(41 days)
No
The document describes a software application for displaying and visualizing ultrasound volume data. It focuses on rendering, editing, and measurement functions, with no mention of AI or ML algorithms for analysis, interpretation, or decision support. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The 5D Viewer is a software application for displaying and visualizing US Volume Data, allowing users to examine, analyze, search, and store images. It is not designed to directly treat or diagnose conditions but rather to facilitate the review of data from an ultrasound system, which is a diagnostic tool.
Yes
The "Intended Use / Indications for Use" section states: "This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system." It also mentions that it uses "US Volume Data measured by an ultrasound system." Furthermore, the device description notes that it "only supports the DICOM files containing the volume data created by Samsung Medison's Diagnostic Ultrasound Systems," and lists a reference device as "WS80A Diagnostic Ultrasound System." These points indicate its role in processing data from diagnostic ultrasound systems for analysis.
Yes
The device is described as "standalone software" installed on laptops/PCs and its primary function is the display and visualization of ultrasound volume data. While it interacts with data from ultrasound systems, the device itself is presented as a software application without mention of accompanying hardware components beyond the standard computer it runs on. The mention of a USB-type dongle for specific functions does not negate its core identity as a software application for data visualization and analysis.
Based on the provided information, the 5D Viewer software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- 5D Viewer's Function: The 5D Viewer software processes and visualizes ultrasound volume data obtained directly from an ultrasound system. It does not analyze biological specimens.
- Intended Use: The intended use is for displaying, visualizing, examining, and analyzing images based on volume data from an ultrasound system. This is related to medical imaging, not in vitro testing.
- Device Description: The description focuses on reviewing, analyzing, editing, and measuring volume data from ultrasound equipment.
- Lack of Specimen Analysis: There is no mention of the software interacting with or analyzing any type of biological specimen.
Therefore, the 5D Viewer falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
5D Viewer is a software application for the display and 3D visualization of US Volume Data measured by an ultrasound system.
This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system. It may also be used to search, and store the volume data.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
5D Viewer is standalone software that can be installed in laptops/PCs with Microsoft Windows 7.
This product lets users use their computers to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as USB drive.
Since this product reads 3D volume data, users can review the test results of patients more quickly and easily. This function allows them to check 3D image results without using an ultrasound system, helping them conduct more tests with the ultrasound system.
5D Viewer only supports the DICOM files containing the volume data created by Samsung Medison's Diagnostic Ultrasound Systems. In other words, you only use the volume data in DICOM files. 5D Viewer is not compatible with the DICOM files from third parties.
Main operational functions
- Display and edit volume data set
- · Save data (video and volume data)
- · Support simple caliper (Distance, Ellipse, or 3 Distance Volume)
Functions that require a USB-type dongle
- HDVI
- · 5D Heart
5D Viewer uses the volume data of Samsung Medison's WS80A, and HS70A Ultrasound systems. The Volume Data contains the raw data obtained during the scan as well as the information required for rendering (e.g., Geometry, View mode, etc.). The patient information is not relevant to the rendering, so it is not included in the Volume Data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The device has been evaluated to conform to applicable voluntary standards: IEC 62304 Medical device software Software life-cycle processes, ISO 14971 Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01), HIPAA COMPLIANCE 5D Viewer is in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and SAMSUNG MEDISON Software Development Procedure (DXQ2-0030K). Clinical studies were not required. The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.
Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K180883
Trade/Device Name: 5D Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 9, 2018 Received: May 10, 2018
Dear Mr. Job:
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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
May 15, 2018
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180883
Device Name 5D Viewer
Indications for Use (Describe)
5D Viewer is a software application for the display and 3D visualization of US Volume Data measured by an ultrasound system.
This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system. It may also be used to search, and store the volume data.
| 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 OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
1. Submitter's Information:
SAMSUNG MEDISON CO., LTD.
