(66 days)
The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A is intended for multiparameter patient monitoring with optional patient care documentation.
The S/57M Compact Anesthesia Monitor with L-CANE02 and L-CANE02A 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/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A 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 Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information.The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for use by qualified medical personnel only.
The S/5™ Compact 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/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Compact Anesthesia Monitor: L-CANE02 and L-CANE02A. L-CANE02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities. this software option is identical to L-CANE02.
The S/5TM CAM 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™ CAM 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/5TM 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™ CAM 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™ CAM is operated by a keyboard. Typically pressing a kev 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-CANE02 and L-CANE02A 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 and evoked potential response averaging. All the module communication is also handled in the main software. The software L-CANE02 and L-CANE02A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthesia 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 keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also available. The S/5TM Compact Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurement data is 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 provided document describes a Premarket Notification 510(k) for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of specific device performance studies against acceptance criteria.
The document states that the device was thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation, and verification of specifications, reporting compliance with safety standards. However, it does not explicitly define acceptance criteria or report specific performance metrics for the device's functions (e.g., arrhythmia detection accuracy, ST-segment analysis sensitivity/specificity) using a defined test set.
Therefore, many of the requested details, especially those related to a clinical study establishing device performance against acceptance criteria, cannot be extracted from this 510(k) summary. The document focuses on regulatory compliance through substantial equivalence to a predicate device and adherence to recognized standards.
Here's a breakdown of the information that can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, etc. | Complies with IEC 60601-1, EN 60601-1, CAN/CSA-C22.2 No.601.1-M90, etc. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2/EN 60601-1-2 |
| Mechanical Tolerance | Compliance with relevant standards (implied) | Thoroughly tested. |
| Environmental Tolerance | Compliance with relevant standards (implied) | Thoroughly tested. |
| Software Validation | Verified specifications (implied) | Validated and specifications verified. |
| Compliance with specific standards (e.g., for ECG, NIBP) | Compliance with IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-40, ISO 9918, ISO 9919, etc. | Complies with listed standards. |
| Overall Safety & Effectiveness | No new questions of safety and effectiveness as compared to the predicate device. | Deemed safe and effective for the intended use and found substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any performance testing. The document refers to "thorough testing" and "verification of specifications" but provides no details on test set sizes for evaluating specific clinical functionalities.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific clinical performance study with a test set and ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a patient monitor, not an AI-based diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the software performs tasks like "arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging," the document does not detail specific standalone performance studies for these algorithms. Its focus is on general compliance and substantial equivalence to the predicate device, which inherently implies that these functions perform as expected for such a device type.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified for any algorithmic performance. For overall safety and compliance, the "ground truth" is adherence to various international and national safety and performance standards (e.g., IEC, EN, ANSI/AAMI).
8. The sample size for the training set:
- Not applicable/Not specified. This document describes a medical device with embedded software, not a machine learning model where a distinct "training set" would typically be discussed in this context. The software is preloaded and performs specific known physiological calculations and analyses based on established algorithms in patient monitoring.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, for the reasons above.
§ 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.