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510(k) Data Aggregation
(467 days)
The HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics.
Intended areas of use:
- · In the MRI department
- · In the intensive care ward or in the recovery room
- · During transfer of ventilated patients within the hospital
The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5 T and 3.0 Tesla static magnetic field scanners.
The HAMILTON-MR1 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-MR1 is an MR-Conditional ventilator which increases the availability of appropriate modes of therapy for ventilated hospital patients requiring MR imaging. It covers a full range of clinical requirements such as: invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive Ventilation (NIV). It can be used at the 500 gauss line, in the presence of either 1.5T or 3T magnets.
In the MRI environment, where strong magnetic fields pose a danger for both the patient and the operator, safety is the highest priority. With the effectively shielded, MRI-compatible HAMILTON-MR1 ventilator, ventilation performance and MR image quality is guaranteed throughout the procedure. The integrated gaussmeter is programmed to alarm when the clinician is placing the HAMILTON-MR1 too close to the MRI magnet, which helps the clinician to properly position the HAMILTON-MR1 at the 50mT (500 gauss) line or less.
The HAMILTON-MR1 can be used in ICU special care areas, cardiac surgery recovery rooms. step-down or sub-acute care units, and when transporting patients to the MRIdepartment. In these cases, the HAMILTON-MR1 guarantees uncompromised continuous ventilation care from the ICU to the MRI and back with its 6-hour long batteries. Alternatively, the HAMILTON-MR1 can be used as an MRI-proprietary ventilator, waiting in the MRI department for the patient. In the MR environment -- when the clinician is unable to stay close to the patient for routine adjustments -- the ASV mode adapts to the patient's lung condition.
Positioning a medical device too close to the MRI can have fatal consequences and cause serious injury to the patient or clinician. In addition, significant financial losses can occur if an MRI shutdown is required. The HAMILTON-MR1's integrated gaussmeter continuously monitors the magnetic field and gives the clinician both an audible and a visual signal if the HAMILTON-MR1 is getting too close to the MRI magnet. For increased MRI safety and ease of use in the MR environment, the integrated gaussmeter continues monitoring -- even when the ventilator is not in use. Close proximity of the ventilator to the MRI machine is crucial. The HAMILTON-MR1 is a ventilator able to be used at a magnetic field strength of 500 gauss, without creating any MR image artifacts.
Both the HAMILTON-MR1's software and ventilation modes are identical to the HAMILTON-C1. One can operate the HAMILTON-MR1 with the touch-screen or with a single-turn wheel. Hard keys give direct access to the most important functions. The two devices are identical with the exception of modifications related to the MR environment (e.g. integrated gaussmeter, special alarm indicators, MR-specific labeling, the reduction in ferromagnetic materials, the removal of the options board, and increased safety measures for battery removal or replacement). Due to these modifications, the HAMILTON-MR1 is able to withstand the challenging conditions found in the MR environment. With the large alarm lamp, a clinician can immediately identify an alarming HAMILTON-MR1 ventilator because the alarm lamp is located at the top of the device, even if the clinician is a long distance away or when several different devices are operating simultaneously in the same room. The high-performance turbine can deliver up to 210 L/min flow, which is potentially helpful when using NIV modes of ventilation. The HAMILTON-MR1 includes a trolley made out of nonferrous materials, which will not be attracted to the powerful electromagnetic forces emanating from the MRI's magnet. The trolley also has a "fail-safe" braking system (i.e., Dead man's brake).
The provided text describes the Hamilton-MR1 ventilator and its compliance with various standards and its suitability for use in an MRI environment. However, it does not explicitly detail a study in the format of a clinical trial or a comparative effectiveness study with human readers that proves the device meets specific acceptance criteria.
The information primarily focuses on non-clinical performance testing and substantial equivalence to a predicate device (HAMILTON-C1) and other MR-compatible ventilators.
