Image Filing Software NAVIS-EX

K181345 · Nidek Co., Ltd. · NFJ · Jul 19, 2018 · Radiology

Device Facts

• Record ID: K181345
• Device Name: Image Filing Software NAVIS-EX
• Applicant: Nidek Co., Ltd.
• Product Code: NFJ · Radiology
• Decision Date: Jul 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Device Story

NAVIS-EX is a client-server software system for ophthalmic data management. It interfaces with compatible NIDEK diagnostic devices (e.g., fundus cameras, OCT, biometers, specular microscopes) to acquire, store, and manage patient examination data. Clinicians use the client interface to display, process, and analyze images and measurement data; perform measurements (e.g., cup/disc ratio, retinal layer thickness, IOL power calculation); and generate reports. The system supports follow-up analysis and data transfer to external systems. It facilitates clinical decision-making by providing organized, longitudinal patient data and automated measurement tools for ophthalmic diagnostics. Used in clinical settings by eye care professionals.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with ISO 14971 (risk management), AAMI/ANSI/IEC 62304 (software lifecycle), and IEC 62366-1 (usability) confirmed the device performs as intended and is substantially equivalent to the predicate.

Technological Characteristics

Client-server software architecture. Features include DICOM connectivity, image processing (sharpening, color correction, rotation, filtering), and automated measurement tools (cup/disc ratio, retinal layer thickness, IOL power calculation). Complies with ISO 14971, AAMI/ANSI/IEC 62304, and IEC 62366-1 standards.

Indications for Use

Indicated for use by clinicians to store, manage, process, measure, analyze, and display patient data and clinical information from compatible NIDEK ophthalmic diagnostic instruments via networks.

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

• FORUM, FORUM Archive, FORUM Archive and Viewer (K122938)

Reference Devices

• RS-3000 Advance (K132323)
• NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 with IMAGE FILING SOFTWARE NAVIS-EX (K113451)
• OPTICAL BIOMETER AL-Scan (K133132)
• Specular Microscope CEM-530 (K173980)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".

July 19, 2018

Nidek Co., Ltd % Enrico Bisson Manager, Regulatory Affairs Department Nidek Technologies srl Via dell'Artigianato, 6/A Albignasego (Padova), 35020 IT

Re: K181345

Trade/Device Name: Image Filing Software NAVIS-EX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: April 30, 2018 Received: May 21, 2018

Dear Enrico Bisson:

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.

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely yours,

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K181345

Device Name Image Filing Software NAVIS -EX

#### Indications for Use (Describe)

The Image Filing Software NAVIS -EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

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

| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|--------------------------------------------------------------------------------------|
| | <input type="checkbox"/> 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 [e-mail]

"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."

{3}------------------------------------------------

# 510(k) Summary

| Applicant: | NIDEK CO., LTD.<br>34-14 Maehama, Hiroishi<br>Gamagori, Aichi, 443-0038 Japan |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoneji Mizuno |
| Contact Title: | Senior Manager, Regulatory Affairs Department |
| Contact Phone Number: | [phone] |
| Contact Fax Number: | [phone] |
| E-mail: | [e-mail]. |
| Official Correspondent: | Enrico Bisson |
| Contact Title: | Manager, Regulatory Affairs Department<br>Nidek Technologies Srl<br>Via dell'Artigianato, 6/A,<br>35020 Albignasego (Padova) , Italy |
| Contact Phone Number: | [phone] |
| Contact Fax Number: | [phone] |
| E-mail: | [e-mail] |

## Date Summary Prepared: July 17, 2018

Classification: 21 CFR§892.2050

### Classification name:

Picture archiving and communications system

## Product Code: NFJ

Trade Name: Image Filing Software NAVIS-EX

# Generic/Common Name:

System, Image Management, Ophthalmic

## Predicate and References Devices

| | Predicate and Reference<br>Devices | Holder/Applicant 510(K) | 510(k) No. |
|------------------|---------------------------------------------------|-------------------------|------------|
| Predicate device | FORUM, FORUM Archive,<br>FORUM Archive and Viewer | Carl Zeiss Meditec AG | K122938 |

