(96 days)
The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash3000/4000/5000 patient monitor is designed as a bedside, portable, and intrahospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK™ indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
The Solar 8000M/i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000M/i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000M/i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000M/i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000M/i patient monitoring system also provides physiological data over the UNITY NETWORK™
The Capnostat / CapnoFlex CO2 System provides end-tidal CO2 monitoring which is continuous, noninvasive technique for determining the concentration of CO2 (carbon dioxide) in respiratory gas by measuring the adsorption of infrared light of specific wavelengths. The light generated in the analyzer bench is passed through respiratory gas samples. The amount of adsorption by CO2 in the sample is measured and digitized by the photodetector. The module processes the electronic signal and displays the waveform (labeled CO2) and digital values for expired CO2 (EXP), inspired CO2 (INSP) and respiratory rate (RR). The Capnostat / CapnoFlex CO2 System consists of a Capnostat Mainstream CO2 module used for intubated patients and a CapnoFlex LF CO2 module used for intubated or nonintubated patients. The Capnostat / CapnoFlex CO2 System uses specially designed sampling cannulas and on-airway adaptor kits. The CapnoFlex LF CO2 module uses a CapnoFlex LF Adapter that connects the CapnoFlex LF CO2 module to the Capnostat Mainstream CO2 module.
The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Capnostat / CapnoFlex CO2 System. This type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials that set acceptance criteria.
Therefore, the document explicitly states that clinical studies were not required to support substantial equivalence. This means there are no acceptance criteria, no study proving the device meets those criteria, and consequently, no information on sample sizes, ground truth, expert qualifications, or comparative effectiveness studies for either training or test sets.
Here is a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not applicable. The submission states, "The subject of this premarket submission, Capnostat / CapnoFlex CO2 System, did not require clinical studies to support substantial equivalence." Therefore, no specific acceptance criteria for device performance are mentioned as part of a clinical trial.
- Reported Device Performance: The document generally states that the device "employs the same fundamental scientific technology as its predicate device" and that GE Healthcare "considers the Capnostat / CapnoFlex CO2 System to be as safe, as effective, and its performance is substantially equivalent to the predicate device." No specific performance metrics (e.g., accuracy, sensitivity, specificity) are reported in this summary.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable as no clinical studies were required or conducted as part of this submission for substantial equivalence.
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)
- Not applicable as no clinical studies were required or conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as no clinical studies were required or conducted.
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
- Not applicable. This device is a physiological monitoring system, not an AI-assisted diagnostic tool for human readers. Furthermore, no clinical studies were required or conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document describes the device as a "Capnostat / CapnoFlex CO2 System" for "end-tidal CO2 monitoring" which processes electronic signals and displays waveforms and digital values. While it operates "standalone" in the sense of continuously monitoring CO2, the submission does not present performance data from a standalone study. The focus is on demonstrating equivalence to an existing predicate device rather than de novo performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no clinical studies were required or conducted. Substantial equivalence was demonstrated based on fundamental scientific technology and adherence to voluntary standards.
8. The sample size for the training set
- Not applicable as no clinical studies were required or conducted.
9. How the ground truth for the training set was established
- Not applicable as no clinical studies were required or conducted.
Summary of Non-Clinical Tests (from the document):
The submission highlights the following quality assurance measures and non-clinical tests applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
These activities are standard for device development to ensure functionality and safety, but they are not presented as "clinical studies" with corresponding acceptance criteria or specific performance data compared to a ground truth in a clinical setting for this 510(k) summary. The device's "acceptance" for market clearance is based on its substantial equivalence to predicate devices and compliance with voluntary standards, rather than direct evidence from a clinical study.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.