows the user to manually adjust the automated retinal layer segmentation results and optic disc analysis results. | Data is automatically processed, segmentation of retinal layers and relative measurements are displayed in the interface through reports. It allows the user to manually adjust the automated retinal layer segmentation results | | Sharing | Share images with current layout with another user via shareable link | Same | Sharing is not available | Drag-and-drop export sharing | # Standards compliance Discovery complies with the following standards: | Standards | Standards organization | Standards title | |------------------------------------------------------|------------------------|----------------------------------------------------------------------| | PS 3.1 - 3.20 (2021e) | NEMA | Digital Imaging and Communications in Medicine (DICOM) Set | | 62304 Edition 1.1 2015-06 Consolidated version | AAMI / ANSI / IEC | Medical device software - Software life cycle processes | | 82304-1 Edition 1.0 2016-10 | AAMI / ANSI / IEC | Health software - Part 1: General requirements for product safety | {8}------------------------------------------------ | 14971:2019 | AAMI / ANSI / ISO | Medical Devices - Application of risk management to medical devices | |-------------------------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | 15223-1 Third Edition 2016-11-01 | AAMI / ANSI / ISO | Medical devices - Symbols to be used with medical devices labels, labeling and information to be supplied - Part 1: General requirements | Regarding the compliance to the PS 3.1 - 3.20 (2021e) standard, RetinAl Discovery supports reading of DICOM objects obtained from Media Storage and File Format for Data Interchange PS 3.10 files loaded from the local file system or from PS 3.12 compliant media according to one of the General Purpose Media Application Profiles of PS 3.11. ## Performance Data Discovery was designed, developed and tested according to the software development lifecycle process implemented at RetinAl Medical AG, based on the IEC 62304 and IEC 82304 standards, and the FDA Guidance for the "General Principles of Software Validation". Testing included verification and validation activities (static code analysis, unit and integration testing, system and functional testing). In addition, comparison testing was performed to demonstrate the equivalence of the manual segmentation and image measurement of retinal OCT scans in Discovery platform, in both "Optimized" and "Device" display modes, with the same images segmented in cleared devices, Heidelberg Engineering Spectralis HRA+OCT (K173648) and Topcon DRI OCT Triton (K173119). The results showed that the computed values from the Discovery platform are substantially equivalent to the computed values from the Reference Devices, for both Optimized and Device display modes. In all instances, Discovery functioned as intended and expected performance was reached. ### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in minor injury to the patient through incorrect or delayed information or through the action of a care provider. ### Conclusions The RetinAl Discovery performs in a manner that is substantially equivalent to the predicate device, OptosAdvance. The RetinAl Discovery has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the RetinAl Discovery and its predicate device do not raise different questions of safety or effectiveness. Thus, the RetinAl Discovery is substantially equivalent.