NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

K013694 · Nidek, Inc. · NFJ · Nov 19, 2002 · Radiology

Device Facts

• Record ID: K013694
• Device Name: NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
• Applicant: Nidek, Inc.
• Product Code: NFJ · Radiology
• Decision Date: Nov 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

NAVIS is a software-based ophthalmic information management system. It collects, stores, and manages patient data, examination records, and diagnostic images from various computerized ophthalmic instruments via direct connection or network. The system provides real-time review of diagnostic information at PC workstations and integrates office scheduling and billing. Optional modules support specific applications, including Cell Analysis Eyebank, Fundus Measurement, and networking/internet connectivity. The software includes an image manipulation module for retinal and slit lamp imaging. Used by eye care professionals in clinical environments to centralize patient records, the system facilitates clinical decision-making by providing organized access to diagnostic data and images, potentially improving workflow efficiency and patient record management.

Clinical Evidence

Bench testing only. Performance testing was conducted based on product specifications and hazard analysis. The system performed as intended and was found equivalent to the predicate device.

Technological Characteristics

Software-based ophthalmic database and image processing system. Operates on PC workstations. Features include data collection/storage, image manipulation (retinal/slit lamp), and optional modules for cell analysis and fundus measurement. Connectivity via direct instrument connection or network. No specific hardware materials or energy sources defined as it is a software system.

Indications for Use

Indicated for use in ophthalmic clinical settings for the collection, storage, and management of patient data, diagnostic information, and images acquired from computerized ophthalmic diagnostic instruments.

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

• AETmed Image Processing Software (K012093)

Reference Devices

• ifa System (ifa Systems)
• IMAGEnet (Topcon Instruments Corporation)

Submission Summary (Full Text)

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Nidek Advanced Vision Information System (NAVIS) Original Premarket 510(k) Notification

K013694

#### 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 Drive<br>Fremont, CA 94539 |
| c. | Company Phone:<br>Company Facsimile: | [phone]<br>[phone] |
| d. | Contact Person: | Hiro Matsuzaki<br>Quality Assurance Manager |
| e. | Date Summary Prepared: | November 18, 2002 |

#### DEVICE IDENTIFICATION 16.2.

| a. Trade/Proprietary Name: | Nidek Advanced Vision Information System<br>(NAVIS) |
|----------------------------|----------------------------------------------------------------|
| b. Classification Name: | Radiological Image Processing System<br>21 CFR 892.2050 86 NFJ |

#### IDENTIFICATION OF PREDICATE DEVICES 16.3

| Company | Device | 510(k) No. | Date Cleared |
|----------------|-------------------------------------|------------|--------------|
| AETmed, S.P.A. | AETmed Image Processing<br>Software | 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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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

K013694

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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-------------------------------------------------------------------------------|----|----------------------|
| | | |
| (Division Sign-Off)<br>Division of Ophthalmic Ear,<br>Nose and Throat Devises | | |
| 510(k) Number_ | | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801 109) | | |