(15 days)
The SIENET Cosmos is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e.
- Manipulating .
- Reading .
- . Reporting
- Viewing .
- Communicating / distributing .
- Storing / archiving .
- of radiological softcopy images and
- . Storing / archiving of structured (DICOM) reports.
The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning,
Therefore SIENET Cosmos supports the following generic imaging workflow:
- . Receive scheduled exams from IS at the SIENET Cosmos archiving component SDM
- Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces .
- . Receive and store new exams from the Modalities at the SDM
- Prepare images for reading .
- . Report new images, if required by comparing them with prior exams and reports
- Demonstrate exams at Radiological Demos .
- View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).
Note:
The workstation deployment syngo® Viewing Studio is not intended for primary diagnosis.
This premarket notification covers Siemens enhanced PACS system SIENET Cosmos, version V15A.
SIENET Cosmos is a "software only"- solution, including a backend communication and storage component and three different workplace deployments for medical imaging tasks and applications. It can be distributed as software only as well as preinstalled on hardware which meets the defined minimum requirements.
SIENET Cosmos is the integrated radiology suite for large radiological practices and community hospitals. Important factors are the centralized server structure, the wide ranging data distribution and the overall integrated concept, ranging from scheduling the examination to reporting and archiving as well as image and report distribution. The version V15A contains improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended service functionality.
The three SIENET Cosmos workplace deployments ...
a) syngo® Viewing Studio - for image distribution (web-based viewing application not intended for primary diagnosis!)
b) syngo® Reporting Studio - for basic reporting, inside as well as outside of the radiology (standalone workstation)
c) syngo® Reporting Studio - Advanced Application Bundle - for use inside the radiology with advanced reporting functionality
... are medical diagnostic and viewing workstations intended for manipulating, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allows radiologists and radiological technicians to receive and process all data needed.
SIENET Cosmos Image 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.
The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the SIENET Cosmos PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.
SIENET Cosmos (version V15A) is a "software only"-system, which will be delivered on CD-ROM / DVD or as a complete radiology solution consisting of hardware and preinstalled software. SIENET Cosmos will be installed by Siemens service engineers.
Defined Hardware requirements are to be met.
The backend communication and storage solution (SDM) is based on the Solaris 8 operating system. The workplaces are based on Windows 2000 / Windows XP operating system.
The herewith described SIENET Cosmos supports DICOM formatted images and objects.
The version V15A contains an extended range of compression mode in comparison to version V10A.
The provided text is a 510(k) summary for the SIENET Cosmos, version V15A, a Picture Archiving and Communications System (PACS). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, and performance metrics is not present in this type of regulatory document.
However, I can extract the available information and state which points are not covered.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use: Enhance the complete imaging workflow for radiological images and structured (DICOM) reports: Manipulating, Reading, Reporting, Viewing, Communicating/distributing, Storing/archiving. | The device performs these functions as well as the predicate device (SIENET Cosmos, K033831). |
| Technological Characteristics: "software only"-system, based on Solaris 8 (backend) and Windows 2000/XP (workplaces), supports DICOM formatted images/objects, extended range of compression modes. | The device operates effectively with the specified operating systems and supports DICOM, with improved compression, similar to or better than the predicate. |
| Safety and Effectiveness: No new potential safety risks and performs as well as the predicate device. | Risk management (risk analysis, software development, verification/validation testing) is in place, and the device adheres to industry practices and standards to minimize hazards. |
Explanation: In a 510(k) process for a PACS, the "acceptance criteria" are generally tied to the demonstration of substantial equivalence to a legally marketed predicate device. This means the new device must perform as well as, or be no less safe or effective than, the predicate. The document doesn't provide quantifiable, specific acceptance thresholds (e.g., "DICOM conformance rate must be >99%"). Instead, it asserts that the new version is substantially equivalent, implying it meets the current standards for such systems.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. This document does not detail any specific clinical performance testing with a "test set" of images or data; rather, it refers to internal "verification and validation testing" (a general quality assurance statement).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as detailed clinical testing with expert-established ground truth is not described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as a test set with expert ground truth establishment is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Was an MRMC study done? No. The document does not mention any MRMC study.
- Effect Size of Human Readers with/without AI assistance: Not applicable, as this is a PACS system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Was a standalone study done? Not applicable in the context of an algorithm's diagnostic performance. This device is a PACS (Picture Archiving and Communications System), which is a software system for managing, viewing, and distributing images, not an autonomous diagnostic algorithm. Its "performance" is related to its functionality, data integrity, and usability within the clinical workflow, rather than a diagnostic accuracy metric. The document mentions "verification and validation testing" which would cover the standalone functionality of the PACS itself (e.g., proper image storage, retrieval, display, and communication).
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for diagnostic performance metrics, as this document is about a PACS system's substantial equivalence, not a diagnostic algorithm's accuracy. For the PACS's own functionality, the "ground truth" would be its adherence to specified technical requirements (e.g., DICOM standards, data integrity, system uptime, and usability).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not pertain to an algorithm developed through machine learning, and therefore, there is no "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no mention of a machine learning training set.
