K Number
K171098
Device Name
AXIS Image Management System
Manufacturer
Date Cleared
2017-05-02

(19 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.
Device Description
AXIS Image Management System is a browser-based ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices. AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices. AXIS Image Management System provides a central database of patient information and exam image history. The AXIS software resides on a server provided by the user and interfaces with networked imaging instruments. Users utilize their existing browser to access the AXIS software to review images, videos, and reports. Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.
More Information

Not Found

No
The description focuses on data storage, retrieval, and display, with no mention of AI/ML terms or functionalities like image processing or analysis using such techniques.

No
The device is described as an image management system for storage, retrieval, and review of ophthalmic images and data, which is a supportive function rather than directly treating or diagnosing a condition.

No

The device is described as an "Image Management System" for storing, retrieving, and reviewing images, videos, and reports from ophthalmic imaging devices. It does not perform diagnostic functions itself but rather manages data from "computerized ophthalmic diagnostic imaging devices."

Yes

The device is described as a "browser-based ophthalmic image management system" and a "software system" that resides on a user-provided server and is accessed via a browser. It manages and displays data from existing ophthalmic imaging devices, without performing image processing or including any proprietary hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices." This describes a system for handling and presenting data that has already been generated by a diagnostic device.
  • Device Description: The description reinforces this by stating it's an "ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices." It acts as a repository and viewing platform for existing diagnostic data.
  • Lack of Diagnostic Function: The device does not perform any tests on biological samples (in vitro) to provide diagnostic information itself. It doesn't analyze blood, tissue, or other bodily fluids. It simply manages and displays the output of other diagnostic devices.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely data management and display, not the generation of diagnostic results from biological samples.

N/A

Intended Use / Indications for Use

Storage, management, and display of 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

AXIS Image Management System is a browser-based ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices.

AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.

AXIS Image Management System provides a central database of patient information and exam image history. The AXIS software resides on a server provided by the user and interfaces with networked imaging instruments. Users utilize their existing browser to access the AXIS software to review images, videos, and reports.

Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted on AXIS Image Management System as part of the software verification and validation and was found to perform as intended. AXIS is DICOM-compliant as stipulated in its DICOM Conformity Statement. There is no stated shelf-life since AXIS is a software device only.

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.

K090439

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2017

Sonomed. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K171098

Trade/Device Name: AXIS Image Management System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: April 11, 2017 Received: April 13, 2017

Dear Mr. Mark Job:

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.

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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 forth in the quality systems (QS) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171098

Device Name

AXIS Image Management System

Indications for Use (Describe)

Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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Section 1: 510(k) Summary

Submitted By

Sonomed, Inc. 1979 Marcus Avenue C105 Lake Success, NY 11042 Tel: 516-354-0900 Fax: 516-354-5902

Establishment Registration Number

2433682

Contact Person

Mark Wallace Chief Operating Officer 414-745-7870 mwallace@escalonmed.com

Date Prepared

August 9, 2016

Submission Type

Traditional 510(k)

Trade Name

AXIS Image Management System

Common Name

System, Image Management, Ophthalmic

Classification Name

Picture Archiving and Communications Systems

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CFR Number: 892.2050 Product Code: NFJ

Intended Use

Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.

Legally-Marketed Equivalent Devices

Carl Zeiss Surgical GmbH FORUM (K090439)

Description of the Device

AXIS Image Management System is a browser-based ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices.

AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.

AXIS Image Management System provides a central database of patient information and exam image history. The AXIS software resides on a server provided by the user and interfaces with networked imaging instruments. Users utilize their existing browser to access the AXIS software to review images, videos, and reports.

Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.

Comparison to Predicate Device

It is the opinion of Sonomed, Inc. that AXIS Image Management System is substantially equivalent to the predicate device, FORUM from Carl Zeiss Surgical GmbH (K090439), as they share similar fundamental technological characteristics. Both systems are comprised of a central database to store diagnostic documents (such as retinal images from other ophthalmic diagnostic devices). These documents are imported from the diagnostic devices via a networked connection.

Both AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.

Both AXIS Image Management System and the predicate device allow a user to search the database for patients and their respective documents and to display multiple documents for comparison

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purposes. In both cases, the software can be used to access the database from a remote location via web-based access.

AXIS Image Management System and the predicate device serve the same principal purpose of clinical usage and provide a wide range of comparable functionality; the table below provides a comparison of technological characteristics with the predicate device.

CharacteristicAXISFORUM (K090439)
Software-only systemYesYes
Patient databaseYesYes
Imaging review capabilityYesYes
Image annotation and
measurement capabilityYesYes
ApplicationBrowser on reviewing device
accesses server (no special
software installed on reviewing
device)Client software installed on
reviewing device, which
accesses server
Secure LoginYesYes
Interface with electronic
medical records (EMR)YesYes
Connects to imaging
instruments via DICOM and
non-DICOM methodsYesYes

The only characteristic difference shown is the manner in which the applications are provided to users. In the case of FORUM, a client application software is installed onto each reviewing device, which then connects to the database software residing on the server. In the case of AXIS Imaging Management System, the database software residing on the server is accessed through an Internet browser program on the reviewing device. The particular program used is the choice of the user (e.g. Microsoft Internet Explorer, Apple Safari, etc.). In this manner, the use of AXIS Image Management System is review device agnostic, and is simpler for the user facility to maintain and use.

The indication for use of AXIS and the predicate device is identical. Evaluation performed on AXIS supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate device, and does not raise new questions regarding safety and effectiveness.

Non-Clinical Performance Data

Performance testing was conducted on AXIS Image Management System as part of the software verification and validation and was found to perform as intended. AXIS is DICOM-compliant as stipulated in its DICOM Conformity Statement. There is no stated shelf-life since AXIS is a software device only.

Clinical Performance Data

None required or submitted.

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Conclusions from Non-Clinical (and Clinical) Data

Based upon the results of the data as summarized above, AXIS Image Management System has demonstrated that it is as safe, as 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 discussion above, as well as guidance provided by FDA 510(k) Substantial Equivalence Decision-Making Process Flowchart, AXIS Image Management System is deemed to be substantially equivalent to the predicate device.