(23 days)
No
The document describes image analysis software with "Basic reading" and "Advanced reading" features, but does not mention AI, ML, or any related terms. The performance studies focus on verification and functional testing, not AI/ML specific metrics or validation.
No
The device is an image analysis software for planning cardiovascular procedures, not for treating conditions.
Yes
Explanation: The device is an "image analysis software package" that supports the "physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures" and includes tools that support the clinician during "diagnosis, including reading and reporting." These functions are directly related to identifying or characterizing diseases, making it a diagnostic device.
Yes
The device is explicitly described as an "image analysis software package" and its function is solely based on processing and analyzing existing CT images. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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 Cardiac Planning is an image analysis software package that processes CT images of the human body. It does not analyze biological samples.
- Intended Use: The intended use is to support physicians in analyzing morphology and pathology of vascular and cardiac structures from these images for planning cardiovascular procedures. This is a diagnostic aid based on imaging, not on in vitro testing of biological samples.
Therefore, syngo.CT Cardiac Planning falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
Product codes
JAK
Device Description
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
syngo.CT Cardiac Planning includes tools that support the clinician at different steps during diagnosis, including reading and reporting. The user has full control of the reported measurements and images and is able to choose the appropriate function suited for their clinical need. Features included in this software that aid in diagnosis can be grouped in the following categories:
- . Basic reading: commodity features that are commonly available on CT cardiac postprocessing workstations
- Advanced reading: additional features for increased user support during CT cardiac ● postprocessing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images (contrast enhanced)
Anatomical Site
Vascular and cardiac structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Performance data was provided in the form of Verification to support the substantial equivalence determination. V&V testing can be found within the Attachment 16 Section.
Integration and Functional testing was conducted for syngo.CT Cardiac Planning during product development. In addition, testing was performed to ensure the corrective measures implemented within this submission meet the predetermined acceptance values. It is in Siemens' opinion that the results of these test activities demonstrate that the subject device performs as intended and the results were found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Siemens Medical Soultions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K200515
Trade/Device Name: syngo.CT Cardiac Planning Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: February 28, 2020 Received: March 2, 2020
Dear Ms. Padharia:
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
March 25, 2020
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
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
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Indications for Use
510(k) Number (if known) K200515
Device Name syngo.CT Cardiac Planning
Indications for Use (Describe)
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching as input for the planning of cardiovascular procedures.
| 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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Image /page/3/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.
Section 5 510(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:
Veronica Padharia Regulatory Affairs Specialist, CNMT Siemens Medical Solutions, Inc. USA 2501 N. Barrington Road Hoffman Estates, IL 60192 Phone: (630) 877-5761 Fax: (847) 304-6023 email: veronica.padharia@siemens-healthineers.com
II. Device Name and Classification
| Product Name: | syngo.CT Cardiac Planning |
|---|---|
| Propriety Trade Name: | syngo.CT Cardiac Planning |
| 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 Cardiac Planning |
|---|---|
| 510(k) Number: | K170221 |
| Clearance Date: | 04/21/2017 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
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Device Class: Class II Product Code: JAK
IV. Device Description
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
syngo.CT Cardiac Planning includes tools that support the clinician at different steps during diagnosis, including reading and reporting. The user has full control of the reported measurements and images and is able to choose the appropriate function suited for their clinical need. Features included in this software that aid in diagnosis can be grouped in the following categories:
- . Basic reading: commodity features that are commonly available on CT cardiac postprocessing workstations
- Advanced reading: additional features for increased user support during CT cardiac ● postprocessing.
V. Indications for Use
syngo.CT Cardiac Planning is an image analysis software package for evaluating contrast enhanced CT images. The software package is designed to support the physician in the qualitative and quantitative analysis of morphology and pathology of vascular and cardiac structures, with the overarching purpose of serving as input for planning of cardiovascular procedures.
Comparison of Technological Characteristics with the Predicate Device VI.
