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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.

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.

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Intended Use: The 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 professionals. 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
• Arterial oxygen saturation
• Pulse rate (SpO2)
• Mainstream etCO2

The Infinity® Acute Care System™ (1ACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside and in transport within the hospital setting. The IACS Monitoring Solution is a combination of two devices; Infinity M540 patient monitor with Infinity M500 docking station; and Infinity C500 software with Infinity C500 Medical Cockpit. Infinity C700 software with C700 Medical Cockpit is an option for a larger screen.

The Infinity M540 patient monitor is a light weight hand held portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity M540 patient monitor is capable of monitoring Heart rate, Arrhythmia (adult and pediatric only), 12-lead monitoring, ST segment analysis including TruST (adult and pediatric only), 12-lead ST segment analysis (adult and pediatric only), Apnea, Respiration rate, Invasive pressure, Noninvasive pressure, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate (SpO2), and Mainstream etCO2. 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 Infinity M540 patient monitor can be used as a stand alone medical device without any integration with the Infinity C500 Medical Cockpit.

The Infinity C500 software allows the user to extend the viewing capability of the Infinity M540 patient monitor and integrates additional patient information on Infinity C500 Medical Cockpit. The Infinity C500 Medical Cockpit is a medical grade display monitor with limited monitoring control features. The Infinity C500 software is capable of displaying real-time patient data, providing control back to the Infinity M540 and integrating other applications with patient data on the Infinity C500 Medical Cockpit.

The provided 510(k) premarket notification for the "Infinity Acute Care System (IACS) Monitoring Solution" is not a study proving the device meets specific acceptance criteria in the way a clinical study for a new AI diagnostic would. Instead, it is a submission demonstrating substantial equivalence to already legally marketed predicate devices.

Therefore, the document does not contain the specific information requested in the prompt, such as a table of acceptance criteria with reported device performance metrics, sample sizes, expert qualifications for ground truth, or details of a multi-reader multi-case (MRMC) study. The focus is on showing that the new device is as safe and effective as existing ones, primarily through a comparison of technological characteristics and adherence to safety standards.

Here's an analysis of what is available in relation to your request, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics (like sensitivity/specificity for arrhythmia detection). Instead, the acceptance criterion is implicitly "as safe and effective for its intended use as the predicate device(s)" and adherence to applicable standards.
• Reported Device Performance: The document states: "Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display." This is a qualitative statement of equivalence, not a quantitative report of performance metrics against specific criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not reported.
• Data Provenance: Not reported (e.g., country of origin, retrospective/prospective).
• Context: Because this is a substantial equivalence submission relying on comparison to predicate devices and adherence to standards, a specific "test set" and corresponding sample size for clinical performance evaluation in the way you might expect for an AI diagnostic algorithm is not detailed here. The clinical performance evaluation mentioned is likely a high-level assessment rather than a detailed study generating novel performance metrics for this specific device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/not reported.
• Qualifications: Not applicable/not reported.
• Reasoning: Ground truth generation by experts is typically done for diagnostic accuracy studies. This submission focuses on comparing the safety and effectiveness to predicate devices and adhering to standards, not on establishing a new diagnostic accuracy claim requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not reported. (e.g., 2+1, 3+1, none)
• Reasoning: See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned as having been done.
• Effect Size: Not applicable as no MRMC study was performed.
• Reasoning: MRMC studies are common for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is for a physiological monitoring system and does not describe such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable/not reported as a separate, isolated algorithm performance.
• Reasoning: The Infinity Acute Care System is a monitoring solution, an integrated system that includes hardware and software for displaying physiological parameters. Its "performance" is implicitly tied to its function in continuously acquiring and displaying data, and triggering alarms, rather than a standalone diagnostic algorithm. The monitoring functions (like arrhythmia detection) are part of the integrated system and are implicitly compared to predicate devices.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for performance evaluation of the IACS itself. The claims are based on "clinical performance evaluations" showing substantial equivalence to predicate devices and adherence to standards. For the predicates, the "ground truth" would have been established through prior regulatory pathways (e.g., device's ability to accurately measure physiological parameters, correctly detect events, etc.).
• Context: For physiological monitors, ground truth often involves calibration against known standards, comparisons to reference devices, or clinical observation by trained professionals to verify correct parameter display and alarm functionality. However, detailed methodology is not in this 510(k) summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/not reported.
• Reasoning: The document doesn't describe the development of a novel algorithm using a training set in the way AI/ML models typically do. This seems to be a hardware/software system that performs known physiological monitoring functions.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable/not reported.
• Reasoning: See point 8.

Summary of Device Performance and Equivalence Statement:

The document states:

• "The Infinity Acute Care System (IACS) Monitoring Solution has been 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 device(s)."
• "Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display."

This 510(k) submission primarily relies on demonstrating that the new device meets relevant electrical safety standards (IEC 60601-1) and that its technological characteristics and performance are comparable to the previously cleared predicate devices (Infinity Alpha, Infinity Kappa and Delta Series Monitors, Infinity Explorer). It does not present detailed quantitative performance data or specific clinical studies in the format requested.

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