(34 days)
The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
The GE Datex-Ohmeda Aisys is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The GE Datex-Ohmeda Aisys Carestation supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow indicators on the system display unit. The Aisys is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aisys system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) and E-Gas Module (E-CAiOVX cleared via K051092) which can be physically intecrated into the Aisys, receive electronic power from the Aisys and communicate measured values to the Aisys for display on the system display unit.
The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane. Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is requlated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit.
The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors.
Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional ootion allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys.
The provided text describes the 510(k) premarket notification for the GE Datex-Ohmeda Aisys Anesthesia System. The key information regarding acceptance criteria and study details is presented in the "SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)" and "SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)" sections.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GE Datex-Ohmeda Aisys Anesthesia System are compliance with various international and national standards related to medical electrical equipment, anesthesia workstations, and gas cylinders. The reported device performance is that it meets these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| EN 740 :1998 (Anesthesia Workstations and their components) | Compliant |
| EN 60601-1:1990 (Medical Electrical Equipment Part 1: General Requirements for Safety) | Compliant |
| EN 60601-1-1:2000 (Medical Electrical Equipment - Medical Electrical Systems) | Compliant |
| EN 60601-1-2:2001 (Medical Electrical Equipment - Electromagnetic Compatibility) | Compliant |
| IEC 60601-1-4:2000 (Safety of Programmable Electronic Medical Systems) | Compliant |
| EN 475:1995 (Electrically Generated Alarm Signals) | Compliant |
| EN 850:1997 (Small Medical Gas Cylinders - Pin Indexed) | Compliant |
| EN 980:1997 (Graphical Symbols) | Compliant |
| EN 1041:1998 (Information to be supplied with medical devices) | Compliant |
| EN 1089-3:1997 (Color coding for medical gases) | Compliant |
| ISO5356-1:1996 (Conical Connectors) | Compliant |
| EN 1820:1997 (Reservoir Bags) | Compliant |
| IEC 60601-2-13:1998 (Particular requirements for the safety of anaesthetic workstations) | Compliant |
| Software Validation | Completed (thoroughly tested through verification and validation) |
| Verification of Specifications | Completed (thoroughly tested) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical study with a defined sample size for evaluating performance against an explicit statistical endpoint. Instead, the evaluation focuses on non-clinical testing, including verification of specifications and software validation, and compliance with established international standards.
The term "data provenance" is not applicable in the traditional sense of clinical data here, as the testing described is primarily engineering and regulatory compliance testing rather than clinical study data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation relies on compliance with technical standards and internal verification/validation processes rather than expert-established ground truth from clinical cases. No external "experts" in the context of clinical ground truth determination are mentioned for the non-clinical testing.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review. The evaluation is based on meeting technical specifications and standards.
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
An MRMC comparative effectiveness study was not performed, and is not applicable. The device is an anesthesia system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone anesthesia system. While it has embedded software and automated functions, the evaluation is of the complete system's compliance with safety and functional standards, not a standalone algorithm's performance in isolation from the hardware or human operator interaction. The "software validation" performed addresses the functionality of the algorithms within the system.
7. The type of ground truth used
The "ground truth" for this device's evaluation is primarily compliance with established international and national engineering, safety, and performance standards (e.g., EN, IEC, ISO standards) and internal product specifications. For the software, it's defined by the software requirements and design specifications.
8. The sample size for the training set
This information is not applicable. The device is an anesthesia system, and its development and testing do not involve a "training set" in the context of machine learning model development. The software development follows traditional engineering verification and validation processes.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of AI/machine learning. The "ground truth" for the device's functionality is established by its design specifications and the requirements of the relevant industry standards.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).