(329 days)
No
The description focuses on manual segmentation, measurement, and display of data, with no mention of automated analysis or algorithms that would typically involve AI/ML. The performance study compares manual segmentation to predicate devices.
No
The device is described as a software application that assists healthcare professionals in making decisions on diagnosis and monitoring disease progression by analyzing and managing diagnostic data. It does not directly provide therapy.
Yes
The 'Intended Use / Indications for Use' states that the software imports data from "ophthalmic diagnostic instruments" and is intended to "assist the user in making decisions on diagnosis and monitoring of disease progression."
Yes
The device is described as a "standalone, browser-based software application" and its description focuses entirely on software functionalities for image processing, analysis, and measurement. There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The RetinAl Discovery software processes and analyzes images and data from ophthalmic diagnostic instruments. It does not perform tests on biological samples taken from the patient. Its function is to assist healthcare professionals in interpreting existing diagnostic information.
- Intended Use: The intended use clearly states it's for importing, storing, managing, displaying, analyzing, and measuring data from ophthalmic diagnostic instruments, and for manual labeling and annotation of retinal OCT scans. This is focused on image and data manipulation, not laboratory testing of biological samples.
Therefore, while it's a medical device used in the diagnostic process, it falls under the category of image analysis and management software, not an in vitro diagnostic device.
N/A
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.
Product codes
NFJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fundus photographs, Optical Coherence Tomography (OCT) scans
Anatomical Site
Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare Professionals
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optos PLC's OptosAdvance (K162039)
Reference Device(s)
Topcon DRI OCT Triton (K173119), Heidelberg Engineering Spectralis (K173648)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
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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.