145, Pangyoyeok-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13530, Korea
1.1. Contact Person
Ji Yea Lee Regulatory Affairs Specialist SAMSUNG MEDISON CO., LTD. Phone: 82.2.2194.1594 FAX: 82.2.556.3974 E-mail: jiyea722.lee@samsungmedison.com
Data Prepared: November 15, 2017
2. Name of the device:
Common/Usual Name: Picture Archiving Communications System Proprietary Name: 5D Viewer Classification Names: FR Number Product Code Picture Archiving Communications System 892.2050 LLZ
3. Identification of the predicate or legally marketed device:
4. Device Description:
5D Viewer is standalone software that can be installed in laptops/PCs with Microsoft Windows 7.
This product lets users use their computers to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as USB drive.
Since this product reads 3D volume data, users can review the test results of patients more quickly and
4
easily. This function allows them to check 3D image results without using an ultrasound system, helping them conduct more tests with the ultrasound system.
5D Viewer only supports the DICOM files containing the volume data created by Samsung Medison's Diagnostic Ultrasound Systems. In other words, you only use the volume data in DICOM files. 5D Viewer is not compatible with the DICOM files from third parties.
Main operational functions
- Display and edit volume data set
- · Save data (video and volume data)
- · Support simple caliper (Distance, Ellipse, or 3 Distance Volume)
Functions that require a USB-type dongle
- HDVI
- · 5D Heart
5D Viewer uses the volume data of Samsung Medison's WS80A, and HS70A Ultrasound systems. The Volume Data contains the raw data obtained during the scan as well as the information required for rendering (e.g., Geometry, View mode, etc.). The patient information is not relevant to the rendering, so it is not included in the Volume Data.
5. Intended Uses:
5D Viewer is a software application for the display and 3D visualization of Ultrasound volume data derived from Ultrasound system. It is designed to allow the user to observe images and perform analysis using the volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data.
6. Technological Characteristics:
5D Viewer is substantially equivalent with respect to safety, effectiveness, and functionality to the 5D Viewer (K161955) and WS80A Diagnostic Ultrasound System (K171070) as a reference. The device is a software application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets volume data being displayed. It is designed to allow the user to observe images and perform analysis using the volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, analyzing, editing, measuring and storing of volume data.
These are described in detail in the technological characteristics comparison table as below.
5
| Feature | Subject Device | The Primary predicate device | The Reference predicate devices |
|---|---|---|---|
| 5D Viewer | |||
| (Under Review) | 5D Viewer | ||
| (K161955) | WS80A | ||
| (K171070) | |||
| Indications for Use | 5D Viewer is a software application for the display and 3D visualization of US Volume Data measured by an ultrasound system. | ||
| This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system. It may also be used to search, analyze, edit, measure, and store the volume data. | 5D Viewer is a software application for the display and 3D visualization of US Volume Data measured by an ultrasound system. | ||
| This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system. It may also be used to search, analyze, edit, measure, and store the volume data. | The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. | ||
| The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal(Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Intra-operative. | |||
| Computer platform | |||
| (minimum requirements) | - CPU: Intel Core i5 |
- VGA: Nvidia graphic card supporting Shader Model 3.0 with 1GB Video Memory
- Resolution: 1280x720
- Memory: 4GB | - CPU: Intel Core i5
- VGA: Nvidia graphic card supporting Shader Model 3.0 with 1GB Video Memory
- Resolution: 1280x720
- Memory: 4GB | Not applicable |
| Computer Operating System | Windows 7 | Windows 7 | Not applicable |
| Opening and saving files | *.mvl, *.sty, *.dcm
※ 5D Viewer only supports the DICOM files containing the volume data created by Samsung Medison. In other words, you only use the volume data in DICOM files. 5D Viewer is not compatible with the DICOM files from third parties. | *.mvl, *.sty, *.dcm
※ 5D Viewer only supports the DICOM files containing the volume data created by Samsung Medison. In other words, you only use the volume data in DICOM files. 5D Viewer is not compatible with the DICOM files from third parties. | *.mvl, *.sty |
| Functionality | (Similarity)
Functionality of 5D Viewer is same with the previously cleared 510(k) submission 5D Viewer (K161955) and WS80A (K171070) that there is not difference in functionality between them.
