(275 days)
No
The summary describes standard digital image processing, storage, and management functionalities, with no mention of AI, ML, or related concepts like algorithms for automated analysis or diagnosis.
No.
The device is described as an imaging system for acquiring, storing, and processing ophthalmic images and explicitly states that it is "not able and intended to provide any diagnosis." It functions as a data management and viewing tool rather than providing direct treatment or therapy.
No
The "Device Description" explicitly states: "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."
No
The device description explicitly states that the system "consists of slit lamp camera (HIS-5000L (10.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software (HIS-5000N)," indicating it includes hardware components (camera and cable) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Huvitz Imaging System (HIS-5000U) is designed to capture, store, display, and process images and videos acquired directly from a slit lamp camera viewing the eye. It does not process specimens taken from the body.
- Intended Use: The intended use is for controlling imaging devices and managing ophthalmic images and videos. It explicitly states that the 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 further reinforces that it's a tool for visualization and data management, not for analyzing biological samples.
- Input Modality: The input is from a slit lamp camera, which is an in-vivo imaging modality, not an in-vitro one.
Therefore, the Huvitz Imaging System (HIS-5000U) falls under the category of an ophthalmic imaging and data management system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NFJ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Slit lamp camera
Anatomical Site
Ophthalmic / eye
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)
Performance testing was conducted on the Huvitz Imaging System (HIS-5000U). and supported instrument testing was completed based 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
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)
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.
| 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, 2017
Huvitz Co., Ltd.
298-29, Gongdan-ro, Gunpo-so, Gyeonggi-do, 435-862, Republic of Korea
Tel: +82-31-428-9100
Establishment Registration Number: 9616199
E-mail: heohm@huvitz.com |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dave Kim
Mtech Group.
8310 Buffalo Speedway, Houston, TX 77025
Tel: +713-467-2607
Fax: +713-583-8988
E-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 892.2050
Picture archiving and communications system
Class II
NFJ |
| Predicate Device:
Regulation Number:
Regulation Name:
Regulatory Class::
Product Code: | EyeSuite Imaging, K142423
21 CFR 892.2050
Picture archiving and communications system
Class II
NFJ |
| 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 |
4
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
| Characteristic | Subject Device
Huvitz Imaging System
HIS-5000U | Predicate Device
Haag-Streit, EyeSuit Imaging |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | New (K161829) | K142423 |
| Manufacturer | Huvitz Co.,Ltd | Haag-Streit |
| Device Name | Huvitz Imaging System
HIS-5000U | EyeSuit Imaging |
| 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. | EyeSuit Imaging is a software program intended for use for
controlling digital imaging devices and for acceptance,
transfer, display, storage and digital processing of
documentational ophthalmic images and videos, acquired
from computerized diagnostic instruments, through direct
connection or through networks.
EyeSuite Basic is a patient and examination management
system, acting as a base and communication platform for
other 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 data
and diagnostic documents | Be comprised of a local database to store patient data and
diagnostic documents | Be comprised of a central database to store patient data and
diagnostic documents |
| Type of images and video
format | 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 Device
Huvitz Imaging System
HIS-5000U | Predicate Device
Haag-Streit, EyeSuit Imaging |
| systems and exposure
parameters like signal
gain, exposure time or
white balance (by default
or an option) | exposure parameters like signal gain, exposure time or white
balance. | exposure parameters like signal gain, exposure time or white
balance |
| Ability to provide the
management, storage and
processing and display of
patient, diagnostic video
and image data | USB Camera has unique power requirement that varies on
image resolution and data bandwidth needed to transport
image data | Provide the management, storage and processing and display
of patient, diagnostic, video and image data |
| Type of system that
provide a software
application (client) to view
or modify the stored data
in the database (server) | Software should be installed in a computer using an installer
file. After the software and camera driver installation, HIS-
5000U program can check patient image data and current
database 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 test
notes to medical records | Diagnosis management can add or edit diagnostic
information. | Provide a function to add text notes to medical records |
| Function to highlight
features in images | User can select a thumbnail image by clicking it, which is
highlighted as bright color, and it is able to select several
images from different exams of the same patient. The
selections are cleared when the processing on image are
completed. | Provide a function to highlight features in images |
| Function to enhance
image brightness, contrast
and sharpness | Provide functions to enhance image brightness, contrast
and sharpness. | Provide functions to enhance image brightness, contrast and
sharpness |
| Characteristic | Subject Device
Huvitz Imaging System
HIS-5000U | Predicate Device
Haag-Streit, EyeSuit Imaging |
| Function to measure
pixels or mm, | Function to measure pixels and mm | Provides the measurement functionality in pixels and
measurements in mm |
| Function to search to
retrieve medical records
lined to a specific patient | All patient data is stored in a database file, and a search
function can retrieve patient database transaction history
stored in the Database Log File. | a search function to retrieve medical records linked to a
specific patient |
| Function to export and
import data | Include a function to export and import data | Include a function to export and import data |
| Function to print out the
stored data | Can produce printouts of the stored data. | Can produce printouts of the stored data |
| Function to compare
images by displaying
images side by side | Function to compare images by displaying images side by
side
More than two images can be selected from Thumbnail List
for comparison. | Comprise an image compare function by displaying images
side by side |
| Function to connect to
LAN and have DICOM
interface | Can connect to LAN but No DICOM interface | Can connect to LAN and have DICOM interface (by default or
as a separate option) |
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