Summary of Document Focus:
This 510(k) summary (K042832) for SIENET Cosmos version V15A primarily focuses on asserting substantial equivalence to an existing legally marketed device (SIENET Cosmos, K033831). It describes the device's intended use (PACS functionality), technological characteristics (software-only, operating systems, DICOM support), and general safety and effectiveness considerations (risk management, adherence to standards). It does not provide details on specific clinical performance studies, such as those that would involve acceptance criteria for diagnostic accuracy, test sets, expert ground truth, or MRMC studies, because a PACS system's regulatory pathway typically emphasizes functionality, safety, and compatibility rather than clinical diagnostic outcome metrics in the same way an AI diagnostic algorithm would.
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OCT 2 8 2004
510(k) Summary
K042832
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.
I. GENERAL INFORMATION
Establishment:
| Address: | Siemens AG, Medical SolutionsHenkestrasse 127D-91052 ErlangenGermany |
|---|---|
| Registration Number: | 3002808157 |
| Contact Person: | Eva Reiter |
Li Regulatory Affairs Manager Telephone: +49 (9131) 84-2680 +49 (9131) 84-2792 Telefax:
Device Name and Classification:
| ● | Trade Name: | SIENET CosmosVersion V15A |
|---|---|---|
| ● | Classification Name: | Picture Archiving and Communications System |
| ● | Classification Panel: | Radiology |
| ● | CFR Section: | 21 CFR §892.2050 |
| ● | Device Class: | Class II |
| ● | Product Code: | LLZ |
Date of Preparation of Summary: September 30, 2004
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
. Device Description and Intended Use:
This premarket notification covers Siemens enhanced PACS system SIENET Cosmos, version V15A.
SIENET Cosmos is a "software only"- solution, including a backend communication and storage component and three different workplace deployments for medical imaging tasks and applications. It can be distributed as software only as well as preinstalled on hardware which meets the defined minimum requirements.
SIENET Cosmos is the integrated radiology suite for large radiological practices and community hospitals. Important factors are the centralized server structure, the wide
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ranging data distribution and the overall integrated concept, ranging from scheduling the examination to reporting and archiving as well as image and report distribution. The version V15A contains improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended service functionality.
SIENET Cosmos Integrated Workplaces / SIENET Cosmos Image Distribution
The three SIENET Cosmos workplace deployments ...
a) syngo® Viewing Studio - for image distribution (web-based viewing application not intended for primary diagnosis!)
b) syngo® Reporting Studio - for basic reporting, inside as well as outside of the radiology (standalone workstation)
c) syngo® Reporting Studio - Advanced Application Bundle - for use inside the radiology with advanced reporting functionality
... are medical diagnostic and viewing workstations intended for manipulating, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allows radiologists and radiological technicians to receive and process all data needed.
SIENET Cosmos Image 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.
Integration: SIENET Cosmos Imaging Workflow Management
The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the SIENET Cosmos PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.
. Technological Characteristics:
SIENET Cosmos (version V15A) is a "software only"-system, which will be delivered on CD-ROM / DVD or as a complete radiology solution consisting of hardware and preinstalled software. SIENET Cosmos will be installed by Siemens service engineers.
Defined Hardware requirements are to be met.
The backend communication and storage solution (SDM) is based on the Solaris 8 operating system. The workplaces are based on Windows 2000 / Windows XP operating system.
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The herewith described SIENET Cosmos supports DICOM formatted images and objects.
The version V15A contains an extended range of compression mode in comparison to version V10A.
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 SIENET Cosmos, Version V15A, addressed in this premarket notification, is substantially equivalent to the following commercially available device:
SIENET Cosmos
The SIENET Cosmos described in this 510(k) has the same intended use and similar technical characteristics as the device listed above.
In summary, Siemens is of the opinion that SIENET Cosmos does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2004
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: K042832 Trade/Device Name: SIENET Cosmos (version V15A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: October 11, 2004 Received: October 13, 2004
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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one 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 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.ggy/cdrh/dsmadsmam.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
Kou2832 510(k) Number (if known): Device Name: _______________ SIENET Cosmos (version V15A)
Indications For Use:
The SIENET Cosmos is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e.
- Manipulating .
- Reading .
- . Reporting
- Viewing .
- Communicating / distributing .
- Storing / archiving .
- of radiological softcopy images and
- . Storing / archiving of structured (DICOM) reports.
The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning,
Therefore SIENET Cosmos supports the following generic imaging workflow:
- . Receive scheduled exams from IS at the SIENET Cosmos archiving component SDM
- Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces .
- . Receive and store new exams from the Modalities at the SDM
- Prepare images for reading .
- . Report new images, if required by comparing them with prior exams and reports
- Demonstrate exams at Radiological Demos .
- View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).
Note:
The workstation deployment syngo® Viewing Studio is not intended for primary diagnosis.
X Prescription Use AND / OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
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Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Special 510(k) SIENET Cosmos V15A | September 24, 2004 |
|---|---|
| Page B2 |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K042832
§ 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).