(59 days)
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.
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 provided 510(k) submission for the Nidek Image Filing Software NAVIS-EX focuses on establishing substantial equivalence to a predicate device (FORUM, FORUM Archive, FORUM Archive and Viewer by Carl Zeiss Meditec AG). It does not contain an independent clinical study with specific acceptance criteria and detailed performance data in the typical sense of a diagnostic Artificial Intelligence (AI) device.
Instead, the submission primarily relies on:
- Comparison of Technological Characteristics: Demonstrating that the NAVIS-EX has similar functions (filing, external interface, image acquisition, image processing) to the predicate and reference devices.
- Compliance with Standards: Stating that testing according to ISO 14971 (risk management), AAMI/ANSI/IEC 62304 (software life cycle processes), and IEC 62366-1 (usability) was performed and showed the device performs as intended and is safe.
Therefore, many of the requested details about acceptance criteria, specific device performance metrics, sample sizes, ground truth establishment, and MRMC studies are not available in this document.
Here's a breakdown of what can be gleaned from the document regarding your request:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for the NAVIS-EX as an AI/CAD-like device. The "performance" claimed is primarily functional equivalence and safety as demonstrated by compliance with general medical device standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs as intended (functionality and safety) | Demonstrated by compliance with ISO 14971, AAMI/ANSI/IEC 62304, IEC 62366-1. |
| Substantially equivalent in technological characteristics | Functional comparisons show similar features for image filing, display, search, zoom, print, external interfaces, image acquisition, and processing compared to predicate and reference devices. Minor differences are argued not to raise new safety/efficacy issues. |
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a specific "test set" in terms of patient data or images used for clinical performance evaluation is provided. The testing mentioned refers to engineering and software validation tests against standards, not a clinical performance study on a dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set using expert-established ground truth is described in this submission.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
No MRMC comparative effectiveness study is mentioned in this submission. The device is image filing software, not a diagnostic AI that would typically undergo such a study for improved reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Study was done:
No standalone clinical performance study is described. The "performance" assessment is based on functional equivalence and safety/software standards compliance.
7. The Type of Ground Truth Used:
Not applicable, as no clinical performance study with defined ground truth is described.
8. The Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device that requires a training set in the conventional sense for diagnostic performance.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets its (implied) acceptance criteria is a combination of:
- Functional Benchmarking/Comparison: The device's features for image filing, management, processing, and display were compared against those of a predicate device (Carl Zeiss Meditec AG's FORUM) and several NIDEK reference devices (K132323, K113451, K152729, K133132, K173980). This comparison (detailed in the tables on pages 6-7 of the document) served to demonstrate that the NAVIS-EX has substantially similar technological characteristics.
- Compliance with International Standards: The submission states that testing according to ISO 14971 (Medical devices – Application of risk management to medical devices), AAMI/ANSI/IEC 62304 (Medical device software – Software life cycle processes), and IEC 62366-1 (Medical devices – Application of usability engineering to medical devices) was performed. These tests are intended to ensure the software is safe, functions reliably, and is usable, thus implying the performance necessary for its intended use without raising new safety or effectiveness concerns.
The conclusion is that the "test results and comparison results show that the proposed device is substantially equivalent to the predicate device in performance." This suggests that the "acceptance criteria" were met by demonstrating an equivalent level of function and safety through these comparisons and standard compliance, rather than through specific quantitative clinical performance metrics typical of AI diagnostic tools.
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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.
