(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.
§ 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).