(18 days)
No
The device description explicitly states, "The software does not use artificial intelligence or machine learning algorithms."
No.
The device is described as a software application intended to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, with explicit statements that "The Subject device neither performs any diagnosis, nor provides treatment recommendations" and "It is solely intended to be used as a support tool by trained healthcare professionals." This indicates it is a diagnostic support tool, not a therapeutic device.
No
The device is a software application that imports, stores, manages, displays, analyzes, and measures data from ophthalmic diagnostic instruments. It is explicitly stated that "The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals." This indicates its role as a data management and analysis tool, not a diagnostic device itself.
Yes
The device is described as a "standalone, browser-based software application" and a "cloud-based software program." It manages and displays data from ophthalmic instruments but does not include or require any specific hardware components beyond a standard internet browser and connection. The description focuses entirely on the software's functions and architecture.
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 Altris IMS is a software application that processes and manages images from ophthalmic diagnostic instruments. It does not analyze biological samples from the patient's body.
- Intended Use: The intended use clearly states it's for importing, storing, managing, displaying, and measuring data from ophthalmic diagnostic instruments, including images. It also allows for manual labeling and annotation of retinal OCT scans. This is focused on image analysis and management, not analysis of biological samples.
- Device Description: The description reinforces that it's a cloud-based software program to assist healthcare professionals with OCT interpretation and image management. It focuses on image manipulation, measurement, and progression tracking.
- Input: The input is DICOM-compliant files from ophthalmic devices, which are image files, not biological samples.
While the device is used in a clinical setting and provides information to healthcare professionals for diagnosis, it does so by processing and presenting image data, not by performing tests on biological samples. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, 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 (comma separated list FDA assigned to the subject device)
NFJ
Device Description
Altris IMS is a cloud-based software program to assist healthcare professionals, specifically Eye Care Practitioners (ECPs) with OCT interpretation. Altris IMS utilizes commonly available internet browsers to locally manage and review data which is uploaded to an Amazon AWS cloud-based server. Its intended use is 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 platform allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances. The platform supports DICOM format files.
Altris IMS is focused on the center sector of the retina. Altris IMS does not perform optic nerve analysis. Altris IMS has tools for manual area of interest image segmentation and labeling/annotation for healthcare professionals to use and review for their own diagnosis.
The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals. The software does not use artificial intelligence or machine learning algorithms.
The Subject device is a client-server model. It utilizes a local user/client internet browser-based (frontend) interface used to upload, manage, annotate, and review imaging data. Data is stored and processed on a remote web-based server (backend).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The software does not use artificial intelligence or machine learning algorithms.
Input Imaging Modality
Scanning Laser Ophthalmoscope, Fundus photographs, Optical Coherence Tomography unit
Anatomical Site
retina, ocular anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Eye Care Practitioners (ECPs)
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)
Due to the difficulty in evaluating this type of software, no direct performance bench testing of software to an established standard was performed.
The following non-clinical performance tests were performed to assist in establishing similarity with the Predicate device and suitability for intended use:
- Software Verification
- Software Validation
- Comparative Software measurement study with the K170164 Reference device.
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
July 31, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Altris, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K232088
Trade/Device Name: Altris IMS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: NFJ Dated: July 13, 2023 Received: July 13, 2023
Dear Prithul Bom:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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 Y. Ng -S
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) K232088
Device Name Altris IMS
Indications for Use (Describe)
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, 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.
| 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 Altris, Inc Altris IMS 7/12/2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Altris, Inc.
