(27 days)
The GE Datex-Ohmeda Anesthesia Delivery Unit 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, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.
The GE Datex-Ohmeda ADU supplies set flows of medical gases to the breathing system using mechanical gas mixing. Gas flows are selected by the user using the rotary controller on the frame and then displayed as electronic flow indicators on the system display unit. The ADU is equipped with a traditional flow tube, as well. The ADU 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 ADU comes with up to two optional gases (air, N2O). Safety features and devices within the ADU are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The anesthetic agent delivery for the ADU is controlled via an anesthesia computer through user input from that computer. An Aladin cassette 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 ADU is designed to allow only one active cassette at a time. Per the user input, valves within the active cassette bay will oney one allow agent to be delivered. The agent is mixed with gas within the FGC unit. After open and the wagent to of gases and agent is delivered to the breathing system and then onto the patient.
The ADU Anesthesia Ventilator is a microprocessor based, electronically controlled, The ADO Ancomesia "Pentilator that provides patient ventilation during surgical procedures. Sensors in the breathing circuit are used to control and monitor patient ventilation. This allows Schools in the oreating of compression losses, fresh gas contribution and small leakage in the for the compensation of our spression. 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 with a sitiple and becare othir pratory Pressure (PEEP) is regulated electronically. Positive ter the paintained in the breathing system so that any leakage that occurs is outward. Pressure is names for the device include Volume Mode, Pressure Control Mode, Pressure Support vith Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation with Aplica Dackap Mode (Optional) and measurements are displayed on the system display unit.
The ADU must be used with additional monitoring that include at least inspired 02, expired volume, expired CO2 and Anesthetic Agent.
An RS-232 serial digital communications port connects to and communicates with external devices such a Datex-Ohmeda S/5 Anesthesia Monitor.
Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). Additional or the Dations allow for the mounting of various patient monitors on the top shelf of the ADU.
This document is a 510(k) summary for the GE Datex-Ohmeda S/5 ADU, an anesthesia delivery unit. It focuses on demonstrating substantial equivalence to previously cleared devices (GE Datex-Ohmeda ADU Carestation and Datex-Ohmeda AS/3 Anesthesia Delivery Unit) rather than detailing specific acceptance criteria and performance studies in the way one might expect for a new AI or diagnostic device.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC study, separate AI performance, training set details) are not applicable or not found within this submission document for a medical device of this type.
Here's the information that can be extracted and a clear statement about what is not included in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Deemed Substantially Equivalent (K042154, K973985) |
| Adherence to Applicable Voluntary Standards (Safety & Performance) | Designed to comply with UL 2601, EN 740, EN/IEC 60601-1, etc. |
| Intended Use (General inhalation anesthesia & ventilatory support) | Provides general inhalation anesthesia and ventilatory support to a wide range of patients. |
| Functionality (Gas mixing, agent delivery, ventilation modes) | Supplies set flows of medical gases, uses Aladin cassette for agent delivery, offers Volume Mode, Pressure Control, Pressure Support, and SIMV with Apnea backup. |
| Safety Features (Hypoxic mixtures, power failures) | Designed to decrease the risk of hypoxic mixtures, agent mixtures, and complete power/gas supply failures. |
| Monitoring Capability (02, CO2, etc.) | Must be used with additional monitoring (inspired O2, expired volume, expired CO2, Anesthetic Agent). |
| Compatibility (External devices) | RS-232 serial digital communications port connects to external devices (e.g., Datex-Ohmeda S/5 Anesthesia Monitor). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. This type of submission for an anesthesia machine typically relies on engineering specifications, adherence to standards, and possibly internal testing data, rather than clinical trials with patient-specific test sets in the context of AI or diagnostic algorithms.
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)
This information is not provided in the document. Ground truth establishment with experts is generally associated with diagnostic or AI algorithm testing, not with the clearance of an anesthesia delivery unit based on substantial equivalence to existing devices and adherence to performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As with the previous points, adjudication methods are typically relevant for human interpretation or AI performance assessment, which is not the primary focus of this 510(k) submission.
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
This information is not provided in the document. MRMC studies are used for evaluating diagnostic devices and AI systems where human interpretation is part of the workflow. This device is an anesthesia delivery unit, not a diagnostic imaging or AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This device is a complex electromechanical system, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the context of this 510(k) appears to be based on compliance with established safety and performance standards (e.g., UL, EN, ISO, ASTM) and the functional specifications meeting the intended use. This is demonstrated through engineering design, internal testing, and comparison to predicate devices, rather than a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
This information is not provided in the document. The device is not learning from a "training set" in the machine learning sense. Its design and functionality are predetermined based on engineering principles and established medical device standards.
9. How the ground truth for the training set was established
This information is not provided in the document, as there is no "training set" in the machine learning sense 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).