(90 days)
Intended Use: Infinity® Acute Care System™ (IACS) Monitoring Solution:
The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network.
Intended Use: Infinity M540 Patient Monitor:
The Infinity M540 is intended for the monitoring of multi-parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professional. The M540 is intended to monitor one patient at a time.
Indications for Use: The M540 monitors the following parameters:
- Heart rate
- Arrhythmia (adult and pediatric only)
- 12-lead analysis
- ST segment analysis including TruST® (adult and pediatric only)
- 12-lead ST segment analysis (adult and pediatric only)
- Apnea
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Temperature
- Cardiac output (only available when the M540 is docked in an IACS configuration)
- Arterial oxygen saturation (SpO2)
- Pulse rate
- Perfusion Index (PI)
- Total hemoglobin (SpHb) adult and pediatric only
- Total oxygen content (SpCO) adult and pediatric only
- Methemoglobin saturation (SpMet)
- Pleth variability index (PVI)
- Mainstream etCO2
The Infinity Acute Care System (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS Monitoring Solution is a combination of two devices ; Infinity M540 patient monitor with Infinity M500 docking station integrated with the Infinity C500 Medical Cockpit or optional C700 (larger screen size) Medical Cockpit and respective software.
The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 patient, and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 patient monitor is a light weight hand held portable patient mor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond present limits and transmits the data over the network. The Infinity M540 patient monitor can be used as a stand alone medical device without any integration with the Infinity Medical Cockpits similar to other Draeger Medical Pick-And-Go patient monitors.
The Infinity Mcable Masimo Rainbow SET is a new Pulse CO-Oximeter model for use with the IACS Infinity M540 Patient Monitor to provide continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), perfusion index (PI), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), pleth variability index (PVI) and total oxygen content (SpOC).
This document is a 510(k) summary for the Draeger Medical Systems, Inc. Infinity® Acute Care System™ (IACS) Monitoring Solution and the Infinity® MCable - Masimo Rainbow SET. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against defined acceptance criteria. It broadly states: "The modified Infinity Acute Care System (IACS) Monitoring Solution VG2 software and Infinity MCable - Masimo Rainbow SET have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective for its intended use as the predicate devices."
Therefore, concrete acceptance criteria and quantitative performance data that would typically be presented in a table are not explicitly detailed within this 510(k) summary. The acceptance criteria essentially revolve around meeting existing safety and performance standards and demonstrating equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for any test sets or data provenance (e.g., country of origin, retrospective/prospective). The general statement "tested in accordance with applicable standards and internal design control procedures" implies testing was performed, but the details are omitted.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts or the establishment of ground truth in the context of clinical studies for this device. The nature of the device (physiological patient monitor) typically relies on direct measurement and established medical standards for accuracy, rather than expert interpretation of data for ground truth in the way an AI diagnostic algorithm might.
4. Adjudication Method for the Test Set:
Since there is no mention of clinical studies involving expert reviews or ground truth establishment in this document, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor does it discuss human reader improvement with or without AI assistance. This type of study is more common for diagnostic imaging AI rather than a physiological patient monitoring system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not explicitly describe a standalone performance study in the way an AI algorithm might be tested. The device itself is a physiological monitor, meaning its "algorithm" is inherent in its measurement capabilities. The "testing in accordance with applicable standards" would pertain to the accuracy and reliability of these measurements.
7. Type of Ground Truth Used:
For a physiological patient monitoring system, the "ground truth" would typically come from direct physiological measurements or validated reference devices. For parameters like SpO2, heart rate, or blood pressure, the ground truth is established through highly accurate, often invasive, or laboratory-grade measurement techniques that are considered the gold standard for those specific parameters. The document does not detail the specific ground truth methodologies used in its testing.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This is consistent with a traditional medical device submission for a physiological monitor, which doesn't typically involve machine learning or AI models requiring separate training sets as understood in the context of diagnostic AI.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the document does not describe how ground truth for a training set was established.
§ 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.