(226 days)
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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 in a hospital environment. 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-Ganz catheter and Swan-Ganz Jr catheter indications for use statements 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.
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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 critical care patients requiring monitoring 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.
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HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric 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 of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
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HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients >=18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.
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HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
- When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >=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 Monitor was designed to simplify the customer experience by providing one platform with modular solutions for all hemodynamic monitoring needs. The user can choose from 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.
The provided FDA 510(k) clearance letter and summary for the Edwards Lifesciences HemoSphere Advanced Monitor (HEM1) and associated components outlines the device's indications for use and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the specific study results (performance data) in the format typically required to answer your request fully, especially for acceptance criteria and performance of an AI/algorithm-based feature like the Hypotension Prediction Index (HPI) or Assisted Fluid Management (AFM).
The document states:
- "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
- "Measured and derived parameters were tested using a bench simulation. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
- "Software verification testing was conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed."
This indicates that internal performance specifications were met, but the specific metrics, thresholds, and study designs for achieving those specifications are not detailed in this public summary.
Therefore, I cannot populate the table with specific numerical performance data against acceptance criteria for the HPI or AFM features, nor can I provide details on sample size, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.
The text primarily focuses on:
- Substantial equivalence to predicate devices.
- Indications for Use for various HemoSphere configurations and modules.
- Description of software and hardware modifications (e.g., integration of HPI algorithm, new finger cuffs).
- General categories of testing performed (Usability, System Verification, Electrical Safety/EMC, Software Verification) with a blanket statement that "All tests passed."
Based on the provided document, here's what can and cannot be stated:
1. A table of acceptance criteria and the reported device performance
Cannot be provided with specific numerical data or thresholds from the given text. The document only states that "all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." No specific acceptance criteria values (e.g., "Accuracy > X%", "Sensitivity > Y%", "Mean Absolute Error
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).