(201 days)
Not Found
No
The summary describes a PACS-like system for managing, displaying, and performing basic measurements on ophthalmic images. There is no mention of AI/ML algorithms for image analysis, diagnosis, or prediction. The focus is on data management and visualization tools.
No
The device is a software application for managing and displaying diagnostic ophthalmic images, not for treating any condition.
No.
The OptosAdvance 4.0 software application is described as 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. It processes and visualizes images and data that have already been acquired by diagnostic instruments, but it does not acquire the diagnostic data itself or perform the diagnostic function. It aids clinicians in their analysis of anatomy and pathology, rather than performing the diagnosis itself.
Yes
The device is described as a "standalone, browser-based software application" and its function is to manage, display, and analyze data from ophthalmic instruments. While it relies on external hardware (ophthalmic instruments) for data input, the device itself is solely the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- OptosAdvance 4.0 Function: The description clearly states that OptosAdvance 4.0 is a software application that imports, stores, manages, displays, analyzes, and measures data from ophthalmic diagnostic instruments. This data consists of images, reports, and videos generated by devices like Scanning Laser Ophthalmoscopes, Fundus Cameras, and Optical Coherence Tomography units.
- No Sample Analysis: The software does not interact with or analyze biological samples taken from a patient. It processes and visualizes data generated by other diagnostic devices that examine the eye.
In summary, OptosAdvance 4.0 is a medical image management and analysis software for ophthalmic data, not a device that performs tests on biological samples.
N/A
Intended Use / Indications for Use
OptosAdvance 4.0 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, videos, and measurement of DICOMcompliant images.
Product codes
NFJ
Device Description
The OA4 software application provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The OptosAdvance user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The key features of OptosAdvance 4.0 include the ability to:
- · Acquire, store, retrieve and display DICOM image data;
- · Access patient data securely:
- · Search patient studies and select images for closer examination:
- Interactively manipulate an image to visualize anatomy and pathology;
- · Select multiple images for comparison;
- · Annotate, tag and record selected views;
- · Measure distance (linear) and area of DICOM images;
- Manage, backup and archive data;
- · Import and export data to network storage devices;
- · Securely access and transfer data: and
- Output selected views to printers.
The software relies on images being provided to a specified network path on the OptosAdvance Server by the connected ophthalmic device (Scanning Laser Ophthalmoscope, Fundus Camera, Optical Coherence Tomography unit, etc.) in a DICOM-compliant format. The software will then place the image and associated data on the network storage unit in a format which will allow the image to be available via a securely connected web browser. Locally archived studies will be securely pushed to the remote archive server for storage. The archive in the remote secure server serves as disaster recovery storage as well as access to the patient history.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM-compliant images from ophthalmic diagnostic instruments (Scanning Laser Ophthalmoscope, Fundus Camera, Optical Coherence Tomography unit, etc.)
Anatomical Site
Not Found
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
Software testing was completed to ensure the new feature operates according to requirements and without impact to existing functionality. Testing included verification, validation, and evaluation of previously acquired medical images.
Equivalence tests were performed to verify that the OptosAdvance 4.0 software application provides equivalent measurements by loading DICOM objects that contain features with known dimensions, displaying these objects to the user, having the user measure these features, and comparing their measurement with the known dimensions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software testing (verification, validation, and evaluation of previously acquired medical images) was performed. Equivalence tests were performed to verify equivalent measurements. Clinical studies were not required. The testing demonstrated that the software's performance is equivalent to that of the legally marketed predicates.
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.
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads in profile, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2017
Optos Plc % Mr. Randy Prebula Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004
Re: K162039
Trade/Device Name: OptosAdvance 4.0 (OA4) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: December 29, 2016 Received: December 29, 2016
Dear Mr. Prebula:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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,
Denise L. Hampton -S
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
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510(k) Number (if known)
Device Name
OptosAdvance 4.0
Indications for Use (Describe)
OptosAdvance 4.0 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, videos, and measurement of DICOMcompliant images.
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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510(k) SUMMARY
Optos Plc's OptosAdvance 4.0 Software
In accordance with 21 CFR §807.92 the following summary of information is provided:
| SUBMITTER: | Optos Plc
Queensferry House
Carnegie Campus
Enterprise Way, Dunfermline
Fife, KY11 8GR,
United Kingdom
FDA Registration Number: 9671767 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:
Facsimile: | 011 44 1383 843300
011 44 1383 843333 |
| Primary Contact Person: | Paul Burns
Vice President, Regulatory Affairs & Quality Assurance
Optos Plc
Phone: +44 1383 843470
Email: pburns@optos.com |
| Secondary Contact Person: | Randy Prebula
U.S Agent
Hogan Lovells U.S. LLP
555 13th Street NW
Washington, DC 20004
U.S.A.
Phone: +1 202-637-6548
Facsimile: +1 202-637-5910
Email: randy.prebula@hoganlovells.com |
| Date Prepared: | July 22, 2016 |
| DEVICE: | |
| Trade Name: | OptosAdvance 4.0 (OA4) Software |
| Common or Usual Name: | Picture Archiving and Communication System (PACS) |
| Classification Name: | System, Image Management, Ophthalmic
(per 21 C.F.R. § 892.2050) |
| Device Classification: | Class II |
| Product Code: | NFJ |
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LEGALLY MARKETED PREDICATE DEVICES
Predicate Device Name: OptosAdvance Software 510(k) Number: K113696 Manufacturer: Optos Plc
Predicate Device Name: Synergy ODM 510(k) Number: K151952 Topcon Medical Systems, Inc Manufacturer:
INTENDED USE / INDICATIONS FOR USE
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, clinical images and information, reports, videos, and measurement of DICOM-compliant images.
