(87 days)
The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A is intended for multiparameter patient monitoring.
The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/57M Compact Critical Care Monitor with L-CICU02 and L-CICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*. (*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software is indicated for use by qualified medical personnel only.
The S/5TM Compact Critical Care Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Critical Care Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5™ Compact Critical Care Monitor: L-CICU02 and L-CICU02A. L-CICU02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CICU02.
The S/5™ CCCM uses several types of plug-in measurement modules. Modules are the subject of separate 510(k)'s and are not part of this notification. The S/5™ CCCM is typically furnished with a module that measures ECG, invasive and noninvasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5™ Compact Monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5™ CCCM can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5™ CCCM is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-CICU02 and L-CICU02A perform some module-related tasks like arrhythmia analysis. ST-value calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5™ Compact Critical Care Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The S/5™ Compact Critical Care Monitor can be in a stand-alone or networked configuration. If networked, measurement data is sent to the network for central station or monitor viewing. Trends can be sent via a network to a central computer for archiving.
This document describes the Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed device performance metrics in the way one might expect for a diagnostic or AI-based device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Substantial Equivalence | To predicate device: Datex-Ohmeda S/5™ Compact Critical Care Monitor with S-00C03, S-00C04 software (K002158) | The general construction, indications for use, and intended use are the same. The arrhythmia analysis functionality of the L-CICU02A software is reported as "substantially equivalent" to that of the predicate device's L-00C04 software. Detailed comparison analysis performed (Tab 4). |
| Electrical Safety | IEC 60601-1:1988+Amdt.1:1991+Amdt.2:1995, EN 60601-1:1990+A1:1993+A2:1995+A13:1996, CAN/CSA-C22.2 No.601.1-M90+S1:1994+Amdt.2:1998, UL 2601-1:1997, ANSI/AAMI ES-1:1993 | Device complies with these standards. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2(1993)/EN 60601-1-2 | Device complies with this standard. |
| Mechanical & Environmental Tolerance | IEC 60068-2 | Device complies with this standard. |
| Software Validation & Verification | General software validation and verification of specifications. IEC 60601-1-4:1996+Amdt.1:1999/EN 60601-1-4 | Device has undergone "thoroughly tested including software validation and verification of specifications." |
| Specific Performance Standards (examples) | IEC 60601-2-27:1994/EN 60601-2-27:1994 (Cardiac Monitoring) | Device complies with these standards. |
| IEC 60601-2-30:1995/EN 60601-2-30:1995 (NIBP) | Device complies with this standard. | |
| IEC 60601-2-34:1994/EN 60601-2-34:1994 (IBP) | Device complies with this standard. | |
| ISO 9919:1992/EN865:1997 (Pulse Oximeters) | Device complies with this standard. | |
| ANSI/AAMI EC57:1998 (Arrhythmia monitors) | Device complies with this standard. | |
| FDA Regulations | FDA 21 CFR 898.12 | Device complies with this regulation. |
The document concludes that "there are no new questions of safety and effectiveness" compared to the predicate, indicating that the device meets the implied performance and safety levels established by the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical testing and compliance with standards rather than a clinical study with a "test set" of patient data in the context of typical AI/diagnostic device validation.
- Test set sample size: Not applicable in the context of a prospective clinical data cohort. The testing involved verification against engineering and safety standards.
- Data provenance: Not explicitly stated as clinical data. The studies performed are compliance-based (electrical safety, EMC, mechanical, environmental, software validation), which would typically use test equipment and simulated scenarios rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document as it focuses on engineering and regulatory compliance rather than a clinical performance study requiring expert adjudication of ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the clinical sense (e.g., for diagnostic accuracy).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
No. The document does not describe an MRMC study. The device is a patient monitor with software enhancements for existing functionalities (like arrhythmia analysis), not an AI-assisted diagnostic tool designed to directly improve human reader performance on a specific task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document primarily describes the standalone performance of the device's enhanced software features (e.g., arrhythmia analysis, ST-segment analysis) against established engineering standards and substantial equivalence to a predicate device. However, this is not in the context of an "AI algorithm" in the modern sense but rather software functions within a patient monitor. The testing implicitly verifies the algorithm's performance in these specific areas (e.g., heart rate calculation, arrhythmia analysis capability) without direct human intervention in its processing, but the device is designed for use by qualified medical personnel (human-in-the-loop).
7. The Type of Ground Truth Used
For the nonclinical testing described:
- Engineering specifications and regulatory standards: The "ground truth" for the tests mentioned (electrical safety, EMC, mechanical, software validation) is the successful adherence to the defined parameters and limits within these international and national standards.
- Predicate device's established performance: The core of the 510(k) submission relies on demonstrating that the updated device is "substantially equivalent" to the previously cleared predicate device. This means the predicate's performance and safety effectively served as a benchmark for what is acceptable.
8. The Sample Size for the Training Set
Not applicable. The document does not describe the development or training of AI/machine learning models in the contemporary sense. The software functions appear to be based on established algorithms in critical care monitoring, rather than data-driven models requiring a specific "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the document does not describe an AI/machine learning training process, there is no mention of a training set or how its ground truth would be 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.