(228 days)
No
The description focuses on quantitative analysis and calculation of hemodynamic parameters from CT data, without mentioning AI or ML techniques.
No.
This device is designed for the evaluation of myocardial perfusion by analyzing dynamic CT data and providing information about blood flow and volume. It aids in assessing potential perfusion disturbances and the hemodynamic relevance of coronary stenosis, which are diagnostic purposes, not therapeutic interventions.
Yes
The device is designed to "evaluate perfusion of the myocardium" and helps in the "assessment of the hemodynamic relevance of coronary stenosis" by providing quantitative analysis of dynamic CT data to calculate blood flow, blood volume, and other hemodynamic parameters, all of which are diagnostic functions.
Yes
The device is described as "post-processing image analysis software" that operates on dynamic CT data, indicating it is a software application that processes existing medical images and does not include any hardware components for image acquisition or patient interaction.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that this software analyzes images reconstructed from dynamic CT data acquired after the injection of contrast media. This is image analysis, not the analysis of biological samples like blood, urine, or tissue.
- The intended use is to evaluate perfusion of the myocardium using imaging data. This is a diagnostic tool that uses imaging to assess a physiological process within the body, not a test performed on a sample outside the body.
The device is a post-processing image analysis software for medical imaging data, specifically CT scans of the heart. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Siemens syngo. CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.
The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
It supports evaluation of regions of interest and the visual inspection of time attenuation curves.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media. By providing information about myocardial blood flow and myocardial blood volume, syngo.CT Myocardial Perfusion allows the evaluation of potential perfusion disturbances in the myocardium due to coronary artery disease. This might aid in the assessment of the hemodynamic relevance of coronary stenosis
syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:
- Myocardial blood flow (MBF) image .
- Myocardial blood volume (MBV) image ●
- Flow Extraction Product (FE) image ●
- Perfused Capillary Blood Volume (PCBV) image ●
- Extravascular Extracellular Volume (EEV) image
- Time to Peak (TTP) image ●
- Time to Start (TTS) image ●
- Tissue Transit Time (TTT) image ●
- Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image
The following modifications have been made to the previously cleared predicate device syngo® Volume Perfusion CT Body (K092013, clearance date July 17, 2009):
- New software version SOMARIS/8 VB10 which supports the 1. following features:
- Separation of the Myocardial Perfusion algorithm from Volume a. Perfusion CT Body into a stand-alone SW application called "syngo.CT Myocardial Perfusion"
- Migration of the Myocardial Perfusion application to the syngo.via ﻗ client server Software platform (cleared in K123375)
- Updated Graphical User Interface C.
- Result Storage Additional option to store image results as d. Enhanced CT
- TAC Display Parallel display of several time attenuation curves e. (TAC)
-
- A modified Indication for Use which is specific to Myocardial Perfusion.
Mentions image processing
syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dynamic CT data
Anatomical Site
myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical tests were conducted for syngo.CT Myocardial Perfusion during product development. The modifications described in this premarket notification are supported with verification and validation testing. Results of this verification and validation testing were found acceptable to support the claim of substantial equivalence.
Performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion. Supportive articles that demonstrate the usability of syngo.CT Myocardial Perfusion were provided to support device performance and functionality. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
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.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the left side of the image. To the right of the text is a symbol consisting of three stylized human profiles facing to the right, with flowing lines extending from the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2015
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65 1-A MALVERN PA 19355
Re: K150713
Trade/Device Name: syngo.CT Myocardial Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 18, 2015 Received: September 29, 2015
Dear Ms. Mangum:
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 O'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
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light blue or teal. The background is plain white, which makes the text stand out. The word is presented in all capital letters.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150713
Device Name syngo.CT Myocardial Perfusion
Indications for Use (Describe)
The Siemens syngo. CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.
The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
It supports evaluation of regions of interest and the visual inspection of time attenuation curves.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
3
Image /page/3/Picture/0 description: The image contains the word "SIEMENS" in a large, sans-serif font. The text is a light blue color, and the letters are evenly spaced. The logo is simple and modern, with a clean design. The image is likely a logo for the Siemens company.