DEVICE DESCRIPTION
The OA4 software application provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The OptosAdvance user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The key features of OptosAdvance 4.0 include the ability to:
- · Acquire, store, retrieve and display DICOM image data;
- · Access patient data securely:
- · Search patient studies and select images for closer examination:
- Interactively manipulate an image to visualize anatomy and pathology;
- · Select multiple images for comparison;
- · Annotate, tag and record selected views;
- · Measure distance (linear) and area of DICOM images;
- Manage, backup and archive data;
- · Import and export data to network storage devices;
- · Securely access and transfer data: and
- Output selected views to printers.
The software relies on images being provided to a specified network path on the OptosAdvance Server by the connected ophthalmic device (Scanning Laser Ophthalmoscope, Fundus Camera, Optical Coherence Tomography unit, etc.) in a DICOM-compliant format. The software will then place the image and associated data on the network storage unit in a format which will allow the image to be available via a securely connected web browser. Locally archived studies will be securely pushed to the remote archive server for storage. The archive in the remote secure server serves as disaster recovery storage as well as access to the patient history.
PERFORMANCE TESTING
OptosAdvance 4.0 is designed and tested according to the software development lifecycle process implemented at Optos Plc. Software testing was completed to ensure the new feature operates according to requirements and without impact to existing functionality. Testing included verification, validation, and evaluation of previously acquired medical images.
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For additional reassurance, equivalence tests were performed to verify that the OptosAdvance 4.0 software application provides equivalent measurements by loading DICOM objects that contain features with known dimensions, displaying these objects to the user, having the user measure these features, and comparing their measurement with the known dimensions.
Risk Management
Each risk pertaining to OptosAdvance 4.0 has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of no more than "Remote". All risks for the updated software feature were collectively reviewed to determine if the benefits outweigh the risk.
The proposed device has been designed and tested taking into account potential cybersecurity risks, to ensure confidentiality, integrity, availability and accountability.
Standards Compliance
| Standard No. | Standards organization | Standards Title |
|---|---|---|
| PS 3.1 - 3.20 (2014c) | NEMA | Digital Imaging and Communications in Medicine (DICOM) Set |
| 14971:2012 | AAMI / ANSI / ISO | Medical Devices – Applications of risk management to medical devices |
| 62304:2006 | AAMI / ANSI / IEC | Medical Device Software - Software life cycle processes |
| 62366-1 Edition 1.0 2015-02 | IEC | Medical Devices – Part 1: Application of usability engineering to medical devices |
The OptosAdvance 4.0 software complies with the following voluntary standards:
Clinical Data
OptosAdvance 4.0 is a PACS system that processes DICOM data. Therefore, any clinical comparison with a predicate that operates per the same DICOM standard will produce the same Thus, clinical studies are not required to support the subject device's safety and result. effectiveness; the non-clinical objective test methods used for evaluation demonstrate that the software's performance is equivalent to that of the legally marketed predicates. Nevertheless, the anticipated clinical equivalence was confirmed with a clinical case.
SUBSTANTIAL EQUIVALENCE
The proposed device is of the same type, common name, classification, and product code as the cleared predicate devices. The devices have the same intended use, and the indications for use of OptosAdvance 4.0 are very similar to the indications for use of the predicate software devices.
OptosAdvance 4.0 is also functionally equivalent to these devices. The proposed and predicate devices are all software-only image management systems with similar acquisition, importing, viewing, measurement and analysis, network and security, print, archive and backup functionalities. The minor technological differences between OptosAdvance 4.0 and its predicate devices raise no new issues of safety or effectiveness, as described below.
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The key difference between the predicate OptosAdvance software (K113696) and the new version of OptosAdvance is the introduction of features to measure distance (linear) and area of DICOM images. The predicate Synergy ODM device (K151952) provides such line and area measurement capabilities, so the inclusion of this feature in the subject software does not raise different questions of safety or effectiveness.
The devices also differ slightly in their approach to data management backup and archiving. While the cleared Synergy ODM uses locally installed customized software to allow the user to view images stored on the local or networked computer system, OptosAdvance 4.0 uses the computer system's web browser with no other software installation required to allow the user to view DICOMcompliant images stored on the server. The verification and validation testing for the subject software covered the comparison of images on custom software and the web client, which were found to display at the same resolution and clarity. OptosAdvance 4.0 also allows the user to connect to a remote secure server to allow greater archiving flexibility. The only minor difference to OptosAdvance 4.0 from Synergy ODM in this respect is that the user can set up an HTTPS connection to the remote server to transfer data to and from the archive, providing greater flexibility on storage. A similar mechanism exists in the Synergy ODM software, where data can be stored on an external network location and accessed externally. In order to do this remotely in the OptosAdvance 4.0 software, a secure protocol is introduced to protect data integrity.
CONCLUSION
OptosAdvance 4.0 has the same intended use and indications for use as the Optos predicate device (K113696), and has very similar principles of operation and technological characteristics as both predicate devices (K113696 and K151952). Any minor differences noted have been explained and do not raise any different questions of safety or effectiveness when the software is used as labelled. The implemented design controls, risk management activities, labelling, and performed tests (software verification & validation) demonstrate the safety and efficacy of the device in comparison to the predicates. Therefore, based on the comparison and test data, the OptosAdvance 4.0 software application is as safe and effective as, and substantially equivalent to, the predicate devices.