syngo Ultrasound Apps Suite (sUSAS)
Device Facts
| Record ID | K201062 |
|---|---|
| Device Name | syngo Ultrasound Apps Suite (sUSAS) |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | May 18, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The syngo® Ultrasound Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis. The software supports the following clinical application packages: . eSie Volume Viewer . eSie LVA . eSie PISA . eSie Valves
Device Story
sUSAS is a software-only application acting as a graphical launch pad on a PACS workstation. It enables clinicians to access Clinical Application Packages (CAPs) for processing ultrasound image data sets (e.g., from ACUSON SC2000 systems). Inputs consist of ultrasound images; the device provides tools for display, manipulation, and quantification (e.g., volume rendering, valve anatomy analysis, cardiac cycle measurements). Outputs are processed images and quantitative data displayed on the workstation for clinician review. The device is used in clinical settings by trained professionals. It does not contact patients. Clinicians use the output to inform clinical decision-making. Benefits include enhanced visualization and standardized quantification of cardiac structures, aiding in diagnosis.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including software verification and validation per IEC 62304 and usability engineering per IEC 62366-1.
Technological Characteristics
Software-only PACS plug-in. Operates on Windows 10 workstations. Supports DICOM standards. Includes eSie Volume Viewer, eSie LVA, eSie PISA, and eSie Valves. Software lifecycle follows IEC 62304. Cybersecurity controls implemented to prevent unauthorized access.
Indications for Use
Indicated for use by qualified clinicians to perform image processing, manipulation, and quantification of ultrasound images on a PACS workstation to assist in clinical diagnosis.
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
Reference Devices
- Syngo® Dynamics PAC System, VA30A (K171053)
Submission Summary (Full Text)
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May 18, 2020
Image /page/0/Picture/1 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.
Siemens Medical Solutions, USA, Inc. % Ms. Christine Dunbar Senior Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043
Re: K201062
Trade/Device Name: syngo Ultrasound Apps Suite™ (sUSAS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 17, 2020 Received: April 21, 2020
Dear Ms. Dunbar:
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.
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) 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
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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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K201062
Device Name syngo® Ultrasound Apps. Suite™ (sUSAS)
#### Indications for Use (Describe)
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
- · eSie Volume Viewer
- eSie LVA
- · eSie PISA
- · eSie Valves
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 1.1.3 510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92(c)
| Date prepared: | May 04, 2020 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Part 1. Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 |
| Contact Person: | Christine Dunbar<br>Senior Regulatory Affairs<br>Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043<br>Email: Christine.dunbar@siemens.com<br>Tel: (925) 374-2045 |
| Part 2. Device Name: | syngo® Ultrasound Apps Suite™ (sUSAS) |
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | Picture Archiving and Communications System |
| Classification: | Regulatory Class: II<br>Review Category: Tier II |
| Classification Panel | Radiology |
| CFR Section | 21 CFR §892.2050 |
| Product Code | 90-LLZ |
| Legal Manufacturer: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 |
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## Part 3. Legally Marketed Predicate Devices
The syngo® Ultrasound Apps Suite™ (sUSAS) as described in this 510(k) submission is substantially equivalent to the company's legally marketed device, the eSie Apps Suite as represented below:
| Primary Predicate<br>Device | 510(k) Number / Clearance<br>Date / ProCode | Substantial Equivalence<br>claimed to: |
|----------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| eSie Apps Suite (Primary<br>Predicate) | K143254 / 12/10/2014 /<br>LLZ | Syngo® Ultrasound Apps<br>Suite VA17A image display,<br>manipulation, post-<br>processing with Clinical<br>Applications Packages<br>(CAPS)<br>• Volume Review<br>• eSie LVA<br>• eSie PISA<br>• eSie Valves<br>• Including image<br>support for SC2000<br>v6.0 image data. |
| Secondary Predicate<br>Device Name | 510(k) Number / Clearance<br>Date | Substantial Equivalence<br>claimed to: sUSAS<br>support clinical image<br>review and post<br>processing using the<br>same CAPS. |
| ACUSON SC2000<br>Diagnostic Ultrasound<br>System (v5.1) – VB21A<br>Reference Predicate | K200585 / 04/22/2020 / IYO | ACUSON SC2000<br>Diagnostic Ultrasound<br>system image display,<br>manipulation, post-<br>processing with Clinical<br>Applications Packages<br>(CAPS)<br>• Volume Review<br>• eSie LVA<br>• eSie PISA<br>• eSie Valves |
| Reference Predicate<br>Devices | 510(k) Number / Clearance<br>Date | sUSAS supports clinical<br>image review and post<br>processing using the<br>same CAPS. |
| Syngo® Dynamics PAC<br>System, VA30A | K171053 / June 1, 2017 /<br>LLZ | Syngo Dynamics PAC<br>System, VA30A and earlier<br>PACS versions supports the<br>sUSAS Plug-in and<br>launches the clinical<br>applications packages<br>(CAPS) contained in the<br>sUSAS application. |
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#### Part 4. Device Description
syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).
