The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

Device Description

The RemotEye Viewer software product is a feature-rich, diagnostic-level, web-based DICOM medical image viewer that allows downloading, reviewing, interpreting, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. The DICOM images may be physically remote with respect to the viewing client, but reachable through a network.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "RemotEye Viewer" device, which is a medical image viewer. However, it does not include detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for performance-based AI/CAD devices.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (eFilm Workstation) based on intended use, technological characteristics, and functionality. It does not present a performance study with defined metrics, sample sizes, expert ground truth, or comparative effectiveness.

Therefore, many of the requested sections will state that the information is not provided in the given text.

Here's a breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or report specific performance metrics for the RemotEye Viewer in the context of diagnostic accuracy, sensitivity, specificity, etc. The "Testing" section broadly mentions that the device is "tested according the specifications that are documented in 013-139 and 009_Al Verification and Validation document." These internal documents are not provided.

Metric	Acceptance Criteria (Not provided in text)	Reported Device Performance (Not provided in text)
(e.g., Diagnostic Accuracy, Sensitivity, Specificity)	N/A	N/A
(e.g., Image Display Quality)	N/A	Performed as intended for viewing DICOM images
(e.g., Functionality)	All features listed in "Technological Characteristics in common" function correctly.	Implemented and functioning as described.

The document's primary claim related to performance is that its "different technological characteristics" (web-based, multi-platform, no local storage) "don't constitute any new intended use and don't raise new questions of safety and effectiveness." This implies that its core viewing and manipulation functions are expected to perform similarly to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set in the context of diagnostic performance evaluation. It mentions "Testing" as an integral part of their software development process, but no details regarding specific test datasets, their size, or provenance are included.

Sample Size for Test Set: Not provided.
Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific diagnostic performance test set is described, there's no mention of experts establishing ground truth. The device is a viewer for images that are "interpreted by a trained physician" to "be used as an element for diagnosis," implying human interpretation is central, not an automated diagnostic output requiring ground truth.

Number of Experts: Not applicable/Not provided.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

Not applicable, as no diagnostic performance test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device itself is a viewer, not an AI/CAD system providing interpretations.

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

Not applicable. The RemotEye Viewer is a medical image viewing software intended for use by "trained professionals" to review and interpret images. It is not an algorithm designed for standalone diagnostic performance.

7. The Type of Ground Truth Used

Not applicable, as no diagnostic performance evaluation requiring ground truth is described for the device itself. The primary function is image display and manipulation, not automated diagnosis.

8. The Sample Size for the Training Set

Not applicable. The RemotEye Viewer is a software viewer, not a machine learning model that requires a training set in the conventional sense for diagnostic performance. Its development involves software engineering, testing, and validation, not training on medical images for algorithmic performance.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set or ground truth in the context of machine learning model development.

Summary

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

August 1, 2014

NEOLOGICA S.R.L. MARCO SAMBIN STRADA VILLE, 58 17014 CAIRO MONTENOTTE (SV) ITALY

Re: K141061 Trade/Device Name: RemotEve Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 16, 2014 Received: July 21, 2014

Dear Mr. Sambin:

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 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 (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.

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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/Resourcesfor You/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 yours.

Smh.f)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141061

Device Name RemotEye Viewer

Indications for Use (Describe)

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.f)

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Image /page/3/Picture/1 description: The image shows the text "005 Al 510(k) Summary of Safety and Effectiveness". The text is in bold font and is centered on the page. The text is likely the title of a document or report. The number 005 is likely a document number or identifier.