Here's an attempt to extract and organize the information based on your request, with a note on where the requested information is not available in the provided text:
Acceptance Criteria and Device Performance for HAMILTON-MR1 Ventilator
The acceptance criteria are generally implied through compliance with various international standards and specific performance thresholds related to MRI compatibility. The device performance is reported through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Target/Threshold) | Reported Device Performance (HAMILTON-MR1) | Reference/Standard |
|---|---|---|---|
| MRI Compatibility | Magnetic Field Threshold (Operation) | Green Light - Acceptable: $\leq$ 50mT (500 gauss) | |
| Yellow Light - Too close: 50 - 80mT | |||
| Red Light - Too close: > 80mT | Internal testing, Philips Achieva 3.0T and 1.5T MRI scanners | ||
| Gaussmeter Accuracy | Integrated gaussmeter accuracy: ± 10% | Comparison with commercially available, calibrated third-party gaussmeter | |
| Functionality at Higher Gauss Levels | Can function "in accordance to its 'essential performance criteria'" at > 100mT (1,000 gauss) (though not recommended for use > 50mT) | Non-clinical performance bench-testing (Philips Achieva 3.0T and 1.5T MRI scanners) | |
| Magnetically Induced Torque | Pulled towards MRI magnet at $\geq$ 445mT (4,450 gauss) | ASTM F2213-06 (Magnetically Induced Torque on Medical Devices in the MR Environment) | |
| Magnetically Induced Displacement Force | Force of 64.2 Newtons at $\geq$ 445mT (4,450 gauss) when brake activated | ASTM F2052-06 (Magnetically Induced Displacement Force on Medical Devices in the MR Environment) | |
| MR Image Artifacts | No MR image artifacts created at 500 gauss | ASTM F2119-07 (Evaluation of MR Image Artifacts from Passive Implants) | |
| Distance to MRI Bore Opening | $\sim$1 m (3.25 ft) at 50mT (500 gauss) | Comparison to other MR-compatible ventilators | |
| General Performance | Tidal Volume (minimal) | $\geq$ 20 mL | Comparison to other MR-compatible ventilators |
| Maximum Inspiratory Flow | 210 L/min | Comparison to predicate device (HAMILTON-C1) | |
| Maximum Working Pressure Limit | 60 cmH20 | Comparison to predicate device (HAMILTON-C1) | |
| Environmental | Operation Temperature Range | 5 to 40° C (41 to 104 °F) | Comparison to predicate device (HAMILTON-C1) and IEC 60601-1 |
| Operating Humidity | 10 to 95%, non-condensing | Comparison to predicate device (HAMILTON-C1) | |
| Operating Atmospheric Pressure | 1100 to 700 hPa | Comparison to predicate device (HAMILTON-C1) | |
| Software/Safety | Software Verification/Validation | Software passed verification/validation tests. Complete revision level history, hazard analysis, and traceability analysis. Risk management report, system-level validation, verification testing according to applicable standards. | Internal software development processes, IEC 62304, IEC 60601-1-4, IEC 60601-1-8, ISO 14971, IEC 60601-1-6, FDA Draft Reviewer Guidance for Ventilators (1995) |
| Battery Safety | Non-spillable | IEC 62133 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The testing described is primarily non-clinical bench testing with specific MRI scanners (Philips Achieva 3.0T and 1.5T). The "test set" in this context refers to the device prototypes/units physically tested.
- Data provenance: The document indicates testing was conducted using Philips Achieva 3.0T and 1.5T MRI scanners, and comparison with commercially available third-party gaussmeters. The location of these tests is not explicitly stated, but the manufacturer is Hamilton Medical AG based in Switzerland. Therefore, the data provenance is likely European-based non-clinical lab testing. The testing is non-clinical/bench testing, implying it is prospective testing of the device's physical properties.
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)
- Number of experts: Not applicable for the described non-clinical performance and safety testing. The "ground truth" for these tests relates to physical measurements and compliance with engineering standards, not expert medical opinion on images or patient outcomes.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. The tests described are objective measurements (e.g., magnetic field strength, displacement force, artifact presence/absence based on established protocols), not subjective interpretations requiring adjudication.
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
- MRMC study: No, a multi-reader multi-case comparative effectiveness study was not done. The document focuses on the ventilator's physical and functional compatibility with the MRI environment, not on AI assistance for human readers or interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No, this is not applicable. The HAMILTON-MR1 is a physical medical device (ventilator) with integrated software and hardware components, not an AI algorithm for diagnostic purposes. Its performance is evaluated as a standalone device in terms of its operational capabilities and safety in an MRI environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: The ground truth for the non-clinical tests is based on defined physical parameters and measurements (e.g., magnetic field strength, force, temperature, flow rates), and compliance with standardized testing protocols (e.g., ASTM standards for MRI compatibility, IEC standards for medical electrical equipment). For the integrated gaussmeter, the ground truth was established by comparison with a "commercially available, calibrated third-party gaussmeter."
8. The sample size for the training set
- Training set sample size: Not applicable. The HAMILTON-MR1 is a medical device, not an AI model trained on a dataset. The software undergoes verification and validation, but this is distinct from machine learning training.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as there is no "training set" in the context of an AI model for this device. Software verification and validation are typically based on predefined requirements, specifications, and established testing methodologies to confirm the software performs as intended.
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