(14 days)
syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
syngo® Imaging also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngo® Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows.
Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.
This premarket notification covers Siemens enhanced PACS system syngo® Imaging, version V20A.
syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
syngo® Imaging also supports storage and archiving of Structured DICOM Reports.
Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.
The system is a "hardware independent" solution to be distributed either as software only or combined with common IT hardware which must comply to predefined minimum hardware requirements.
The version V20A contains improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended functionality.
The three syngo® Imaging workplace deployments ...
- syngo® Web Studio a web-based viewing application mainly used for image distribution a)
- syngo® Basic Studio for basic reporting, inside as well as outside of the radiology b) (standalone workstation)
- syngo® Advanced Studio Advanced Application Bundle for use inside the radiology c) with advanced reporting functionality
... are medical diagnostic and viewing workstations intended for postprocessing, reporting, viewing and communicating / distributing of radiological softcopy images (including digital mammographic images) and so allow radiologists and radiological technicians to receive and process all data needed.
Based on Siemens syngo® software, the syngo® Imaging supports the wide variety of image types and its modular design and is capable of combining applications from different modalities in one workstation.
The syngo® Advanced Studio integrates the modality specific application package syngo® CT Colonography (K042605).
By usage of specific FDA approved monitors (Barco: Coronis dual head 21.3" Medical -K042221; Siemens AG: SMVD 21500 or DjSB-2103-D-5MP - K043122; Planar, Dome C5i-1 and C5i-2 - K032202) diagnosis on digital mammography images is possible, if images are not compressed lossy, as disclaimed respectively.
syngo® Imaging Data Management ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy.
The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports.
For PACS server the syngo® Imaging Data Management can be used as a DICOM-Archive (LTS Longterm Storage) in accordance with the DICOM Conformance Statement.
syngo® Imaging (version V20A) is a "software only"-system, which will be delivered on CD-ROM / DVD or as a complete radiology solution consisting of common IT hardware and preinstalled software. syngo® Imaging will be installed by Siemens service engineers.
Defined Hardware requirements are to be met.
The backend communication and storage solution (DM) is based on the Solaris 8 operating system. The workplaces are based on Windows XP, as well as LINUX and IBM operating systems.
The herewith described syngo® Imaging supports DICOM formatted images and objects.
This 510(k) summary for the syngo® Imaging (V20A) PACS system does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) that would typically be required to prove a device meets specific acceptance criteria in the way you've outlined.
This document is a premarket notification for a Picture Archiving and Communication System (PACS), which is a general imaging software. The FDA 510(k) pathway for such devices often relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific performance metrics and acceptance criteria for diagnostic accuracy.
Therefore, I cannot fill out the requested table or answer most of the questions fully as the provided text does not contain this information.
Here's what I can extract and explain based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not specify quantitative acceptance criteria for image display, processing, or diagnostic accuracy. For a PACS, acceptance criteria would typically focus on functionalities like image loading speed, display quality (resolution, grey-scale accuracy), data integrity, storage capacity, and adherence to DICOM standards. These are generally verified through engineering and functional testing rather than clinical study performance metrics.
- Reported Device Performance: The document states that the device "performs as well as the predicate devices" in terms of its intended use and similar technical characteristics. It notes "improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended functionality." However, it doesn't provide specific performance metrics (e.g., image loading times, display luminance, or diagnostic accuracy scores) to quantify these improvements or compare them against predifined acceptance criteria.
2. Sample size used for the test set and the data provenance:
* Not explicitly stated. The document mentions "verification and validation testing" as part of risk management, but it does not specify any test set size or data provenance (e.g., country of origin, retrospective/prospective) for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/not stated. As there's no diagnostic performance study described, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/not stated. No adjudication method is mentioned as there's no described diagnostic performance study.
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:
* No. The document does not describe an MRMC study. This device is a PACS, not an AI-powered diagnostic tool, so such a study would not typically be performed or relevant for its 510(k) submission based on the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. This is a PACS, an infrastructure and viewing system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable/not stated. No ground truth is discussed as no diagnostic performance study is presented.
8. The sample size for the training set:
* Not applicable/not stated. This is a PACS, not a machine learning model, so there is no concept of a "training set" in the context of its performance validation as described here.
9. How the ground truth for the training set was established:
* Not applicable/not stated. As there is no training set mentioned, there's no information on how its ground truth was established.
Summary of what the document does communicate regarding safety and effectiveness:
- Intended Use: Display, process, read, report, communicate, distribute, store, and archive digital radiological images, including digital mammography images, to support physicians in diagnosis and treatment planning.
- Predicate Devices: Siemens SIENET Cosmos (K042832), LEONARDO (K040970), MammoReport Softcopy Workstation (K042868).
- Substantial Equivalence Argument: Siemens argues that syngo® Imaging (V20A) "has the same intended use and similar technical characteristics" as the predicate devices and "does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."
