(34 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 image processing and analysis techniques, but does not mention AI, ML, or related concepts like deep learning.
No
The device is described as display and analysis software that aids clinicians in assessing and quantifying pathologies from scans, and it facilitates comparison and calculation of uptake rates. It does not directly treat or cure any condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the software has been developed to aid clinicians in the "assessment and quantification of pathologies" from medical scans, which directly relates to diagnosing conditions. It also mentions facilitating comparison with existing scans and calculating uptake ratios to aid in this assessment.
Yes
The device is described as "Scenium display and analysis software" and its function is post-processing of existing image data. There is no mention of any associated 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:
- IVDs are used to examine specimens derived from the human body. The description of Scenium clearly states it analyzes data from PET and SPECT scans, which are imaging modalities that capture images of the body, not analyze biological specimens like blood, urine, or tissue.
- The intended use is to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans. This is a function of medical imaging analysis, not in vitro testing of biological samples.
The device is a software tool for analyzing medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
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 (comma separated list FDA assigned to the subject device)
LLZ and KPS
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.
Mentions image processing
Yes
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, 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)
Not Found
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).
0
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: (865) 218-2873 (865) 218-3019 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
1
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
2
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.
4
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 (800) 638 2041 or (301) 796-7100 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
5
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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