Manipulating
Reading
Reporting
Vicwing
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
Domonstante onations at Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).
Note:
The workstation deployment syngo Viewing Studio is not intended for primary diagnosis.

Device Description

This premarket notification covers Siemens' cnhanced PACS system SIENET Cosmos.
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.
SIENET Cosmos is the integrated radiology suite for large radiological practices and community hospitals. Important factors are the centralized server structure, the wideranging data distribution and the overall integrated concept, ranging from scheduling the examination to reporting and archiving as well as image and report 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.
The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHF 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 is a "software only"-system, which will be delivered on CD-ROM / DVD and installed by Siemens service engineers. Hardware-Requirements to be met arc therefore defined.
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.

AI/ML Overview

The provided 510(k) summary for K033831, SIENET Cosmos, does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria in the traditional sense of a performance study for an AI-powered diagnostic device.

Instead, this submission is for a Picture Archiving and Communication System (PACS), which is a software-only solution for managing, viewing, reporting, and archiving medical images. For such devices, the "proof" often involves demonstrating substantial equivalence to predicate devices, adherence to recognized standards, and thorough verification and validation (V&V) testing as part of a risk management process, rather than a clinical trial with specific performance metrics like sensitivity and specificity.

Therefore, many of the requested fields cannot be directly answered from the provided text as they pertain to performance studies that are not typically required or included for PACS systems.

Here's an analysis based on the available information:

Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating substantial equivalence to predicate devices, adhering to general safety and effectiveness concerns, and fulfilling the intended uses as a PACS system. Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for image analysis are not provided, as this is a PACS system, not an AI diagnostic algorithm. The "performance" is implicitly tied to its ability to manipulate, read, report, view, communicate/distribute, and store/archive radiological softcopy images and structured reports.
- Reported Device Performance:
  - Functional Performance: The device performs the functions of a PACS system, including image data management (storage, archiving, availability, data security, interfaces), workflow management (integration with HL7/DICOM RIS), and various workplace deployments for viewing, reporting, and advanced reporting.
  - Safety and Effectiveness: "The device labeling 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."
Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The submission focuses on software validation and substantial equivalence, not a clinical performance study with a specific test set of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment by experts is not described, as this is not a diagnostic AI algorithm study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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 MRMC comparative effectiveness study was done or mentioned. This device is a PACS system, not an AI-assisted diagnostic tool in the typical sense for which such studies are conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a system that supports human radiologists, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. The concept of "ground truth" for diagnostic accuracy is not relevant to a PACS system's validation as presented here. The validation likely focused on functional correctness, data integrity, and compliance with standards.
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning model where a "training set" would be used to develop an algorithm.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary

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K033831

510(k) Summary

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 SolutionsHenkestrasse 127D-91052 ErlangenGermany
Registration Number:	3002808157
Contact Person:	Eva ReiterQuality ManagerTelephone: +49 (9131) 84-2680Telcfax: +49 (9131) 84-8812

Device Name and Classification:

Trade Name:	will be first marketed as SIENET Cosmos
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' cnhanced PACS system SIENET Cosmos.

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.

SIENET Cosmos is the integrated radiology suite for large radiological practices and community hospitals. Important factors are the centralized server structure, the wideranging data distribution and the overall integrated concept, ranging from scheduling the examination to reporting and archiving as well as image and report distribution.

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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 (IHF 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 is a "software only"-system, which will be delivered on CD-ROM / DVD and installed by Siemens service engineers. Hardware-Requirements to be met arc therefore defined.

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.

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.

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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, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:

SIENET Diagnostic Reporting Console (DRC)	K920309
SIENET Diagnostic Reporting Console VA02 Upgrade	K935694
SIENET Teleradiology Product Line	K955394
syngo® Multimodality Workstation	K010938
SIENET MagicWeb (Webserver), SIENET MagicLink I	K973131
SIENET Archive Server, ISA I, ISA II, Storage Server	K920310

The SIENET Cosmos described in this 510(k) has the same intended use and similar technical characteristics as the devices listed above together.

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 devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

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: K033831

Trade/Device Name: SIENET Cosmos Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: 90 LLZ Dated: November 28, 2003 Received: December 10, 2003

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 (PMA), 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 clectronic 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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

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):	K033831
Device Name:	SIENET Cosmos

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
Vicwing .
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 .
Domonstante onations at Radiology (e.g. Surgery, Intensive Case Unit, wards, external � referring physicians).

Note:
The workstation deployment syngo Viewing Studio is not intended for primary diagnosis.

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K033831
510(k) Number

(Please do not write below this line - continue on another page if needed)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of the CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use_ OR Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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).