(43 days)
Not Found
No
The document describes standard image processing and quantitative analysis techniques for PET images, with no mention of AI or ML algorithms. The emphasis is on visualization, measurement tools, and calculations based on established methods, with the clinician retaining ultimate responsibility for interpretation.
No
The device is a software product for visualization, assessment, and quantification of PET images, providing quantitative measurements to aid clinicians in interpretation. It is not designed to directly treat, prevent, or mitigate a disease or condition.
Yes
The software "aids in the interpretation of myocardial perfusion PET images" and "calculates measurements of myocardial blood flow", which are quantitative assessments used in conjunction with visual assessment for the "assessment of coronary artery disease". This directly supports diagnosis by providing data for clinical interpretation and decision-making regarding a medical condition.
Yes
The device description explicitly states "syngo MBF is a software only product".
Based on the provided information, the Siemens syngo MBF device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes images of the human body (PET images).
- The intended use is for visualization, assessment, and quantification of images, not biological samples.
- The device processes imaging data to provide measurements related to blood flow within the myocardium. This is an analysis of physiological function as depicted in an image, not an analysis of a biological specimen.
Therefore, syngo MBF falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.
The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.
The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.
Product codes
LLZ
Device Description
syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The application supports dynamic Rubidium – PET and dynamic Ammonia - PET images.
The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, for the Clinician to assess these results. The user may save the results.
The application is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion PET images. The quantitative assessment is to be used in conjunction with traditional visual assessment of myocardial perfusion PET images for the assessment of coronary artery disease, and quantitatively by comparing to a database.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET images
Anatomical Site
myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals
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
syngo MBF Special 510(k) Premarket Notification Strictly Confidential
APR - 6 2011
510(k) Summary
as required by 21 CFR Part 807.87(h)
Elaine Chang Submitter: Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 USA (847) 304-7516 Telephone Number: (865) 218-3019 . Fax Number: Siemens Medical Solutions USA, Inc. Name / Address of Molecular Imaging Manufacturer 2501 N. Barrington Road Hoffman Estates, IL 60192 USA 02/18/2011 Date of Submission: Identification of the product Device Proprietary Name: syngo MBF Picture Archiving and Communication System Common Name: Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050 LLZ Product Code: Radiology Classification Panel: Class II Device Class:
1
Marketed Devices to which Equivalence is claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| SyngoCirculation | ||
| Dynamic PET 1.0 | Siemens Medical Solutions USA, Inc. | K083327 |
Device Description:
syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The application supports dynamic Rubidium – PET and dynamic Ammonia - PET images.
The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, for the Clinician to assess these results. The user may save the results.
The application is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion PET images. The quantitative assessment is to be used in conjunction with traditional visual assessment of myocardial perfusion PET images for the assessment of coronary artery disease, and quantitatively by comparing to a database.
Safety and Effectiveness:
Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 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 considers that the proposed device does not introduce new safety concerns, and is substantially the same in indications for use, design, materials, energy sources and technology as the predicate devices. Siemens Medical Solutions USA, Inc believes that the syngo MBF software application is substantially equivalent to the predicate devices.
Indications for Use:
Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.
2
The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.
The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.
3
Indications for Use
14110494 510(k) Number (if known):
Device Name: syngo MBF
Indications for Use:
Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.
The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.
The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
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 Devices (OIVD)
Page 1 of __
4
Image /page/4/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 emblem resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a head.
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. Molecular Imaging Group 2501 North Barrington Road HOFFMAN ESTATES IL 60192
APR -- 6 2011
Re: K110494
Trade/Device Name: syngo MBF Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 29, 2011 Received: March 30, 2011
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
5
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 5 00%) premarket notification. The FDA finding of substantial equivalence of your device to a logal y 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 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.
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: syngo MBF
Indications for Use:
Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.
The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.
The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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 Devices (OIVD)
Mary Scott
(Division Sign-Off)
Division of Radiological Device
Office of In Vitro Diagnostic Device Evaluat.
510K K110494
Page 1 of __