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510(k) Data Aggregation
(171 days)
Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere Pressure Cable and StO2 is acquired by the ForeSight Oximeter Cable.
CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring.
CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.
Cerebral Adaptive Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to show the level of coherence between MAP and cerebral StO2. The output will be represented as an index value and a trended graph.
MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).
The CAI parameter can enhance clinician's understanding of the underlying hemodynamic changes behind cerebral desaturation events. It helps the clinician recognize/ identify possible causes of, for example, decrease in StO2 and clinical events related to StO2 decrease (e.g., hypotension as opposed to inadequate oxygen content).
CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will only be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation Whereas a low CAI value (CAI
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study for Cerebral Adaptive Index (CAI) Algorithm
The Cerebral Adaptive Index (CAI) Algorithm is an informational index designed to assess the coherence between Mean Arterial Pressure (MAP) and Absolute Levels of Blood Oxygenation (StO2) in cerebral tissue.
1. Acceptance Criteria and Reported Device Performance
The performance goals for the CAI algorithm were established using a CAI threshold of 45.
| Acceptance Criteria | Reported Device Performance at CAI Threshold of 45 |
|---|---|
| Sensitivity ≥ 80% | 0.84 [0.78, 0.88] (84%) |
| Specificity ≥ 80% | 0.80 [0.76, 0.85] (80%) |
| ROC AUC (summarizes overall performance) | 0.88 [0.85, 0.90] |
Conclusion: The device met all pre-defined acceptance criteria for sensitivity, specificity, and ROC AUC at the specified CAI threshold of 45.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 145 subjects aged 18 or older.
- Data Provenance: Retrospectively obtained from four different clinical sites within the US:
- Northwestern University, Chicago
- UC Davis, Sacramento
- University of Minnesota, Minneapolis
- Stanford University, Stanford
- Patient Characteristics: Adult surgical patients (cardiac surgery, general surgery, and surgical ICU) whose StO2 (via Foresight Sensors) and MAP (via Flotrac Sensors) were being monitored. Patients were randomly selected.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth.
4. Adjudication Method for Test Set
The document does not explicitly state an adjudication method. The ground truth was based on the Pearson's Correlation Coefficient (Corr) between MAP and StO2 from the clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned in the provided text. The study focused on the standalone performance of the algorithm.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was conducted. The reported sensitivity, specificity, and ROC AUC values are for the CAI Algorithm operating without human intervention, based on the retrospective clinical data.
7. Type of Ground Truth Used
The ground truth was established by classifying the relationship between MAP and StO2 using the Pearson's Correlation Coefficient (Corr) from the utilized time-series clinical data.
- Weak/Moderate MAP-StO2 association: 0
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(162 days)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requiring of venous oxygen saturation (SvO2 and Scv02) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards Lifesciences Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure
The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function. HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Technology Module (K190205 August 29, 2019). HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).
The provided FDA 510(k) summary (K221704) for the HemoSphere Advanced Monitoring Platform does not contain a table of acceptance criteria and reported device performance for the modifications made (specifically the Right Ventricular Pressure (RVP) algorithm). While it states that "All tests passed" and "demonstrated that the subject devices meet their predetermined design and performance specifications," specific numerical performance metrics and their corresponding acceptance criteria are not detailed in this document.
However, based on the information provided, here's a breakdown of the other requested information regarding the study supporting the device:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that "all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications" and "All tests passed," but it does not specify the quantitative acceptance criteria or the numerical results achieved by the device against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm."
- Sample Size for Test Set: Not specified. The document does not provide the number of patients or waveforms used for the clinical data collection for the RVP algorithm validation.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable/Not specified. The document mentions the collection of "clinical data (waveforms)" for the RVP algorithm validation, but it does not describe a process involving human experts to establish ground truth from this data. The RVP algorithm likely derives its parameters directly from physiological waveform data obtained from the Swan-Ganz Module and Pressure Cable, rather than relying on expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable/Not specified. As there is no mention of human expert-established ground truth, an adjudication method is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in a comparative context. The device focuses on monitoring physiological parameters rather than image interpretation or diagnostic tasks involving human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The validation of the RVP algorithm described in the document is a standalone performance assessment. The statement "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm" implies that the algorithm's performance was evaluated based on this collected data. The conclusion that the device "has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies" further supports that the algorithm's performance was assessed. However, specific standalone performance metrics are not provided.
