(59 days)
No
The summary describes standard image filing, management, and processing software without mentioning any AI/ML specific terms or functionalities. The performance studies focus on standard software and risk management standards, not AI/ML validation.
No
The device is described as a software system for storing, managing, processing, measuring, analyzing, and displaying patient data and clinical information. It does not provide any treatment or therapy.
No
Explanation: The device is software for storing, managing, and displaying patient data from diagnostic instruments. It works with compatible ophthalmic devices (which are diagnostic), but the software itself does not perform diagnosis; it only handles the data generated by those diagnostic devices.
Yes
The device description explicitly states it is a "software system" and describes its function as managing, processing, and displaying data from other diagnostic instruments. While it interacts with hardware (ophthalmic devices), the device itself is presented as a software application running on a client-server model.
Based on the provided information, the Image Filing Software NAVIS-EX is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks." This describes a system for handling and presenting data generated by other devices, not a device that performs a diagnostic test on a biological sample itself.
- Device Description: The description focuses on data management, display, analysis, and reporting of data from connected ophthalmic devices. It doesn't mention any interaction with biological samples or performing tests on them.
- Anatomical Site: The device is intended for use with ophthalmic devices, which are used to examine the eye (an in vivo process), not to perform tests on samples taken from the eye (an in vitro process).
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD devices. The performance studies mentioned focus on software and safety standards, not the analytical or clinical performance of a diagnostic test.
In summary, the NAVIS-EX is a software system for managing and displaying data from ophthalmic diagnostic devices. It does not perform diagnostic tests on biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / 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 codes (comma separated list FDA assigned to the subject device)
NFJ
Device 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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image data from computerized ophthalmic diagnostic instruments (e.g., fundus camera, OCT, microperimeter, optical biometer, specular microscope).
Anatomical Site
Ophthalmic
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)
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. 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. The test results and comparison results show that the proposed device is substantially equivalent to the predicate device in performance.
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.
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.
K132323, K113451, K133132, K173980
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).
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 (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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Applicant: | NIDEK CO., LTD.
34-14 Maehama, Hiroishi
Gamagori, 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 Department
Nidek Technologies Srl
Via 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 Reference
Devices | Holder/Applicant 510(K) | 510(k) No. |
|------------------|---------------------------------------------------|-------------------------|------------|
| Predicate device | FORUM, FORUM Archive,
FORUM Archive and Viewer | Carl Zeiss Meditec AG | K122938 |
4
| Reference device | RS-3000 Advance | NIDEK | K132323 |
|---|---|---|---|
| Reference device | NON-MYDRIATIC AUTO | ||
| FUNDUS CAMERA AFC-330 | |||
| with IMAGE FILING | |||
| SOFTWARE 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.
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 | ||||
| NAVIS-EX | FORUM, | |||
| FORUM Archive, | ||||
| FORUM Archive and | ||||
| Viewer | 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 software | |||
| NAVIS-EX | FORUM, | |||
| FORUM Archive, | ||||
| FORUM Archive and | ||||
| Viewer | AFC-330 with NAVIS- | |||
| EX | RS-3000 Advance | |||
| Sending saved image by e-mail | Yes | Unknown | Yes | Yes |
| Outputting report with saved | ||||
| image and patient information to | ||||
| output designation | Yes | Yes | Yes | Yes |
| Startup of external application | Yes | Unknown | Yes | Yes |
| Patient selection from external | ||||
| 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 | |||
| software | ||||
| NAVIS-EX | FORUM, | |||
| FORUM Archive, | ||||
| FORUM Archive and | ||||
| Viewer | AFC-330 with NAVIS- | |||
| EX | RS-3000 Advance | |||
| Interfacing with diagnostic | ||||
| 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 | ||||
| well as images | Yes | Yes | Yes | Yes |
Image processing
| Subject device | Predicate device | Reference device | Reference device | |
|---|---|---|---|---|
| Device name | Image filing software | |||
| NAVIS-EX | FORUM, | |||
| FORUM Archive, | ||||
| FORUM Archive and | ||||
| Viewer | AFC-330 with NAVIS- | |||
| EX | RS-3000 Advance | |||
| Effect (sharpening and blurring) | Yes | Unknown | Yes | No |
| Color correction (gray scale, color | ||||
| inversion, brightness, contrast, | ||||
| contrast RGB, histogram, channel | ||||
| division, 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 software | |||
| NAVIS-EX | FORUM, | |||
| FORUM Archive, | ||||
| FORUM Archive and | ||||
| Viewer | AFC-330 with NAVIS- | |||
| EX | RS-3000 Advance | |||
| Measurement | ||||
| Cup/Disc ratio measurement on | ||||
| fundus images or OCT images | Yes | No | Yes | Yes |
| Measurement of disc diameter | ||||
| and cup diameter in vertical and | ||||
| horizontal directions on fundus | ||||
| images or OCT images | Yes | Unknown | Yes | Yes |
| Measurement between 2 points | ||||
| on fundus images or OCT images | Yes | Yes | Yes | Yes |
| Measurement of area on fundus | ||||
| images or OCT images, | ||||
| measurement of perimeter on | ||||
| fundus images | Yes | No | Yes | No |
| Measurement of thickness | ||||
| between retinal layer borderline | ||||
| on 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 software | |||
| NAVIS-EX | FORUM, | |||
| FORUM Archive, | ||||
| FORUM Archive and | ||||
| Viewer | 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 layer | ||||
| ret/ | ||||
| anterior segment border reference | ||||
| position | Yes | Yes | No | Yes |
| Editing retinal layer/ anterior | ||||
| 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.