Siemens' syngo.CT Cardiac Planning post-processing software package is substantially equivalent to the following medical device in commercial distribution:
| Predicate Device | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| syngo.CT Cardiac Planning | K170221 | 04/21/2017 |
The differences and similarities between the above referenced predicate device are listed at a high-level in the following table:
| Subject Device
syngo.CT Cardiac Planning
(SOMARIS/8 VB40) | Predicate Device
syngo.CT Cardiac Planning
(SOMARIS/8 VB20) | Comparison Table |
|-----------------------------------------------------------------|-------------------------------------------------------------------|--------------------------------------------|
| TAVI Feature | | |
| • Evaluation of the Aortic Root | • Evaluation of the Aortic Root | Same |
| • Curved Planar Reformation | • Curved Planar Reformation | Same |
| • Measurement Tools | • Measurement Tools | Correction of the
measurement algorithm |
| • C-arm Angulation | • C-arm Angulation | Same |
5
| Subject Device
syngo.CT Cardiac Planning
(SOMARIS/8 VB40) | Predicate Device
syngo.CT Cardiac Planning
(SOMARIS/8 VB20) | Comparison Table | | |
|-----------------------------------------------------------------|-------------------------------------------------------------------|------------------|--|--|
| Other Features | | | | |
| Basic Reading Functionality | Basic Reading Functionality | Same | | |
| Cardiac, Aortic Valve and Mitral Valve
Planes | Cardiac, Aortic Valve and Mitral Valve
Planes | Same | | |
| Review Marker | Review Marker | Same | | |
| Integrated Reporting | Integrated Reporting | Same | | |
| Heart Isolation | Heart Isolation | Same | | |
| Blood Pool Removal | Blood Pool Removal | Same | | |
| Image Processing and Evaluation | Image Processing and Evaluation | Same | | |
| Archiving / Storing | Archiving / Storing | Same | | |
| User Interface (syngo.via based GUI) | User Interface (syngo.via based GUI) | Same | | |
| Communication (DICOM) | Communication (DICOM) | Same | | |
There are no differences between the subject device and the predicate device. The subject device does not introduce any new features or modification to already cleared features. The subject device provides an error correction that return the Cardiac Planning software to its original specifications. It is Siemens' opinion that syngo. CT Cardiac Planning-with the measurement tool error correction implemented-is substantially equivalent to the predicate device.
VII. Performance Data / Safety and Effectiveness
Performance data was provided in the form of Verification to support the substantial equivalence determination. V&V testing can be found within the Attachment 16 Section.
This submission contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk Management has been ensured via the risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.
For this submission, the risk analysis was performed to ensure the risk control was 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. Siemens adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304.
Verification and Validation activities demonstrate continued conformance with special controls for medical devices containing software, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. Integration and Functional testing was conducted for syngo.CT Cardiac Planning during product development. In addition, testing was performed to ensure the corrective measures implemented within this submission meet the predetermined acceptance values. It is in Siemens' opinion that the results of these test activities demonstrate that the subject device performs as intended and the results were found acceptable to support the claim of substantial equivalence.
Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.
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Image /page/6/Picture/1 description: The image shows 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.
Siemens hereby certifies that syngo.CT Cardiac Planning will meet the following FDA recognized standards 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; 62304:2006/A1:2016 | 01/14/2019 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971 | 06/27/2016 | ISO |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 12/23/2016 | IEC |
VIII.Statement Regarding Substantial Equivalence
There are no differences in the Indications for Use or Fundamental Technology Characteristics of the syngo.CT Cardiac Planning software as compared to the currently commercially available software (K170221).
Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device, only modifications to already existing fundamental scientific technology to bring the system back to commercially cleared (K170221) specifications. Based on this information, as well as documentation in support of modifications made, it is Siemens' opinion that the syngo.CT Cardiac Planning software is substantially equivalent to the predicate device.