7. Type of Ground Truth Used for the Test Set
The ground truth for the RVP algorithm's validation would be the physiological waveform data itself, specifically from the Swan-Ganz Module and Pressure Cable. The algorithm processes this raw physiological data to derive parameters like SYSRVP, DIARVP, MRVP, PRRVP, RV dp/dt, and RVEDP. The validation would involve comparing the algorithm's derived parameters against established methods or calculations from the same direct physiological measurements (e.g., from the Swan-Ganz catheter and pressure sensors).
8. Sample Size for the Training Set
Not specified. The document mentions "clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm," but it does not differentiate between data used for design/training and data used specifically for validation (test set), nor does it specify the sample size for any such training.
9. How the Ground Truth for the Training Set Was Established
Not specified/Not explicitly described. Given that the RVP algorithm processes physiological signals from existing, cleared hardware, the "ground truth" for any potential training would inherently be the raw physiological signals themselves, as measured by the Swan-Ganz Module and Pressure Cable. The algorithm's development would likely be based on established physiological principles and signal processing techniques to derive the mentioned RVP parameters. The document does not detail a specific "training set" or a separate process for establishing ground truth for training data beyond the intrinsic nature of the physiological measurements.
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(137 days)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric crtical care patients requring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure
HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).
Acceptance Criteria and Device Performance for Edwards HemoSphere ClearSight Module
Based on the provided text, the Edwards HemoSphere ClearSight Module has undergone a modification to its existing APCO algorithm. The acceptance criteria and performance evaluation are related to ensuring this modification did not adversely affect the safety and effectiveness of the device, particularly concerning Cardiac Output accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predicate Device Specifications: The modified algorithm's performance (specifically Cardiac Output accuracy) should meet the specifications cleared for the predicate device (Edwards HemoSphere Advanced Monitoring Platform, K201446). | "All testing passed without exception." The retrospective analysis of clinical data demonstrated that the modification did not adversely affect the safety and effectiveness of the subject device, and "All tests passed." |
| No Adverse Effect on Safety and Effectiveness: The modification should not negatively impact other aspects of the device's safety and effectiveness. | "System verification activities confirmed that the modification to the device did not adversely affect the safety and effectiveness of the subject device." |
| Software Verification: The software modification should comply with FDA guidance for software in medical devices, including design, development, and traceability. | "Software verification was performed per FDA's Guidance for Industry and FDA Staff... All tests passed." |
| System Verification: The algorithm change should be integrated without issues. | "the change in the algorithm was integrated without any concern and all integration passed with no exceptions." |
| Unchanged Design, Materials, Energy Source, User Interface, Measurement Principle, and Performance Specifications: These aspects of the HemoSphere ClearSight Module should remain the same. | "Design, materials, energy source, user interface, measurement principle, and all performance specifications of the modified HemoSphere ClearSight Module remain unchanged." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states that "retrospective analysis of clinical data from multiple independent datasets, comprised of data from patients over the age of 18 years" was used. However, a specific numerical sample size (e.g., number of patients or data points) is not provided in the document.
- Data Provenance: The data was "retrospective analysis of clinical data from multiple independent datasets." The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text does not describe how the "ground truth" for the clinical data used in the retrospective analysis was established, nor does it mention the use of experts for this purpose.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 is not mentioned or described in the document. This study focuses on an algorithm modification for a medical device (HemoSphere ClearSight Module) measuring physiological parameters, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation of the algorithm was done. The "Algorithm Verification (Clinical Performance Data)" section specifically states: "Algorithm performance was tested using clinical data." This indicates an evaluation of the algorithm's performance independent of real-time human interaction.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document refers to the evaluation of "Cardiac Output accuracy." For a device that measures physiological parameters like Cardiac Output, the "ground truth" would typically refer to a gold standard measurement technique for that parameter. However, the exact gold standard method used to establish the ground truth for Cardiac Output in the clinical data is not explicitly stated in the provided text. It implies the use of "clinical data" which would have reference measurements for comparison but does not detail the nature of these reference measurements.
8. The Sample Size for the Training Set
The document only mentions "retrospective analysis of clinical data" for testing the algorithm modification. It does not provide any information regarding a "training set" or its sample size. This suggests that the modification might have been made to an existing algorithm, and the focus of this submission is on verifying the impact of that modification using a test set, rather than developing a new algorithm from scratch requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this information is not provided in the document.
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(35 days)
Indications for Use: HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Gatheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and Scv02) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ, and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
· When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >3 kg.
· When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects
The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.
HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).
The regulatory submission K223127 for the HemoSphere Advanced Monitoring Platform indicates a modification to the existing StO2 algorithm of the HemoSphere ForeSight Oximeter Cable. The submission claims substantial equivalence to a predicate device (K213682 cleared June 22, 2022) and an additional predicate (Fore-Sight Elite Module Tissue Oximeter, K143675 cleared April 10, 2015) for the StO2 algorithm.
