(21 days)
None
No
The document describes standard image viewing, manipulation, and processing software without mentioning AI or ML capabilities.
No.
The device is described as a software solution for viewing, manipulating, communicating, and storing medical images to support diagnosis and treatment planning, not for providing therapy.
Yes
Explanation: The "Device Description" states that the system "has workplaces which can be used to review, edit, and manipulate image data, as well as generate quantitative and qualitative data to support an authorized user in diagnosis and treatment planning." This directly indicates its role in supporting diagnosis.
Yes
The device description explicitly states "syngo®.via protoNeo version VA20 is a software only medical device." It also clarifies that the hardware it runs on is not considered a medical device and is outside the scope of the submission.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of syngo.via protoNeo is for "viewing, manipulation, communication, and storage of medical images." This involves processing and displaying images acquired from medical imaging modalities, not analyzing biological samples.
- Device Description: The device description explicitly states it "receives, stores and distributes images from digital image acquisition devices such as computer tomography and magnetic resonance scanners." This reinforces its role in handling medical images, not biological samples.
- Lack of Mention of Biological Samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample throughout the provided text.
Therefore, syngo.via protoNeo is a medical image processing and management software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo.via protoNeo is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.
syngo.via protoNeo supports interpretation and evaluation of examinations within healthcare institutions network, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S
Product codes
LLZ
Device Description
This premarket submission addresses the Siemens syngo®.via protoNeo Version VA20 Picture Archiving and Communication System.
syngo®.via protoNeo, version VA20, is a medical software system that provides tools and features to cover the radiological tasks of reading images. The system receives, stores and distributes images from digital image acquisition devices such as computer tomography and magnetic resonance scanners. The system has workplaces which can be used to review, edit, and manipulate image data, as well as generate quantitative and qualitative data to support an authorized user in diagnosis and treatment planning.
syngo®.via protoNeo version VA20 is a software only medical device. It defines recommended configurations for the hardware to run on. The hardware itself is not seen as a medical device and is not within the scope of this 510(k) submission.
syngo®.via protoNeo is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage while incorporating the local database. The client provides the user interface for interactive image viewing and processing and can be installed and stored on each workplace which is connected to the server over a network. Since the majority of the data processing is performed by the server, the client can be installed on standard off-the-shelf computers with a variety of monitor types. Using the industry standard application virtualization infrastructure, the client systems can also be distributed as a virtual application.
The quality of displayed images highly depends on the quality and settings of monitors, graphics cards, and graphics drivers. It is the customer's responsibility that client monitors are compatible with graphics cards and graphics drivers. It is also the customer's responsibility to use suitable monitors for diagnostic purposes.
In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM Ultrasound, XA, RF, CT, MR, DX, CR and Nuclear Medicine, including PET.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare institutions' network, for example, in Radiology, Nuclear Medicine and Cardiology environments. The device is only used by trained professionals.
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
No clinical studies were carried out for syngo.via protoNeo VA20. All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device. Non-clinical testing was conducted for the device syngo.via protoNeo during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Key Metrics
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, there 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, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
November 20, 2017
Siemens Healthcare GmbH % Dawn Tibodeau Third Party 510(k) Project Coordinator TUV SUD America Inc. 1775 Old Highway 8 NW NEW BRIGHTON, MN 55112
Re: K173378
Trade/Device Name: syngo®.via protoNeo (Version VA20) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 23, 2017 Received: October 30, 2017
Dear Dawn Tibodeau:
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 (QS) regulation (21 CFR Part 820);
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Page 2 - Dawn Tibodeau
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 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 A. 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K173378
Device Name syngo®.via protoNeo (Version VA20)
Indications for Use (Describe)
syngo.via protoNeo is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.
syngo.via protoNeo supports interpretation and evaluations within healthcare institutions' network, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The logo consists of the words "SIEMENS" in a bold, sans-serif font on the top line, and "Healthineers" in a similar font on the bottom line. To the right of the word "Healthineers" is a cluster of dots arranged in a circular pattern, with the dots increasing in size from left to right.
510(k) Summary
syngo®.via protoNeo (Version VA20)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date prepared: July 19, 2017
1. Submitter
Siemens Healthcare GmbH Henkestrasse 127 D-91052 Erlangen Germany
Establishment Registration Number 3002808157
2. Contact Person
Mr. Abhineet Johri Regulatory Affairs Manager Siemens Healthcare GmbH 40 Liberty Boulevard Mail code: 65-3 Malvern, PA 19355 USA Email: abhineet.johri@siemens.com Telephone: +1 (484) 680 - 8723 Fax: +1 (610) 448 – 6557
3. Device Name and Classification
| Trade Name: | syngo®.via protoNeo (Version VA20) |
|---|---|
| Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
4. Legally Marketed Predicate Device
| Trade Name: | syngo®.via protoNeo |
|---|---|
| 510(k) Clearance: | K161685 |
©Siemens Healthcare GmbH, 2017
40 Liberty Boulevard Malvern, PA 19355-9998 USA
Tel.: +1-888-826-9702 www.usa.siemens.com/healthcare
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© Siemens Healthcare GmbH, 2017
Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:
July 11, 2016 Picture Archiving and Communication System Radiology 21 CFR §892.2050 Class II LLZ This predicate device has not been the subject of any design related recalls.
