(30 days)
No
The summary describes a digital imaging system for capturing, storing, and displaying ophthalmic images. It mentions "digital processing" but explicitly states 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." There is no mention of AI, ML, or any algorithms that would perform analysis or interpretation beyond basic image handling.
No
The device is described as an imaging system for acquiring, processing, and storing ophthalmic images and explicitly states that it is "not able and intended to provide any diagnosis" and "is not a treatment device or a diagnostic device."
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." Additionally, the performance study summary mentions: "the risk is also low because the device is not a treatment device or a diagnostic device."
No
The device description explicitly states that the system "consists of slit lamp camera (HIS-5000U(10.0M), HIS-5000U(5.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software (HIS-5000N)." This indicates the device includes hardware components (camera and cable) in addition to the software.
Based on the provided information, the Huvitz Imaging System (HIS-5000U) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for controlling digital imaging devices, and for the acceptance, transfer, display, storage, and digital processing of ophthalmic images and videos acquired from a slit lamp camera. It focuses on managing and processing images, not on analyzing biological samples or providing diagnostic information based on in vitro testing.
- Device Description: The description reinforces this by stating the system is for controlling imaging devices and managing ophthalmic images. Crucially, it 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." This directly contradicts the purpose of an IVD, which is to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Performance Studies: The performance studies focus on the technical performance of the imaging system (camera resolution, image capture, saving files, etc.) and its equivalence to a predicate device, not on the accuracy or reliability of diagnostic results derived from in vitro testing.
In summary, the Huvitz Imaging System (HIS-5000U) is an ophthalmic imaging system designed to capture, manage, and display images of the eye. It is explicitly stated that it does not provide diagnosis, which is a key function of an IVD.
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- 5000U(10.0M), HIS-5000U(5.0M), 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
optical (from 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). System 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.
Also, the following tests have been conducted to validate the performance of Huvitz Imaging System (HIS-5000U).
- Camera Resolution, 2) Camera Time machine Function, 3) Camera Flicker, 4) Camera Image Capture 5) Saving image file, 6) Adjust Color as per the manufacturer's performance report. The reasons for selecting the test items 1), 4), 5), 6) are for checking camera functions due to the introduction of a new image sensor. The reasons for selecting the test items 2), 3) are for checking camera resolution due to the additional functionalities.
Huvitz Imaging system (HIS-5000U) does not require clinical testing, given the precedent of predicate equipment. No clinical test has been conducted.
In the performance test report, the performance was evaluated at an equivalent level in tests compared to the predicate device, and the risk is also low because the device is not a treatment device or a diagnostic device. 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 as safe, as effective, and performs as well as the legally marketed device predicate K161829.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2019
Huvitz Co., Ltd. % Dave Kim President MTech Group 8310 Buffalo Speedway Houston, TX 77025
Re: K191615
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: June 10, 2019 Received: June 18, 2019
Dear Dave 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Bradley Cunningham Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191615
Device Name Huvitz Imaging System HIS-5000U (10.0M, 5.0M, 1.4M)
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: | 7/12/2019 |
|---|---|
| Submitter: | Huvitz Co., Ltd. |
| 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, | |
| 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: | Huvitz Imaging System (HIS-5000U), K161829 |
| 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- |
| 5000U(10.0M), HIS-5000U(5.0M), 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 |
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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.
- 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.
Technological characteristics:
Huvitz Imaging system (HIS-5000U) has been compared to the predicated device. The following attachment shows differences and similarities among the device.
Performance test:
Non-clinical tests:
Performance testing was conducted on the Huvitz Imaging System (HIS-5000U). System 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.
Also, the following tests have been conducted to validate the performance of Huvitz Imaging System (HIS-5000U).
- Camera Resolution, 2) Camera Time machine Function, 3) Camera Flicker, 4) Camera Image Capture 5) Saving image file, 6) Adjust Color as per the manufacturer's performance report. The reasons for selecting the test items 1), 4), 5), 6) are for checking camera functions due to the introduction of a new image sensor. The reasons for selecting the test items 2), 3) are for checking camera resolution due to the additional functionalities.
Clinical test:
Huvitz Imaging system (HIS-5000U) does not require clinical testing, given the precedent of predicate equipment. No clinical test has been conducted.
Conclusions:
In the performance test report, the performance was evaluated at an equivalent level in tests compared to the predicate device, and the risk is also low because the device is not a treatment device or a diagnostic device. 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 as safe, as effective, and performs as well as the legally marketed device predicate K161829.
