(20 days)
Not Found
Yes
The document mentions that the "automatic scoring algorithm was retrained on re-annotated data" and that a "complete performance evaluation (bench test) of the algorithm has been conducted additionally." This retraining and performance evaluation on data strongly suggests the use of a machine learning algorithm.
No.
Explanation: The device is described as image analysis software for evaluating CT data sets to support physicians in evaluating and documenting calcified coronary lesions. It calculates scores related to these lesions. There is no mention of it providing any form of therapy or treatment.
Yes
This device is designed to support physicians in evaluating and documenting calcified coronary lesions by calculating various scores (Agatston equivalent, mass, volume), which are used for disease assessment and management recommendations.
Yes
The device is described as an "image analysis software package" and a "post-processing application" that operates on existing CT data sets. There is no mention of accompanying hardware or 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.
- Device function: syngo.CT CaScoring is an image analysis software that processes CT images of the heart. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to support physicians in evaluating and documenting calcified coronary lesions based on imaging data, not laboratory test results.
Therefore, syngo.CT CaScoring falls under the category of medical imaging software, not in vitro diagnostics.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
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 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 userdocumented images, cited literature and additional relevant information.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The post-processing application syngo.CT CaScoring SOMARIS/8 VB70 is 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 lessions 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.
For the current software version SOMARIS/8 VB70 one major and one minor change have been implemented:
- . Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB50, K201034, clearance date 05/14/2020) the algorithm to precompute the calcium score has been enhanced. In the subject device, the CaScoring algorithm was retrained on a larger database.
- This version contains UI (user-interface) modifications. .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found. The term algorithm is used and retrained, however no specific mention of AI/ML/DNN.
Input Imaging Modality
CT
Anatomical Site
Heart / Chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (Prescription Use)
Description of the training set, sample size, data source, and annotation protocol
The CaScoring algorithm was retrained on a larger database.
Description of the test set, sample size, data source, and annotation protocol
A complete performance evaluation (bench test) of the algorithm has been conducted additionally. The algorithm was successfully executed on all testing datasets. No data has been excluded from the analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: This submission contains performance tests (Non-clincal test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT CaScoring during product development. These tests have been performed to test the ability of the included 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.
Performance Evaluation of the Algorithm: Since the automatic scoring algorithm was retrained on re-annotated data, a complete performance evaluation (bench test) of the algorithm has been conducted additionally. The algorithm was successfully executed on all testing datasets. No data has been excluded from the analysis. The summary of the bench test is that an adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories, which are the aspects of calcium scoring that have a wellestablished impact on management recommendations. All pre-specified acceptability criteria were passed.
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
§ 892.1750 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Monsuru Bello Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K221219
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: April 25, 2022 Received: April 27, 2022
Dear Monsuru Bello:
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/cfpmp/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 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
May 17, 2022
1
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
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Rav Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221219
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 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 userdocumented images, cited literature and additional relevant information.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
510(k) Summary
I. Identification of the 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
Submitter Contact Person:
Monsuru K Bello Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (202) 856-6099 Email: Monsuru.bello@siemens-healthineers.com
Alternate Contact:
Alaine Medio Regulatory Affairs Manager Siemens Medical Solutions, Inc. USA (MI) 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (865) 206-0337 Email: alaine.medio@siemens-healthineers.com
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 |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
III. Predicate Device
| Trade Name: | syngo.CT CaScoring |
|---|---|
| 510(k) Number: | K201034 |
| Clearance Date: | 05/14/2020 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
4
IV. Device Description
The post-processing application syngo.CT CaScoring SOMARIS/8 VB70 is 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 lessions 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.
For the current software version SOMARIS/8 VB70 one major and one minor change have been implemented:
- . Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB50, K201034, clearance date 05/14/2020) the algorithm to precompute the calcium score has been enhanced. In the subject device, the CaScoring algorithm was retrained on a larger database.
- This version contains UI (user-interface) modifications. .
Indications for Use V.
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 mark calcified coronary lessions 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.
