(120 days)
The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST Segment Analysis, and 12-Lead ST Segment Analysis.
The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system.
Kappa XLT receives EEG signals when connected to an Infinity EEG pod.
The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device.
The SCIO module sample breathing gases from adults and pediatrics. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to Kappa XLT.
With etCO2 the Kappa XLT can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The device can interface with specific third party devices via an RS 232 connection.
The device is 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 devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations.
The Infinity Kappa XLT is an addition to Draeger's INFINITY patient monitoring system that combines on one platform the patient monitoring features of the Infinity Delta/DeltaXL/Kappa and the Infinity Explorer, Draeger's software-driven critical care workstation.
The Kappa XLT System consists of three basic components:
- The Kappa XLT Vital Signs Engine that acquires all signals
- The Kappa XLT Display, a medical grade display unit
- The Kappa XLT Power Supply.
The provided 510(k) summary for the Draeger Medical Systems' Infinity Kappa XLT does not contain specific acceptance criteria or an explicit study proving performance against such criteria. Instead, it relies on a declaration of substantial equivalence to predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for arrhythmia detection, ST segment analysis) are detailed in the submission. The document primarily focuses on stating the device's capabilities and its equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The Infinity Kappa XLT was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices." |
| Not specified | "Clinical performance evaluation indicates that the Infinity Kappa XLT is substantially equivalent to the Infinity Delta series monitors and the Infinity Explorer." |
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding sample size for a test set, nor data provenance (country of origin, retrospective/prospective), is provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
No information is provided regarding experts, their number, or qualifications for establishing ground truth.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as there is no specific test set described in the context of performance metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The submission focuses on device equivalence rather than demonstrating AI-assisted human performance improvement.
6. Standalone (Algorithm Only) Performance Study:
No standalone algorithm performance study is detailed. The device is a physiological monitoring system with integrated analysis capabilities, not a standalone AI algorithm being evaluated for its own performance metrics. The "clinical performance evaluation" mentioned appears to be a general assessment of the device's overall function in comparison to predicates.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. Given the nature of the device (physiological monitor), ground truth would typically come from:
- Reference Devices/Gold Standards: Comparison of measurements (e.g., heart rate, respiration rate, SpO2, invasive pressure) against calibrated reference instruments or established clinical methods.
- Expert Clinical Assessment: For aspects like arrhythmia detection or ST segment analysis, comparison against interpretations by qualified clinicians (cardiologists, intensivists).
However, the submission does not elaborate on these methodologies.
8. Sample Size for the Training Set:
No sample size for a training set is mentioned, as this is a traditional medical device submission based on predicate equivalence, not a machine learning model requiring a distinct training set for algorithm development.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as no training set for a machine learning model is described.
Summary of the K042904 Submission:
This 510(k) submission for the Infinity Kappa XLT primarily relies on demonstrating substantial equivalence to previously cleared predicate devices (Infinity Explorer, Infinity Delta/DeltaXL/Kappa, Infinity SC 8000). The "Assessment of non-clinical performance data for equivalence" and "Assessment of clinical performance data for equivalence" sections state that the device was tested in accordance with applicable standards and internal design control procedures and found to be "as safe and effective" and "substantially equivalent" to its predicates. This is a common pathway for medical device clearance, where detailed performance metrics against specific acceptance criteria for novel algorithms might not be required if the device's functionality and technology are similar to existing cleared devices.
§ 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.