(176 days)
The GE Datex-Ohmeda Aisys 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 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 (neonatal, pediatric, adult). 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 svstem display unit. The Aisvs 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 02. 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 cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092) which can be physically integrated 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 Aisvs 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 on to 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 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) and Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV). Ventilator parameters and measurements are displayed on the system display unit.
The provided text describes a premarket notification (510(k)) for the GE Datex-Ohmeda Aisys Anesthesia System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device.
The submission states that the modifications made did not require clinical testing, and the functionality was evaluated through nonclinical tests of design verification and validation testing. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for a new clinical claim is not present in this document.
However, I can extract information about the type of testing performed and the conclusion regarding substantial equivalence.
Here's a breakdown of the available information based on your request, with an emphasis on what is not present:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided in the document. The document states "The GE Datex-Ohmeda Aisys has been thoroughly tested through verification of specifications and validation, including software validation," but it does not list specific, quantitative acceptance criteria or corresponding reported performance metrics for clinical efficacy or diagnostic accuracy.
- The overall "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to predicate devices. The conclusion states: "The performance data demonstrates the device is substantially equivalent to the predicates."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. No clinical test set or patient data is mentioned as the basis for the 510(k) in this document. The testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No clinical ground truth was established as no clinical testing was performed for this 510(k). Non-clinical testing would involve engineering and quality assurance experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical test set or adjudication method is mentioned.
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 device is an anesthesia system, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an anesthesia system. The software updates relate to user interface, control of gas delivery, and ventilator modes, not standalone algorithmic performance in a diagnostic context. "Standalone" performance testing would be more relevant to the device's functional operation (e.g., accuracy of gas delivery, ventilator parameters) which was covered by non-clinical verification and validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided in a clinical sense. For the non-clinical testing, the "ground truth" would be the device's technical specifications and established engineering standards, against which its performance was verified and validated.
8. The sample size for the training set
- Not applicable/Not provided. This document is not describing a machine learning or AI model that requires a training set in the conventional sense. The "software updates" are likely improvements to existing control algorithms and user interface logic.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set for a machine learning model is mentioned.
Summary of what is present regarding testing:
The document states:
- Reason for 510(k): Updates to the software for the GE Datex-Ohmeda Aisys Anesthesia System, introducing several new features (e.g., pediatric improvements, new ventilation mode CPAP/PSV with backup breaths, lung mechanics procedure options, UI enhancements).
- Basis for Substantial Equivalence: Comparison to legally marketed predicate devices (GE Datex-Ohmeda Aisys (K090233) and GE Datex-Ohmeda Engstrom ventilator (K093886)). No changes to intended use or fundamental scientific technology.
- Testing Performed:
- Nonclinical Testing: "thoroughly tested through verification of specifications and validation, including software validation."
- Quality Assurance Measures applied:
- 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)
- Clinical Testing: "The modifications made to the GE Datex-Ohmeda Aisys did not require clinical testing. The functionality of the modified software features were completely evaluated by performing nonclinical tests of design verification and validation testing."
- Conclusion: The performance data (nonclinical) demonstrates the device is substantially equivalent to the predicates, with no new questions of safety and effectiveness.
In essence, this 510(k) leverages the predicate devices' established safety and effectiveness, and for the software updates, relies on rigorous non-clinical engineering verification and validation testing rather than new clinical trials or performance studies against specific acceptance criteria for a novel claim.
§ 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).