Scenium VE20 Software

K173597 · Siemens Medical Solutions USA, Inc. · LLZ · Apr 4, 2018 · Radiology

Device Facts

• Record ID: K173597
• Device Name: Scenium VE20 Software
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 4, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 databases of normal patients and normal parameters derived from these databases, derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Device Story

Scenium VE20 is medical imaging software for PET/SPECT brain scan analysis; operates on workstations (e.g., syngo.MI Workflow). Inputs: functional PET/SPECT image data. Processing: automated quantification of mean pixel values in regions of interest (ROI); comparison against normal patient databases; calculation of uptake ratios; subtraction of functional scans. Outputs: quantitative metrics and visual renderings for clinician review. Used by physicians to assist in diagnosing dementia, movement disorders, and epilepsy. Benefits: provides standardized, objective data to support clinical assessment of brain pathologies.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed that software functions perform as designed, performance requirements are met, and all hazard mitigations were implemented. No clinical data provided.

Technological Characteristics

Software-based image processing system; operates on standard medical imaging workstations. Features four workflows: Database Comparison, Striatal Analysis, Cortical Analysis, and Subtraction. Complies with ISO 14971:2012 (risk management), ISO 13485 (quality management), and IEC 62304 (software lifecycle).

Indications for Use

Indicated for clinicians to aid in assessment and quantification of pathologies in human brain PET and SPECT scans, including dementia (e.g., Alzheimer's), movement disorders (e.g., Parkinson's), and seizure analysis (e.g., Epilepsy).

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 VE10 (K162339)

Reference Devices

• Siemens syngo.MI Workflow software platform (K150843)

Submission Summary (Full Text)

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Siemens Medical Solutions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

April 4, 2018

## Re: K173597

Trade/Device Name: Scenium VE20 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 7, 2018 Received: February 8, 2018

Dear Ms. Padharia:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D 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) K173597

Device Name Scenium VE20

#### Indications for Use (Describe)

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 databases of normal patients and normal parameters derived from these databases, derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Summary

AS REQUIRED BY 21 CFR PART 807.87(H) AND 807.92(c)

#### Identification of the Submitter

| Submitter: | Veronica Padharia<br>Regulatory Affairs Specialist<br>Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>810 Innovation Drive<br>Knoxville, TN 37932 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name / Address of<br>Manufacturer(s) | Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60192 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Submission: | November 21st, 2017 |

#### Identification of the product

| Device Proprietary Name: | Scenium VE20 |
|--------------------------|----------------------------------------------------------------|
| Common Name: | Image Processing Software |
| Classification Name: | Picture Archiving and Communication System per 21 CFR 892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |

## Predicate Marketed Device to which Equivalence is claimed:

| Device Proprietary Name: | Scenium VE10 |
|--------------------------|-------------------------------------|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | LLZ |
| Device Class: | Class II |
| 510(k) Number: | K162339 |

QRMI0097-T-03

Reference: QRMI0080-M

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#### Device Description:

Scenium VE10 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VE10 consists of three workflows:

- Database Comparison -
- -Ratio Analysis
- -Subtraction

These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).

The modifications made to the Scenium VE10 software (K162339) to create the Scenium VE20 software include:

- . The ability to create and support normal databases in the Striatal Analysis workflow o DaTSCAN-SPECT normals database
- . Improvements related to the analysis screen for reporting in Striatal Analysis

In addition, workflow structures changed within the VE20 release. Previously, the three workflows (Database Comparison, Ratio Analysis, and Subtraction) encompassed the Scenium software. Ratio Analysis has since been split into two separate workflows. Now, the following four workflows exist within Scenium VE20:

- Database Comparison -
- -Striatal Analysis
- -Cortical Analysis
- -Subtraction

These changes are based on current commercially available software features and do not change the technological characteristics of the device.

Scenium VE20 analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K150843).

#### Performance Testinq / Safety and Effectiveness:

Risk Management has been ensured via risk analyses in compliance with ISO 14971:2012 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA, Inc. adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304.

Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitiqations have been fully implemented. All testinq has met the predetermined acceptance values.

Traceability of the requirements specified in the requirement specifications and functional specifications are ensured during component integration, software validation and system testing.

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

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The device is designed and manufactured in accordance with Quality System Regulations as outlined in 21 CFR 820.

#### Intended Use:

A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

#### 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 orqanized 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 databases of normal patients and normal parameters derived from these databases, derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

#### Statement Regarding Substantial Equivalence:

There are no differences in the Indications for Use or Fundamental Technological Characteristics of the Scenium VE20 software as compared to the currently commercially available Scenium VE10 software (K162339). Both devices are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans.

Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information as well as the documentation in support of the modifications, it is Siemens' opinion that the Scenium VE20 software, with the modifications outlined in this application, is substantially equivalent to the predicate device.