(Difference)
In the 5D Viewer, some functionality (Crystal Vue Flow) that was previously cleared on WS80A (K171070) has been added with 5D Viewer.
It doesn't impact on device safety and effectiveness. It is substantially equivalent with respect to safety, effectiveness, and functionality to the 5D Viewer (K161955) and WS80A (K171070) in | | |
| Feature | Subject Device | The Primary predicate device | The Reference predicate devices |
| | 5D Viewer
(Under Review) | 5D Viewer
(K161955) | WS80A
(K171070) |
| regards to the device with 5D Viewer. | | | |
| - MPR | Yes | Yes | Yes |
| - Slub 3D | Yes | Yes | Yes |
| - Accept ROI | Yes | Yes | Yes |
| - FAD | Yes | Yes | Yes |
| - Curved ROI | Yes | Yes | Yes |
| - Mirror View | Yes | Yes | Yes |
| - MagiCut | | | |
| - Smooth Cut | Yes | Yes | Yes |
| - Volume Slice | Yes | Yes | Yes |
| - MSV | Yes | Yes | Yes |
| - Oblique View | Yes | Yes | Yes |
| - Volume CT | Yes | Yes | Yes |
| - VOCAL | Yes | Yes | Yes |
| - XI VOCAL | Yes | Yes | Yes |
| - Cine View | | | |
| 3D Cine | Yes | Yes | Yes |
| 4D Cine | Yes | Yes | Yes |
| - 5D Functions | | | |
| 5D NT | Yes | Yes | Yes |
| 5D CNS+
(old name: 5D
CNS) | Yes | Yes | Yes |
| 5D Follicle | Yes | Yes | Yes |
| 5D LB | Yes | Yes | Yes |
| 5D Heart | Yes | Yes | Yes |
| 5D Limb Vol | Yes | No | Yes |
| - Measurement | | | |
| Distance | Yes | Yes | Yes |
| Ellipse | Yes | Yes | Yes |
| 3 Distance
Volume | Yes | Yes | Yes |
| - Render Setup
functions | | | |
| Realistic Vue | Yes | Yes | Yes |
| VSI | Yes | Yes | Yes |
| ClearVision | Yes | No | Yes |
| Crystal Vue | Yes | No | Yes |
| Crystal Vue
Flow | Yes | No | Yes |
| Natural Vue | Yes | No | No |
| - Post Processing
functions | | | |
| Post Gain | Yes | Yes | Yes |
| Feature | Subject Device | The Primary
predicate device | The Reference
predicate devices |
| | 5D Viewer
(Under Review) | 5D Viewer
(K161955) | WS80A
(K171070) |
| Clear SFVI | Yes | Yes | Yes |
| Detailed SFVI | Yes | Yes | Yes |
| HDVI | Yes | Yes | Yes |
| - Chroma map
function | Yes | Yes | Yes |
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7
| 5D Viewer | Addition of V2.00 | Remarks | ||||
|---|---|---|---|---|---|---|
| Model Name | N/A | |||||
| SW Features | Adding the predicate S/W features: Crystal Vue Flow Improving the S/W feature that was previously cleared in 5D Viewer (K161955): 5D Follicle | Description of S/W Features Crystal Vue Flow: This feature is to display rendered images in Crystal Vue with Color Doppler. | ||||
| SW Features The previously cleared SW Features Crystal Vue Flow K171070 |
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7. A brief discussion of the non-clinical and clinical tests conducted on the subject device
The device has been evaluated to conform to applicable voluntary standards.
- IEC 62304 Medical device software Software life-cycle processes
- ISO 14971 Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- HIPAA COMPLIANCE 5D Viewer is in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
- SAMSUNG MEDISON Software Development Procedure (DXQ2-0030K)
Summary of Clinical Tests:
Not applicable. The subject of this submission, 5D Viewer, did not require clinical studies to support substantial equivalence.
8. Conclusion
SAMSUNG MEDISON CO., LTD. considers the 5D Viewer to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
- The 510(k) Pre-Market Notification for the 5D Viewer contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
- The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
- The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.