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The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) are capable of

• monitoring:
• · Heart rate
• · Respiration rate
• · Invasive pressure
• · Non-invasive pressure
• · Arrhythmia
• · Temperature
• · Cardiac output
• · Arterial oxygen saturation
• · Pulse rate
• · Apnea
• · ST Segment Analysis
• 12-Lead ST Segment Analysis
• · tcp02/tcpC02
• · EEG signals
• · FiO2
• etCO2
• · Respiratory mechanics
• · Anesthetic agents
• · Neuromuscular transmission

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians. Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Infinity Delta Series (Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arthythmia which are intended for use in the adult and pediations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.

For combination with Scio gas module:

Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.

Infinity Delta and Kappa Series Monitors (Delta XL/ Kappa) are multi-parameter patient monitors intended for use at the patient bedside for the collection of physiological data. The intent of this 510(k) is to describe the proposed software and hardware modifications to the Infinity Delta and Kappa Series Monitors version VF9.1 which includes the integration of an alternative etCO2 solution for the Delta and Delta XL patient monitors as well as software enhancements for the Delta, Delta XL and Kappa patient monitors.

The provided text is a 510(k) summary for the Infinity Delta, Infinity Delta XL, and Infinity Kappa patient monitors. It describes software and hardware modifications to the existing devices, primarily the integration of an alternative etCO2 solution. However, it does not contain a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, or ground truth establishment.

Instead, the summary states:

• "The substantial equivalence was assessed via internal verification tests, validation evaluations and external tests to FDA recognized consensus standards."
• "Performance data related to each proposed modification has been tested and evaluated."
• "High level summary reports are included in this special 510k demonstrate the changes to the monitors are substantially equivalent to the predicate devices."
• "The modified Infinity Delta and Kappa Series Monitors have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective as the predicate device for its intended use."

This indicates that testing was performed, but the details of those tests, including specific acceptance criteria and detailed performance results, are not present in this document. The document focuses on demonstrating substantial equivalence to a predicate device (K070566) rather than providing a detailed performance study against specific acceptance criteria for a novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, or adjudication methods from the provided text. The document asserts that testing was done to ensure substantial equivalence, but it does not present the results of such testing in the format you've requested.

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