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.

Device Description

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.

AI/ML Overview

This document, K200515, describes Siemens' syngo.CT Cardiac Planning software. It states that the submission aims to clear an "error correction that return the Cardiac Planning software to its original specifications" and mentions that there are "no differences between the subject device and the predicate device" and no "new features or modification to already cleared features." Based on this, a full comparative effectiveness study with human readers (MRMC) or a standalone (algorithm only) performance study against clinical ground truth is not expected or provided. The document focuses on verification and validation demonstrating that the software performs as intended after the error correction, aligning with the original cleared specifications.

Given the nature of this 510(k) submission, the provided text does not contain information about specific acceptance criteria related to clinical performance metrics (like sensitivity, specificity, accuracy) or a study proving the device meets these criteria in the typical sense for a new AI/ML device. Instead, the "acceptance criteria" discussed are largely related to software verification and validation, ensuring the corrected software meets its design specifications and maintains substantial equivalence to the predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of performance acceptance criteria (e.g., sensitivity, specificity, or specific measurement accuracy thresholds) for the device's diagnostic capabilities. Instead, it refers to:

Acceptance Criteria Type	Reported Device Performance (Summary)
Software Specifications	- All software specifications met.
Corrective Measures	- Corrective measures implemented meet predetermined acceptance values.
Verification & Validation	- Functions work as designed, performance requirements and specifications met. - All hazard mitigations fully implemented.
Risk Management	- Risk analysis performed (ISO 14971 compliant). - Risk control implemented to mitigate identified hazards.

The "Correction of the measurement algorithm" for "Measurement Tools" within the TAVI Feature is the specific area where a change was made and subsequently verified. The performance reported is that this correction brings the software back to its "original specifications" and achieves "substantially equivalent" performance to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size of a test set (e.g., number of patient cases) used for clinical performance evaluation. The testing described is primarily focused on software verification and validation, rather than a clinical performance study with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of clinical performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as a clinical performance study with a test set requiring expert ground truth is not detailed in this submission. The focus is on software function and correction verification.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted and is not mentioned. The submission's core purpose is to demonstrate that an error correction maintains the device's original cleared specifications, not to show improvement over human readers.

6. Standalone (Algorithm Only) Performance Study:

A standalone (algorithm only) performance study (e.g., measuring diagnostic accuracy independent of a human user) was not conducted and is not described. The document pertains to an error correction in existing, cleared software.

7. Type of Ground Truth Used:

The document implies a ground truth based on the original design specifications and expected behavior of the syngo.CT Cardiac Planning software (K170221). The testing confirmed that the corrected measurement algorithm performs according to these original specifications, which serve as the implicit "ground truth" for the verification activities. There is no mention of external clinical ground truth (e.g., pathology, outcomes data) for validating a diagnostic claim in this submission.

8. Sample Size for the Training Set:

Not applicable. This submission is for an error correction to an existing software product, not the development of a new algorithm that would involve a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned or implied for this submission.

Summary

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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

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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)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(k) Summary

K200515

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

. 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

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 Devicesyngo.CT Cardiac Planning(SOMARIS/8 VB40)	Predicate Devicesyngo.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 themeasurement algorithm
• C-arm Angulation	• C-arm Angulation	Same

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Subject Devicesyngo.CT Cardiac Planning(SOMARIS/8 VB40)	Predicate Devicesyngo.CT Cardiac Planning(SOMARIS/8 VB20)	Comparison Table
Other Features
Basic Reading Functionality	Basic Reading Functionality	Same
Cardiac, Aortic Valve and Mitral ValvePlanes	Cardiac, Aortic Valve and Mitral ValvePlanes	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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Siemens hereby certifies that syngo.CT Cardiac Planning will meet the following FDA recognized standards prior to introduction into interstate commerce:

RecognitionNumber	ProductArea	Title of Standard	Date ofRecognition	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 – 3.20	06/27/2016	NEMA
13-79	Software	Medical Device Software – Software Life CycleProcesses; 62304:2006/A1:2016	01/14/2019	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971	06/27/2016	ISO
5-114	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 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.

Regulation Number and Section

§ 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.