{4}------------------------------------------------

| Reference device | RS-3000 Advance | NIDEK | K132323 |
|------------------|---------------------------------------------------------------------------------------|-------|---------|
| Reference device | NON-MYDRIATIC AUTO<br>FUNDUS CAMERA AFC-330<br>with IMAGE FILING<br>SOFTWARE NAVIS-EX | NIDEK | K113451 |
| Reference device | OPTICAL BIOMETER AL-<br>Scan | NIDEK | K133132 |
| Reference device | Specular Microscope CEM-<br>530 | NIDEK | K173980 |

## Indications for use

The Image filing software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

## Product Description

The NAVIS-EX is compatible with the following devices:

- · previously cleared NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 (K113451);
- · previously cleared OPTICAL COHERENCE TOMOGRAPHY RS-3000 Advance (K132323);
- · Digital Medical Scope DS-10 (Digital Eye-Fundus Camera DS-10F of the DS-10 was previously cleared under k120982.);
- previously cleared MICROPERIMETER MP-3 by way of the previously cleared MP-Viewer (K152729):
- · previously cleared OPTICAL BIOMETER AL-Scan (K133132) by way of the proposed AL-Scan Viewer;

and

- · previously cleared SPECULAR MICROSCOPE CEM-530 (K173980) by way of the proposed CEM Viewer
The NAVIS-EX is an application of client-server model. Patient information and examination data are managed in a server database. These data are saved in the database from a device connected with the NAVIS-EX or from software related to the NAVIS-EX. In the client, the examination data can be displayed and analyzed, and the images can be processed. In addition, those results can be printed or be transferred to an external system in the form of a report.

The NAVIS-EX system includes specific optional viewers AL-Scan Viewer, CEM Viewer, and Data Acquisition Service (DAS).

The AL-Scan Viewer is intended to handle the AL-Scan data within NAVIS-EX. The measured value data and waveform can be displayed, the intraocular lens (hereafter referred to as "IOL") power can be calculated, and the toric lens assist data can be created

The CEM Viewer is intended to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within the NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up.

The CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen.

{5}------------------------------------------------

The Data Acquisition Service is intended to acquire data from measurement devices such as Optical Biometer AL-Scan and the Specular Microscope CEM-530 and transfers it to the NAVIS-EX. In addition to acquisition of measurement data, the DAS registers patients newly registered with the AL-Scan and CEM-530 to the NAVIS-EX.

#### Comparison of Technological Characteristics

The NAVIS-EX represents an update of the NAVIS-EX contained in the cleared Nidek devices:

· NIDEK RS-3000 Advance (K132323)

• NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 with IMAGE FILING SOFTWARE NAVIS-EX (K113451)

• NIDEK MICROPERIMETER MP-3 (K152729)

The comparison table of technological characteristics is here documented.

{6}------------------------------------------------

# Filing function

| Device name | Subject device | Predicate device | Reference device | Reference device |
|-----------------------------------|---------------------------------------------------------|---------------------------|------------------|------------------|
| Image filing software<br>NAVIS-EX | FORUM,<br>FORUM Archive,<br>FORUM Archive and<br>Viewer | AFC-330 with NAVIS-<br>EX | RS-3000 Advance | |
| Network (Data management) | Yes | Yes | Yes | Yes |
| Image display | Yes | Yes | Yes | Yes |
| Search | Yes | Yes | Yes | Yes |
| Zoom in/out | Yes | Yes | Yes | Yes |
| Print | Yes | Yes | Yes | Yes |

# External interface

| | Subject device | Predicate device | Reference device | Reference device |
|----------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------|---------------------------|------------------|
| Device name | Image filing software<br>NAVIS-EX | FORUM,<br>FORUM Archive,<br>FORUM Archive and<br>Viewer | AFC-330 with NAVIS-<br>EX | RS-3000 Advance |
| Sending saved image by e-mail | Yes | Unknown | Yes | Yes |
| Outputting report with saved<br>image and patient information to<br>output designation | Yes | Yes | Yes | Yes |
| Startup of external application | Yes | Unknown | Yes | Yes |
| Patient selection from external<br>system | Yes | Yes | Yes | Yes |
| DICOM | Yes | Yes | No | No |