The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.
#### Part 5. Intended Use and Indications for Use Statement
The syngo® Ultrasound Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis. The software supports the following clinical application packages:
The software supports the following clinical application pack.
- . eSie Volume Viewer
- . eSie LVA
- . eSie PISA
- . eSie Valves
The indications for use for syngo® Ultrasound Apps Suite™ (sUSAS), VA17A remains unchanged from the primary predicate device eSie Apps Suite currently cleared in K143254 except for the device name.
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## Part 6. Technological Characteristics as compared to Predicate Device
The subject device: syngo® Ultrasound Apps Suite ™ (sUSAS) is substantially equivalent to the cleared primary predicate device, eSie Apps Suite (K143254) that employs the same fundamental scientific technology and intended use/indications for use.
The clinical applications packages (CAPS) are the same version as used on the currently cleared SC2000 Diagnostic Ultrasound system v6.0 cleared under K200585 to ensure consistent functionality between the SC2000 Diagnostic Ultrasound system and the sUSAS software plug-in applications. Therefore, the SC2000 v6.0 K200585 is a secondary predicate as v6.0 contains the same CAPS as sUSAS VA17A and syngo® Dynamics PACs K171053 will be used as a reference predicate since the sUSAS application is installed as a plug-in and will be included in the comparison table.
A comparison table as Table 2 is provided on the following page:
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| Table 1: List of Technological Characteristics and SE Comparison Table | | | | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Feature /<br>Characteristic | eSie Apps Suite K143254<br>(Predicate device) | ACUSON SC2000<br>Ultrasound System<br>K200585<br>(Secondary Predicate)<br>Syngo Dynamics K171053<br>(Reference Predicate) | syngo® Ultrasound Apps<br>Suite™ (SUSAS)<br>(this submission) | |
| Device Classification<br>(Device class/Product<br>code &<br>panel/description) | Class II<br>LLZ & Radiology<br>Picture archiving and<br>Communications system | Class II<br>IYN, IYO, ITX, OBJ<br>Ultrasonic pulsed doppler<br>imaging system – and -<br>Class II<br>LLZ - PACS | Class II<br>LLZ & Radiology<br>Picture archiving and<br>Communications system | |
| Intended<br>Use/Indication for<br>Use statement | eSie Apps Suite software is a<br>software-only product to be<br>run on a user's PACS (Picture<br>Archiving and<br>Communication System)<br>workstation. It is intended<br>to launch Siemens CAPs<br>(Clinical Application<br>Packages) for image<br>processing, including the<br>acceptance, transfer, display<br>and digital processing of<br>ultrasound images. Digital<br>processing includes image<br>manipulation and<br>quantification on a<br>workstation. Use of a clinical<br>application package by a<br>qualified clinician can add<br>information to the study to be<br>used for a clinical diagnosis.<br>The software supports the<br>following clinical application<br>packages:<br>• eSie Volume<br>Viewer<br>• eSie LVA<br>• eSie PISA<br>• eSie Valves | See clearance letter for<br>K200585 in Attachment<br>B2a.<br>See reference device<br>clearance letter for<br>K171053 in Attachment<br>B3. | syngo® Ultrasound Apps<br>Suite software is a software-<br>only product to be run on a<br>user's PACS (Picture<br>Archiving and Communication<br>System) workstation. It is<br>intended to launch Siemens<br>CAPs (Clinical Application<br>Packages) for image<br>processing, including the<br>acceptance, transfer, display<br>and digital processing of<br>ultrasound images. Digital<br>processing includes image<br>manipulation and<br>quantification on a<br>workstation. Use of a clinical<br>application package by a<br>qualified clinician can add<br>information to the study to be<br>used for a clinical diagnosis.<br>The software supports the<br>following clinical application<br>packages:<br>• eSie Volume<br>Viewer<br>• eSie LVA<br>• eSie PISA<br>• eSie Valves<br>SAME AS PREDICATE | |
