(63 days)
The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.
The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The systems are to be used only by trained and qualified medical professionals.
The Aespire 7900 and Aespire View supply set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. They are available in trolley and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air, N2O). The Aespire systems accept Tec 4. Tec 5. Tec 6. Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aespire View product provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display, while the Aespire 7900 uses a monochromatic display.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in this family of 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 and secure 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 (VCV) Mode, Pressure Control (PCV) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup.(PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation – Volume Guaranteed (PCV-VG) mode (Optional on Aespire View variant only).
This document describes a 510(k) premarket notification for a medical device. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical setting.
Therefore, many of the requested items related to clinical studies, such as sample size, ground truth establishment, expert qualifications, and comparative effectiveness studies (MRMC), are not applicable or not provided in this type of submission.
Here's an analysis of the provided text based on your request, highlighting what information is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical or standalone performance study. Instead, it focuses on verifying specifications and safety against existing standards and the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Risk analysis conducted | Completed |
| Design reviews conducted | Completed |
| Performance testing (Verification) | Completed (e.g., environmental, electromagnetic compatibility) |
| Safety testing (Verification) | Completed |
| No change to intended use | Confirmed |
| No change to fundamental scientific technology | Confirmed |
| Functional equivalence to predicate device (K092864) | Stated as "substantially equivalent," "as safe," and "as effective" |
| Airway overpressure detection | Mechanical switch replaced with electronic monitoring circuit; existing mechanical relief valve remains |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission focuses on verification testing (engineering/bench testing) of the updated circuit board and overall system against specifications, not a clinical "test set" in the context of diagnostic or AI performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no mention of a "test set" requiring expert ground truth in the context of clinical performance evaluation for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as there is no mention of a "test set" requiring expert-based ground truth adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The modification to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator did not require clinical testing." This indicates no clinical study comparing human readers (or human readers with AI assistance) was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of this device. The changes were to an internal electronic sensor interface circuit board within an anesthesia system, not a diagnostic algorithm. The "performance testing (Verification)" and "safety testing (Verification)" would be akin to standalone engineering tests to ensure the updated component functions correctly and safely within the system, but not "algorithm only without human-in-the-loop performance" in the sense of an AI/diagnostic device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering specifications, safety standards, and validated performance characteristics of the device and its components, verified through various engineering and quality assurance measures (e.g., risk analysis, design reviews, environmental testing, electromagnetic compatibility testing). There is no "clinical ground truth" (like pathology or outcomes data) mentioned because no clinical study was performed.
8. The Sample Size for the Training Set
Not applicable. This device is an anesthesia system with an updated circuit board, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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).