(57 days)
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.
syngo plaza is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. syngo.plaza will be installed by Siemens service engineers. The backend communication and storage solution is based in Windows 2008 operating systems as described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The clients are based on Windows XP as also described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519) The syngo plaza will be marketed as a software only solution for the end-user (with recommended hardware requirements). It will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be I any spond individual service contract and fulfilled by special trained service technicians. This is also applicable for the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The herewith described syngo plaza VA20A supports DICOM formatted images and This which is also described for the predicate devices syngo.plaza VA10A (093612), syngo.x (K092519) and syngo Imaging (K071114).
The provided text describes the syngo.plaza VA20A, a Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically found in performance studies for AI/CADe devices.
The document is a 510(k) summary for a PACS system, which primarily focuses on stating substantial equivalence to predicate devices based on intended use and technical characteristics, rather than detailed performance metrics of a novel algorithm or diagnostic aid.
Here's a breakdown of what is and is not present, based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document describes the system's functionalities (display, process, read, report, communicate, distribute, store, and archive digital medical images) and states that software verification and validation were performed according to various standards (DICOM, JPEG, ISO, IEC, HL7). It concludes that "Siemens is of the opinion, that syngo plaza is substantially equivalent to and performs as well as the predicate device." There are no quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance criteria for such metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No specific test set, sample size, or data provenance is mentioned as this is not a clinical performance study of an AI algorithm.
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 provided. Ground truth establishment is not relevant in this context, as there's no clinical performance study reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Not applicable.
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 provided. No MRMC study is mentioned. The device is a PACS system, not an AI or CADe product designed to assist human readers in a diagnostic task in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. Not applicable, as this is a PACS system and not a standalone AI algorithm with diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. Not applicable.
8. The sample size for the training set:
- Not provided. Not applicable, as this is a PACS system, not an AI algorithm that undergoes specific training on a dataset.
9. How the ground truth for the training set was established:
- Not provided. Not applicable.
In summary, the provided document is a regulatory submission (510(k) summary) for a PACS system (syngo.plaza VA20A) demonstrating its substantial equivalence to previously cleared predicate devices. It focuses on functional descriptions, compliance with technical standards, and risk management, rather than detailed performance studies of an AI diagnostic component as would be required for a device claiming to interpret images or assist in diagnosis via AI/CAD.
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510(k) Summary
AUG 1 0 2010
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.
GENERAL INFORMATION
Establishment:
FDA CDRH DMC
| Address: | Siemens AG, Medical SolutionsHenkestrasse 127D-91052 ErlangenGermany |
|---|---|
| Registration Number: | 3002808157 |
| Contact Person: | Sabine Schroedel |
JUN 14 2010,
ReceivedSabine Schroedel Regulatory Affairs Manager Telephone: +49 (9131) 84-8285 Telefax: +49 (9131) 84-2792
Device Name and Classification:
Trade Name:
šyngo.plazaVA20A
Classification Name: Picture Archiving and Communications System
Classification Panel:
21 CFR §892.2050
Class II
LLZ
Radiology
Device Class:
Product Code:
CFR Section:
Date of Submission:
May 17, 2010
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
Device Description and Intended Use: .
syngo nlaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images.
It supports the physician in diagnosis and treatment planning.
For primary image diagnosis in Mammography only uncompressed or non-lossy I or primary images and only preprocessed DICOM "For Presentation" images must be
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used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports.
In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information
Systems (HIS/RIS) to enable customer specific workflows.
syngo.plaza optionally uses a variety of advanced postprocessing applications.
Note:
Web-based image distribution is not intended for reporting.
syngo.plaza Workplaces
The three syngo.plaza workplace deployments ...
syngo.plaza Cluster Client a)
syngo.plaza Web Client b)
- syngo.plaza Standalone Workstation c)
... are medical diagnostic and viewing workstations intended for post processing, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allow radiologists and radiological technicians to receive and process all data needed.
By usage of only specific FDA approved monitors validated together with the software, diagnosis on digital mammography images is possible.
Integration
The integration of syngo plaza shall be applied at different levels and by using technologies like sharing the same HW/SW platform, offering an open interface for other vendors to connect with other DICOM nodes and especially the DICOM Archive functionality, with other information systems (mainly RIS).
Technological Characteristics: .
syngo plaza is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. syngo.plaza will be installed by Siemens service engineers.
The backend communication and storage solution is based in Windows 2008 operating systems as described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The clients are based on Windows XP as also described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519)
The syngo plaza will be marketed as a software only solution for the end-user (with recommended hardware requirements). It will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be I any spond individual service contract and fulfilled by special trained service technicians. This is also applicable for the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519).
The herewith described syngo plaza VA20A supports DICOM formatted images and This which is also described for the predicate devices syngo.plaza VA10A (093612), syngo.x (K092519) and syngo Imaging (K071114).
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Summary of Non-Clinical Testing:
The software verification and validation (Unit Test Level, Integration Test Level and System Test Level) was performed for all newly developed components and the complete system according the following standards:
- DICOM Standard [2008]
- JPEG/JPEG 2000 Standard [1992, 2002]
- SMPTE Test Pattern [1995]
- ISO 14971:2007
- IEC 60601-1-4 + A1 [1999]
- IEC 60601-1-6 [2006]
- HL7 [2006]
- IEC 62304 [2006]
- ISO/IEC 13818 [2009]
After completion of the system test and comparison of the test results with the software release acceptance criteria, Siemens is of the opinion, that syngo plaza is substantially equivalent to and performs as well as the predicate device.
General Safety and Effectiveness Concerns: .
The device labelling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.
Substantial Equivalence:
The syngo.plaza, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:
| Siemens | syngo.plaza VA10A | K093612 |
|---|---|---|
| Siemens | syngo Imaging V30 | K071114 |
| Siemens | syngo.x | K092519 |
The syngo.plaza described in this 510(k) has the same intended use and similar technical characteristics as the devices listed above in regard to the specific functionalities. In summary, Siemens is of the opinion that syngo.plaza VA20A does not introduce any new
ally liew predicate devices.
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TUV SUD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
AUG 1 0 2010
Re: K101666
Trade/Device Name: syngo, plaza VA20A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 16, 2010 Received: July 22, 2010
Dear Mr. Preiss:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device or your device to a regally marke to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFN Palis 101 796 5450. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollit me (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): Device Name:
syngo, plaza VA20A
Indications For Use:
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images.
It supports the physician in diagnosis and treatment planning.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used.
syngo.plaza also supports DICOM Structured Reports.
In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications.
Note:
Web-based image distribution is not intended for reporting.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
| (Please do not write below this line - continue on another page if needed) |
|---|
rrence of the CDRH, Office of In Vitro Diagnostics (OIVD) (Division Sign-Off)
Division of Nadiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K
510(k) for syngo.plaza VA20A
1 0 2010
માલિ
§ 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).