5
VI. Comparison of Technological Characteristics with the Predicate Device
The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table:
| Feature | Subject Device | Predicate Devices |
|---|---|---|
| syngo.CT CaScoring | ||
| (SOMARIS/8 VB70) | syngo.CT CaScoring | |
| (SOMARIS/8 VB50) | ||
| Modality | CT | CT |
| Loading of a series of | ||
| appropriate CT from the patient | ||
| database | Yes | Yes |
| Body Part | Heart / Chest | Heart / Chest |
| Acquisition Part | ECG-gated / ECG-triggered | ECG-gated / ECG-triggered |
| 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. | ||
| Each calcification is labeled | ||
| according to one of four coronary | ||
| arteries it most probably belongs to. | ||
| In addition, results of the evaluation | ||
| can be sent via Rapid Results | ||
| Technology to any generic DICOM | ||
| viewer. | ||
| Comparison to the predicate | ||
| device: | ||
| The algorithm was re-trained on a | ||
| larger database. | ||
| A configuration option was added so | ||
| the user can disable the 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. | ||
| Each calcification is labeled according to one | ||
| of four coronary arteries it most probably | ||
| belongs to. | ||
| In addition, results of the evaluation can be | ||
| sent via Rapid Results Technology to any | ||
| generic DICOM viewer. | ||
| 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 |
| Automatic definition of ROIs and | ||
| assignment of a generic calcium | ||
| label to the lesions | Yes | Yes |
| Calculation and display of the | ||
| 2D-Agatston score/factor or | ||
| other metric on the defined ROIs | Agatston, volume and mass scores | Agatston, volume and mass scores |
| Interactive definition of ROIs (for | ||
| example noise) to disqualify the | ||
| region from participation in the | ||
| score | Yes | Yes |
| Displaying the score in form of | ||
| result tables/reports on paper | ||
| and/or film | Yes | Yes |
| Feature | Subject Device | Predicate Devices |
| syngo.CT CaScoring | ||
| (SOMARIS/8 VB70) | syngo.CT CaScoring | |
| (SOMARIS/8 VB50) | ||
| Pan and Zoom | ||
| functionality/windowing | Yes | Yes |
| Reformatting | Yes | Yes |
| Comparison of Score to Cited | ||
| Literature (including calculation | ||
| of coronary age) | Yes | Yes |
| User Interface | syngo.via GUI | syngo.via GUI |
| Archiving/Storing | CD-R, film, DVD, USB, Network | CD-R, film, DVD, USB, Network |
| Hardware | As specified by syngo.via | As specified by syngo.via |
| Communication | DICOM compatible | DICOM compatible |
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Image /page/6/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
The subject device syngo.CT CaScoring does not have changes in fundamental scientific technology compared to the predicate device. The post-processing software functionality remains unchanged from the subject device and the predicate device. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT CaScoring application is substantially equivalent to the predicate device. The major change in this software version is that the Automated Calcium Scoring Evaluation algorithm has been re-trained on a larger database.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
This submission contains performance tests (Non-clincal test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT CaScoring during product development. These tests have been performed to test the ability of the included 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.
Performance Evaluation of the Algorithm
Since the automatic scoring algorithm was retrained on re-annotated data, a complete performance evaluation (bench test) of the algorithm has been conducted additionally. The algorithm was successfully executed on all testing datasets. No data has been excluded from the analysis. The summary of the bench test is that an adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories, which are the aspects of calcium scoring that have a wellestablished impact on management recommendations. All pre-specified acceptability criteria were passed.
Risk Analysis
The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
7
Siemens hereby certifies that syngo.CT CaScoring will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA |
| 13-79 | Software | Medical Device Software -Software Life Cycle
Processes; 62304:2015-06 (Edition 1.1) | 01/14/2019 | AAMI, ANSI,
IEC |
| 5-125 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971 Third
Edition 2019-12 | 12/23/2019 | ISO |
| 5-129 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 +AMD1:2020 | 07/06/2020 | ANSI, AAMI, IEC |
| 5-117 | General I
(QS/RM) | Medical devices - Symbols to be used with
medical device labels, labelling, and
information to be supplied - Part 1: General
requirements 15223-1:2016 | 8/21/2017 | ISO |
VIII. Conclusion
syngo.CT CaScoring has the same intended use and same indication for use as the predicate device. 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, nonclinical 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 device.