(65 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 iVent™ 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 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.
The provided text describes a 510(k) premarket notification for the iVent™ 201 Portable Ventilator, seeking to establish substantial equivalence to predicate devices. It states that the device complies with voluntary performance standards and mentions "non clinical testing results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed study results for device performance.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text.
Here's a summary of what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance against such criteria. It generally states: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not mentioned in the document. The testing described is "non-clinical," implying bench testing rather than studies involving patient data.
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)
Not applicable, as the testing described is non-clinical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the testing described is non-clinical.
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
Such a study was not performed or mentioned. This device is a ventilator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to a ventilator. The document describes the device's functionality as a standalone ventilator.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For "non clinical testing," the ground truth would typically be established by engineering specifications, calibration standards, and established mechanical/electrical measurement techniques. No details are provided.
8. The sample size for the training set
Not applicable, as this is a medical device, not an AI/machine learning model that typically has "training sets." The assessment is based on non-clinical testing of the device itself.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
Summary of available information related to performance and standards:
The document states that a "non-clinical testing" was performed and that the device complies with several voluntary performance standards. These standards implicitly set performance criteria that the device must meet.
Voluntary Performance Standards the iVent™ 201 portable ventilator complies 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
- ISO 9919
- EN 865 (section 6)
Study proving the device meets acceptance criteria:
The document broadly states: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use." No specific study name, methodology, or detailed results are provided beyond this general statement. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices and compliance with recognized voluntary standards rather than providing detailed clinical study results in this particular summary.
§ 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).