5. Device Description
This premarket submission addresses the Siemens syngo®.via protoNeo Version VA20 Picture Archiving and Communication System.
syngo®.via protoNeo, version VA20, is a medical software system that provides tools and features to cover the radiological tasks of reading images. The system receives, stores and distributes images from digital image acquisition devices such as computer tomography and magnetic resonance scanners. The system has workplaces which can be used to review, edit, and manipulate image data, as well as generate quantitative and qualitative data to support an authorized user in diagnosis and treatment planning.
syngo®.via protoNeo version VA20 is a software only medical device. It defines recommended configurations for the hardware to run on. The hardware itself is not seen as a medical device and is not within the scope of this 510(k) submission.
syngo®.via protoNeo is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage while incorporating the local database. The client provides the user interface for interactive image viewing and processing and can be installed and stored on each workplace which is connected to the server over a network. Since the majority of the data processing is performed by the server, the client can be installed on standard off-the-shelf computers with a variety of monitor types. Using the industry standard application virtualization infrastructure, the client systems can also be distributed as a virtual application.
The quality of displayed images highly depends on the quality and settings of monitors, graphics cards, and graphics drivers. It is the customer's responsibility that client monitors are compatible with graphics cards and graphics drivers. It is also the customer's responsibility to use suitable monitors for diagnostic purposes.
In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.
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syngo®.via protoNeo and its predicate device have the same fundamental technical characteristics.
6. Intended Use
syngo.via protoNeo is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.
syngo.via protoNeo supports interpretation and evaluation of examinations within healthcare institutions network, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S
7. Summary of Differences Between the Subject Device and the Predicate Device
The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison table:
| Functionality | syngo®.via protoNeo
version VA20 | syngo®.via protoNeo
version VA10A
(K161685) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Browser | Yes, Import, Query and retrieve
available | Yes |
| Image Display | DICOM Ultrasound, XA, RF, CT,
MR, DX, CR and Nuclear
Medicine, including PET.
Fused view. | CT and MR |
| Imaging Algorithms | - Multiplanar reconstruction
(MPR)
- Maximum Intensity Projection
(MIP) - Volume Rendering Technique
(VRT) with edge and surface
enhancements and control
over rendering parameters - MPR Curved (Curved Planar
Reformat, CPR) with threshold
based contour and stenosis
display - Region growing
- Edge enhancement( Unsharp
Masking Technique) | - Multiplanar reconstruction
(MPR) - Maximum Intensity Projection
(MIP) - Volume Rendering Technique
(VRT) with edge and surface
enhancements and control
over rendering parameters - MPR Curved (Curved Planar
Reformat, CPR) - Region growing |
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| Quantitative
Algorithms | Distance, angle, area, and pixel
value evaluation including SUV
and Volume measurement
enhancements | Distance, angle, area, and pixel
value evaluation. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automatic self tests | - Client installer checks that the
client has supported version of
.NET framework
- A version check for compatibility
between client and server on
every start-up - DICOM parser checks if the
image object is corrupted - If there is image missing in a
volume, show the according
message to the user and then
load the data to 2D view only | - Client installer checks that the
client's has supported version of
.NET framework - A version check for
compatibility between client and
server on every start-up - DICOM parser checks if the
image object is corrupted - If there is image missing in a
volume, do not load the data and
ask the user to check data
source |
| Dual monitor support | Yes | No |
| Series navigator | Yes | No |
| Cyber security | Login with encryption
Client-server communication
encrypted | Login with encryption |
8. Clinical Testing
No clinical studies were carried out for syngo.via protoNeo VA20. All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.
9. Non-Clinical Performance Testing
Non-clinical testing was conducted for the device syngo.via protoNeo during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens claims conformance to the following standards:
- . NEMA PS3.1-3.20. 2016: Digital Imaging and Communications in Medicine (DICOM)
- ISO 14971:2007 .
- ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, clauses 14.11 and 14.13 .
- . AAMI ANSI IEC 62304: 2006
- IEC 62366-1:2015 .
- . IEC 10918-1:1994 + Technical Corrigendum 1:2005
- IEC 15444-1:2005 + Technical Corrigendum 1:2007 .
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Software Verification and Validation
In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.
Cybersecurity considerations related to syngo.via protoNeo are included within this submission. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
A risk analysis, in compliance with ISO 14971:2007, for syngo.via protoNeo was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirms that all software specifications have been implemented met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.
10. Safety and Effectiveness Information
Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.
The device does not come into contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.
Siemens believes that syngo.via protoNeo version VA20 is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.
11. Conclusion as to Substantial Equivalence
The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo.via protoNeo is safe, effective and performs as well as the predicate device.
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© Siemens Healthcare GmbH, 2017
In summary, Siemens is of the opinion that syngo.via protoNeo version VA20 does not introduce any new significant potential safety risks and is substantially equivalent to the predicate device.