(30 days)
No
The description focuses on automated analysis through quantification of mean pixel values within standard regions of interest and comparisons to existing databases, which are standard image processing techniques and do not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or related terms.
No
The device is described as software that aids clinicians in assessing and quantifying pathologies from PET and SPECT scans, primarily for diagnosis and analysis, not for direct treatment or therapy.
Yes.
Explanation: The device aids clinicians in assessing and quantifying pathologies from PET and SPECT scans, analyzing brain scans for conditions like dementia, movement disorders, and seizures, which are all diagnostic activities.
Yes
The device is described as "display and analysis software" and is intended to be run on commercially available software platforms. There is no mention of accompanying hardware developed or provided by the manufacturer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Scenium software analyzes medical images (PET and SPECT scans) of the human brain. It processes and quantifies data from these images to aid clinicians in assessing pathologies.
- No Sample Analysis: The software does not perform any analysis on biological samples taken from the patient. Its input is image data, not biological specimens.
Therefore, while the software is a medical device used in diagnosis, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 guantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-PET, and SPECT studies, calculation of uptake ratios between regions of interest and subtraction between two functional scans.
Product codes
LLZ
Device Description
Scenium VD20 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 VD20 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 VD20 software (K150192) to create the Scenium VE10 software include:
- Enabled comparative quantification between Scenium workflows -
- User interface and usability improvements to improve consistency with the syngo.via platform
- Addition of new normal databases to the Database Comparison workflow
- o SPECT HMPAO (Chang AC) normal database
- PET Florbetaben normal database o
- -Stereotactic Surface Projection (SSP) for Amyloid uptake images can now be viewed
These changes are based on current commercially available software features and do not change the technological characteristics of the device.
Scenium VE10 analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K150843).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET and SPECT scans
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, medical imaging workplaces
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 mitigations have been fully implemented. All testing 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Siemens Medical Solutions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K162339
Trade/Device Name: Scenium VE10 Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 19, 2016 Received: August 22, 2016
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'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
2
Indications for Use
510(k) Number (if known)
Device Name Scenium VE10 Software
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 scans 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
Regulatory Affairs Specialist
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name / Address of
Manufacturer(s) | Siemens Medical Solutions USA, Inc.
Molecular Imaging
2501 N. Barrington Road
Hoffman Estates, IL 60192 |
| Telephone Number: | (630) 877-5761 |
| Fax Number: | (865) 218-3019 |
| Date of Submission: | August 19th, 2016 |
Identification of the product
| Device Proprietary Name: | Scenium VE10 |
|---|---|
| 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 VD20 |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Product Code: | LLZ |
| Device Class: | Class II |
| 510(k) Number: | K150192 |
QRMI0097-T-03
4
Device Description:
Scenium VD20 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 VD20 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 VD20 software (K150192) to create the Scenium VE10 software include:
- Enabled comparative quantification between Scenium workflows -
- User interface and usability improvements to improve consistency with the syngo.via platform
- Addition of new normal databases to the Database Comparison workflow
- o SPECT HMPAO (Chang AC) normal database
- PET Florbetaben normal database o
- -Stereotactic Surface Projection (SSP) for Amyloid uptake images can now be viewed
These changes are based on current commercially available software features and do not change the technological characteristics of the device.
Scenium VE10 analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K150843).
Performance Testing / 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 mitigations have been fully implemented. All testing 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.
The device is designed and manufactured in accordance with Quality System Requlations as outlined in 21 CFR 820.
5
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 guantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-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 VE10 software as compared to the currently commercially available Scenium VD20 software (K150192). 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 VE10 software, with the modifications outlined in this application, is substantially equivalent to the predicate device.