125 South Clark Street
17th Floor
Chicago, Illinois 60603 | Regulatory Consultant: | Aclivi, LLC
3250 Brackley Drive
Ann Arbor, MI 48105 |
|----------------------------|---------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------|
| Telephone: | +1 773 382 8709 | | +1 (810) 360-9773 |
| Official Contact
Email: | Andrey Kuropyatnyk, Director
andrey@altris.ai | | Chris Brown, Manager
acliviconsulting@gmail.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Altris IMS |
|---|---|
| Classification Name: | System, Image Management, Ophthalmic |
| Classification Regulations: | 21 CFR 892.2050 |
| Device Class: | Class II |
| Product Code: | NFJ |
| Review Panel: | Ophthalmic |
PREDICATE DEVICE INFORMATION
The Subject device is highly similar in Indications for Use, and technological/design principles to the following legally marketed Predicate device:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K211715 | RetinAl Discovery | RetinAl Medical AG |
| 510(k) | Reference Device Name | Company Name |
|---|---|---|
| K170164 | 3D OCT-1 Maestro | Topcon Corporation |
DEVICE DESCRIPTION
Altris IMS is a cloud-based software program to assist healthcare professionals, specifically Eye Care Practitioners (ECPs) with OCT interpretation. Altris IMS utilizes commonly available internet browsers to locally manage and review data which is uploaded to an Amazon AWS cloud-based server. Its intended use is 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 platform allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances. The platform supports DICOM format files.
4
Altris IMS is focused on the center sector of the retina. Altris IMS does not perform optic nerve analysis. Altris IMS has tools for manual area of interest image segmentation and labeling/annotation for healthcare professionals to use and review for their own diagnosis.
The Subject device neither performs any diagnosis, nor provides treatment recommendations. It is solely intended to be used as a support tool by trained healthcare professionals. The software does not use artificial intelligence or machine learning algorithms.
The Subject device is a client-server model. It utilizes a local user/client internet browser-based (frontend) interface used to upload, manage, annotate, and review imaging data. Data is stored and processed on a remote web-based server (backend).
INDICATIONS FOR USE
The Altris IMS is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, 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.
EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The Comparison tables below compare Indications for Use and Technological Characteristics of the Subject device and Predicate device.
| Device | Indications for Use Statement |
|---|---|
| Subject Device | |
| Altris IMS | |
| Altris, Inc. | The Altris IMS 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. | |
| Predicate Device | |
| RetinAl Discovery | |
| RetinAl Medical AG | |
| K211715 | 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. | |
| Reference Device | |
| 3D OCT-1 Maestro | |
| Topcon Corporation | |
| K170164 | The 3D OCT-1 Maestro with new line CCD has the following intended use and indications for use: |
| The Topcon 3D OCT-1 Maestro 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 3D OCT-1 Maestro is indicated for in vivo viewing, axial cross sectional, and three-dimensional | |
| imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula | |
| and optic disc as well as imaging of anterior ocular structures. | |
| It also includes a Reference Database for posterior ocular measurements which provide for the | |
| quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina | |
| to a database of known normal subjects. The 3D OCT-1 Maestro is indicated for use as a diagnostic device | |
| to aid in the diagnosis, documentation and management of ocular health and diseases in the adult | |
| population. |
Indications for Use Statement (IFUS)
The wording of the Indications for Use Statement (IFUS) of the Subject device is highly similar to that of the Predicate device, differing only in device name. This does not change the intended use of the devices to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments.
The wording of the Indications for Use Statement (IFUS) of the Subject device is similar to that of the Reference device. The Reference device includes imaging equipment and additional imaging measurement and comparison
5
features. This does not change the fundamental intended use of the devices to store, manage, display, analyze and measure data from ophthalmic diagnostic instruments.
