(120 days)
The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
The GE Healthcare anesthesia systems supply set flows of medical gases to the breathing system. Gas flows are selected by the user and displayed on the display unit or through pneumatic flow meters. A large selection of options may be available to configure the system, including frames, brake style, gases, and anesthetic agents.
The GE anesthesia machines include a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure, and inhaled and exhaled volume. Flow, gas, and pressure 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. 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).
This is a 510(k) premarket notification for a medical device family (GE Healthcare anesthesia machines) and not a study describing a new algorithm or AI. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.
However, based on the provided text, I can infer the acceptance criteria for substantial equivalence and summarize the study that proves the device meets those criteria.
The primary purpose of this 510(k) submission is to demonstrate that the modified GE Healthcare anesthesia machines, incorporating two alternate flow sensors, are substantially equivalent to their previously cleared predicate devices. The "study" here refers to the non-clinical testing performed to establish this substantial equivalence.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implicitly tied to the performance requirements of the predicate devices. The goal is to show that the modified devices perform equivalently and raise no new questions of safety or effectiveness.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Equivalent Intended Use/Indications for Use: No change to the intended use or indications for use compared to the predicate devices. | "There is no change to the intended use or indications for use of the GE anesthesia machines as a result of the introduction of the proposed alternative flow sensors. Each anesthesia machine retains its intended use as previously cleared and legally marketed." (Page 12) |
| Equivalent Technical Characteristics: The modified device employs the same fundamental scientific technology and does not introduce new technology. | "The GE Healthcare anesthesia machines employ the same fundamental scientific technology as their predicate devices. This 510(k) does not introduce new technology to the anesthesia machine or the two alternate flow sensors." (Page 14) |
| "The GE Healthcare anesthesia machines are identical to the predicate GE Healthcare anesthesia machines, except for the introduction of two alternate flow sensors." (Page 14) | |
| Biocompatibility: New materials in the patient gas path must not introduce new biomaterials risks and must be substantially equivalent to the predicate. | "Material composition: There are some new materials which are introduced to the patient gas path. Biocompatibility testing has been completed to demonstrate that the proposed materials do not introduce any new biomaterials risk, and are substantially equivalent to the predicate." (Page 14) |
| Specific tests mentioned: "Biocompatibility – Cytotoxicity testing per ISO 10993-5, Sensitization testing per ISO 10993-10, Extractable testing" (Page 14) | |
| Performance Equivalence: The performance of the anesthesia machine and the changed components must be identical or equivalent to the predicate, with minor changes delivering equivalent performance. | "Performance: The performance requirements of the anesthesia machine and the changed components are identical. Minor changes were made to the proposed alternative flow sensors to deliver equivalent performance. There is no change to the performance of the anesthesia machine or the alternate flow sensors." (Page 14) |
| "As described below, the performance of the GE Healthcare anesthesia machines has been fully verified and validated with the changes described in this 510(k)." (Page 14) | |
| Testing performed included verification of specifications related to: Mating parts and interface, Accuracy, sensitivity and pressure drop, Leak, Over range flow, Breath cycle life, Shipping, Agent exposure, Connector performance, MRI compatibility and MR safety, Power, communications and data, System pressure drop, System electrical safety, EMC and EMI, Operational temperature and humidity, Storage environment, System ventilation accuracy, System water management, System communication, Agent compatibility. (Page 14) | |
| Reprocessing Effectiveness: Updated reprocessing instructions for new components must be verified and validated. | "Reprocessing instructions: the proposed components are reprocessed differently from the predicate version, and the updated reprocessing instructions are included with the device and the spare parts. The updated reprocessing instructions have been verified and validated." (Page 14) |
| Validation of design inputs including "Reprocessing" was performed. (Page 14) | |
| Overall Safety and Effectiveness: The modified devices must perform in a manner that is substantially equivalent to the predicate devices without raising new safety or effectiveness concerns. | All testing passed, demonstrating that all design outputs meet the intended design inputs, and all product specifications continue to be met and the GE anesthesia machines perform in a manner which is substantially equivalent to the predicate products. (Page 14) |
Study Details (Non-AI Specific)
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Sample size used for the test set and the data provenance:
- The document describes a series of non-clinical tests (component-level and system-level testing, biocompatibility testing, reprocessing validation). It does not specify a "test set" in the context of patient data or algorithm performance. Instead, it refers to tests on the device's components and the complete system.
- Data provenance: Not explicitly stated as country of origin, but the submission is from GE Healthcare, Datex-Ohmeda, Inc., located in Madison, Wisconsin, USA. The testing is described as occurring prior to the submission date (September 2017). This is a retrospective analysis of engineering, functional, and safety tests performed on the device.
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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. This submission does not involve clinical data that would require expert ground truth labeling in the context of an AI/algorithm study. The "ground truth" for these tests are engineering specifications, validated test methods, and compliance with industry standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image review), not for objective engineering tests on a physical device.
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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/software device that assists human readers. It is a modification to an anesthesia gas machine.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/algorithm. Performance tests were conducted on the modified physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these tests are established engineering specifications, validated test methods, and compliance with relevant voluntary industry standards (e.g., ISO 10993 for biocompatibility) that define the expected performance and safety characteristics of an anesthesia gas machine.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning model that undergoes training with a dataset.
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How the ground truth for the training set was established:
- Not applicable. See #7.
§ 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).