(93 days)
Not Found
No
The summary describes automated analysis based on standard regions of interest and comparisons, but does not mention AI, ML, or related concepts like deep learning or neural networks.
No
The device is described as display and analysis software that aids clinicians in the assessment and quantification of pathologies from PET and SPECT scans, and helps in the visual evaluation and assessment of conditions. It does not provide any form of treatment or therapy.
Yes
The device aids clinicians in the 'assessment and quantification of pathologies' from medical scans and 'facilitates comparison with existing scans' and 'calculation of uptake ratios', all of which are functions typically associated with diagnostic devices.
Yes
The device is described solely as "display and analysis software" and its functions are entirely software-based (visualization, processing, analysis, quantification, comparison, calculation, subtraction) operating on existing image data. There is no mention of any accompanying hardware component being part of the device itself.
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 in vivo imaging data (PET and SPECT scans) acquired from the human brain. It processes and quantifies information from these images to aid clinicians in assessing pathologies.
- Lack of Sample Analysis: The device does not perform any analysis on biological samples taken from the patient. Its input is image data, not biological specimens.
Therefore, while it is a medical device used for diagnosis and assessment, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ and KPS
Device Description
Scenium VD10 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 VD10 consists of three main workflows: Database Comparison Workflow, Ratio Analysis Workflow, and Subtraction Workflow. These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (ie. Alzheimer's), movement disorders (ie. Parkinson's), and seizure analysis (ie. Epilepsy).
Mentions image processing
Scenium VD10 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET and SPECT scans
FDG-PET, amyloid-PET, and SPECT studies
Anatomical Site
human brain scans
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met.
In addition, risk management is ensured via a risk analysis in compliance with ISO 14971:2007 and 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.
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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F23 Z 8 2014
Page 39 of 123
Scenium VD10
510(k) Premarket Notification
510(k) Summary
as required by 21 CFR Part 807.92(c)
| Submitter: | Elaine Chang
Regulatory Technical Specialist
Siemens Medical Solutions USA, Inc.
Molecular Imaging
2501 N. Barrington Road
Hoffman Estates, IL 60192
USA |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | (865) 218-2873 |
| Fax Number: | (865) 218-3019 |
| Name / Address of
Manufacturer: | Siemens Medical Solutions USA, Inc
Molecular Imaging
2501 N. Barrington Road
Hoffman Estates, IL 60192
USA |
| Date of Submission: | November 26, 2013 |
| Identification of the product | |
| Device Proprietary Name: | Scenium VD10 |
| Common Name: | Picture Archiving and Communication System |
| Classification Name: | Picture Archiving and Communication System per 21
CFR 892.2050
Emission Computed Tomography System per 21 CFR
892.1200 |
| Product Code: | LLZ and KPS |
| Classification Panel: | Radiology |
| Device Class: | Class II |
1
Scenium VD10 510(k) Premarket Notification
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Scenium 3.0 | Siemens Medical Solutions USA, Inc | K121074 |
| Neurogam Oasis | Segami Corporation | K071584 |
| MIMNeuro | MIMVista Corp | K060816 |
Device Description:
Scenium VD10 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 VD10 consists of three main workflows: Database Comparison Workflow, Ratio Analysis Workflow, and Subtraction Workflow. These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (ie. Alzheimer's), movement disorders (ie. Parkinson's), and seizure analysis (ie. Epilepsy).
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 imaqing 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.
Performance Testing:
Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met.
In addition, risk management is ensured via a risk analysis in compliance with ISO 14971:2007 and 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.
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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Scenium VD10 510(k) Premarket Notification
Substantial Equivalence:
Scenium VD10 device has the same intended use and utilizes the same fundamental scientific technology as 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. The primary difference lies in the addition of a new subtraction workflow which is based on the existing software architecture of the primary predicate device, Scenium 3.0. The subtraction workflow allows for the analysis of difference images for epilepsy analysis.
These changes do not affect the fundamental scientific technology of the device, and Siemens considers Scenium VD10 to be as safe, as effective, and with performance substantially equivalent to its predicate devices.
Safety and Effectiveness:
The device is designed and manufactured under Quality System Regulations 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.
3
Image /page/3/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, with three stylized wing-like shapes above a flowing, ribbon-like form.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Siemens Medical Solutions USA, Inc. % Ms. Elaine Chang Regulatory Technical Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K133654
Trade/Device Name: Scenium VD10 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, KPS Dated: November 26, 2013 Received: November 27, 2013
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 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.
4
Page 2-Ms. Chang
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetv/ReportaProblem/delault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K133654
Device Name: Scenium VD10
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 FDGPET, and SFECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K133654
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