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The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools.

The device is intended to be used on either or both of the following populations:

Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.

Device Description

SIEMENS Medical Solutions USA. Inc. intends to market the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B), a hemodynamic and electrophysiological recording system. This 510(k) submission describes modifications to the previously cleared Primary Predicate Device the Sensis (K150493). Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. There are two configurations for this device: Sensis Vibe-Hemo and Sensis Vibe Combo.

Hemodynamic and electrophysiologic signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system; several hemodynamic calculations are performed based on the measured values of the input signals. These data can be recorded in real-time and stored on removable media or in a digital DICOM archive.

The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) system is comprised of the following basic hardware components: a small cabinet (video distribution box), front-end electronics, a keyboard with a mouse, and master and slave monitor(s) for real-time presentation of ECG tracings and pressure and ICEG waveforms. The small cabinet (video distribution box) contains power distribution electronics, video drivers, and a separation device for electrical isolation between the small cabinet and the signal input box. The front-end electronics contain modules for the acquisition of invasive blood pressure, ECG, SpO2, CO, and optionally ICEG and NBP, and are normally stalled at the operating table.

AI/ML Overview

The Siemens Medical Solutions USA Inc. Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) are electrophysiological and hemodynamic recording systems. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that the provided document outlines conformity to standards and non-clinical performance testing for specific modifications to an existing cleared device (Sensis K150493) rather than a comprehensive de novo clinical study for the entire system.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
New System Software Changes
Temperature Display	The addition of a temperature display (measured by third-party temperature probes) with the use of an adapter cable connecting to the HiSiB should not raise any new safety or effectiveness issues.	Comparable: "Testing was performed and test results indicate this feature does not raise any new safety or effectiveness issues."
DFR™ Assessment	Introduction of Diastolic Hyperemia-Free Ratio (DFR™) assessment of blood flow through single or multiple lesions without inducing hyperemia. The algorithm used to calculate DFR™ should have the same measuring points as the predicate device (iLabs Polaris Multi-Modality Guidance System K191008).	Comparable: "The algorithm used to calculate DFRTM has the same measuring points." "Testing was performed and test results indicate this feature does not raise any new safety or effectiveness issues." Numerical equivalence to iLab Polaris' DFR index demonstrated via bench testing.
IFU Statement	Revised IFU Statement should be comparable to the Primary Predicate Device (Sensis VC12 K150493) except for the name change and corrected verb usage typos, and should not raise new safety or effectiveness issues.	Comparable: "Same as Primary Predicate Device except for the Name change from 'Sensis' to 'Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B)' Corrected verb usage typos."
Software Conformance	Continued conformance with special controls for medical devices containing software (Major Level of Concern per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005, and "Off-The-Shelf Software Use in Medical Devices").	Software documentation for a Major Level of Concern was included. Testing results support that all software specifications have met the acceptance criteria.
Risk Management	Risk analysis completed, and risk control implemented to mitigate identified hazards.	Risk analysis was completed, and risk control was implemented to mitigate identified hazards.
Human Factors	Human factors are addressed in the system test according to the operator's manual. Customer employees are adequately trained in the use of this equipment.	The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator’s manual.
Cybersecurity	Conforms to cybersecurity requirements, including 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 (considering IEC 80001-1:2010).	A cybersecurity statement considering IEC 80001-1:2010 was provided. Required cybersecurity information was included in the Software Section.
Overall Safety & Effectiveness	The device is safe and effective for intended users, uses, and use environments through the design control verification and validation process, and does not raise any new safety or effectiveness issues compared to predicate devices.	The comparison of technological characteristics, non-clinical performance data, and software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Devices that are currently marketed for the same intended use. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new safety or effectiveness issues.

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

The document primarily describes non-clinical bench testing for the modifications made to the device.

DFR™ Bench Test Study: DFR indices obtained from Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) were compared with DFR indices obtained from a previous bench test study performed and submitted for iLab Polaris-Modality Guidance System (K191008).
Other Testing: General "verification and validation testing," "non-clinical tests," and "software documentation" were performed. No specific sample sizes for clinical data sets are mentioned, as the focus is on a substantial equivalence claim based on modifications and adherence to standards.
Data Provenance: The data provenance for the DFR™ comparison is a prior bench test study. For other aspects, it is internal company testing and validation processes. No mention of country of origin for specific test data is provided. Given it's premarket notification, it's likely internal development and testing data.

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

The document does not specify the number or qualifications of experts used to establish ground truth for this submission, as it relies heavily on bench testing and reference to prior clearances. For the DFR™ comparison, the "ground truth" is essentially the established performance of the legally marketed predicate device (iLab Polaris).

4. Adjudication Method for the Test Set:

Given that the testing described is primarily non-clinical bench testing, there is no mention of an adjudication method (e.g., 2+1, 3+1). Such methods are typically used in clinical studies involving interpretation by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described in this submission. The device is a "programmable diagnostic computer" intended as a "diagnostic and administrative tool," not an AI-assisted diagnostic aid that directly improves human reader performance in interpreting medical images or signals. Its function is to measure, display, and record bio-physiological events and perform calculations like DFR™.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The description of the device and its testing suggests that it functions as a standalone system (algorithm/hardware only) for measuring, displaying, and recording physiological data, and performing calculations like DFR™. The DFR™ bench test compared the device's output numerically to that of a predicate device, indicating a standalone performance evaluation of this specific function.

7. The Type of Ground Truth Used:

For the DFR™ assessment modification, the ground truth relied upon was the numerical output and algorithm of a legally marketed predicate device (iLab Polaris-Modality Guidance System). For other aspects (temperature display, software, etc.), the "ground truth" is adherence to established engineering specifications, safety standards, and performance benchmarks as determined by internal verification and validation processes. There is no mention of pathology or outcomes data as ground truth for this submission.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The submission focuses on modifications to an existing device, which implies that core algorithms have likely been developed and validated previously. The new DFR™ functionality appears to be a direct implementation of an existing, cleared algorithm from a predicate device, rather than a novel AI model requiring a new training set.

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

As no specific training set is mentioned for the modifications, the document does not describe how ground truth for any training set was established.

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