(60 days)
Not Found
No
The summary describes automated analysis and quantification based on standard regions of interest and comparison with existing scans, which are typical features of image processing software but do not explicitly indicate the use of AI or ML algorithms. There is no mention of AI, DNN, or ML in the provided text, nor are there details about training or test sets which would be expected for an AI/ML device.
No
The device is a software for display and analysis of PET and SPECT scans, designed to aid clinicians in assessment and quantification of pathologies, not to directly treat or prevent a disease.
Yes
Explanation: The device is described as "analysis software" that "aids the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans" and "aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values." These functions indicate it is used to analyze medical data to help identify and quantify disease, which is a diagnostic purpose.
Yes
The device is described as "Scenium display and analysis software" and its function is post-processing and analysis of existing image data. There is no mention of any associated hardware components 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. They are used to provide information for diagnosis, monitoring, or screening.
- Scenium's Function: Scenium processes and analyzes medical images (PET and SPECT scans) of the human brain. It does not analyze biological samples taken from the body.
- Intended Use: The intended use clearly states it aids the clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. This is image analysis, not in vitro testing.
Therefore, Scenium falls under the category of medical image analysis software, not 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 and calculation of uptake ratios between regions of interest.
Product codes
LLZ, KPS
Device Description
Scenium 2.0 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 2.0 is post processing and does not control the scanning features of the system.
Mentions image processing
Scenium 2.0 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET and SPECT scans
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
JUN - 8 2012
Scenium 2.0 510(k) Premarket Notification
510(k) Summary as required by 21 CFR Part 807.87(h)
Submitter:
Elaine Chang Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 810 Innovation Dr Knoxville, TN 37932 USA
Telephone Number:
Fax Number:
Name / Address of Manufacturer
(865) 218-3019
(865) 218-2873
Siemens Medical Solutions USA, Inc Molecular Imaging 2501 N. Barrington Road Hoffman Estates, IL 60192 USA
Date of Submission:
April 6, 2012
Scenium 2.0
Identification of the product
Device Proprietary Name:
Common Name:
Classification Name:
Picture Archiving and Communication System
Picture Archiving and Communication System per 21 CFR 892.2050
Emission Computed Tomography System per 21 CFR 892.1200
Product Code:
Classification Panel:
Device Class:
Radiology
LLZ and KPS
Class II
1
Scenium 2.0 510(k) Premarket Notification
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Scenium 1.1 | Siemens Medical Solutions, LTD | K061545 |
| Neuro Trans3D | Segami Corporation | K043441 |
| Brass | Hermes Medical Solution | K021656 |
Device Description:
Scenium 2.0 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 2.0 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.
Technological 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 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.
Substantial Equivalence:
2
Scenium 2.0 510(k) Premarket Notification
Based on the above considerations, Siemens Medical Solutions USA, Inc believes that the Scenium 2.0 software is substantially equivalent to the predicate devices. The device and the predicate devices are all post-processing and provide similar features of visualization and numerical data.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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. 810 Innovation Drive KNOXVILLE TN 37932
Re: K121074
Trade/Device Name: Scenium 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ and KPS Dated: April 6, 2012 Received: April 9, 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.
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
JUN - 8 2012
4
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 11 you desire openers the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Scenium 2.0
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.
Prescription Use X (Part 21 CFR 801 Subpart D) Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ·
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O,
Division of Radiological Device:
Office of In Vitro Diagnostic Device Evaluation
47
510K K1a1074
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