SYNGO. PLAZA VA20A

K101666 · Siemens AG Medical Solutions · LLZ · Aug 10, 2010 · Radiology

Device Facts

• Record ID: K101666
• Device Name: SYNGO. PLAZA VA20A
• Applicant: Siemens AG Medical Solutions
• Product Code: LLZ · Radiology
• Decision Date: Aug 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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.

Device Story

syngo.plaza is a PACS software platform for radiological image management. It ingests digital medical images and DICOM structured reports, integrating with HIS/RIS to support clinical workflows. The system provides tools for post-processing, reading, reporting, and distributing images across cluster clients, web clients, or standalone workstations. Radiologists and technicians operate the system to view and analyze images; output is used for clinical diagnosis and treatment planning. The device facilitates efficient image access and workflow management in clinical environments. Web-based distribution is restricted from diagnostic reporting. The system supports advanced post-processing applications to aid physician decision-making.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation performed at unit, integration, and system levels according to standards including DICOM, JPEG/JPEG 2000, SMPTE, ISO 14971, IEC 60601-1-4, IEC 60601-1-6, HL7, IEC 62304, and ISO/IEC 13818.

Technological Characteristics

Software-only system installed on common IT hardware. Backend runs on Windows 2008; clients run on Windows XP. Supports DICOM standard for image communication and storage. Connectivity via network integration with HIS/RIS. Software development follows IEC 62304. Installation performed by trained service engineers.

Indications for Use

Indicated for use by radiologists and radiological technicians to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammography, for diagnosis and treatment planning. For primary mammography diagnosis, requires uncompressed or non-lossy compressed images, preprocessed DICOM "For Presentation" images, and FDA-cleared monitors/printers.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• syngo.plaza VA10A (K093612)
• syngo Imaging V30 (K071114)
• syngo.x (K092519)

Submission Summary (Full Text)

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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 Solutions<br>Henkestrasse 127<br>D-91052 Erlangen<br>Germany |
|----------------------|----------------------------------------------------------------------------------|
| Registration Number: | 3002808157 |
| Contact Person: | Sabine Schroedel |

JUN 14 2010,
ReceivedSabine Schroedel Regulatory Affairs Manager Telephone: [phone] Telefax: [phone]

## 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 [phone] or [phone] 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)

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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

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