| | | YES -(eSie volume viewer) | Yes - SC2000 6.0 and lower | SAME - (eSie volume viewer) |
| ■ | Viewing and<br>manipulation of<br>volume datasets | YES -(eSie volume viewer) | | |
| | | | Yes - <i>syngo</i> Dynamics via<br>sUSAS installed | |
| ■ | 2D quantitative<br>tool for<br>assessment of<br>global and<br>regional<br>myocardial<br>mechanics | No | Yes SC2000 only<br>(eSie VVI) | No |
| | | | No - <i>syngo</i> Dynamics via<br>sUSAS installed | |
| ■ | 3D Left<br>Ventricle volume<br>quantitative<br>analyses (Single<br>+ Multibeat) | YES (eSie LVA) | Yes - SC2000<br>(eSie LVA) +5 beats | YES (eSie LVA) + 5 beats<br>Update to number of<br>cardiac cycles supported<br>from 3 to 5 beats, SAME<br>As SC2000 6.0 |
| | | | No - <i>syngo</i> Dynamics via<br>sUSAS installed | |
| ■ | Quantification of<br>proximal<br>isovelocity<br>surface area | YES (eSie PISA)<br>2D data acquired with TTE<br>probe | Yes - SC2000<br>(eSie PISA) 2D and 3D<br>volume date acquired with<br>TTE, TEE and ICE probes.<br>Color Doppler & B mode. | YES (eSie PISA)<br>2D and 3D volume date<br>acquired with TTE, and TEE<br>probes.<br>Color Doppler only. |
| | | | No- <i>syngo</i> Dynamics via<br>sUSAS installed | |
| ■ | 2D Automated<br>tool to identify<br>and measure<br>contours of left<br>ventricle and<br>atrium from<br>transthoracic<br>exams (TTE) | No | Yes - SC2000<br>(eSie Left Heart) | No |
| | | | No- <i>syngo</i> Dynamics via<br>sUSAS installed | |
| ■ | Visualize and<br>quantify mitral<br>and aortic valve<br>anatomy | YES (eSie Valves) | Yes - SC2000<br>(eSie Valves) | YES (eSie Valves)<br>Same as SC2000 6.0 with<br>defect corrections |
| | | | No - <i>syngo</i> Dynamics via<br>sUSAS installed | |
| ■ | GUDID<br>Compliance | Yes VA16A | Yes - SC2000 | YES<br>VA16A |
| | | | Yes - <i>syngo</i> Dynamics | |
| ■ | Volume Load<br>Performance | 80 secs | N/A for SC2000 | 40 secs<br>SAME AS VA16A |
| (Volume load<br>time in volume<br>review) | | | | |
| ■ Support SC2000<br>datasets<br>compatibility | Yes -<br>VA16A - v5.0<br>VA16B - v5.1 | Yes - <i>syngo</i> Dynamics<br>VA30A and earlier via sUSAS<br>installed. | Yes, SC2000<br>6.0 clearance (K200585) | |
| ■ eSie PISA and<br>TTE (only<br>support with<br>TTE Color<br>Doppler volume<br>data) | YES VA16A | Yes for SC2000 5.0 and<br>higher.<br>----------------------------------<br>Yes, supported on <i>syngo</i><br>Dynamics imaging via sUSAS<br>VA16A | YES (eSie PISA)<br>Supports TTE Color Doppler<br>Volume same as VA16A | |
| ■ <i>Syngo</i> Dynamics<br>(sUSAS support<br>for SC2000 5.1<br>data) | YES SyDx VA10 | Yes - <i>syngo</i> Dynamics<br>With sUSAS VA16B | YES SyDx VA20 | |
| ■ <i>Syngo</i> Dynamics<br>(sUSAS support<br>for SC2000 6.0<br>data) | YES SyDx VA10 | Yes - <i>syngo</i> Dynamics<br>With sUSAS VA17A | YES SyDx VA20 | |
| ■ Windows 10<br>Support | No | Yes - SC2000 6.0<br>----------------------------------<br>Yes - <i>syngo</i> Dynamics via<br>sUSAS installed | YES (New) for VA17A<br>SAME as SC2000 6.0 | |
| ■ DICOM Media<br>Storage Service | YES | Yes - SC2000 6.0 and lower<br>----------------------------------<br>Yes - <i>syngo</i> Dynamics via<br>sUSAS installed | YES - SAME | |
| ■ DICOM Structed<br>Reporting | YES | Yes - SC2000 6.0 and lower<br>----------------------------------<br>Yes - <i>syngo</i> Dynamics via<br>sUSAS installed | √ YES - SAME | |
| ■ Display<br>Improvements | No | SC2000 v6.0 - Yes | Yes aligns with SC2000<br>6.0 | |
| VR Measurement<br>Tools<br>■ (Volume) | No | SC2000 v6.0 - Yes | The ability to measure anatomy<br>and pathology directly on the<br>Volume Rendered (VR) images<br>in CINE and acquired in 4D.<br>Same as on SC2000 6.0 | |
| Reference Lines<br>One-click MPR<br>alignment<br>■ | No | SC2000 v6.0 - Yes | New Display Feature<br>Same as on SC2000 6.0 | |
| Volume Reference<br>Line Projections<br>eSie Slice / eSie<br>Lines<br>■ | No | SC2000 v6.0 - Yes | New Display Feature<br>Same as on SC2000 6.0 | |
| ■ One-click MPR<br>A/B Align on<br>Volume Review<br>(VR) | No | SC2000 v6.0 - Yes | New Display Feature<br>Same as on SC2000 6.0…
