CONTINUUM PACS

K200385 · Integrated Ophthalmic Systems, Inc. · NFJ · Mar 16, 2020 · Radiology

Device Facts

• Record ID: K200385
• Device Name: CONTINUUM PACS
• Applicant: Integrated Ophthalmic Systems, Inc.
• Product Code: NFJ · Radiology
• Decision Date: Mar 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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

Device Story

CONTINUUM PACS is a browser-based ophthalmic image management system; stores, retrieves, and displays patient data, reports, videos, and images generated by ophthalmic diagnostic imaging devices. Operates on user's network infrastructure; utilizes a central database for patient information and historical exams. Inputs include data via DICOM, JPEG, PDF, WMV, and AVI formats. Clinicians access the system via standard web browsers to review images, perform annotations, and conduct measurements. Facilitates comparison of multiple images; supports remote access via web connectivity. Integrates with electronic medical records (EMR). Benefits include centralized data management and efficient clinical review of ophthalmic diagnostic information.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical software verification and validation testing, confirming performance as intended and DICOM compliance.

Technological Characteristics

Software-only ophthalmic image management system. Browser-based (HTML5 interface). Operates on existing network infrastructure (server/client). Supports DICOM, JPEG, PDF, WMV, AVI. Features include central database, secure login, image annotation, measurement tools, and EMR integration.

Indications for Use

Indicated for use by clinicians to store, manage, and display patient data, diagnostic data, videos, and images acquired from computerized ophthalmic diagnostic imaging devices.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Sonomed, Inc. AXIS Image Management System (K171098)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

#### Contact Person

Matthew Carnevale President and CEO 877-263-0003 [e-mail]

# 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.