510(K) SUMMARY FOR syngo.CT Myocardial Perfusion
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Date Prepared: September 18, 2015
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
-
- General Information lmporter/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Facility: Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
- General Information lmporter/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
2. Contact Person:
Kimberly Mangum Requlatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard, Mail Code 65 1-A Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
3. Device Name and Classification
| Product Name: | syngo.CT Myocardial Perfusion |
|---|---|
| Propriety Trade Name: | syngo.CT Myocardial Perfusion |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
4
Image /page/4/Picture/1 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.
| বা | Legally Marketed Predicate Device | ||
|---|---|---|---|
| Trade Name: | syngo® Volume Perfusion CT Body | ||
| 510(k)#: | K092013 | ||
| Clearance Date: | July 17, 2009 | ||
| Classification Name: | Computed Tomography X-ray System | ||
| Classification Panel: | Radiology | ||
| Classification Regulation: 21 CFR § 892.1750 | |||
| Device Class: | |||
| Product Code: | 90JAK | ||
| Recall Information: | This predicate device has not been the | ||
| subject of any design related recalls |
5. Device Description:
syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media. By providing information about myocardial blood flow and myocardial blood volume, syngo.CT Myocardial Perfusion allows the evaluation of potential perfusion disturbances in the myocardium due to coronary artery disease. This might aid in the assessment of the hemodynamic relevance of coronary stenosis
syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:
- Myocardial blood flow (MBF) image .
- Myocardial blood volume (MBV) image ●
- Flow Extraction Product (FE) image ●
- Perfused Capillary Blood Volume (PCBV) image ●
- Extravascular Extracellular Volume (EEV) image
- Time to Peak (TTP) image ●
- Time to Start (TTS) image ●
- Tissue Transit Time (TTT) image ●
- Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image
The following modifications have been made to the previously cleared predicate device syngo® Volume Perfusion CT Body (K092013, clearance date July 17, 2009):
- New software version SOMARIS/8 VB10 which supports the 1. following features:
- Separation of the Myocardial Perfusion algorithm from Volume a. Perfusion CT Body into a stand-alone SW application called "syngo.CT Myocardial Perfusion"
5
Image /page/5/Picture/1 description: The image features the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light blue or teal. The word is horizontally oriented and appears to be a logo or brand name.
- Migration of the Myocardial Perfusion application to the syngo.via ﻗ client server Software platform (cleared in K123375)
- Updated Graphical User Interface C.
- Result Storage Additional option to store image results as d. Enhanced CT
- TAC Display Parallel display of several time attenuation curves e. (TAC)
-
- A modified Indication for Use which is specific to Myocardial Perfusion.
6. Indications for Use
The Siemens syngo.CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.
The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
It supports evaluation of regions of interest and the visual inspection of time attenuation curves.
-
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Myocardial Perfusion software package has the same intended use and operating principle as the predicate syngo® Volume Perfusion-CT Body (K092013, clearance date 06/17/2009). syngo.CT Myocardial Perfusion is a post-processing application operating on the syngo.via platform in a single or multi user environment.
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Myocardial Perfusion does not have significant changes in technological characteristics when compared to the predicate device. The Indications for Use and fundamental scientific technology are similar. The subject device and the predicate device are the same in regards to:
- Application and Acquisition ●
- Motion Correction ●
- CT Scanning Mode ●
- Time Point Removal ●
- 4D Noise Reduction ●
- Organ Segmentation ●
- Arterial Input Function Definition ●
- Vessel Definition ●
- Region of Interest and Volume of Interest ●
- Archiving/Storage
- Communication DISOM compatible. ●
6
The myocardial and body perfusion algorithms use a deconvolution algorithm to estimate the perfusion parameters. The algorithms differ in the parametric convolution kernel. Body perfusion uses an adiabatic approximation to the tissue homogeneity model. The parameter map calculation in myocardial perfusion is based on the Tofts' model. According to the different scanning modes, the registration is different. A global registration is used in body perfusion. This global registration for myocardial perfusion is applied after a preceding rigid registration that aligns the stitching slices. The same algorithms and registrations were used in the predicate device syngo® Volume Body Perfusion CT Body (K092013, clearance date July 17, 2009).
The following table shows the differences in technological characteristics between the subject device and the predicate device.
