(22 days)
The Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 or L-ANE07A software is intended for multiparameter patient monitoring with optional patient care documentation.
The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Entropy (State Entropy and Response Entropy) and neurophysiological status of all hospital patients. When the BIS module is used with the S/5 Anesthesia Monitor with L-ANE07 and L-ANEO7A. it is intended for use by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The Bispectral index (BIS), a processed EEG variable, and one component of the BIS module. may be used in adults as an aid in monitoring the effects of certain anesthetic agents. The Bispectral index is a complex technology, intended for use only as an adjunct to clinical judgment and training. In addition, the clinical utility, risk/benefit, and application of BIS have not undergone full evaluation in the pediatric population.
The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is also indicated for documenting patient care related information.
The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software is indicated for use by qualified medical personnel only.
The S/5 Anesthesia 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/5 Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Anesthesia Monitor: L-ANE07 and L-ANE07A: L-ANE07A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ANE07. There are two monitor frame options; the 5-module F-CU5(P) monitor frame and the 8-module F-CU8 module frame which can be extended with an Extension Frame. F-EXT4, via the Extension Module E-EXT. The monitor can be equipped with a Recorder Module, E-REC. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A user several types of plugin measurement modules. Modules (with the exception of E-REC and E-EXT) are the subject of separate 510(k)'s and are not part of this notification. The S/5 Anesthesia Monitor with L-ANE07 and L-ANEO7A is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5 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 Anesthesia Monitor with L-ANE07 and L-ANEO7A can display measurements in the form of numeric values, waveforms and trends. Audible and visual alorms are used to indicate patient status. The alarm priority of an alarm depends on the parameter. The S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then made easily from the menu using a unique designed pointing device on the keyboard called a ComWheel. The software L-ANE07 and L-ANE07A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation. EEG spectrum analysis evoked potential response averaging and entropy calculations. All the module communication is also handled in . the main software. The software L-ANE07 and L-ANE07A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthetic record, and the related events and medication can be easily entered with the same user interface as the monitor itself. There are various optional types of keyboards, some are like standard keyboard and another is a hand-held Remote Controller (REMCO) which is still directly connected to the S/5 Anesthesia Monitor via a long cord but provides flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper option, patient related care events are documented using the keyboard. The S/5 Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving. The S/5 Anesthesia Monitor can also be uparaded to L-ANEO7(A) software using the CARESCAPE Life Uparade Program that offers a means to continuously keeping products up-to-date, by upgrading modular anesthesia dating back to 1992 to the last S/5 software level. Upgrading of modular monitors is performed with one of the available U-LIFE upgrade kits. The kit includes all hardware and main software components needed to make the monitor compatible with the last main software being delivered.
The provided text is a 510(k) Summary for the Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE07 and L-ANE07A software. It describes the device, its intended use, and its substantial equivalence to a predicate device.
After reviewing the document, I can confirm that it does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.
Instead, the document states:
- "Summary of Non-Clinical Tests: Determination of Substantial Equivalence:" The device and its applications comply with voluntary standards as detailed in Section 9 of the premarket submission. Quality assurance measures applied to the development include risk analysis, requirements reviews, design reviews, unit level testing, integration testing, final acceptance testing (validation), performance testing (verification), safety testing (verification), and environmental testing.
- "Summary of Clinical Tests: The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
This indicates that while various non-clinical tests and quality assurance measures were performed, a specific clinical study with defined acceptance criteria and performance metrics (as typically expected for AI/ML device evaluations) was not conducted or not deemed necessary for this particular submission to demonstrate substantial equivalence to its predicate device. This is common for traditional medical devices where equivalence to an existing device is the primary pathway.
Therefore, I cannot populate the requested table or provide details on the study's methodology as the information is not present in the provided text. The device's approval appears to be based on demonstrating equivalence to a previously cleared device through non-clinical testing and adherence to voluntary standards, rather than a prospective clinical study with predefined acceptance criteria.
§ 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.