Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.

Device Description

Huvitz Imaging System (HIS-5000U) consists of slit lamp camera (HIS-5000L (10.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software (HIS-5000N). It is a digital imaging system with a high resolution digital camera and PC based patient diagnostic data management software intended for controlling digital imaging devices, acceptance, transfer, display, storage and digital processing of ophthalmic images including videos, acquired from a of a slit lamp camera through direct connection or network. The imaging software (HIS-5000N) supports networking function to share patient information and examination images between multiple PCs existing on the local network or internet via TCP/IP protocol. Also, this version uses MS-SQL server solution as more reliable database, and includes additional HIS Server Management software to support to back up or restore patient and imaging data. HIS-5000N imaging system software is not able and intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings.

AI/ML Overview

The Huvitz Imaging System (HIS-5000U) is intended for controlling digital imaging devices and for the acceptance, transfer, display, storage, and digital processing of documented ophthalmic images and videos, acquired from a slit lamp camera.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Report)	Reported Device Performance
Functional Performance:	The Huvitz Imaging System (HIS-5000U) performed as intended.
Camera Image capture	Tested and validated.
Saving image file	Tested and validated.
Adjust color of capture image	Tested and validated.
Measurement of figures (pixels and mm)	Tested and validated. The device has a function to measure pixels and mm. (Also, function for brightness, contrast, sharpness; function to highlight features; function to add test notes; function to search medical records; function to export/import data; function to print; function to compare images side-by-side).
Camera resolution & data transfer speed	Tested and validated as per the manufacturer's performance report. (Specific resolution/speed not provided in the document, but performance was confirmed against specifications).
Safety and Effectiveness:	The device "introduces no new concern for safety and effectiveness" based on non-clinical tests.
Substantial Equivalence:	The device is deemed substantially equivalent to the predicate device, EyeSuite Imaging (K142423), based on non-clinical tests and comparison of technological characteristics (Memory, Graphic Card, Operating System, Interface, Monitor resolution, how to store patient data, type of images/video format, ability to control camera, ability to manage/store/process/display patient data, type of system for viewing/modifying data, functions for notes, highlighting, enhancement, measurement, search, export/import, print, and image comparison). The primary differences noted were the operating system (Windows 7 vs. Vista/XP), memory (2048MB vs 1GB), graphic card (512MB vs 120MB), monitor resolution (1920x1080 vs 1280x800), interface (USB 2.0 vs DICOM PACS), and DICOM interface absence.
Intended Use:	Matches the intended use: "controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network."
No Diagnostic Capability (Limitation):	"Huvitz-5000N imaging system software is not able and intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings." (This is a condition/limitation, not an acceptance criterion to be met, but an explicit statement about its function.)

Study Proving Device Meets Acceptance Criteria:

The study was a non-clinical performance testing along with a comparison to a predicate device.

2. Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or image count. The performance testing was conducted on the Huvitz Imaging System (HIS-5000U) itself, focusing on its functionalities and adherence to product specifications.
- The data provenance is not explicitly mentioned as involving clinical data. The tests are described as non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study was non-clinical performance testing of the device's functions, not a diagnostic accuracy study requiring expert ground truth on patient cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was not a study involving human reader interpretation or diagnostic outcomes on a test set.
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:
- No MRMC comparative effectiveness study was done. The device is an imaging system for display and management, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance testing was done on the "Huvitz Imaging System (HIS-5000U)" as a standalone device. The device itself (software and hardware components) was tested for its intended functions. The software "is not able and intended to provide any diagnosis."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical performance tests would be the device's own product specifications and design requirements. The functions (image capture, saving, color adjustment, measurement, resolution, data transfer speed) were verified to work as defined by the manufacturer's standards.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Huvitz Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, TX 77025

Re: K161829

Trade/Device Name: Huvitz Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: March 2, 2017 Received: March 6, 2017

Dear Mr. Kim:

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.

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.

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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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Denise L. Hampton -S

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) K161829

Device Name Huvitz Imaging System

Indications for Use (Describe)

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

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date Prepared:Submitter:	April 4, 2017Huvitz Co., Ltd.298-29, Gongdan-ro, Gunpo-so, Gyeonggi-do, 435-862, Republic of KoreaTel: +82-31-428-9100Establishment Registration Number: 9616199E-mail: heohm@huvitz.com
Contact person:	Dave KimMtech Group.8310 Buffalo Speedway, Houston, TX 77025Tel: +713-467-2607Fax: +713-583-8988E-mail: davekim@mtech-inc.net
Trade Name:Common Name:Regulation Number:Regulation Name:Regulatory Class::Product Code:	Huvitz Imaging System (HIS-5000U)System, Image Management, Ophthalmic.21 CFR 892.2050Picture archiving and communications systemClass IINFJ
Predicate Device:Regulation Number:Regulation Name:Regulatory Class::Product Code:	EyeSuite Imaging, K14242321 CFR 892.2050Picture archiving and communications systemClass IINFJ
Device Description:	Huvitz Imaging System (HIS-5000U) consists of slit lamp camera (HIS-5000L(10.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software(HIS-5000N). It is a digital imaging system with a high resolution digitalcamera and PC based patient diagnostic data management softwareintended for controlling digital imaging devices, acceptance, transfer,display, storage and digital processing of ophthalmic images includingvideos, acquired from a of a slit lamp camera through direct connection ornetwork.The imaging software (HIS-5000N) supports networking function to sharepatient information and examination images between multiple PCs existingon the local network or internet via TCP/IP protocol. Also, this version usesMS-SQL server solution as more reliable database, and includes additionalHIS Server Management software to support to back up or restore patientand imaging data. HIS-5000N imaging system software is not able and

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intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings.

