(27 days)
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No
The summary describes a standard PACS system for image storage and retrieval, with no mention of AI/ML features or performance metrics typically associated with such technologies.
No
The device is described as an image management system (PACS) for storing, retrieving, and reviewing ophthalmic data, not for treating or diagnosing patients. Its function is to manage data generated by other diagnostic imaging devices.
No
The device is an image management system designed to store, retrieve, and display data and images from diagnostic devices, but it does not perform diagnostic functions itself.
Yes
The device description explicitly states "CONTINUUM PACS is a software system" and "an ophthalmic image management system" that is "installed on the user's server" and accessed via "existing browser software." There is no mention of proprietary hardware components included with the device.
Based on the provided information, CONTINUUM PACS is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CONTINUUM PACS is a software system designed to store, manage, and display images and data from ophthalmic diagnostic imaging devices. It deals with images and data generated by diagnostic devices, not with analyzing biological specimens directly.
The intended use and device description clearly indicate its function is as an image management system for ophthalmic images, not for performing tests on biological samples.
N/A
Intended Use / Indications for Use
CONTINUUM PACS is a software system to store, manage and display patient data, diagnostic data, videos and images from computerized ophthalmic diagnostic imaging devices.
Product codes (comma separated list FDA assigned to the subject device)
NFJ
Device Description
CONTINUUM PACS is an ophthalmic image management system that has been designed to store, retrieve and provide browser-based review of reports, videos and images which were generated by ophthalmic imaging devices.
CONTINUUM PACS and the predicate device both are software systems designed to operate on the user's network, which may consist of a server, computers and network infrastructure.
CONTINUUM PACS has a central database for patient information and historical exams. CONTINNUM PACS is installed on the user's server and communicate with the networked imaging devices. The users review images, reports, and videos via their existing browser software.
Images can be obtained from diagnostic devices using numerous industry standards, including DICOM, JPEG, PDF, WMV, AVI.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed on CONTINUUM PACS during software verification and validation and was found to perform as intended. CONTINUUM PACS is DICOM compliant, as specified in its DICOM Conformance Statement. There is no stated shelf-life, as CONTINUUM PACS is a software-only device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/0 description: The image shows 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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2020
Integrated Ophthalmic Systems, Inc. % Anna Reifschneider Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 444 Ludlum, Florida 33155-3708
Re: K200385
Trade/Device Name: Continuum PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: February 17, 2020 Received: February 18, 2020
Dear Ms. Reifschneider:
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
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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 Ng Acting 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
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Indications for Use
510(k) Number (if known) K200385
Device Name CONTINUUM PACS
Indications for Use (Describe)
CONTINUUM PACS is a software system to store, manage and display patient data, diagnostic data, videos and images from computerized ophthalmic diagnostic imaging devices
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submitted By
Integrated Ophthalmic Systems, Inc. 596 Main Street Woburn, MA 01845 Tel: 877-263-0003 Fax: 978-824-9308
Contact Person
Matthew Carnevale President and CEO 877-263-0003 mcarnevale@integratedophthalmic.com
Date Prepared
December 23, 2019
Submission Type
Traditional 510(k)
Trade Name
CONTINUUM PACS
Common Name
Ophthalmic Image Management System
Classification Name
System, Image Management, Ophthalmic CFR Number: 21 CFR 892.2050 Product Code: NFJ Class II
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Indications for Use
CONTINUUM PACS is a software system to store, manage and display patient data, diagnostic data, videos and images from computerized ophthalmic diagnostic imaging devices.
Predicate Device
Sonomed, Inc. AXIS Image Management System K171098 CFR Number: 21 CFR 892.2050 Product Code: NFJ
Description of the Device
CONTINUUM PACS is an ophthalmic image management system that has been designed to store, retrieve and provide browser-based review of reports, videos and images which were generated by ophthalmic imaging devices.
CONTINUUM PACS and the predicate device both are software systems designed to operate on the user's network, which may consist of a server, computers and network infrastructure.
CONTINUUM PACS has a central database for patient information and historical exams. CONTINNUM PACS is installed on the user's server and communicate with the networked imaging devices. The users review images, reports, and videos via their existing browser software.
Images can be obtained from diagnostic devices using numerous industry standards, including DICOM, JPEG, PDF, WMV, AVI.
Comparison to Predicate Device
CONTINNUM PACS and the AXIS Image Management System predicate device are the same in terms of intended use, performance and technological characteristics and is therefore substantially equivalent to the Axis Image Management System. The intended use of both devices is the same in that they are both intended to store, manage and display patient data from ophthalmic diagnostic imaging devices.
Both systems have a central database for storing patient data and store diagnostic images, such as retinal images and images from other ophthalmic diagnostic devices that are transferred by network connection.
CONTINUUM PACS and the predicate device are both software systems that function on the user's network infrastructure, which may include a server, computers and network infrastructure.
CONTINUUM PACS and the predicate device provide the ability for the user to search the database for patients and their respective images and to display multiple images for comparison. Both devices can be used to access the data from remote locations with web access. CONTINUUM PACS and the predicate device serve the same clinical purpose and provide the same functionality.
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| Characteristic | CONTINUUM PACS | AXIS Image Management |
|---|---|---|
| Software-only system | Yes | Yes |
| Patient database | Yes | Yes |
| Imaging review capability | Yes | Yes |
| Image annotation and | Yes | Yes |
| measurement capability | ||
| Browser-based application | Yes | Yes |
| User interface design | HTML5 | Silverlight |
| Secure login | Yes | Yes |
| Interface with electronic | Yes | Yes |
| medical records (EMR) | ||
| Connects to imaging | Yes | Yes |
| instruments vis DICOM and | ||
| non-DICOM methods |
The following table provides a comparison of the technological characteristics to the predicate device:
The only minor difference in technology between the 2 products is the user interface design in the AXIS Image Management System was developed in Silverlight, and in the CONTINUUM PACS the user interface was developed in HTML5.
Evaluation performed on CONTINUUM supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate device, and does not raise any new questions regarding safety and effectiveness.
Non-Clinical Performance Data
Performance testing was performed on CONTINUUM PACS during software verification and validation and was found to perform as intended. CONTINUUM PACS is DICOM compliant, as specified in its DICOM Conformance Statement. There is no stated shelf-life, as CONTINUUM PACS is a software-only device.
Conclusions from Non-Clinical Data
Based upon the results of the data as summarized above, CONTINUUM PACS has demonstrated that it is as safe, effective and performs as well as or better than the predicate device. Furthermore, based on the comparison with the predicate device as shown in the summary above, CONTINUUM PACS is deemed to be substantially equivalent to the predicate device.
Clinical Performance Data
None required or submitted.