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510(k) Data Aggregation
(269 days)
Sensis Vibe (VD15)
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.
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.
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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(125 days)
Sensis
The Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the data using the administrative tools.
The device is intended to be used on either or both of the following populations:
-
Adult and pediatic populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
-
Adult and pediations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.
Sensis is a multi-channel computer-based stationary system for the display, and printout of bio-physiological measurement. events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG) The user can perform a number of calculations based on manual input and / or on the input signals and other hemodynamic parameter values from the Sensis system.
The Sensis System can be used also for vascular procedures in interventional radiology and surgery the same way as for cardiac procedures in interventional cardiology. The Sensis functionality remains the same.
For more flexibility in the department, additional post processing and reporting workplaces can always be connected to the network.
A Drug Med Calculator has been added to the Sensis. It uses established formulas which could also be used in Siemens secondary predicate the Cathcor system. The Drug Med Calculator provides a workflow improvement for the users and allows ease calculations for the drug amount dosage and creatinine clearance.
The provided document is a 510(k) summary for the Siemens Sensis Electrophysiological and Hemodynamic Recording System (K150493). This submission describes modifications to a previously cleared device (K131812), primarily updating the indications for use and adding a Drug Med Calculator.
Based on the provided text, the device is considered substantially equivalent to a predicate device, and the evaluation relies heavily on non-clinical testing and verification/validation of software and adherence to recognized standards. Therefore, the information regarding specific acceptance criteria and detailed study results might not be as explicit as a clinical trial report for an AI algorithm.
Here's an attempt to answer your questions based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics for an AI algorithm. Instead, the acceptance criteria are framed in terms of conformance to safety and performance standards for a medical device with software, and the performance refers to the functionality and safety of the updated Sensis system.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Software Functionality | All software specifications met. |
| Continuous conformance with special controls for medical devices containing software. | |
| Safety - Electrical | Complies with IEC 60601-1, IEC 60601-2-25, IEC 80601-2-30, IEC 60601-2-34, IEC 80601--61. All tests passed. |
| Safety - EMC (Electromagnetic Compatibility) | Complies with IEC 60601-1-2. All tests passed. |
| Risk Management | Risk analysis completed; risk controls implemented to mitigate identified hazards. |
| Usability (Human Factors) | Complies with IEC 62366 and IEC 60601-1-6. |
| Quality Management System | Conforms to ISO 14971 (Risk Management). |
| Cybersecurity | Implements a process of preventing unauthorized access, modifications, misuse, or denial of use. Conforms to IEC 80001-1:2010. |
| Drug Med Calculator Accuracy | Uses established formulas (same as Siemens Cathcor K002137). |
| Overall Performance | Performance tests showed the functionality of the Sensis Electrophysiological and Hemodynamic Recording System. Results were found acceptable in supporting the claim of substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on sample sizes for a test set in the context of an AI algorithm or clinical data. The testing mentioned is primarily for device verification and validation (V&V) and conformity to standards rather than a clinical performance study with patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable or stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The submission focuses on device V&V and safety, not on a clinical performance study involving expert assessment of outputs or ground truth establishment by clinical experts. The device (Sensis) is a recording system, and the updates concern software functionality and expanded indications, not a diagnostic AI that would require expert-established ground truth for its outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable given the nature of the device and testing described. Adjudication methods are typically used in clinical studies for diagnostic accuracy, which is not the focus of this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was 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 conducted or reported in this document. The Sensis system is described as a "diagnostic and administrative tool," not an AI-powered diagnostic aide designed to improve human reader performance in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a medical device (Sensis recording system) with updated software, not a standalone AI algorithm. The "Drug Med Calculator" is a feature, not a complex AI algorithm, and its performance relies on "established formulas." Therefore, a standalone AI algorithm performance study as typically understood in the context of machine learning was not performed or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Drug Med Calculator," the ground truth implicitly used would be the established formulas themselves, which are stated to be "the same as used with Siemens Cathcor." For the overall Sensis system, the ground truth for its functionality would be its adherence to design specifications and recognized medical device standards during verification and validation testing. There is no mention of ground truth derived from expert consensus, pathology, or outcomes data in the context of a diagnostic performance study for this device.
8. The sample size for the training set
The device described is a recording system with software updates, not a machine learning model that requires a "training set" in the conventional AI sense. Therefore, information on a training set sample size is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no mention of a traditional AI training set, this question is not applicable. The "ground truth" for the device's functionality is its compliance with engineering specifications, industry standards, and the accuracy of its calculations based on established formulas.
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(36 days)
SENSIS, SENSIS LITE
The Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies. The system is equipped by modules, enabling various configurations ranging from a stand-alone 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 intracardiac electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias.
