SCENIUM

K123528 · Siemens Medical Solutions USA, Inc. · LLZ · Dec 20, 2012 · Radiology

Device Facts

• Record ID: K123528
• Device Name: SCENIUM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-PET, amyloid-PET, and SPECT studies and calculation of uptake ratios between regions of interest.

Device Story

Scenium 3.0 is post-processing software for medical imaging workstations; it does not control scanner hardware. Input consists of multimodality PET and SPECT brain scan data. Software provides workflows for specific drug/disease combinations; performs automated quantification of mean pixel values within standard regions of interest (ROI); calculates uptake ratios between ROIs; and facilitates comparison with existing FDG-PET, amyloid-PET, and SPECT scans. Clinicians use the output for visual evaluation and assessment of pathologies. The device benefits patients by providing standardized, quantitative data to assist in clinical decision-making regarding brain pathologies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Post-processing software for medical imaging workstations. Complies with 21 CFR 892.2050 (PACS) and 21 CFR 892.1200 (Emission Computed Tomography). Software development follows ISO 14971 (risk management) and ISO 62304 (software lifecycle).

Indications for Use

Indicated for clinicians to aid in the assessment and quantification of pathologies in human brain PET and SPECT scans. Facilitates analysis via mean pixel value quantification in standard regions of interest and calculation of uptake ratios.

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

• Scenium 2.0 (K121074)
• NeuroTrans3D (K043441)
• Brass (K021656)

Submission Summary (Full Text)

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K123528

Scenium 3.0 Special 510(k) Premarket Notification

## 510(k) Summary

as required by 21 CFR Part 807.87(h)

# DEC 2 0 2012

Elaine Chang Submitter: Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 810 Innovation Dr Knoxville, TN 37932 USA Telephone Number: [phone] [phone] Fax Number: Siemens Medical Solutions USA, Inc Name / Address of Manufacturer: Molecular Imaging 2501 N. Barrington Road Hoffman Estates, IL 60192 USA Date of Submission: November 15, 2012 ldentification of the product Device Proprietary Name: Scenium 3.0 Picture Archiving and Communication System Common Name: Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050 Emission Computed Tomography System per 21 CFR 892.1200 Product Code: LLZ and KPS Classification Panel: Radiology Device Class: Class II

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Scenium 3.0 Special 510(k) Premarket Notification

### Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|--------------|------------------------------------|---------------|
| Scenium 2.0 | Siemens Medical Solutions USA, Inc | K121074 |
| NeuroTrans3D | Segami Corporation | K043441 |
| Brass | Hermes Medical Solutions | K021656 |

#### Device Description:

Scenium 3.0 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. Scenium 3.0 is post processing and does not control the scanning features of the system.

#### Indications for Use:

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-PET, amyloid-PET, and SPECT studies and calculation of uptake ratios between regions of interest.

#### Technoloqical characteristics:

The software is similar in uses and applications to the predicate devices. Both the device and predicates are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans.

#### Safety and Effectiveness:

The device is designed and manufactured under Quality System Requlations as outlined in 21 CFR 820. All requirements of Emission Computed Tomography system standards (21 CFR 892.1200) and Picture Archiving and Communications System (21 CFR 892.2050) are met, and software is in compliance with ISO 14971 and ISO 62304.

#### Substantial Equivalence:

Based on the above considerations, Siemens Medical Solutions USA, Inc believes that the Scenium 3.0 software is substantially equivalent to the predicate devices. The device and the

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Scenium 3.0 Special 510(k) Premarket Notification

predicate devices are all post-processing and provide similar features of visualization and numerical data.

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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 eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

Siemens Medical Solutions USA, Inc. % Ms. Elaine Chang Regulatroy Technical Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K123528

Trade/Device Name: Scenium 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and KPS Dated: November 15, 2012 Received: November 16, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I catal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rece related adverse overals)S) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality of cromp (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Chang

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Janine M. Morris -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known):

Scenium 3.0 Device Name:

Indications for Use:

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-PET, amyloid-PET, and SPECT studies and calculation of uptake ratios between regions of interest.

OR

Prescription Use_ × (Part 21 CFR 801 Subpart D)

Ov
(21

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Division of

**Office of In Vitro Diagnostics and Radiological Health**

510(k) K123528

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