{7}------------------------------------------------

# Image acquisition

| | Subject device | Predicate device | Reference device | Reference device |
|-------------------------------------------------------------|--------------------------------------|---------------------------------------------------------|---------------------------|------------------|
| Device name | Image filing<br>software<br>NAVIS-EX | FORUM,<br>FORUM Archive,<br>FORUM Archive and<br>Viewer | AFC-330 with NAVIS-<br>EX | RS-3000 Advance |
| Interfacing with diagnostic<br>devices and acquiring images | Yes | Yes | Yes | Yes |
| DICOM import | Yes | Yes | No | No |
| Import function | Yes | Yes | Yes | Yes |
| Import/export of patient data as<br>well as images | Yes | Yes | Yes | Yes |

# Image processing

| | Subject device | Predicate device | Reference device | Reference device |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------|---------------------------|------------------|
| Device name | Image filing software<br>NAVIS-EX | FORUM,<br>FORUM Archive,<br>FORUM Archive and<br>Viewer | AFC-330 with NAVIS-<br>EX | RS-3000 Advance |
| Effect (sharpening and blurring) | Yes | Unknown | Yes | No |
| Color correction (gray scale, color<br>inversion, brightness, contrast,<br>contrast RGB, histogram, channel<br>division, gamma correction, red-free,<br>luminous area detection) | Yes | Yes | Yes | Yes |
| Rotation/flip | Yes | Unknown | Yes | No |
| Resize | Yes | Unknown | Yes | No |
| | Subject device | Predicate device | Reference device | Reference device |
| Device name | Image filing software<br>NAVIS-EX | FORUM,<br>FORUM Archive,<br>FORUM Archive and<br>Viewer | AFC-330 with NAVIS-<br>EX | RS-3000 Advance |
| | | | | |
| Measurement | | | | |
| Cup/Disc ratio measurement on<br>fundus images or OCT images | Yes | No | Yes | Yes |
| Measurement of disc diameter<br>and cup diameter in vertical and<br>horizontal directions on fundus<br>images or OCT images | Yes | Unknown | Yes | Yes |
| Measurement between 2 points<br>on fundus images or OCT images | Yes | Yes | Yes | Yes |
| Measurement of area on fundus<br>images or OCT images,<br>measurement of perimeter on<br>fundus images | Yes | No | Yes | No |
| Measurement of thickness<br>between retinal layer borderline<br>on OCT images | Yes | Unknown | No | Yes |
| Filter | Yes | Unknown | Yes | No |
| Simple image processing (RGB, red-<br>free, emboss) | Yes | Unknown | Yes | No |
| Stereo function | Yes | Unknown | Yes | No |
| Panorama function | Yes | Unknown | Yes | No |
| Drawing | Yes | Yes Partially | Yes | No |
| | Subject device | Predicate device | Reference device | Reference device |
| Device name | Image filing software<br>NAVIS-EX | FORUM,<br>FORUM Archive,<br>FORUM Archive and<br>Viewer | AFC-330 with NAVIS-<br>EX | RS-3000 Advance |
| Optical Coherence Tomography<br>(OCT) image display in 3D | Yes | Unknown | No | Yes |
| Display of position of retinal layer<br>ret/<br>anterior segment border reference<br>position | Yes | Yes | No | Yes |
| Editing retinal layer/ anterior<br>segment border | Yes | Unknown | No | Yes |
| Editing optic disc shape | Yes | Unknown | No | Yes |
| Recording 3D movie | Yes | Unknown | No | Yes |
| Followup | Yes | Yes | Yes | Yes |

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

#### Testing in Support of Substantial Equivalence Determination

Testing according to ISO 14971, AAMI/ANSI/IEC 62304, and IEC 62366-1 demonstrated that the NAVIS-EX performs as intended. The primary predicate device has been tested according to the equivalent standards.

#### Summary of Safety and Effectiveness

All the necessary safety tests were performed and documented. The results demonstrate that the subject device complies with applicable international standards (ISO 14971, AAMI/ANSI/IEC 62304, and IEC 62366-1) and it is safe as the predicate devices. All the necessary performance tests in support of substantial equivalence determination were conducted. The tests demonstrate that the subject device is effective and performs as well as the predicate devices.

#### Conclusion:

The proposed and the predicate devices have similar indications for use and technological characteristics. The minor differences between the proposed CEM Viewer and its reference device CEM-530 do not raise any new issues of safety or efficacy because the substantial equivalence of these minor differences are supported by the corresponding, similar functions of the other reference devices. The test results and comparison results show that the proposed device is substantially equivalent to the predicate device in performance.

Based on the intended use, technological characteristics, and performance testing, the proposed NAVIS-EX system has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.