(377 days)
The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
The Nidek Advanced Vision Information System (NAVIS) is a computer technology software that collects, stores and maintains patient data information. NAVIS provides real-time review of diagnostic patient information from a number of ophthalmic medical instruments at any PC workstation. NAVIS incorporates patient data, examination data, office scheduling and billing into one system. The Nidek Advanced Vision Information System (NAVIS) contains a main core software program and a number of optional software modules that can be installed. The additional software modules support the number of application instruments that can be used with NAVIS in order to directly transfer and enhance the patient examination data. Additional software modules include the Cell Analysis Eyebank module, the Fundus Measurement module and a software module to allow for networking of several PC workstations and internet access.
The Nidek Advanced Vision Information System (NAVIS) 510(k) summary does not contain specific acceptance criteria with numerical targets. Instead, the performance data section states that "Performance testing was conducted on the Nidek Advanced Vision Information System. System and supported instrument testing was completed based on product specifications and hazard effects determined from the risk analysis. The Nidek Advanced Vision Information System performed as intended and has thus is deemed substantially equivalent to the predicate device and comparable to other ophthalmic patient database devices." This indicates a qualitative assessment against product specifications rather than predefined quantitative acceptance criteria.
The study presented is a substantial equivalence comparison to a predicate device, the AETmed Image Processing Software (K012093), and comparisons to IFA Systems ifa System device and Topcon Instruments Corporation IMAGEnet device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet product specifications | "The Nidek Advanced Vision Information System performed as intended." |
| Functional equivalence to predicate device (AETmed Image Processing Software K012093) in image processing, patient data collection, and data management. | "The Nidek Advanced Vision Information System is substantially equivalent to the AETmed Image Processing Software is terms of image processing, patient data collection and data management." |
| Comparability to IFA Systems ifa System and Topcon Instruments Corporation IMAGEnet in collecting and storing clinical data from ophthalmic instruments. | "NAVIS is also comparable to IFA Systems ifa System device and the Topcon Instruments Corporation IMAGEnet device in terms of their use in ophthalmic practice to collect and store clinical data." |
| Perform as intended for its indicated use (collection, storage, and clinical information management of patient and diagnostic data/images from computerized instruments). | "The Nidek Advanced Vision Information System (NAVIS) has been tested and found to perform as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). The performance testing description is high-level and refers to "system and supported instrument testing" based on specifications and risk analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The study focuses on substantial equivalence based on functionality and performance against product specifications, not on diagnostic accuracy requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the study does not involve a diagnostic test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or conducted. The device is described as an information management system, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone software system for data management. Its performance was assessed based on its ability to collect, store, and manage data and images as intended, rather than a diagnostic algorithm's accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the diagnostic sense (e.g., pathology, expert consensus) is not applicable to this device's performance evaluation. The "ground truth" for this device's performance would be its adherence to its own product specifications and its functional comparability to predicate data management systems.
8. The sample size for the training set
This information is not provided. The device is a data management system, not a machine learning model that would typically have a "training set" in the conventional sense of AI/ML development.
9. How the ground truth for the training set was established
Not applicable, as the device is not an AI/ML system requiring a training set with established ground truth.
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Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 16.1
| a. | Company Name: | Nidek, Inc. |
|---|---|---|
| b. | Company Address: | 47651 Westinghouse DriveFremont, CA 94539 |
| c. | Company Phone:Company Facsimile: | (510) 226-5700(510) 226-5750 |
| d. | Contact Person: | Hiro MatsuzakiQuality Assurance Manager |
| e. | Date Summary Prepared: | November 18, 2002 |
DEVICE IDENTIFICATION 16.2.
| a. Trade/Proprietary Name: | Nidek Advanced Vision Information System(NAVIS) |
|---|---|
| b. Classification Name: | Radiological Image Processing System21 CFR 892.2050 86 NFJ |
IDENTIFICATION OF PREDICATE DEVICES 16.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| AETmed, S.P.A. | AETmed Image ProcessingSoftware | K012093 | 09/21/2001 |
DEVICE DESCRIPTION 16.4
The Nidek Advanced Vision Information System (NAVIS) is a computer technology software that collects, stores and maintains patient data information.
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Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification
NAVIS provides real-time review of diagnostic patient information from a number of ophthalmic medical instruments at any PC workstation. NAVIS incorporates patient data, examination data, office scheduling and billing into one system.
The Nidek Advanced Vision Information System (NAVIS) contains a main core software program and a number of optional software modules that can be installed. The additional software modules support the number of application instruments that can be used with NAVIS in order to directly transfer and enhance the patient examination data. Additional software modules include the Cell Analysis Eyebank module, the Fundus Measurement module and a software module to allow for networking of several PC workstations and internet access.
SUBSTANTIAL EQUIVALENCE 16.5
The Nidek Advanced Vision Information System is substantially equivalent to the AETmed Image Processing Software is terms of image processing, patient data collection and data management. NAVIS is also comparable to IFA Systems ifa System device and the Topcon Instruments Corporation IMAGEnet device in terms of their use in ophthalmic practice to collect and store clinical data. These devices transfer patient data from computerized diagnostic ophthalmic instruments via direct connections or through networks.
16.6 INDICATIONS FOR USE
The Nidek Advanced Vision Information System (NAVIS) is a software program intended for use in collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
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TECHNOLOGICAL CHARACTERISTICS 16.7
The fundamental technical characteristics of NAVIS are similar to those of the predicate devices. The functionality and the indications for use for NAVIS are similar to the predicates. NAVIS and the predicate devices are patient databases that collect and store data from connected medical ophthalmic instruments. NA VIS differs from the predicate devices in that it contains an image manipulation module, which contains functions for retinal imaging and slit lamp imaging. The Imaging module can also contain the Cell Analysis and Fundus Measurement software for advanced data analysis.
PERFORMANCE DATA 16.8
Performance testing was conducted on the Nidek Advanced Vision Information System. System and supported instrument testing was completed based on product specifications and hazard effects determined from the risk analysis. The Nidek Advanced Vision Information System performed as intended and has thus is deemed substantially equivalent to the predicate device and comparable to other ophthalmic patient database devices.
16.9 CONCLUSIONS
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. The Nidek Advanced Vision Information System (NAVIS) has been tested and found to perform as intended. NAVIS has been compared to a legally cleared predicate device and found to be substantially equivalent. Comparisons to other ophthalmic patient database software have also been performed and NAVIS was found to have equivalent functions.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, with wavy lines below them.
NOV 1 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NIDEK, Inc. c/o Ms. Carol White Patterson Consulting Group, Inc. · 21911 Erie Lane Lake Forest, CA 92630
Re: K013694 Trade/Device Name: Nidek Advanced Vision Information System (NAVIS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: November 5, 2002 Received: November 7, 2002
Dear Ms. White:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Carol White
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification
INDICATION FOR USE
510(k) Number:
To Be Assigned By FDA
Device Name:
Nidek Advanced Vision Information System (NAVIS)
The Nidek Advanced Vision Information System (NAVIS) is a Indications for Use: software program intended for use in the collection, storage and clinical information management of patient data, diagnostic data and the images from computerized diagnostic instruments through direct connection with the instruments, or through networks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off)Division of Ophthalmic Ear,Nose and Throat Devises | ||
| 510(k) Number_ | ||
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801 109) |
§ 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).