- Adult and pediatric populations requiring intracardiac hemodynamic examinations, typically when the patient has a heart disease resulting in insufficient hemodynamic functionality.
The Sensis Electrophysiological and Hemodynamic Recording System with software VC12 is a further SW and HW development of the commercially available Siemens AXIOM Sensis K020440.
The Sensis is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. Hemodynamic and electrophysiological signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system. Sensis software provides the ability to monitor and assess invasive blood pressure, ECG signals, and optionally intracardiac electrograms (ICEG) The user can perform a number of calculations based on manual input and / or on the input signals and other hemodynamic parameter values from the Sensis system.
For more flexibility in the department, additional post processing and reporting workplaces can always be connected to the network.
The software and hardware modification does not affect the intended use of the device nor does it alter its fundamental scientific technology.
This 510(k) summary for the Siemens Sensis device is primarily a substantial equivalence claim based on modifications to an existing predicate device (AXIOM Sensis K020440). As such, it does not detail a traditional "study" with new performance metrics or acceptance criteria for the modified device in the same way a de novo device might. Instead, it relies on reaffirming the performance of the predicate and demonstrating that the changes do not negatively impact safety or effectiveness.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Software Functionality | Conformance to software specifications. No identified hazards. | All software specifications have met the acceptance criteria. Risk control implemented to mitigate identified hazards. Testing for verification and validation found acceptable. |
| Electrical Safety | Conformance to IEC Standards. | EMC/electrical safety evaluated according to IEC Standards. Conformance to Voluntary Standards covering Electrical and Mechanical Safety certified. Identified risk of electrical hazards mitigated. |
| Mechanical Safety | Conformance to Voluntary Standards. | Conformance to Voluntary Standards covering Electrical and Mechanical Safety certified. |
| Biocompatibility | OEM manufacturer ensures biocompatibility for patient-contacting sensors. | Sensors applied to patients are provided by OEM with their own 510(k) clearances, ensuring biocompatibility and sterilization (where applicable). Sensis components do not directly contact patients. |
| Safety and Effectiveness | Substantial equivalence to predicate (AXIOM Sensis K020440) in terms of safety and effectiveness, despite SW/HW development. | The identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation have been completed. The Sensis VC12 is substantially equivalent to the AXIOM Sensis (K020440). |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify a sample size for a clinical test set.
- Data Provenance: The performance testing mentioned is "Non clinical tests (integration and functional) conducted on the Sensis software during product development." This implies retrospective data generated internally during development and verification/validation processes. There is no mention of patient data, country of origin, or prospective studies for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided. As the testing was "non-clinical" and focused on software and system functionality, the concept of "ground truth" derived from expert clinical opinion in the traditional sense for diagnostic accuracy studies does not apply here. The "ground truth" for software testing would be the expected output or behavior defined by design specifications.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers resolve discrepancies in diagnostic interpretations. Given the non-clinical nature of the testing described, this would not be relevant.
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
- An MRMC comparative effectiveness study was not performed, and is not applicable. The Sensis device is described as a "diagnostic and administrative tool" for recording and monitoring bio-physiological events, not an AI-powered diagnostic aid that improves human reader performance in interpreting images or complex data. The document explicitly states: "Clinical testing was not applicable as Sensis has no new indications for use nor new clinical applications were introduced to the system."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device Sensis is not described as an "algorithm only" device. It is a "multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events." Therefore, the concept of "standalone (algorithm only)" performance as it relates to AI is not applicable. The device's performance is tied to its function as a recording and display system, which inherently involves human interaction for interpretation and use. The non-clinical tests would have evaluated the system's ability to accurately measure, display, and process signals as designed.
7. The Type of Ground Truth Used
- For the non-clinical software and integration tests, the ground truth would have been based on predefined design specifications and expected system behavior. For example, a "ground truth" for a signal measurement might be a known electrical input signal, and the system's output is compared against that. For functional tests, the ground truth would be the correct execution of a function according to its requirements. There is no mention of expert consensus, pathology, or outcomes data as ground truth for this device's validation.
8. The Sample Size for the Training Set
- Not applicable/Not provided. The Sensis system is not described as an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on established engineering principles for signal acquisition, processing, and display, rather than learned patterns from a large dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided. As there is no mention of a training set, the establishment of its ground truth is not relevant here.
In summary: The submission for the Sensis device is a "Special 510(k)" which focuses on demonstrating substantial equivalence through non-clinical testing of software and hardware modifications. It explicitly states that clinical testing was not applicable because there were no new indications for use or clinical applications introduced. The "acceptance criteria" and "study" largely revolve around internal verification and validation against engineering specifications and industry standards to ensure the modified device remains safe and effective, and substantially equivalent to its predicate.
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