(151 days)
The iVent™ 201 MR Conditional is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, who require invasive or non-invasive assistance via the following general modes of ventilatory support, as prescribed by an attending physician:
- Assist/Control (Pressure Controlled or Volume Controlled)
- SIMV (Pressure Controlled or Volume Controlled)
- CPAP/PSV
The iVent™ 201 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional.
The optional non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas, excluding MR environments.
The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.
The iVent™ 201 MR Conditional is a compact, portable, fully featured, microprocessorcontrolled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn and click control knob, quick choice push buttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
Optional equipment:
- Non-invasive pulse oximeter (not to be used in MR environments) .
- . Remote Alarm Adapter
Testing has been performed according to ASTM F2052-06-e1 in 1.5 and 3.0 Tesla environments.
The provided text describes a 510(k) submission for the VersaMed iVent™ 201 MR Conditional ventilator. This document focuses on demonstrating substantial equivalence to predicate devices, particularly regarding its functionality within a Magnetic Resonance (MR) environment.
Here's an analysis of the acceptance criteria and the study information present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values and actual results for a clinical study on a disease. Instead, the focus is on the device's MR Conditional status and equivalence to predicate devices. The key "performance" aspect is the device's safe operation in MR environments, which is confirmed through a specific standard.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safe operation in MR environment (1.5 and 3.0 Tesla). | Testing performed according to ASTM F2052-06-e1. |
| Functionality in MR environment (up to 3.0 Tesla static field). | Device is "MR Conditional" for up to 3.0 Tesla static magnetic field. |
| Substantial equivalence to predicate ventilators (VersaMed iVent™ 201 - K061627 and Maquet SERVO-i - K063404) for intended use (continuous/intermittent ventilatory support for adult/pediatric patients in various modes). | "No significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices." (Differences primarily relate to MR environment use). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in terms of patient data or clinical cases. The testing mentioned (ASTM F2052-06-e1) is a physical and electromagnetic compatibility standard for medical devices in MR environments. This standard typically involves testing the device itself, not a patient population. Therefore, there is no sample size of patients or images.
- Data Provenance: Not applicable, as the testing is for device safety in an MR environment rather than a clinical data set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The "ground truth" for MR Conditional status is established by adhering to an industry standard (ASTM F2052-06-e1) and demonstrating that the device meets its requirements for safe operation in specified MR environments. This does not involve expert readers or clinical ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing is based on objective measurements against a standard, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI devices where the performance of human readers with and without AI assistance is compared. The iVent™ 201 MR Conditional is a ventilator, a life-support device, and its safety in an MR environment is assessed through engineering and physical standards, not through clinical reader studies.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical device (ventilator), not an algorithm or AI software intended for standalone diagnostic performance. Its "standalone performance" relates to its mechanical and electrical operation, and its ability to function within an MR field without causing harm or malfunction, which is covered by the ASTM testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this submission is adherence to the ASTM F2052-06-e1 standard for testing medical devices in MR environments. This standard specifies test methods to evaluate potential hazards and effects (e.g., magnetic force, induced heating, artifact generation) when a medical device is exposed to MR fields. The device demonstrating compliance with this standard against predetermined thresholds effectively establishes its "MR Conditional" ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).