| Technological Characteristics of the Subject Device as Compared to the Predicate Device | |||
|---|---|---|---|
| Feature | Subject Device | ||
| syngo.CT Myocardial | |||
| Perfusion | Predicate Device | ||
| syngo® Volume | |||
| Perfusion CT Body | |||
| (K092013) | Comparison | ||
| Result | |||
| Storage | Storage of all result | ||
| images in the | |||
| database as DICOM | |||
| CT grayscale, color | |||
| RGB, Enhanced CT | Storage of all result | ||
| images in the | |||
| database as DICOM | |||
| CT grayscale, color | |||
| RGB | The subject device has the | ||
| additional option of saving | |||
| images as Enhanced CT. | |||
| Verification and Validation | |||
| testing supports this | |||
| modification. | |||
| TAC | |||
| Display | Parallel display of | ||
| several time | |||
| attenuation curves | Display of a single | ||
| time attenuation | |||
| curve | The subject device can display | ||
| multiple Time Attenuation | |||
| Curves, instead of only one. | |||
| Verification and Validation | |||
| testing supports this | |||
| modification. | |||
| User | |||
| Interface | syngo.via based GUI | syngo® based GUI | The user interface has been |
| adapted to the current syngo.via | |||
| framework. Changes are | |||
| cosmetic in nature. Verification | |||
| and Validation testing supports | |||
| this modification. | |||
| Operating | |||
| Software | |||
| Platform | syngo.via: Windows | ||
| XP, Windows Vista or | |||
| Windows 7 systems. | |||
| Multiuser HW/SW | |||
| architecture with | |||
| client/server support | syngo®: | ||
| Windows XP | |||
| Professional or | |||
| equivalent | |||
| Single-user HW/SW | |||
| architecture | syngo.via is a client/server multi- | ||
| user framework and is further | |||
| development of syngo®. It runs | |||
| on updated Windows systems, | |||
| and can support multiple users. | |||
| Verification and Validation | |||
| testing supports this | |||
| modification. |
Subject and Predicate Device Compared Technological Characteristics
7
SIEMENS
As the predicate device, syngo.CT Myocardial Perfusion uses scans of Siemens SOMATOM Definition Flash and Siemens SOMATOM Force scanners. These scanners are fast enough to acquire data of the left ventricle in the end systolic phase without motion. As the images are acquired in a single heart phase without motion. ECG gating is used to trigger the scans.
The detectors of these two scanners are not wide enough to scan the complete left ventricle in one scan, dedicated shuttle mode scans are used instead. These scans acquire the heart in two alternating slabs, scanning the upper and lower part of the heart. In between the scans the patient is moved. The scan protocols are described in Attachment 5 and 6 in more detail.
Currently two Siemens scanners (namely SOMATOM Definition Flash K082220, clearance date 10/10/08 the SOAMTOM Definition Flash and SOMATOM Force K133589, clearance date 04/17/2014), can provide data for CT Myocardial Perfusion. In the future scanners that are fast enough might be able to support scanning with a normal perfusion scan without shuttle because they are wide enough to scan the entire heart.
As syngo.CT Myocardial Perfusion is a post processing application only, it can use both types of data. normal perfusion data (non-shuttle mode) as well as shuttle mode data. The application was tested with both types, emulating the normal perfusion data by only using one of the slabs.
8. Nonclinical Testing:
Nonclinical tests were conducted for syngo.CT Myocardial Perfusion during product development. The modifications described in this premarket notification are supported with verification and validation testing. Results of this verification and validation testing were found acceptable to support the claim of substantial equivalence.
Siemens claims conformance to the following five safety and performance standards for syngo.CT Myocardial Perfusion.
| Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| Digital Imaging and Communications
in Medicine (DICOM) Set | PS 3.1 – 3.18 | 03/16/2012 | NEMA |
| Medical device software – Software
life cycle processes | 62304 First
edition 2006-05 | 08/20/2012 | IEC |
| Medical devices – Application of risk
management to medical devices | 14971 Second
Edition 2007-03-
01 | 08/20/2012 | ISO |
8
| Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------|------------------------------------------|
| Medical electrical equipment -- Part
1-6: General requirements for basic
safety and essential performance --
Collateral Standard: Usability | 60601-1-6
Edition 3.0 2010-
01 | 1/30/2014 | IEC |
| Medical electrical equipment - Part
1-4: General requirements for safety
-- Collateral standard:
Programmable electrical medical
systems, edition 1.1 | 60601-1-4:2000,
Consol. Ed. 1.1 | 09/08/2009 | IEC |
Verification and Validation
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Integration and functional tests were conducted for syngo.CT Myocardial Perfusion during product development.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The test results show that all of the software specifications have met the acceptance criteria.
Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. It is the hospital's responsibility to comply with IEC 8001-1-2010.
Summarv
Performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion. Supportive articles that demonstrate the usability of syngo.CT Myocardial Perfusion were provided to support device performance and functionality. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
9. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical,
9
SIEMENS
mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
10. Conclusion as to Substantial Equivalence
The predicate device was cleared based on non-clinical supportive information. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that syngo.CT Myocardial Perfusion performs as intended. The non-clinical test data demonstrates that syngo.CT Myocardial Perfusion device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens is of the opinion that the syngo.CT Myocardial Perfusion does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.