syngo Imaging CCF is a Picture Archiving and Communication System intended for enterprise wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing of current and prior studies. It is not intended for primary diagnosis.

Device Description

This premarket notification addresses the Siemens syngo-based Picture Archiving and Communication System syngo® Imaging CCF VA10A.

It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of storage space.

All lossy compressed images are displayed with warning triangles to indicate that the images are not suitable for diagnosis. In DICOM transfers, the respective compression related DICOM attributes are filled.

In a comprehensive imaging suite, syngo Imaging integrates hospital information systems (HIS) to enable customer specific workflows.

The system is a "hardware independent" solution to be distributed combined with common IT hardware which must comply to predefined minimum hardware requirements.

syngo® Imaging CCF VA10A supports the following additional features:

NAS based central enterprise storage of 10x compression
Data replication between sites in a multisite environment
Automatic data reconciliation (in synch with information systems)
Client redirectin - for high availability and to enable cross reading
Enterprise patient context (multi MRN support)
Comprehensive server performance monitoring

Basically these functionalities do not alter the fundamental scientific technology of syngo® Imaging CCF VA10A.

syngo® Imaging (CCF VA10A) is a "software plus hardware"-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 CCF_VA10A will be installed by Siemens service engineers.

Defined Hardware requirements are to be met.

The backend communication and storage solution (DM) is based on LINUX and Windows 2003 operating system. The workplaces are based on Windows XP. Any hardware platform, which is Windows / Windows XP certified, will be supported.

The herewith described syngo® Imaging (CCF VA10A) supports DICOM formatted images and objects.

AI/ML Overview

This document (K073418) is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS) named syngo® Imaging CCF VA10A. It is not a study reporting on the performance of a new diagnostic device. The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices rather than to prove that the device meets specific acceptance criteria through a performance study in the way a diagnostic AI would.

Therefore, many of the requested sections about acceptance criteria, clinical study details, and reader performance are not applicable to this submission. The device is intended for "enterprise-wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing," and not for primary diagnosis. As such, the typical performance metrics for diagnostic accuracy (sensitivity, specificity, AUC) are not relevant here.

Here's a breakdown of the information that is available or derivable from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of a 510(k) for a PACS system intended for archiving and viewing, not primary diagnosis. The "performance" is primarily related to its functional capabilities and safety, which are addressed through substantial equivalence.

The document states, "syngo Imaging CCF is a Picture Archiving and Communication System intended for enterprise wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing of current and prior studies. It is not intended for primary diagnosis."

Key functional characteristics and related "performance" claims are:

Storage of images in uncompressed/lossless compressed and lossy compressed formats.
Warning triangles displayed for lossy compressed images to indicate they are not suitable for diagnosis.
Integration with hospital information systems (HIS).
Multisite data replication.
Automatic data reconciliation.
Client redirection for high availability and cross-reading.
Enterprise patient context (multi MRN support).
Comprehensive server performance monitoring.
Compliance with DICOM conformance statement for PACS server use.
Integration with HL7-/DICOM-compatible RIS.

These are not quantitative performance metrics that would have specific acceptance criteria reported in a table in this type of submission.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This 510(k) submission does not describe a clinical performance study using a test set of patient data to evaluate diagnostic accuracy. Its purpose is to demonstrate substantial equivalence to predicate devices for its intended use as an archiving and viewing system.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical performance study for diagnostic accuracy was conducted or reported in this submission, there was no "ground truth" to establish for a test set in that context.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication for diagnostic performance was described.

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 applicable. This device is a PACS for archiving and viewing, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a PACS system, not a standalone diagnostic algorithm. Its function is to display images for human review, not to make diagnostic decisions independently.

7. The Type of Ground Truth Used

Not applicable. As no diagnostic performance study was conducted, no "ground truth" (e.g., pathology, expert consensus, outcomes data) was established for this device's evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is a software system for image management and viewing. It is not an AI/ML model that would require a "training set" of patient data in the typical sense for learning diagnostic patterns. Its development would involve software engineering and testing against functional requirements and standards, not a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML diagnostic algorithm, there is no ground truth establishment methodology described.

Summary

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K073418

FEB 2 9 2008

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.

I. GENERAL INFORMATION

Establishment:

Address:	Siemens AG, Medical SolutionsHenkestrasse 127D-91052 ErlangenGermany
Registration Number:	3002808157
Contact Person:	Sabine SchroedelRegulatory Affairs ManagerTelephone: +49 (9131) 84-8285Telefax: +49 (9131) 84-2792
Device Name and Classification:
• Trade Name:	syngo® ImagingCCF_VA10A
• 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 addresses the Siemens syngo-based Picture Archiving and Communication System syngo® Imaging CCF VA10A.

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It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of storage space.

In a comprehensive imaging suite, syngo Imaging integrates hospital information systems (HIS) to enable customer specific workflows.

The system is a "hardware independent" solution to be distributed combined with common IT hardware which must comply to predefined minimum hardware requirements.

syngo® Imaging CCF VA10A supports the following additional features:

NAS based central enterprise storage of 10x compression 배
. Data replication between sites in a multisite environment
트 Automatic data reconciliation (in synch with information systems)
프 Client redirectin - for high availability and to enable cross reading
Enterprise patient context (multi MRN support)
의 Comprehensive server performance monitoring

Basically these functionalities do not alter the fundamental scientific technology of syngo® Imaging CCF VA10A.

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 CCF VA10A Data Management can be used as a DICOM-Archive (LTS Long-term Storage) in accordance with the DICOM Conformance Statement.

Integration:

The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the syngo® Imaging CCF VA10A PACS a consistent workflow - from patient registration to requirement scheduling to a personal work list and supports therefore reporting, documentation or administrative tasks.

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Technological Characteristics: .

Defined Hardware requirements are to be met.

The herewith described syngo® Imaging (CCF VA10A) supports DICOM formatted images and objects.

t 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.

t . Substantial Equivalence:

The syngo® Imaging CCF VA10A, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:

Siemens	syngo Imaging	K071114
Siemens	SIENET MagicWeb (Web Server), MagicLink I	K973131

The syngo® Imaging CCF VA10A 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 CCF VA10A 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 stylized graphic of an abstract human figure with three lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

FEB 2 9 2008

Siemens AG, Medical Solutions % Mr. Stefan Preiss TUV SUD America, Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891

Re: K073418

Trade/Device Name: syngo® Imaging CCF VA10A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 11, 2008 Received: February 14, 2008

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.

Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are three stars at the bottom of the logo.

Protecting and Promoting Public Health.

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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.

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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

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): Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of storage space.

In a comprehensive imaging suite, syngo Imaging integrates hospital information systems (HIS) to enable customer specific workflows.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

510(k) for syngo® Imaging CCF VA10A

October 22nd, 20

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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K073418

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).