(78 days)
Unknown
The document mentions an "automated calcium scoring evaluation" and "precompute the calcium score" which could potentially utilize AI/ML, but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The description of testing focuses on functionality and accuracy without detailing the underlying algorithm's nature.
No
The device is an image analysis software for evaluating CT data sets to support physicians in diagnosing and documenting calcified coronary lesions. It does not provide any therapeutic intervention.
Yes
The device is an image analysis software package designed to support physicians in evaluating and documenting calcified coronary lesions. It calculates various scores (Agatston, mass, volume) related to coronary calcium, which are used for diagnostic purposes (e.g., assessing cardiovascular risk).
Yes
The device is explicitly described as an "image analysis software package" and a "post processing application" for evaluating CT data sets. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided text, 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 description clearly states that syngo.CT CaScoring is an image analysis software package that evaluates CT data sets. It processes medical images obtained from a CT scanner.
- No Biological Samples: There is no mention of the device analyzing any biological samples from the patient. Its input is imaging data.
Therefore, since the device operates on medical images and not biological samples, it does not fit the definition of an In Vitro Diagnostic. It is a medical image analysis software.
N/A
Intended Use / Indications for Use
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.
The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).
syngo. CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.
Product codes
JAK
Device Description
syngo.CT CaScoring is a post processing application designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.
A listing of device modifications as part of the new software version SOMARIS/8 VB40 of syngo.CT CaScoring is as follows:
- Updated Indications for Use Statement .
- Support of the CaScoring algorithm to precompute the calcium score ●
- Support of Rapid Results Technology for the CaScoring algorithm ●
Mentions image processing
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.
syngo.CT CaScoring is a post processing application designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data sets, noncontrasted cardiac CT images
Anatomical Site
coronary arteries (right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX))
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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
For the new feature automated calcium scoring evaluation, a bench test has been conducted to show it performs as intended. The algorithm was successfully executed on all test data. An adequate overall accuracy of the prediction of the calcium risk category was found.
Non-clinical tests (integration and functional) were conducted for syngo.CT CaScoring to establish the proficiency of the features of the subject device. The results of these tests demonstrate that the subject device performs as intended.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of the syngo.CT CaScoring. These tests have been performed to test the ability of the included features of the results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
For the new feature automated calcium scoring evaluation, a bench test has been conducted to show it performs as intended. The algorithm was successfully executed on all test data. An adequate overall accuracy of the prediction of the calcium risk category was found.
Non-clinical tests (integration and functional) were conducted for syngo.CT CaScoring to establish the proficiency of the features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
An adequate overall accuracy of the prediction of the calcium risk category was found.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Siemens Medical Solutions USA, Inc. c/o Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE, TN 37932
December 17, 2019
Re: K192763
Trade/Device Name: syngo.CT CaScoring Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 27, 2019 Received: September 30, 2019
Dear Tabitha Estes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name syngo.CT CaScoring
Indications for Use (Describe)
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.
The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).
syngo. CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.
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) |
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3
510(k) Summary FOR SYNGO.CT CASCORING
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
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.
l. Submitter
Importer/Distributor
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany
Establishment Registration Number
3004977335
Contact Person
Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Fax: (865) 218-3019 Email: tabitha.estes@siemens-healthineers.com
Alternate Contact:
Alaine Medio
II. Device Name and Classification
Product Name: syngo.CT CaScoring Propriety Trade Name: syngo.CT CaScoring Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90JAK
4
III. Predicate Device
Primary Predicate Device:
| Trade Name: | Calcium Scoring |
|---|---|
| 510(k) Number: | K990426 |
| Clearance Date: | 05/12/1999 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
| Recall Information: | There are currently no recalls for this device. |
Secondary Predicate Device:
| Trade Name: | HealthCCS |
|---|---|
| 510(k) Number: | K172983 |
| Clearance Date: | 06/13/2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
IV. Device Description
syngo.CT CaScoring is a post processing application designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.
A listing of device modifications as part of the new software version SOMARIS/8 VB40 of syngo.CT CaScoring is as follows:
- Updated Indications for Use Statement .
- Support of the CaScoring algorithm to precompute the calcium score ●
- Support of Rapid Results Technology for the CaScoring algorithm ●
V. Indications for Use
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.