Intended Use: Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.

Technological characteristics:

Huvitz Imaging system (HIS-5000U) has been compared to the predicated device. The following attachment shows differences and similarities among the device.

Non-clinical and clinical tests:

Performance testing was conducted on the Huvitz Imaging System (HIS-System and supported instrument testing was completed based 5000U). on product specifications and hazard effects determined from the risk analysis. The Huvitz Imaging System (HIS-5000U) performed as intended and is deemed substantially equivalent to and comparable to the predicate device, an ophthalmic patient database device.

Also, the following tests have been conducted to validate the performance of Huvitz Imaging System (HIS-5000U).

Camera Image capture, 2) Saving image file, 3) Adjust color of capture image, 4) Measurement of figures, 5) Camera resolution & data transfer speed as per the manufacturer's performance report.

No clinical test has been conducted.

Conclusions: Based on non-clinical tests, the subject device, Huvitz Imaging System (HIS-5000U) introduces no new concern for safety and effectiveness. Therefore it is the sponsor's opinion that Huvitz Imaging System (HIS-5000U) is substantially equivalent to the predicate device.

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Attachment

< Comparison Table of Technical Characteristics >

Characteristic	Subject DeviceHuvitz Imaging SystemHIS-5000U	Predicate DeviceHaag-Streit, EyeSuit Imaging
510(k) number	New (K161829)	K142423
Manufacturer	Huvitz Co.,Ltd	Haag-Streit
Device Name	Huvitz Imaging SystemHIS-5000U	EyeSuit Imaging
Intended Use	Huvitz Imaging system (HIS-5000U) is intended forcontrolling digital imaging devices and for acceptance,transfer, display, storage and digital processing ofdocumentation ophthalmic images and videos, acquiredfrom a slit lamp camera through a direct connection to aPC or to multiple PCs via a local network.	EyeSuit Imaging is a software program intended for use forcontrolling digital imaging devices and for acceptance,transfer, display, storage and digital processing ofdocumentational ophthalmic images and videos, acquiredfrom computerized diagnostic instruments, through directconnection or through networks.EyeSuite Basic is a patient and examination managementsystem, acting as a base and communication platform forother EyeSuite software components
Memory	2,048MB	1GByte
Graphic Card	512MB	120MB
Operating System	Window 7	Windows Vista, Window XP
Interface	USB 2.0	DICOM PACS
Monitor resolution	1920 x 1080	1280 x 800
How to store patient dataand diagnostic documents	Be comprised of a local database to store patient data anddiagnostic documents	Be comprised of a central database to store patient data anddiagnostic documents
Type of images and videoformat	JPEG	JPEG, TIFF, MJPEG
Ability to control camera	Be capable of controlling supported camera system and	Be capable of controlling supported camera systems and
Characteristic	Subject DeviceHuvitz Imaging SystemHIS-5000U	Predicate DeviceHaag-Streit, EyeSuit Imaging
systems and exposureparameters like signalgain, exposure time orwhite balance (by defaultor an option)	exposure parameters like signal gain, exposure time or whitebalance.	exposure parameters like signal gain, exposure time or whitebalance
Ability to provide themanagement, storage andprocessing and display ofpatient, diagnostic videoand image data	USB Camera has unique power requirement that varies onimage resolution and data bandwidth needed to transportimage data	Provide the management, storage and processing and displayof patient, diagnostic, video and image data
Type of system thatprovide a softwareapplication (client) to viewor modify the stored datain the database (server)	Software should be installed in a computer using an installerfile. After the software and camera driver installation, HIS-5000U program can check patient image data and currentdatabase information on a local computer.	Client-server systems that provide a software application(client) to view or modify the stored data in the database(server)
Functions to add testnotes to medical records	Diagnosis management can add or edit diagnosticinformation.	Provide a function to add text notes to medical records
Function to highlightfeatures in images	User can select a thumbnail image by clicking it, which ishighlighted as bright color, and it is able to select severalimages from different exams of the same patient. Theselections are cleared when the processing on image arecompleted.	Provide a function to highlight features in images
Function to enhanceimage brightness, contrastand sharpness	Provide functions to enhance image brightness, contrastand sharpness.	Provide functions to enhance image brightness, contrast andsharpness
Characteristic	Subject DeviceHuvitz Imaging SystemHIS-5000U	Predicate DeviceHaag-Streit, EyeSuit Imaging
Function to measurepixels or mm,	Function to measure pixels and mm	Provides the measurement functionality in pixels andmeasurements in mm
Function to search toretrieve medical recordslined to a specific patient	All patient data is stored in a database file, and a searchfunction can retrieve patient database transaction historystored in the Database Log File.	a search function to retrieve medical records linked to aspecific patient
Function to export andimport data	Include a function to export and import data	Include a function to export and import data
Function to print out thestored data	Can produce printouts of the stored data.	Can produce printouts of the stored data
Function to compareimages by displayingimages side by side	Function to compare images by displaying images side bysideMore than two images can be selected from Thumbnail Listfor comparison.	Comprise an image compare function by displaying imagesside by side
Function to connect toLAN and have DICOMinterface	Can connect to LAN but No DICOM interface	Can connect to LAN and have DICOM interface (by default oras a separate option)

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Regulation Number and Section

§ 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).