(60 days)
The GE Datex-Ohmeda Avance 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 Avance is not suitable for use in a MRI environment.
The GE Datex-Ohmeda Avance 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 Aisys Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The Datex-Ohmeda Avance Anesthesia System 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 meters on the system display unit. The Avance 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 Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The Avance comes with up to two optional qases (air, N2O).
The Avance systems accept Tec 4. Tec 5. Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance 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-CAiQV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance 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 qas 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), Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional), Pressure Controlled Ventilation with Volume Guarantee (PCV-VG), and Volume Control Ventilation Mode for Cardiac Bypass Mode. Ventilator parameters and measurements are displayed on the system display unit.
Several options enable the mounting of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K051400). An additional option allows the S/5 AM to be linked to the power supply of the Avance such that when the Avance 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 Avance.
The provided document is a 510(k) Premarket Notification for the GE Datex-Ohmeda Avance Anesthesia System. This submission focuses on software updates to an existing, legally marketed device (K071142) and claims substantial equivalence to its predicate device and another similar device (GE Datex-Ohmeda Aisys K073707).
The document explicitly states: "The modifications made to the GE Datex-Ohmeda Avance did not require clinical testing."
Therefore, the sections of your request pertaining to clinical studies and performance metrics against acceptance criteria cannot be fulfilled, as no such study was conducted or reported in this 510(k) submission. This K081844 submission is primarily about non-clinical verification of changes through engineering and software validation, and compliance with recognized standards.
Here's a breakdown of the information that can be extracted or inferred from the provided text, primarily regarding non-clinical testing and the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed, there are no reported device performance metrics from a clinical setting to compare against acceptance criteria. The document focuses on compliance with recognized standards and non-clinical verification.
| Acceptance Criteria Category | Specific Criteria (from Standards) | Reported Device Performance (Verification/Validation) |
|---|---|---|
| Non-Clinical Testing | EN 740:1998 (Anesthesia Workstations and their components) | "Thoroughly tested through verification of specifications and validation, including software validation." "Verification of compliance with the following standards has also been made to support safe use of the device in its intended environment." (Implies the device met the requirements of this standard through testing and documentation). |
| EN 60601-1:1990 (Medical Electrical Equipment Part 1: General Requirements for Safety, with amendments) | Adherence verified. | |
| EN 60601-1-1:2000 (Medical Electrical Equipment - Medical Electrical Systems) | Adherence verified. | |
| EN 60601-1-2:2001 (Medical Electrical Equipment - Electromagnetic Compatibility) | Adherence verified. | |
| IEC 60601-1-4:2000 (Safety of Programmable Electronic Medical Systems) | Adherence verified. | |
| EN 475:1995 (Electrically Generated Alarm Signals) | Adherence verified. | |
| EN 850:1997 (Small Medical Gas Cylinders - Pin Indexed) | Adherence verified. | |
| EN 980:1997 (Graphical Symbols) | Adherence verified. | |
| EN 1041:1998 (Information to be supplied with medical devices) | Adherence verified. | |
| EN 1089-3:1997 (Color coding for medical gases) | Adherence verified. | |
| ISO 5356-1:1996 (Conical Connectors) | Adherence verified. | |
| EN 1820:1997 (Reservoir Bags) | Adherence verified. | |
| IEC 60601-2-13:1998 (Particular requirements for the safety of anaesthetic workstations) | Adherence verified. | |
| Software Validation | Functionality as per updated features (Alarm Improvements, User Configurations, Fresh gas flow look-ahead VCV, Usability, MAC Age, Agent usage estimation, Preset ventilator settings, Auto exit PSVPro backup mode, Calibrate flow sensors reminder) | "Thoroughly tested through verification of specifications and validation, including software validation." (Implies the new software features were validated to perform as intended and meet their specifications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- None. No clinical test set or data provenance is mentioned as no clinical testing was performed for this 510(k) submission.
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)
- None. Not applicable as no clinical test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. Not applicable as no clinical test set was used.
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
- No. This is not an AI-assisted diagnostic device, and no MRMC study was performed. The device is an anesthesia system undergoing software updates.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the context of diagnostic algorithms. This device is an anesthesia system with integrated software, not a standalone diagnostic algorithm. The software validation would have assessed its performance in an integrated system, but not in a "standalone" sense as understood for diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For non-clinical testing: The "ground truth" was established by the specifications for the device, the requirements of the listed international standards (e.g., EN, IEC, ISO), and the intended functionality of the software updates. Verification and validation activities confirmed that the device operated according to these established engineering and regulatory requirements.
8. The sample size for the training set
- Not applicable. This submission describes software updates to an existing anesthesia system, not a machine learning or AI model trained on a specific dataset.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI model was used in this submission.
§ 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).