CONTINUUM PACS is a software system to store, manage and display patient data, diagnostic data, videos and images from computerized ophthalmic diagnostic imaging devices.

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 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.

AI/ML Overview

The provided document, K200385 for CONTINUUM PACS, is a 510(k) summary for an ophthalmic image management system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel safety and effectiveness through extensive clinical trials or performance metrics against strict acceptance criteria.

Therefore, many of the requested details, such as specific acceptance criteria for a device's performance, the sample size of a test set, the number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and the sample size/ground truth for a training set, are NOT PRESENT in this document because they are typically not required for a 510(k) submission of this nature. The document explicitly states "Clinical Performance Data: None required or submitted."

The document focuses on comparing the new device (CONTINUUM PACS) to a predicate device (Sonomed, Inc. AXIS Image Management System K171098). The acceptance criteria, in this context, are primarily centered around demonstrating functional equivalence and no new safety or effectiveness concerns compared to the predicate.

Here's a breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a quantitative table of acceptance criteria and performance metrics in the way one would expect for an AI/ML device or a device requiring specific performance thresholds. Instead, the "acceptance criteria" are implied by the comparison to the predicate device, demonstrating functional parity and compliance with industry standards.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (for CONTINUUM PACS)
Software-only system	Yes	Yes
Patient database	Yes	Yes
Imaging review capability	Yes	Yes
Image annotation and measurement capability	Yes	Yes
Browser-based application	Yes	Yes
Secure login	Yes	Yes
Interface with electronic medical records (EMR)	Yes	Yes
Connects to imaging instruments via DICOM and non-DICOM methods	Yes	Yes
Intended Use	Store, manage, display patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.	Stores, manages, and displays patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.
Compliance	DICOM compliant	DICOM compliant (as specified in its DICOM Conformance Statement).
Performance as intended	Performs as intended	Performance testing during software V&V found to perform as intended.
Safety & Effectiveness	As safe, effective, and performs as well as or better than the predicate.	Demonstrated to be as safe, effective, and performs as well as or better than the predicate device.

The key difference highlighted is the User Interface design (HTML5 for CONTINUUM PACS vs. Silverlight for AXIS Image Management), which is stated to be a "minor difference" and does not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document states "Performance testing was performed on CONTINUUM PACS during software verification and validation." This implies internal testing against defined requirements, but not a specific "test set" in the context of clinical or AI performance evaluation with a defined sample size of cases.
Data Provenance: Not specified. As there are no clinical studies, no patient data or images were used for performance evaluation in the context of this submission beyond general software functionality testing.
Retrospective/Prospective: Not applicable, as no clinical study or test set of patient data was used in the described manner.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. No clinical test set requiring expert-established ground truth was part of this 510(k) summary.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. No clinical test set requiring adjudication was part of this 510(k) summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

MRMC Study: No. The document explicitly states "Clinical Performance Data: None required or submitted."
Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as no MRMC study or AI assistance component is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: No. This device is a PACS system, not an AI algorithm. Its function is to store, manage, and display data for human review, not to provide diagnostic output itself.

7. The type of ground truth used:

Type of Ground Truth: For the software functionality testing, the "ground truth" would be the expected behavior of the system based on design specifications and industry standards (e.g., DICOM conformance). No "clinical ground truth" (like pathology or outcomes data) was used or required for this type of submission.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device is a PACS system and does not involve AI/ML models that require a training set.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML model, no ground truth needed to be established in this context.

Summary

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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 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.

Regulation Number and Section

§ 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).