Here's an analysis based on the provided text, fulfilling the requested information points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "All testing passed without exception" and the "modification did not adversely affect the safety and effectiveness of the subject device." However, specific numerical acceptance criteria (e.g., accuracy +/- X%, bias Y, precision Z) and the corresponding reported performance values for the StO2 algorithm are not explicitly provided in the given text.
The text vaguely indicates that:
- "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
- "The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification."
- "Design, materials, energy source, user interface, measurement principle and all performance specifications of the modified HemoSphere ForeSight Oximeter cable remain unchanged."
Without the actual specific criteria and reported values from the predicate device's clearance, a detailed table with numerical data cannot be generated from this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It mentions "Algorithm Verification" and "System Verification" without detailing the number of cases or patients included in these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Given that the modified device measures "absolute regional hemoglobin oxygen saturation (StO2)," the ground truth would typically be established through a reference method (e.g., co-oximetry of arterial and venous blood samples, or another validated oximetry technique) rather than expert consensus on images.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was performed. The device is a monitoring platform providing quantitative physiological parameters, not an imaging device requiring human reader interpretation in the same way.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study of the algorithm was done. The submission explicitly states:
- "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
- "The results establish that the modification did not adversely affect the safety and effectiveness of the subject device."
This "Algorithm Verification" section refers to directly testing the algorithm's performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used but implies it would be a comparison to existing specifications from the predicate devices. For a tissue oximeter measuring StO2, the ground truth would typically involve comparison to a validated reference method for oxygen saturation, possibly through in-vivo or in-vitro testing. It is not expert consensus on images or pathology in this context.
8. Sample Size for the Training Set
The document does not provide the sample size for the training set. This is a modification to an existing algorithm, so the original algorithm would have been developed and trained, but details about that original training are not in this submission.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set (of the original algorithm) was established. It only refers to the modification of an "existing StO2 algorithm."
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(58 days)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and SevO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function. fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 3 kg.
· When used with small sensors, the Fore-Sight Elite tissue oximeter module is indicated for cerebral use on pediatric subjects
The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.
HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019), HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 cleared October 1, 2020).
The HemoSphere Advanced Monitor (K201446 most recently cleared October 1, 2020), subject of this submission, is being modified to enable connectivity to a Viewfinder Remote mobile application via a software-based Viewfinder Hub and Viewfinder Cloud.
The Viewfinder Remote mobile application provides clinicians with a supplemental near-real time display of the patient hemodynamic data from the connected HemoSphere Advanced Monitoring Platform. The Viewfinder Remote application is part of the Edwards Viewfinder network, which includes Viewfinder Hub and Viewfinder Cloud. The Viewfinder Remote mobile application functions as a supportive visual aid for patient status communication between clinicians and allows them to view multiple patient monitoring sessions at once from their mobile device. The near-real time updates to patient monitoring sessions includes non-invasive hemodynamic parameter data and the associated physiological alarm notifications, historical trend data and parameter waveform data.
The provided text describes modifications to an existing device, the HemoSphere Advanced Monitoring Platform, to include a new feature: the Viewfinder Remote mobile application. The primary predicate device is the HemoSphere Advanced Monitoring Platform itself (K201446). The submission focuses on the addition of the Viewfinder Remote and changes to the HemoSphere Advanced Monitor to support this remote viewing functionality.
The acceptance criteria and study information provided are primarily related to the safety and functionality of the new remote viewing feature and the integrated system, rather than the clinical performance of the underlying hemodynamic monitoring parameters. No clinical performance data is deemed necessary for the modifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for parameters like accuracy, sensitivity, or specificity for the Viewfinder Remote mobile application. Instead, it states that "All tests passed" for various verification activities, implying that the device met internal performance specifications for these tests. The focus is on ensuring data integrity, safety, and usability of the remote viewing function.
| Acceptance Criteria Category | Specific Test/Description | Reported Device Performance |
|---|---|---|
| System Verification | End-to-end system verification for data integrity and accuracy (Monitor to Remote View mobile application) | All tests passed. |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34 and IEC 60601-2-49 standards | All tests passed. |
| Wireless Coexistence | ANSI C63.27/D1.0, bench and simulated environment testing on the entire platform, including modules and the Viewfinder Remote | All tests passed. |
| Software Verification | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | All tests passed. (HemoSphere Advanced Monitor: Major Level of Concern; Viewfinder Remote: Moderate Level of Concern) |
| Usability Study | FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices" | All tests passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the verification tests (system, wireless, software, usability). It does not mention clinical data proving the device meets the acceptance criteria, as clinical data was not required for the modifications. The tests appear to be non-clinical (bench and simulated environment).
