(42 days)
The GE Datex-Ohmeda Avance CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
The GE Datex-Ohmeda Avance CS2 anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). They represent one of the systems in a long line of products based on the Datex-Ohmeda Excel. Aestiva, and Aespire Anesthesia Systems. Avance systems are to be used only by trained and qualified medical professionals trained in the administration of general anesthesia.
The Avance and Avance CS2 anesthesia systems supply set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the electronic controls on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance systems are equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames options including central brake or individual caster brakes, gases, and vaporizers are available to give the user control of the system configuration. The Avance systems are also available in pendant models. Avance systems are available with two or three gases, up to three vaporizer positions and up to three cvlinder connections. All models have O2. The Avance systems come with up to two optional gases (air, N2O).
The Avance systems accept Tec 6 Plus and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance systems are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance systems are available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the GE Compact Gas Airway Modules Series: M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Compact Gas Airway Module (E-CAiOVX software revision 3.2 and above cleared via K051092) which can be physically integrated into the Avance, receive electronic power from the Avance and communicate measured values to the Avance for display on the system display unit. In addition to M-Gas and E-gas modules, the Avance CS- can utilize the GE CARESCAPE Respiratory Module (E-sCAiO, E-sCAiOV cleared via K123195).
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia Systems. 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 setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated 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 Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional), Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV), Pressure Control Ventilation-Volume Guaranteed with Pressure Support Ventilation (SIMV PCV-VG) (optional), and Volume Control Ventilation Mode for Cardiac Bypass Mode (optional). Ventilator parameters and measurements are displayed on the system display unit.
Several frame configurations are available, including one that allows for the physical integration of the GE Monitor Series (cleared Carescape B850 via K092027 and B650 cleared on K102239). These configurations also provide cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Avance frame. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.
The provided text is a 510(k) summary for the GE Datex-Ohmeda Avance CS2 Anesthesia System. It details the device's description, intended use, and a comparison to a predicate device. However, it explicitly states that no clinical testing was required or conducted for the modifications made to this version of the device.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, as these are typically derived from clinical or comprehensive performance studies which were not performed in this case.
Specifically, the document states:
- "The modifications made to the GE Datex-Ohmeda Avance CS2 did not require clinical testing. The functionality of the modified features was completely evaluated by performing nonclinical tests of design verification and validation testing."
Without a clinical study or a study specifically designed to establish performance against acceptance criteria, I cannot fill out the requested table or provide details on sample sizes, expert involvement, ground truth establishment, or comparative effectiveness.
The only "testing" mentioned is nonclinical verification and validation testing, which includes:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
This nonclinical testing served to confirm that the changes made (primarily updated labeling to include the use of an optional CARESCAPE respiratory module) did not alter the fundamental scientific technology or indications for use, and that the device remained substantially equivalent to its predicate.
§ 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).