- Safety and Effectiveness Concerns: Risk management via risk analysis, software development, verification and validation testing, and adherence to industry practices and standards to minimize electrical, mechanical, and radiation hazards. The device labeling contains instructions for use and warnings.
- Key Features Highlighted: Enhanced workplace functionality, layout and display improvements, amended functionality, support for various image types, modular design, integration of syngo® CT Colonography, data management for storage and archiving, HL7/DICOM compatible RIS integration, and support for specific FDA approved monitors for digital mammography.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence of the syngo® Imaging PACS to existing predicate devices based on intended use, technological characteristics, and safety considerations. It does not contain the detailed, quantitative performance study data with specific acceptance criteria, sample sizes, ground truth establishment, or reader studies that would be present for a novel diagnostic algorithm or a device requiring specific performance claims. For a PACS, the "acceptance criteria" are predominantly functional and safety standards, verified through internal engineering and quality assurance processes, rather than clinical efficacy trials.
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510(k) Summary
K0524lel
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 I.
Establishment:
| • Address: | Siemens AG, Medical Solutions |
|---|---|
| Henkestrasse 127 | |
| D-91052 Erlangen | |
| Germany |
- Registration Number: 3002808157 .
| Contact Person: | Eva ReiterRegulatory Affairs ManagerTelephone: +49 (9131) 84-2680Telefax: +49 (9131) 84-2792 |
|---|---|
| ----------------- | ---------------------------------------------------------------------------------------------------------- |
Device Name and Classification:
| Trade Name: | syngo® ImagingVersion V20A |
|---|---|
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
. Device Description and Intended Use:
This premarket notification covers Siemens enhanced PACS system syngo® Imaging, version V20A.
syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
syngo® Imaging also supports storage and archiving of Structured DICOM Reports.
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Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.
The system is a "hardware independent" solution to be distributed either as software only or combined with common IT hardware which must comply to predefined minimum hardware requirements.
The version V20A contains improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended functionality.
syngo® Imaging Workplaces
The three syngo® Imaging workplace deployments ...
- syngo® Web Studio a web-based viewing application mainly used for image distribution a)
- syngo® Basic Studio for basic reporting, inside as well as outside of the radiology b) (standalone workstation)
- syngo® Advanced Studio Advanced Application Bundle for use inside the radiology c) with advanced reporting functionality
... are medical diagnostic and viewing workstations intended for postprocessing, reporting, viewing and communicating / distributing of radiological softcopy images (including digital mammographic images) and so allow radiologists and radiological technicians to receive and process all data needed.
Based on Siemens syngo® software, the syngo® Imaging supports the wide variety of image types and its modular design and is capable of combining applications from different modalities in one workstation.
The syngo® Advanced Studio integrates the modality specific application package syngo® CT Colonography (K042605).
By usage of specific FDA approved monitors (Barco: Coronis dual head 21.3" Medical -K042221; Siemens AG: SMVD 21500 or DjSB-2103-D-5MP - K043122; Planar, Dome C5i-1 and C5i-2 - K032202) diagnosis on digital mammography images is possible, if images are not compressed lossy, as disclaimed respectively.
syngo® Imaging Data Management
... ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy.
The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports.
For PACS server the syngo® Imaging Data Management can be used as a DICOM-Archive (LTS Longterm Storage) in accordance with the DICOM Conformance Statement.
105246
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Integration:
The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the syngo® Imaging PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.
Technological Characteristics: .
syngo® Imaging (version V20A) is a "software only"-system, which will be delivered on CD-ROM / DVD or as a complete radiology solution consisting of common IT hardware and preinstalled software. syngo® Imaging will be installed by Siemens service engineers.
Defined Hardware requirements are to be met.
The backend communication and storage solution (DM) is based on the Solaris 8 operating system. The workplaces are based on Windows XP, as well as LINUX and IBM operating systems.
The herewith described syngo® Imaging supports DICOM formatted images and objects.
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. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
. Substantial Equivalence:
The syngo® Imaging, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:
| Siemens | SIENET Cosmos | K042832 |
|---|---|---|
| Siemens | LEONARDO | K040970 |
| Siemens | MammoReport Softcopy Workstation | K042868 |
The syngo® Imaging 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® Imaging does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
SEP 2 2 2005
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K052461
Trade/Device Name: syngo® Imaging (Version V20A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II . Product Code: LLZ Dated: September 1, 2005 Received: September 8, 2005
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 either class II (Special Controls) or class III (Premarket : Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter will anow you to begin maneting your antial equivalence of your device to a legally premarket nothleation: "The I Driving of easilication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your active of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entition, to mation on your responsibilities under the Act from the 807.97). You may obtain other gollord missistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K 052461 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
syngo® Imaging also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngo® Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows.
Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.
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)
============================================================================================================================================================================== ncurrence of the CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number R052461
§ 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).