(43 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 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 02. The Avance comes with up to two optional gases (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-CAiOV 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 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 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 K030812). 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, K071142, is a 510(k) summary for the GE Datex-Ohmeda Avance Anesthesia System. This document describes the device, its intended use, and its substantial equivalence to predicate devices, along with compliance to voluntary standards. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML medical device (e.g., sensitivity, specificity, or F1 score with associated confidence intervals).
The document is a submission for an anesthesia system, a traditional medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the concepts of "test set," "ground truth," "experts for ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set" as they relate to AI/ML device performance evaluation are not applicable or present in this 510(k) summary.
Instead, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a device like the GE Datex-Ohmeda Avance Anesthesia System are typically related to:
- Compliance with recognized voluntary standards: This is explicitly stated in the document.
- Performance specifications: Such as accuracy of gas delivery, ventilator performance (e.g., tidal volume, respiratory rate accuracy), pressure and oxygen monitoring accuracy, and safety features. These are usually evaluated through engineering tests, bench testing, and potentially animal or human factors studies, but the specifics are generally not detailed in a 510(k) summary document itself.
- Substantial equivalence: Demonstrating that the new device performs as safely and effectively as a legally marketed predicate device.
Given the information available in K071142, I can only extract details related to the voluntary standards compliance, which serves as a form of acceptance criteria for this type of device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Voluntary Standards Complied With) | Reported Device Performance (as stated in document) |
|---|---|
| EN 740: 1998 (Anesthesia Workstations and their components) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies the device meets the safety and performance requirements for anesthesia workstations. The device provides "general inhalation anesthesia and ventilatory support," with features like "electronic gas mixing," "pneumatic back-up O2 delivery system," and "various ventilator modes" (Volume Mode, Pressure Control Mode, etc.), all of which would need to conform to this standard. |
| EN 60601-1:1990 (Medical Electrical Equipment Part 1: General Requirements for Safety) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies the device meets general safety requirements for medical electrical equipment. |
| EN 60601-1-1:2000 (Medical Electrical Equipment - Medical Electrical Systems) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies compliance for the system as a whole. |
| EN 60601-1-2:2001 (Medical Electrical Equipment - Electromagnetic Compatibility) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies appropriate electromagnetic compatibility is ensured. |
| IEC 60601-1: 4:2000 (Safety of Programmable Electronic Medical Systems) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies safety of its microprocessor-based components (e.g., 7900 Anesthesia Ventilator). |
| EN 475:1995 (Electrically Generated Alarm Signals) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies alarms meet specified standards. |
| EN 850:1997 (Small Medical Gas Cylinders - Pin Indexed) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies compatibility and safety with gas cylinders. |
| EN 980:1997 (Graphical Symbols) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies use of standardized symbols on the device. |
| EN 1041:1998 (Information to be supplied with medical devices) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies proper labeling and user information are provided. |
| EN 1089-3:1997 (Color coding for medical gases) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies gas inputs and connections are appropriately color-coded. |
| ISO5356-1:1996 (Conical Connectors) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies connectors are standard and compatible. |
| EN 1820:1997 (Reservoir Bags) | "The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of [this standard]." "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above." Implies reservoir bags meet specified standards. |
| General Safety and Effectiveness (Substantial Equivalence) | "The GE Datex-Ohmeda Avance is substantially equivalent to the following currently marketed devices: Datex-Ohmeda S/5 Avance (K040743) and Datex-Ohmeda Aisys (K061609)." "The GE Datex-Ohmeda Avance and the currently marketed device are substantially equivalent in design concepts, technologies and materials." This implies that the device's overall safety and effectiveness are comparable to its predicate devices. |
The statement "The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above" serves as the proof that the device meets these acceptance criteria. The specific details of this "rigorous testing" (e.g., test protocols, results, sample sizes for engineering tests) are not provided in this 510(k) summary, as they are typically part of a more extensive submission file.
For the remaining AI/ML specific questions (2-9), the relevant information is NOT present in this 510(k) document because it pertains to a traditional medical device (anesthesia system), not an AI/ML algorithm.
Summary for AI/ML Specific Questions (N/A for this device):
- Sample size used for the test set and the data provenance: Not applicable. (No AI/ML test set.)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No AI/ML ground truth.)
- Adjudication method: Not applicable. (No AI/ML adjudication.)
- 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 is not an AI-assisted diagnostic or prognostic device.)
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. (This is not an AI/ML algorithm.)
- The type of ground truth used: Not applicable. (No AI/ML ground truth.)
- The sample size for the training set: Not applicable. (No AI/ML training set.)
- How the ground truth for the training set was established: Not applicable. (No AI/ML training set.)
§ 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).