(161 days)
Not Found
No
The description explicitly states the software "does not automatically highlight, annotate, or otherwise alter the images," indicating a lack of automated analysis or interpretation typically associated with AI/ML in image processing. The functions described are primarily storage, management, display, and manual annotation.
No.
The device is described as software for storing, managing, and displaying patient data, diagnostic data, videos, and images, and does not mention any therapeutic function or action.
No
The device is described as a web-based software application for storing, managing, and displaying patient data, including diagnostic data, images, and videos from other computerized diagnostic instruments. It is explicitly stated that the software does not automatically highlight, annotate, or otherwise alter the images, suggesting it is a data management and viewing tool rather than a diagnostic tool itself.
Yes
The device is described as a "web-based software system application" and its function is to store, manage, and display data and images. While it interfaces with hardware (diagnostic cameras and a server), the device itself, as described in the summary, is the software application. The summary explicitly states it does not require customized software on the client PC and the images, annotations, and DICOM data are stored on the server, which handles the data management. The description focuses solely on the software's functionality.
Based on the provided information, the Optos Advance Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Optos Advance Software Function: The software's intended use is to store, manage, and display patient data, diagnostic data, videos, and images from computerized diagnostic instruments or video documentation systems. It's primarily an image review and management system.
- Input Modalities: The input modalities are imaging devices like Scanning Laser Ophthalmoscopes, Fundus Cameras, and OCTs. These devices capture images of the eye, which are then managed by the software. This is distinct from analyzing biological specimens.
- No Specimen Analysis: The description does not mention the software analyzing any biological specimens. Its function is centered around handling and displaying images and associated data.
Therefore, the Optos Advance Software falls under the category of medical image management and review software, not an IVD.
N/A
Intended Use / Indications for Use
The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.
The Optos Advance Software is an image review application that allows the user to view DICOM compatible images. The Optos Advance Software organizes the digitized images into studies and sessions. The digitized studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between old and new images). The software also allows physicians or technicians to create on-line notes with the ability to zoom in or out (i.e., enlarge or decrease magnification of images) and annotate such images with arrows or text boxes to highlight areas the user determines by training and experience to be of interest. The Optos Advance Software does not automatically highlight, annotate, or otherwise alter the images. In addition, the digitized studies and sessions and on-line notes may be viewed, archived on a central file server, or electronically shared in a secure manner with other health care professionals.
The Optos Advance Software allows the user to interface a Scanning Laser Ophthalmoscope, Fundus Camera, OCT or other DICOM compliant diagnostic camera with the Optos Advanced Software via a secure network connection to the Optos Advance Server. The server has a watchdog service which processes the DICOM information sent via the network. The information is then processed and placed in local storage on the Optos Advance Server. The data is obfuscated at the server side to protect any patient information transferred.
The Optos Advance Software does not require any customized software installed on the client PC. The images, annotations and DICOM data are all stored on the Optos Advance Server, which handles the archiving, reporting, and retrieval of the data. This server can be set up remotely over an HTTPS connection which allows secure remote transfer of the stored data for archive purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanning Laser Ophthalmoscope, Fundus Camera, OCT or other DICOM compliant diagnostic camera
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians or technicians
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
A full software and system verification and validation was performed as per the Software Development Lifecycle Process in Optos PLC.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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).
0
MAY 2 5 2012
510(k) SUMMARY
Optos' Optos Advance Software
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Sponsor: | Optos plc |
|---|---|
| Queensferry House | |
| Carnegie Business Campus | |
| Dunfermline | |
| Fife KY11 8GR | |
| United Kingdom |
Phone: 01144 1383 843300 Fax: 01144 1383 843333
Contact Person: Graham McLeod MSc.
Date Prepared: 16 December 2011
Name of Device: Optos Advance
Picture Archiving and Communications System Common Name:
Picture Archiving and Communications System Classification: (per 21 C.F.R. § 892.2050)
NFJ Product Code:
System, Image Management, Ophthalmic Device Device:
Carl Zeiss Surgical GmbH FORUM Software (K090439) Predicate Device:
Indications for use
The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.
Technological Characteristics
The Optos Advance Software is an image review application that allows the user to view DICOM compatible images. The Optos Advance Software organizes the digitized images into studies and sessions. The digitized studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between old and new images). The software also allows
1
physicians or technicians to create on-line notes with the ability to zoom in or out (i.e., enlarge or decrease magnification of images) and annotate such images with arrows or text boxes to highlight areas the user determines by training and experience to be of interest. The Optos Advance Software does not automatically highlight, annotate, or otherwise alter the images. In addition, the digitized studies and sessions and on-line notes may be viewed, archived on a central file server, or electronically shared in a secure manner with other health care professionals.
The Optos Advance Software allows the user to interface a Scanning Laser Ophthalmoscope, Fundus Camera, OCT or other DICOM compliant diagnostic camera with the Optos Advanced Software via a secure network connection to the Optos Advance Server. The server has a watchdog service which processes the DICOM information sent via the network. The information is then processed and placed in local storage on the Optos Advance Server. The data is obfuscated at the server side to protect any patient information transferred.
The Optos Advance Software does not require any customized software installed on the client PC. The images, annotations and DICOM data are all stored on the Optos Advance Server, which handles the archiving, reporting, and retrieval of the data. This server can be set up remotely over an HTTPS connection which allows secure remote transfer of the stored data for archive purposes.
Performance Testing
A full software and system verification and validation was performed as per the Software Development Lifecycle Process in Optos PLC.
Substantial Equivalence
The Optos Advance Software has the same intended use and substantially similar indications for use as the cleared Carl Zeiss Surgical GmbH FORUM Software (K090439). Minor differences in technological characteristics allow the user to access the software from any web enabled browser without the need for any customizable software installed on their personal computer and to archive their data to a remote server for retrieval over an HTTPS protocol driven server. Both Optos Advance and FORUM Software are intended for the review, storage and retrieval of images and image data supplied by ophthalmic medical devices. Thus, the minor differences between the Optos Advance Software and its predicate device raise no new questions of safety and effectiveness and the Optos Advance is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Optos Plc c/o Mr. Howard M. Holstein, Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington DC 20004
MAY 2 5 2012
Re: K113696
Trade/Device Name: Optos Advance Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: May 8, 2012 Received: May 8, 2012
Dear Mr. Holstein:
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 that I Dr has Intatutes and regulations administered by other Federal agencies. You must or uny I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of K F ar 807), acomig (21 CFR 803); good manufacturing practice requirements as set de rico-related adverse overies) (2 - Salation (21 CFR Part 820); and if applicable, the electronic
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Page 2 - Mr. Howard M. Holstein
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
K 113696
Device Name: Optos Advance Software
Indications for Use:
The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.
Prescription Use _ > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sem
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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510(k) Number_
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