5D Viewer

K180883 · Samsung Medison Co., Ltd. · LLZ · May 15, 2018 · Radiology

Device Facts

• Record ID: K180883
• Device Name: 5D Viewer
• Applicant: Samsung Medison Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: May 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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.

Device Story

5D Viewer is standalone software installed on Windows 7 PCs/laptops. It processes 3D ultrasound volume data (DICOM files) exported from Samsung Medison ultrasound systems via storage media (USB). The software enables clinicians to review, edit, measure, and visualize volume data offline, away from the ultrasound system. Key functions include multi-planar reconstruction (MPR), volume rendering (e.g., Realistic Vue, Crystal Vue), and specialized analysis tools (e.g., 5D Heart, 5D Follicle, 5D CNS+). Some advanced features require a USB-type hardware dongle. By offloading data review from the ultrasound system, the device increases clinical workflow efficiency. Output is displayed on the PC monitor for physician interpretation to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing and verification/validation of software features.

Technological Characteristics

Standalone software application for Windows 7. Minimum requirements: Intel Core i5 CPU, 1GB Video Memory (Nvidia, Shader Model 3.0), 4GB RAM. Supports DICOM volume data files (*.mvl, *.sty, *.dcm) from Samsung Medison systems. Features include MPR, 3D/4D rendering, and measurement tools. Software life-cycle processes follow IEC 62304; risk management follows ISO 14971. HIPAA compliant.

Indications for Use

Indicated for the display, 3D visualization, examination, analysis, editing, measurement, and storage of ultrasound volume data acquired from specified Samsung Medison diagnostic ultrasound systems. Intended for use by clinicians.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• 5D Viewer (K161955)

Reference Devices

• WS80A Diagnostic Ultrasound System (K171070)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] FAX: [phone] E-mail: [e-mail]

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:

- -5D Viewer (K161955)
- WS80A Diagnostic Ultrasound System (K171070) -

### 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<br>(Under Review) | 5D Viewer<br>(K161955) | WS80A<br>(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.<br>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.<br>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.<br>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<br>(minimum requirements) | - CPU: Intel Core i5<br>- VGA: Nvidia graphic card supporting Shader Model 3.0 with 1GB Video Memory<br>- Resolution: 1280x720<br>- Memory: 4GB | - CPU: Intel Core i5<br>- VGA: Nvidia graphic card supporting Shader Model 3.0 with 1GB Video Memory<br>- Resolution: 1280x720<br>- Memory: 4GB | Not applicable |
| Computer Operating System | Windows 7 | Windows 7 | Not applicable |
| Opening and saving files | *.mvl, *.sty, *.dcm<br>※ 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<br>※ 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)<br>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.<br>(Difference)<br>In the 5D Viewer, some functionality (Crystal Vue Flow) that was previously cleared on WS80A (K171070) has been added with 5D Viewer.<br>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<br>(Under Review) | 5D Viewer<br>(K161955) | WS80A<br>(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+<br>(old name: 5D<br>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<br>Volume | Yes | Yes | Yes |
| - Render Setup<br>functions | | | |
| Realistic Vue | Yes | Yes | Yes |
| VSI | Yes | Yes | Yes |
| ClearVision | Yes | No | Yes |
| Crystal Vue | Yes | No | Yes |
| Crystal Vue<br>Flow | Yes | No | Yes |
| Natural Vue | Yes | No | No |
| - Post Processing<br>functions | | | |
| Post Gain | Yes | Yes | Yes |
| Feature | Subject Device | The Primary<br>predicate device | The Reference<br>predicate devices |
| | 5D Viewer<br>(Under Review) | 5D Viewer<br>(K161955) | WS80A<br>(K171070)…