Date Prepared: April 15, 2014 Date of Additional Information: July 16, 2014

Submitter's Name: NeoLogica s.r.l. Submitter's Address: Strada Ville, 58 - 17014 - Cairo Montenotte (SV) - Italy Submitter's Phone Number: +39 019 505314 Submitter's E-mail: info@neologica.it Submitter's Website: www.neologica.it

Establishment Registration Name: NEOLOGICA S.R.L. Establishment Registration Number: 3005202320

Contact person's Name: Marco Sambin Contact person's Title: Director Contact person's Phone Number: +39 019 505314 Contact person's E-mail: marco.sambin@neologica.it

Device Common Name: DICOM-compliant medical image viewer Device Trade Name: RemotEye Viewer Device Classification Name: System, Image Processing, Radiological Device Regulation Description: Picture archiving and communications system Device Regulation Medical Specialty: Radiology Device Review Panel: Radiology Product Code: LLZ Device Regulation Number: 892.2050 Device Class: II Device 510(k) Number: K141061

Predicate Device: eFilm Workstation Predicate Device Original Applicant: eFilm Medical, Inc. - 500 University Ave., Suite 300, Toronto, Ontario Canada M5G 1V7 Predicate Device 510(k) Number: K012211 Predicate Device Classification Name: System, Image Processing, Radiological Predicate Device Regulation Description: Picture archiving and communications system Predicate Device Classification Advisory Committee: Radiology

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Image /page/4/Picture/1 description: The image shows a logo with the word "neologica" in a stylized font. Below the word, there are two smaller words, "Research" and "Development", separated by a curved line. The logo has a modern and clean design, with a focus on the company's name and its areas of expertise.

Predicate Device Review Advisory Committee: Radiology Predicate Device Product Code: LLZ Predicate Device Requlation Number: 892.2050 Predicate Device Class: II Date Received: 07/16/2001 Decision Date: 07/31/2001 Decision: Substantially Equivalent (SE)

Device Description

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

Device Intended Use

The RemotEye Viewer software product is intended to be used as a fully functional, webbased medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format. also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis.

Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

Technological Characteristics

Both the RemotEye Viewer and the eFilm Workstation are stand-alone medical imaging software packages which can be used on more than one hardware platform. As long as minimum requirements are met, the user is free to choose his/her own hardware platform. Hardware and software requirements for RemotEye Viewer are described both in the Installation Manual and in the User Manual. Please refer to pages 008 Al - 4, 008 Al - 5, 008_Al - 15, 008_Al - 16 of the 008_Al RemotEye Viewer Installation Manual and pages 007_Al - 6, 007_Al - 7, 007_Al - 8 of the 007_Al RemotEye Viewer User Manual.

Technological Characteristics in common:

Studies and patients search, Display of grayscale and color DICOM images, On-screen presentation of images with several different layouts, Image navigation, Synchronized series navigation for CT and MR, Textual overlays of main image info, Image zooming, Image panning, Window/level contrast manipulation, Image rotation, Image flipping,

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Image enhancement, Display of references lines, Cine-playback, Distance measurements, Area measurements, Angle measurements, Graphical annotations, Normal print, DICOM print, Image export, DICOM CD/DVD burning, Report creation and viewing, MPR (Multi-Planar Reconstruction).

Different Technological Characteristics:

RemotEye Viewer is a software product based on a web-enabled architecture. . eFilm Workstation is a traditional Windows native desktop application.
. RemotEye Viewer is a multi-platform viewer, it can successfully run on Windows, Mac OS X and Linux.

eFilm Workstation is a Windows-only software solution.

. RemotEye Viewer is a web-based software designed to integrate with an external DICOM archive. No DICOM files are permanently stored on the client PCs by RemotEye Viewer.
eFilm Workstation includes an embedded DICOM server, and stores DICOM files locally on the host PC.

These differences don't constitute any new intended use and don't raise new questions of safety and effectiveness.

Testing

RemotEye Viewer is tested according the specifications that are documented in 013-139 and 009_Al Verification and Validation document.

Testing is an integral part of NeoLogica's software development process as described in 013-126.

Conclusions

eFilm Workstation and RemotEye Viewer have similar intended use, typical users, functionality and technological characteristics.

RemotEye Viewer provides some different technological characteristics compared to eFilm Workstation; however these differences neither constitute any new intended use, nor raise any questions that affect safety and effectiveness.

Hence RemotEye Viewer is substantially equivalent to eFilm Workstation.

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).