(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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).