The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).
syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any userdocumented images, cited literature and additional relevant information.
VI. Comparison of Technological Characteristics with the Predicate Device
syngo.CT CaScoring is a post-processing application operating on the multi-user syngo.via client/server platform. It provides the same fundamental technology as the primary predicate device Calcium Scoring
5
(e. g. evaluation and documentation of calcified coronary lesions, calculation of the Agatston equivalent score). The automated calcium scoring algorithm which is implemented in the software version SOMARIS/8 VB40 of the subject device is equivalent to the secondary predicate device HealthCCS. The automatic calcium scoring algorithm works in the same manner as cleared with the secondary predicate device. From a functional perspective there are no difference between the subject device and the secondary predicate device is, syngo.CT CaScoring can send DICOM data to any generic DICOM viewer. This information flow has been realized for other Siemens post-processing applications (e.g. syngo.CT Single Source Dual Energy (Twin Beam), K163289, clearance date 02/09/2017).
The differences between the above referenced predicate devices are described at a high-level in the table below:
| Feature | Subject Device | Predicate Devices |
|---|---|---|
| syngo.CT CaScoring | Calcium Scoring | |
| K990426 | ||
| HealthCCS | ||
| K172983 | ||
| Automated Calcium Scoring | ||
| Evaluation | Assignment of a probability of a | |
| candidate being a coronary | ||
| calcification based on location | ||
| within the heart, density, shape | ||
| and similar properties: if the | ||
| probability of a candidate is | ||
| higher than a predefined | ||
| threshold, the candidate is | ||
| labelled as a calcification. | ||
| In addition, results of the | ||
| evaluation can be sent via Rapid | ||
| Results Technology any generic | ||
| DICOM viewer. | The technology is equivalent to | |
| HealthCCS: | ||
| Assignment of a probability of a | ||
| candidate being a coronary | ||
| calcification based on location | ||
| within the heart, density, shape | ||
| and similar properties: if the | ||
| probability of a candidate is | ||
| higher than a predefined | ||
| threshold, the candidate is | ||
| labelled as a calcification. | ||
| Browsing, selecting, and | ||
| displaying images for | ||
| searching calcium | ||
| regions/lesions | Yes | Yes |
| Interactive definition of ROIs | ||
| and assignment of the four | ||
| major coronary arteries (LM, | ||
| LAD,CRC and RCA) to the | ||
| lesions | Yes | Yes |
| Displaying the score in form | ||
| of result tables/reports on | ||
| paper and/or film | Yes | Yes |
| Pan and Zoom | ||
| functionality/windowing | Yes | Yes |
| Reformatting | Yes | Yes |
| Comparison of Score to | ||
| Cited Literature | Yes | Yes |
The subject device syngo.CT CaScoring does not have changes in fundamental scientific technology compared to the predicate devices. The post-processing software functionality remains unchanged from the subject device and the predicate devices. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT CaScoring application is substantially equivalent to the predicate devices.
VII. Performance Data
Software Verification and Validation
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.
6
Non-Clinical/Clinical Testing Summary
Performance tests were conducted to test the functionality of the syngo.CT CaScoring. These tests have been performed to test the ability of the included features of the results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
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.
| syngo.CT CaScoring is designed to fulfill the requirements of the following safety and performance | |||||||
|---|---|---|---|---|---|---|---|
| standards: |
| Recognition
Number | Product
Area | Title of Standard | Publicatio
n Date | Standards
Developme
nt
Organizatio
n |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software -Software Life
Cycle Processes: 62304:2006 (1st
Edition) | 08/20/2012 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices - Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 08/20/2012 | ISO |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 2/23/2016 | IEC |
For the new feature automated calcium scoring evaluation, a bench test has been conducted to show it performs as intended. The algorithm was successfully executed on all test data. An adequate overall accuracy of the prediction of the calcium risk category was found.
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT CaScoring to establish the proficiency of the features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
VIII. Conclusions
syngo.CT CaScoring has the same intended use and similar indication for use as the predicate devices. The technological characteristics such as evaluation and documentation of calcified coronary lesions are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, syngo.CT CaScoring, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT CaScoring to be as safe, as effective and with performance substantially equivalent to the commercially available predicate devices.