(528 days)
Intended Use
Infinity® Acute Care System™ (IACS)
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 health care professionals.
The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.
The IACS and optional connected hardware are not intended for use in the following hospital environments:
- Hyperbaric chambers
- Environments containing MRI equipment
Indications for Use
The IACS, in connection with the M540 Patient Monitor, monitors the following parameters:
- Heart rate
- Arrhythmia (adult and pediatric patients only)
- 12-lead Rest ECG analysis (adult and pediatric patients only)
- ST segment analysis including TruST (adult and pediatric patients only)
- Apnea
- Impedance respiratory rate RRi
- Invasive blood pressure IBP
- Non-invasive blood pressure NIBP
- Temperature
- Cardiac output (adult and pediatric patients only)
- Carbon dioxide etCO2, inCO2, RRc
- Arterial oxygen saturation SpO2
- Pulse rate
- Perfusion index PI
- Total hemoglobin SpHb, (adult and pediatric patients only)
- Total oxygen content SpOC, (adult and pediatric patients only)
- Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
- Methemoglobin saturation SpMet
- Pleth variability index PVI
The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.
Intended Use
The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).
Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.
The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.
Indications for Use
As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.
Intended Use
The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient in environments where patient care is provided by trained health care professionals.
The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.
The M540 and any connected hardware are not intended for use in the following hospital environments:
- Hyperbaric chambers
- Environments containing MRI equipment
Indications for Use
The M540 monitors the following parameters:
- Heart rate
- Arrhythmia (adult and pediatric patients only)
- 12-lead Rest ECG analysis (adult and pediatric patients only)
- ST segment analysis including TruST (adult and pediatric patients only)
- Apnea
- Impedance respiratory rate RRi
- Invasive blood pressure IBP
- Non-invasive blood pressure NIBP
- Temperature
- Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
- Carbon dioxide etCO2, inCO2, RRc
- Arterial oxygen saturation SpO2
- Pulse rate
- Perfusion index PI
- Total hemoglobin SpHb, (adult and pediatric patients only)
- Total oxygen content SpOC, (adult and pediatric patients only)
- Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
- Methemoglobin saturation SpMet
- Pleth variability index PVI
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 is a combination of the following devices Infinity M540 Patient Monitor (Model # MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model # MK31501 - 17" screen or MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).
The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held portable patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset 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 Cockpit.
Associated accessories may include:
- · Infinity MCable Masimo SET Model #MS20667
- •Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
- ·Infinity MCable Nellcor OxiMax Model #MS20668
- · Infinity MPod Quad Hemo Model #MS20725
- •Infinity MCable Dual Hemo Model #MS20783
- •Infinity MCable Mainstream CO2 Model #6871950
- ●Infinity MCable Analog/Sync Model #MS20662
- •Infinity MCable Nurse Call Model #8417370
- •PS120 Desktop Power Supply Model #2606270
- •Y-Adapter (for PS120) Model #MS29702
The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.
Here's a breakdown of the acceptance criteria and study information for the Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria or a direct table comparing them to reported device performance. It focuses on demonstrating equivalence to a predicate device and adherence to recognized standards. However, it does highlight areas where "verification testing was conducted to confirm the new requirements."
Based on the information, the implicit acceptance criteria are compliance with relevant safety and performance standards, and successful verification of new software requirements and algorithms.
| Feature Area / Standard | Reported Device Performance Summary |
|---|---|
| Biocompatibility | Device and components not intended for direct patient contact; transient contact with intact skin. |
| Electrical Safety | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 606001-2-25, IEC 60601-2-27, ISO 80601-2-55. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2. |
| Software Verification & Validation | Testing conducted; documentation provided as recommended by FDA guidance ("Major Level of Concern" assigned due to diagnostic information driving treatment decisions and vital signs monitoring). |
| Cardiac Rhythm & ST Segment Algorithms | EC57 testing conducted for performance. |
| Human Factors/Usability Engineering | Validation testing conducted based on changes to Instructions for Use. |
| Substantial Equivalence | Found substantially equivalent to the predicate device (K113798). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for test sets in relation to patient data or specific parameters. It references "verification testing" and "EC57 testing" but does not provide details on the number of cases or data points used.
The data provenance is also not explicitly stated. The studies mentioned appear to be internal performance bench testing rather than studies involving external clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth for any test set or their qualifications. The testing described appears to be technical verification against standards and internal requirements.
4. Adjudication Method
No adjudication method is described, as there is no mention of expert review of test set results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a monitoring solution, and the focus is on technical performance and equivalence to a predicate, not on human-AI assistive improvement.
6. Standalone (Algorithm Only) Performance Study
Yes, standalone (algorithm only) performance was indirectly assessed through the "Performance Bench Testing" and "EC57 testing conducted for performance of cardiac rhythm and ST segment measurement algorithms." This testing evaluates the device's algorithms and functions independent of human interpretation in a clinical setting.
7. Type of Ground Truth Used
The ground truth for the performance bench testing and EC57 testing would implicitly be:
- Established Standards: Compliance with the requirements of relevant IEC and ISO standards (e.g., IEC 60601 series, ISO 80601-2-55, EC57 for ECG performance).
- Engineering Specifications/Reference Values: For internal verification, ground truth would be against predetermined engineering specifications, simulated inputs, or known reference signals.
There is no mention of ground truth established via expert consensus, pathology, or direct outcomes data from human patients for the clearance of this device.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This device is a multi-parameter patient monitoring system, which typically involves rule-based algorithms, signal processing, and established physiological measurement techniques, rather than machine learning models that require extensive training data.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned as being used for machine learning, this point is not applicable. The device's functionality is based on established medical device engineering principles and adherence to regulatory standards.
§ 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.