(7 days)
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require 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 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
The iVeur™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
The iVent201 is a compact, portable, fully featured, microprocessor-controlled 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 pushbuttons, 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.
Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.
The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.
This document is a 510(k) premarket notification for a medical device (Ventilator). These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria, ground truth, and statistical analyses of algorithm performance, as would be common for AI/ML device submissions.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available within the provided text.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML submission would. Instead, it states compliance with voluntary performance standards and highlights modifications that indicate improved capabilities or ranges compared to the predicate.
| Criterion Type | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (iVent 201) |
|---|---|---|
| General Performance | Compliance with ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-1/2/3, IEC 60601-1, IEC 60601-2-12, IEC 60601-1-2, CAN/CSA-C22.2 No.601.1 180, EN 865 (section 6) | "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use." (General statement of compliance) |
| Low Tidal Volume Setting | 100ml (on cleared predicate) | 50ml (new) |
| Maximum Respiratory Rate | 50 BPM (on cleared predicate) | 80 BPM (new) |
| Maximum Inspiratory Pressure | 60 cmH2O (on cleared predicate) | 80 cmH2O (new) |
| Maximum PEEP Setting | 20 cmH2O (on cleared predicate) | 40 cmH2O (new) |
| Maximum PSV Setting | 30 cmH2O (on cleared predicate) | 60 cmH2O (new) |
| I:E Ratio Inspiratory Time Range | 0.3-3 seconds (for 1:4 to 2:1 ratio on cleared predicate) | 0.2-3 seconds (for 1:4 to 2:1 ratio on new device) |
| Trigger Sensitivity (lpm) | 2-9 lpm (on predicate) | 1-20 lpm (new) |
| Trigger Sensitivity (cmH2O) | -1 to -8 cmH2O (on predicate) | 0.5 to 20 cmH2O (new) |
| Intended Use | Continuous or intermittent ventilatory support for patients >= 10kg requiring mechanical ventilation. Suitable for intra-hospital, home, alternative-site, transport, emergency. | Same as predicate. |
| Safety and Effectiveness | No significant differences from predicate that affect safety or effectiveness. | Stated as substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. This is a ventilator, not an AI/ML diagnostic device with a "test set" in the context of imagery or other data. The "testing" referred to is non-clinical performance and safety testing against engineering specifications and voluntary standards. No specific sample sizes for such tests are provided in this summary.
- Data Provenance: Not applicable in the context of "data" for a test set. The non-clinical testing would have been conducted by the manufacturer, VersaMed Medical Systems Inc., likely at their facilities or certified labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment in the AI/ML sense for this type of device. The verification of the device's performance against specifications would be done through engineering tests, calibration, and safety assessments.
4. Adjudication method for the test set
- Not applicable. No adjudication method is mentioned, as there is no "test set" requiring human interpretation or consensus.
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 a hardware medical device (ventilator), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study is not relevant and was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a ventilator, which is a standalone machine. Its performance parameters are assessed directly (e.g., airflow, pressure, tidal volume delivery accuracy) rather than through separate algorithm-only performance. It operates with human input (setting parameters) but its core function is mechanical ventilation, not an algorithm providing diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a ventilator, the "ground truth" for performance would be its physical output and functional accuracy compared to its specified engineering parameters and relevant performance standards (e.g., "does it deliver 50ml tidal volume when set to 50ml?" This is measured directly, not compared to human labels or pathology).
8. The sample size for the training set
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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).