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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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Applicant: | NIDEK CO., LTD.34-14 Maehama, HiroishiGamagori, Aichi, 443-0038 Japan |
|---|---|
| Contact Person: | Yoneji Mizuno |
| Contact Title: | Senior Manager, Regulatory Affairs Department |
| Contact Phone Number: | +81-533-67-8901 |
| Contact Fax Number: | +81-533-67-6628 |
| E-mail: | yoneji_mizuno@nidek.co.jp. |
| Official Correspondent: | Enrico Bisson |
| Contact Title: | Manager, Regulatory Affairs DepartmentNidek Technologies SrlVia dell'Artigianato, 6/A,35020 Albignasego (Padova) , Italy |
| Contact Phone Number: | +39-049 8629200 |
| Contact Fax Number: | +39-049 8626824 |
| E-mail: | enricobisson@nidektechnologies.it |
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 ReferenceDevices | Holder/Applicant 510(K) | 510(k) No. | |
|---|---|---|---|
| Predicate device | FORUM, FORUM Archive,FORUM Archive and Viewer | Carl Zeiss Meditec AG | K122938 |
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| Reference device | RS-3000 Advance | NIDEK | K132323 |
|---|---|---|---|
| Reference device | NON-MYDRIATIC AUTOFUNDUS CAMERA AFC-330with IMAGE FILINGSOFTWARE NAVIS-EX | NIDEK | K113451 |
| Reference device | OPTICAL BIOMETER AL-Scan | NIDEK | K133132 |
| Reference device | Specular Microscope CEM-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.
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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.
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Filing function
| Device name | Subject device | Predicate device | Reference device | Reference device |
|---|---|---|---|---|
| Image filing softwareNAVIS-EX | FORUM,FORUM Archive,FORUM Archive andViewer | AFC-330 with NAVIS-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 |
| Yes | Yes | Yes | Yes |
External interface
| Subject device | Predicate device | Reference device | Reference device | |
|---|---|---|---|---|
| Device name | Image filing softwareNAVIS-EX | FORUM,FORUM Archive,FORUM Archive andViewer | AFC-330 with NAVIS-EX | RS-3000 Advance |
| Sending saved image by e-mail | Yes | Unknown | Yes | Yes |
| Outputting report with savedimage and patient information tooutput designation | Yes | Yes | Yes | Yes |
| Startup of external application | Yes | Unknown | Yes | Yes |
| Patient selection from externalsystem | Yes | Yes | Yes | Yes |
| DICOM | Yes | Yes | No | No |
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Image acquisition
| Subject device | Predicate device | Reference device | Reference device | |
|---|---|---|---|---|
| Device name | Image filingsoftwareNAVIS-EX | FORUM,FORUM Archive,FORUM Archive andViewer | AFC-330 with NAVIS-EX | RS-3000 Advance |
| Interfacing with diagnosticdevices and acquiring images | Yes | Yes | Yes | Yes |
| DICOM import | Yes | Yes | No | No |
| Import function | Yes | Yes | Yes | Yes |
| Import/export of patient data aswell as images | Yes | Yes | Yes | Yes |
Image processing
| Subject device | Predicate device | Reference device | Reference device | |
|---|---|---|---|---|
| Device name | Image filing softwareNAVIS-EX | FORUM,FORUM Archive,FORUM Archive andViewer | AFC-330 with NAVIS-EX | RS-3000 Advance |
| Effect (sharpening and blurring) | Yes | Unknown | Yes | No |
| Color correction (gray scale, colorinversion, brightness, contrast,contrast RGB, histogram, channeldivision, gamma correction, red-free,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 softwareNAVIS-EX | FORUM,FORUM Archive,FORUM Archive andViewer | AFC-330 with NAVIS-EX | RS-3000 Advance |
| Measurement | ||||
| Cup/Disc ratio measurement onfundus images or OCT images | Yes | No | Yes | Yes |
| Measurement of disc diameterand cup diameter in vertical andhorizontal directions on fundusimages or OCT images | Yes | Unknown | Yes | Yes |
| Measurement between 2 pointson fundus images or OCT images | Yes | Yes | Yes | Yes |
| Measurement of area on fundusimages or OCT images,measurement of perimeter onfundus images | Yes | No | Yes | No |
| Measurement of thicknessbetween retinal layer borderlineon OCT images | Yes | Unknown | No | Yes |
| Filter | Yes | Unknown | Yes | No |
| Simple image processing (RGB, red-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 softwareNAVIS-EX | FORUM,FORUM Archive,FORUM Archive andViewer | AFC-330 with NAVIS-EX | RS-3000 Advance |
| Optical Coherence Tomography(OCT) image display in 3D | Yes | Unknown | No | Yes |
| Display of position of retinal layerret/anterior segment border referenceposition | Yes | Yes | No | Yes |
| Editing retinal layer/ anteriorsegment 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 |
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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.
§ 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).