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Attachment
- Summary of technological differences and similarities
1.1 Technological differences:
-
Hardware: image sensor size(1" CMOS), image pixel size(up to 2592 x 2048 pixels), Data transmit speed(5.0 Gbps), Memory capacity (4GB), Graphic Card(On board graphics chip(PC/PCle graphics card with DirectDraw supporting DirectX 9.0 0 or Higher)) and Interface(USB 3.0)
-
Software: Operating System(Windows 10), software version(updated Ver. 4.04.19A)
1.2 Technological similarities:
- Frame rate, Monitor resolution, storage method, type of images and video format, Ability to control camera systems and exposure parameters, database and functions.
- Comparison of features and specifications of the predicate devices and subject devices
- New nodel HIS-5000 (5.0M) is added 5.0M imaging sensor compared with predicate device. Added the model HIS-5000 (5.0M) doesn't affect safety or performance's concern because differences of feature are just about image size, transmit speed, frame rate and interface.
| Characteristic | Predicate Device
Huvitz Imaging System
HIS-5000U | Subject Device
Huvitz Imaging System
HIS-5000U |
|----------------|--------------------------------------------------------|--------------------------------------------------------|
| 510(k) number | K161829 | New |
| Manufacturer | Huvitz Co.,Ltd | Huvitz Co.,Ltd |
| Device Name | Huvitz Imaging System
HIS-5000U (1.4M, 10.0M) | Huvitz Imaging System
HIS-5000U (1.4M, 10.0M, 5.0M) |
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| Characteristic | Predicate Device
Huvitz Imaging System
HIS-5000U | Subject Device
Huvitz Imaging System
HIS-5000U | | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------|
| 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. | 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. | | | |
| Specification | HIS-5000U(1.4M) | HIS-5000U(10.0M) | HIS-5000U(1.4M) | HIS-5000U(10.0M) | HIS-5000U(5.0M) |
| Image sensor | 1/2" CCD | 1/2" CMOS | 1/2" CCD | 1/2" CMOS | 1" CMOS |
| Image size | up to 1280x1024 pixels | up to 3840 x 2748 pixels | up to 1280x1024 pixels | up to 3840 x 2748 pixels | up to 2592 x 2048 pixels |
| Transmit speed | 480Mbps | 480Mbps | 480Mbps | 480Mbps | 5.0 Gbps |
| Frame rate | Maximum 15fps | Maximum 30fps | Maximum 15fps | Maximum 30fps | Maximum 30fps |
| Memory | 2,048MB | 2,048MB | 2,048MB | 2,048MB | 4GB |
| Graphic Card | 512MB | 512MB | 512MB | 512MB | On board graphics
chip(PCI/PCle
graphics card with
DirectDraw
support DirectX
9.0 0 or Higher) |
| Operating System | Window 7 | Window 7 | Window 7 | Window 7 | Window 10 |
| Interface | USB 2.0 | USB 2.0 | USB 2.0 | USB 2.0 | USB 3.0 |
| Monitor resolution | 1920 x 1080 | 1920 x 1080 | 1920 x 1080 | 1920 x 1080 | 1920 x 1080 |
| How to store patient data | Be comprised of a local database to store patient data and | Be comprised of a local database to store patient data and | Be comprised of a local database to store patient data and | | |
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| Characteristic | Predicate Device
Huvitz Imaging System
HIS-5000U | Subject Device
Huvitz Imaging System
HIS-5000U |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and diagnostic documents | diagnostic documents | diagnostic documents |
| Type of images and video
format | JPEG | JPEG |
| Ability to control camera
systems and exposure
parameters like signal gain,
exposure time or white
balance (by default or an
option) | Be capable of controlling supported camera system and
exposure parameters like signal gain, exposure time or white
balance. | Be capable of controlling supported camera system and
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 | USB Camera has unique power requirement that varies on
image resolution and data bandwidth needed to transport
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. | 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. |
| Functions to add test notes
to medical records | Diagnosis management can add or edit diagnostic
information. | Diagnosis management can add or edit diagnostic
information. |
| 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 | 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 |
| Characteristic | Predicate Device
Huvitz Imaging System
HIS-5000U | Subject Device
Huvitz Imaging System
HIS-5000U |
| | selections are cleared when the processing on image are
completed. | selections are cleared when the processing on image are
completed. |
| 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. |
| Function to measure pixels
or mm, | Function to measure pixels and mm | Function to measure pixels |
| 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. | 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. |
| 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. | Function to compare images by displaying images side by
side
More than two images can be selected from Thumbnail List
for comparison. |
| Function to connect to LAN
and have DICOM interface | Can connect to LAN but No DICOM interface | Can connect to LAN but No DICOM interface |
| HIS-5000N Software
Version | Ver. 2.04.13 | Ver. 4.04.19A |
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