- Test Set Sample Size: Not specified.
- Data Provenance: Non-clinical (bench and simulated environment testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The verification activities mentioned are technical and regulatory compliance tests, not typically requiring expert ground truth in the way a diagnostic algorithm's performance would. For the usability study, "clinicians" are mentioned as users, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided.
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
No such study was mentioned. The device (Viewfinder Remote) is a "supportive visual aid" for remote display of parameters, not an AI-assisted diagnostic tool that would improve human reader performance in interpreting complex medical images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Viewfinder Remote itself is a standalone application in the sense that it displays data from the HemoSphere monitor, but its "performance" is based on accurately reflecting the data generated by the primary monitoring platform. The verification activities focus on the integrity and accuracy of this data transfer and display, not on the Viewfinder Remote generating independent algorithmic outputs. The "Acumen Hypotension Prediction Index Feature" is mentioned as a component of the HemoSphere system, providing "additional quantitative information," but the document doesn't detail standalone performance studies for this specific AI feature outside of its integration with the HemoSphere platform and the context of the Viewfinder Remote submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the HemoSphere Advanced Monitoring Platform itself, the ground truth for its core hemodynamic parameters would typically be established through validation against gold-standard invasive measurements or other well-established methods. However, for the modifications related to the Viewfinder Remote, the "ground truth" for the verification tests involved comparing the displayed data on the remote application against the data displayed on the primary HemoSphere monitor, and ensuring it passed technical and regulatory standards.
- For the Viewfinder Remote modifications: The ground truth for data integrity and accuracy would be the parameters and alarms generated and displayed on the HemoSphere Advanced Monitor itself.
- For the overall HemoSphere Advanced Monitor (implied from its existing clearance K201446 and general device type): Ground truth for hemodynamic parameters like cardiac output, pressure, and oxygen saturation would typically rely on established clinical measurement techniques (e.g., thermodilution for CO, direct arterial line measurement for BP, co-oximetry for SvO2).
8. The Sample Size for the Training Set
This information is not provided. Given that clinical data was not required for these specific modifications, and the focus is on a remote display application rather than a new diagnostic algorithm requiring extensive training data, a training set as typically understood for AI models is not explicitly mentioned. If the Acumen HPI feature involves AI, its training data details are not provided in this document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See point 8).
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HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediativ critical care patients requiring of venous oxygen saturation (Sv02 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure
HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).
The HemoSphere Advanced Monitor with HemoSphere ClearSight module is a non-invasive monitoring platform intended to continuously and noninvasively measure blood pressure and associated hemodynamic parameters.
The HemoSphere Advanced Monitoring Platform when used with ClearSight Module uses the same technology as the predicate device. The volume clamp method of Peñáz is the measurement method, and the pressure waveform reconstruction is based on the generalized transfer function and level of correction of Gizdulich.
The platform also includes the Acumen Hypotension Prediction Index (HPI) feature for the ClearSight (non-invasive) technology. Currently, the HemoSphere Pressure Cable enables the HPI feature when connected to an Acumen IQ sensor. This feature has been updated to also enable the HPI feature when connected to the Acumen IQ finger cuff (ClearSight finger cuff).
The modified ClearSight System receives the pressure signal from the finger cuff and reconstructs it to a radial arterial pressure representation of the signal. This radial reconstructed signal is then used to calculate the previously available key hemodynamic parameters; PR, MAP, SYS, DIA, PPV and SVV. Additionally, the radial reconstructed signal is also used to calculate the parameters associated with the Hypotension Prediction Index feature (HPI, Eadyn, and dP/dt).
The cardiac output (CO) and other measurements derived from cardiac output, such as stroke volume (SV), cardiac output index (CI), stroke volume index (SVI) remain unchanged and will continue to use previously cleared ClearSight algorithm to reconstruct the finger pressure waveform into a brachial arterial pressure waveform.
The provided text describes the HemoSphere Advanced Monitoring Platform, which is a medical device. The submission focuses on modifications to the ClearSight algorithm and the addition of the Acumen Hypotension Prediction Index (HPI) feature for non-invasive technology.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." and "All tests passed." for various types of testing. The primary performance claim is related to the substantial equivalence to the predicate device, particularly regarding safety and effectiveness.
For the Acumen HPI feature, the indication states: "The Acumen HPI feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure
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