SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827

K100619 · Siemens Medical Solutions USA, Inc. · LLZ · May 7, 2010 · Radiology

Device Facts

• Record ID: K100619
• Device Name: SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

Device Story

Symbia.net is a client/server software solution for SPECT and SPECT-CT systems; enables deployment of MI Applications on standard hardware (desktops, laptops, workstations). Server-side software processes imaging data; client-side software displays rendered images. Clinicians access system via PCs or Macs. System ensures clinical equivalence between server and client image rendering; no degradation in resolution, color, or timing. Used by physicians and healthcare professionals in clinical settings to aid in assessment, quantification, and diagnosis of pathologies; supports radiotherapy planning and interventional procedures. Benefits include flexible remote access to diagnostic imaging tools while maintaining diagnostic quality.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through technical comparison and verification of image rendering consistency between server and client platforms.

Technological Characteristics

Client/server software architecture; compatible with standard desktop/laptop/workstation hardware. Supports SPECT, PET, CT, and other imaging modalities. Software-based display and analysis package. Risk management compliant with ISO 14971.

Indications for Use

Indicated for use by trained healthcare professionals to aid in detection, localization, diagnosis, staging, and restaging of lesions, tumors, disease, and organ function. Applicable to cardiovascular disease, neurological disorders, and cancer. Used for radiotherapy treatment planning and interventional radiology. Software aids in assessment and quantification of pathologies from SPECT, PET, CT, and other imaging modalities.

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

• Symbia 4.0 (MI Applications 2009A) (K082506)
• Visage PACSICS (K072205)

Submission Summary (Full Text)

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Klooiq

Siemens Symbia.net
Special 510(k) Premarket Notification

Strictly Confidential

# 510(k) Summary
as required by 21 CFR Part 807.87(h)

MAY - 7 2010

| Submitter: | Elaine Chang<br>Regulatory Technical Specialist<br>Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>810 Innovation Drive<br>Knoxville, TN 37932 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Name / Address of<br>Manufacturer | Siemens Medical Solutions USA, Inc<br>Molecular Imaging<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60192<br>USA |
| Date of Submission: | March 3, 2010 |
| Identification of the product | |
| Device Proprietary Name: | Symbia.net |
| Common Name: | Picture Archiving and Communication System |
| Classification Name: | Picture Archiving and Communication System per 21<br>CFR 892.2050<br>Emission Computed Tomography System per 21 CFR<br>892.1200 |
| Product Code: | LLZ and KPS. |
| Classification Panel: | Radiology |
| Device Class: | Class II |

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### Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|---------------------------------------|-------------------------------|---------------|
| Symbia 4.0 (MI<br>Applications 2009A) | Siemens Medical Solutions | K082506 |
| Visage PACSICS | Mercury Computer Systems, Inc | K072205 |

#### Device Description:

Symbia.net introduces client/server functionality allowing the MI Applications product to be deployed on any compatible hardware (includinq desktops, laptops and workstations) that meet minimal hardware reguirements. Symbia.net is a solution for SPECT and SPECT-CT systems.

The software application is provided on a server. Clients running on any personal computer or Mac, meeting minimum requirements, can have access to the system. The rendered images on the client and server side are clinically equivalent with each other. No imaqe quality degradation on any of the imaqes shown in the clients compared to the images shown on the server related to resolution, color and timing.

#### Safety and Effectiveness:

Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitiqation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens considers that the proposed device does not introduce new safety concerns, and is substantially the same in indications for use. design, materials, energy sources and technology as the predicate devices. Siemens believes that Symbia.net is substantially equivalent to the predicate devices.

#### Indications for Use:

The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY - 7 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Elaine Chang Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2501 North Barrington Road HOFFMAN ESTATES IL 60192 .

Re: K100619

Trade/Device Name: Symbia.net Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2010 Received: April 8, 2010

Dear Ms. Chang:

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 and thus, permits your device 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 and Safety at [phone]. 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Bohn

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): K1006 19

Device Name: Symbia.net

Indications for Use:

The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

Prescription Use × (Part 21 CFR 801 Subpart D) OR

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of ORH, Office of Device Evaluation (ODE)

Booker
Rbott
K 100619

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