(24 days)
The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device: 1. Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160. The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System is a gas machine for anesthesia or analgesia, designed to provide the functionalities of a conventional anesthesia system within an MRI environment.
Here's an analysis of its acceptance criteria and the study that supports it:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Compliance to Standards and Stated Functionality) | Reported Device Performance |
|---|---|
| Functional Equivalence: Provide the functional feature set of the conventional Aestiva 3000 (K973896). | The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000, including the Datex-Ohmeda user interface, all ventilation parameters of the SmartVent (including K023366 cleared features), and the Aestiva breathing circuit. |
| MRI Compatibility: Ability to be used in the MR environment. | The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to cryogenic magnets. It performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Specifically, it performed to specifications when tested next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength not exceeding 300 gauss. |
| Safety Features: Decrease the risk of hypoxic mixtures, agent mixtures, and complete power or sudden gas supply failures. | Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. (Implied by compliance to safety standards). |
| Compliance with Voluntary Standards: | The Aestiva SmartVent MRI was designed to comply with the applicable portions of the following voluntary standards, and "rigorous testing" supported this compliance: |
| - EN 740 Anesthetic Work Stations | - Compliance to EN 740 is indicated. |
| - EN 60601-1, IEC 601-1: 1988 Medical Electrical Equipment | - Compliance to EN 60601-1, IEC 601-1: 1988 is indicated. |
| - EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment - Electromagnetic Compatibility | - Compliance to EN 60601-1-2, IEC 601-1-2: 1998 is indicated. |
| - ISO 5358 Anesthetic Gas Machines | - Compliance to ISO 5358 is indicated. |
| - ASTM F1208-94 Anesthesia Breathing Circuit Standard | - Compliance to ASTM F1208-94 is indicated. |
| Adherence to FDA Guidance: Incorporate testing and labeling requirements derived from "A Primer on Medical Device Interactions with Resonance Imaging Systems." | This document was used to help determine testing and labeling requirements, indicating adherence. |
The "study" evidencing these criteria is described as "rigorous testing" that validated the device, in part, supporting its compliance with the mentioned standards. This testing focused on both functional equivalence to its predicate device (Aestiva 3000) and its specific performance in an MRI environment (non-ferrous nature and specified operation near 1.5T and 3.0T MRI devices within 300 gauss field strength).
Details of the Study:
This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy or safety from scratch. Therefore, the "study" described is primarily a series of engineering tests and compliance evaluations against recognized standards and predicate device performance.
- 2. Sample size used for the test set and the data provenance:
- Test Set: Not explicitly stated as a "sample size" in the context of patients or data records. Instead, the testing likely involved a limited number of physical prototype devices.
- Data Provenance: The testing was conducted by the manufacturer (Datex-Ohmeda, Inc.) as part of the device development and validation process. This would be considered prospective engineering validation and verification testing. The geographical origin of the data is not specified beyond the manufacturer's location in Wisconsin, USA.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A): This type of device (Anesthesia System) and submission (510(k) of an MRI-compatible version of an existing device) does not typically involve expert consensus to establish a "ground truth" on a test set of medical data (e.g., images for diagnosis). Instead, performance is assessed against engineering specifications and voluntary standards. Experts would be involved in the design, testing protocols, and interpretation of results (e.g., engineers, medical device specialists, potentially anesthesiologists for functional review), but not in creating a diagnostic ground truth.
- 4. Adjudication method for the test set:
- N/A: As there's no "ground truth" to adjudicate in the typical sense of diagnostic accuracy, an adjudication method like 2+1 or 3+1 is not applicable. Performance would be determined by meeting predefined engineering criteria and passing standard-specific tests.
- 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-enabled diagnostic device and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or performed for this type of submission.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A: This is a physical medical device, not a software algorithm, so the concept of standalone performance (without human-in-the-loop) is not applicable in the typical sense of AI/software. Its functionality is inherently tied to human operation and interaction. The "standalone" performance here refers to the device itself operating according to specifications.
- 7. The type of ground truth used:
- Engineering Specifications and Voluntary Standards: The "ground truth" for this device's performance is its adherence to its own design specifications, the functional features of its predicate device, and the requirements outlined in the cited voluntary standards (EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, ASTM F1208-94) and relevant FDA guidance. For MRI compatibility, the ground truth was "performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss."
- 8. The sample size for the training set:
- N/A: This is not a machine learning model, so there is no concept of a "training set" of data for an algorithm. The development process would involve iterative design, prototyping, and testing.
- 9. How the ground truth for the training set was established:
- N/A: See point 8.
§ 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).