| Technological Characteristics | |||
|---|---|---|---|
| Parameter | Subject Device | ||
| Altris IMS | |||
| Altris, Inc. | Predicate Device | ||
| RetinAl Discovery | |||
| RetinAl Medical AG | |||
| K211715 | Reference Device | ||
| 3D OCT-1 Maestro | |||
| Topcon Corporation | |||
| K170164 | |||
| Reason for Predicate | n/a | Ophthalmic software to import, store, | |
| manage, display, analyze and measure | |||
| data from ophthalmic diagnostic | |||
| instruments | Measurement comparison | ||
| Device | System, image management, | ||
| ophthalmic | System, image management, | ||
| ophthalmic | Tomography, Optical Coherence | ||
| Trade Name | Altris IMS | RetinAl Discovery | 3D OCT-1 Maestro |
| Regulation # | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 886.1570 |
| Regulation Name | Medical Image Management and | ||
| Processing System | Medical Image Management and | ||
| Processing System | Ophthalmoscope | ||
| Product Code | NFJ | NFJ | OBO |
| Classification | Class II | Class II | Class II |
| User Population | Trained medical professionals | Trained medical professionals | Trained medical professionals |
| Device Type | Software only | Software only | Imaging system with |
| storage/management software | |||
| Operating System | Internet Web Browser-based | ||
| • Google Chrome: Version v.88 and later | |||
| • Mozilla Firefox: Version v.89 and later | |||
| • Opera: Version v.74 and later | |||
| • Apple Safari: Version v.15 and later | Internet Web Browser-based | ||
| • Browsers and versions not specified | PC-based with dedicated software | ||
| • Operating system not specified | |||
| Data and Supported | |||
| Formats | DICOM-compliant files from an | ||
| ophthalmic device (Scanning Laser | |||
| Ophthalmoscope, Fundus photographs, | |||
| Optical Coherence Tomography unit, | |||
| etc.) | DICOM-compliant files from an | ||
| ophthalmic device (Scanning Laser | |||
| Ophthalmoscope, Fundus photographs, | |||
| Optical Coherence Tomography unit, | |||
| etc.) | DICOM-compliant files (based on | ||
| device labeling) and different types of | |||
| scans and photography protocols | |||
| Supported Machines | DICOM-compliant devices | DICOM-compliant devices | DICOM-compliant devices |
| Image Annotation and | |||
| Measurement | Yes | Yes | Yes |
| Sharing | Share images with current layout with | ||
| another user via shareable link | Share images with current layout with | ||
| another user via shareable link | Not defined in device labeling | ||
| Biocompatible | n/a | n/a | n/a |
| Sterility | n/a | n/a | n/a |
| OTC or Rx | Rx | Rx | Rx |
The Subject and Predicate devices are highly similar standalone browser-based software devices intended to display, and annotate previously acquired images of the eye in order to streamline review of such images by healthcare professionals. Neither the Subject or Predicate devices are used to offer capture components or are used directly to acquire images. The Subject device can be used on a variety of web browsers (i.e., Google Chrome, Mozilla Firefox, Opera, Apple Safari). The Predicate device also operates with an internet web browser interface but has not provided specific browser and version information in public facing documents. Internet web browsers are ubiquitous and regularly updated, so use of a specific browser or browser version number does not impact evaluation of device similarities as the browser is simply the interface to the Subject device and numerous options exist for users. Therefore, the Subject and Predicate are highly similar in the use of a web-browser interface. The Subject and Predicate device feature highly similar capabilities of manual measurement and annotation of OCT imaging.
The K170164 Reference device does not share the same regulation or product code as the Subject device as it is a combined imaging and image management device with the imaging device as the primary product code. Both the Subject and Reference devices are operated from a computer, but the Reference device has a dedicated software program rather than a web-browser based interface. Both the Subject and Reference devices support image annotation and measurement from DICOM-compliant imaging systems and both work with a variety of photography formats. Differences between the Subject and K170164 Reference device software formats do not change the intended uses to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments. The Reference device is included in support of comparative
6
measurement validation of the Subject device. The use of Predicate device as a standalone, web-browserbased program supports the Subject device web-browser-based program configuration.
Software validation and verification and validation were used to demonstrate the Subject device performs as intended similarly to the Predicate device.
PERFORMANCE DATA
Due to the difficulty in evaluating this type of software, no direct performance bench testing of software to an established standard was performed.
The following non-clinical performance tests were performed to assist in establishing similarity with the Predicate device and suitability for intended use:
- Software Verification
- . Software Validation
- Comparative Software measurement study with the K170164 Reference device.
CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices is highly similar.
Overall, the Technological Characteristics of the Subject device are highly similar to the Predicate device.
The conclusions drawn from the nonclinical tests demonstrate that the proposed Subject device is as safe, as effective, and performs as well as the legally marketed Predicate device, according to 807.92(b)(3).
Overall, the Altris IMS software is substantially equivalent to the Predicate device.