(41 days)
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.
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.
The provided text is a 510(k) summary for the SAMSUNG MEDISON 5D Viewer, a software application for displaying and 3D visualizing ultrasound volume data. It mostly focuses on establishing substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and detailed study results. The document states that clinical studies were not required to support substantial equivalence.
Therefore, based on the provided document, I cannot provide a complete answer to your request. However, I can extract the information available from the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it establishes substantial equivalence based on technological characteristics and functionality compared to predicate devices. The "reported device performance" is implicitly that it performs similarly to the predicate devices in the functions listed.
Here's a table based on the functional similarity described:
| Feature | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance (Implied: Performs as follows) |
|---|---|---|
| Display/Edit Data | Same as 5D Viewer (K161955) & WS80A (K171070) | Display and edit volume data set |
| Save Data | Same as 5D Viewer (K161955) & WS80A (K171070) | Save data (video and volume data) |
| Simple Caliper | Same as 5D Viewer (K161955) & WS80A (K171070) | Support simple caliper (Distance, Ellipse, or 3 Distance Volume) |
| HDVI Function | Same as 5D Viewer (K161955) & WS80A (K171070) | Requires USB-type dongle; performs HDVI function |
| 5D Heart Function | Same as 5D Viewer (K161955) & WS80A (K171070) | Requires USB-type dongle; performs 5D Heart function |
| Other listed functionalities (MPR, Slub 3D, FAD, 5D NT, Realistic Vue, etc.) | Functionality of 5D Viewer is same with the previously cleared 510(k) submission 5D Viewer (K161955) and WS80A (K171070). | Performs listed functionalities as per predicate devices. Note: Crystal Vue Flow added to 5D Viewer, previously cleared on WS80A. ClearVision, Crystal Vue, Crystal Vue Flow, and Natural Vue are new to the 5D Viewer compared to the primary predicate K161955, but ClearVision and Crystal Vue were present in K171070. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Not applicable. The subject of this submission, 5D Viewer, did not require clinical studies to support substantial equivalence." This implies there was no specific "test set" in the context of clinical performance evaluation with patient data. Non-clinical tests were conducted for conformity to voluntary standards, but detailed information about test sets for those is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies requiring ground truth from experts were conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies requiring adjudication were conducted for this submission.
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
Not applicable. The document states no clinical studies were performed. The 5D Viewer is a software for visualization and analysis, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This would fall under non-clinical testing for functionality and safety, which was done for compliance with IEC 62304, ISO 14971, and HIPAA, as well as Samsung Medison's own software development procedures. However, specific details or results of these standalone tests in terms of quantitative performance metrics are not provided in this summary. The device's performance is gauged through its functional equivalence to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies requiring ground truth were conducted for this submission.
8. The sample size for the training set
Not applicable. The device is described as a software application for display and visualization, not an AI/machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set (for an AI/ML model) was described or used.
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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
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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
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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
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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.
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| 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: 5DCNS) | 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 DistanceVolume | Yes | Yes | Yes |
| - Render Setupfunctions | |||
| Realistic Vue | Yes | Yes | Yes |
| VSI | Yes | Yes | Yes |
| ClearVision | Yes | No | Yes |
| Crystal Vue | Yes | No | Yes |
| Crystal VueFlow | Yes | No | Yes |
| Natural Vue | Yes | No | No |
| - Post Processingfunctions | |||
| Post Gain | Yes | Yes | Yes |
| Feature | Subject Device | The Primarypredicate device | The Referencepredicate 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 mapfunction | Yes | Yes | Yes |
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| 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.
END of 510(K) Summary
N/A