(17 days)
The iVenf™ 201 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 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 iVently 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The 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.
The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician
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, the iVent™ 201 Portable Ventilator. It focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or comprehensive performance testing against numerical targets.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, and ground truth establishment, typically found in a clinical study report for AI/CADe devices, is not present in this submission.
Here's a breakdown of what can be extracted and what cannot based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not provide a table of numerically defined acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, latency) or corresponding reported performance metrics from a specific study. Instead, it references compliance with voluntary standards and general specifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Available. This document describes a traditional medical device (ventilator) and its components, not an AI/CADe device. Therefore, there is no "test set" in the context of algorithm evaluation with patient data. The non-clinical testing mentioned is likely engineering verification and validation against design specifications and voluntary standards, not a data-driven performance evaluation.
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 / Not Available. As above, there is no "test set" or "ground truth" establishment in the context of expert review for an AI/CADe system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. No such adjudication method is mentioned or relevant for this type of device submission.
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
- Not Applicable / Not Available. This device is a ventilator, not an AI-assisted diagnostic or CADe device. Therefore, MRMC studies and "human readers" are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Available. There is no standalone algorithm in the context of an AI device being evaluated. The device itself is a standalone medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available. No "ground truth" in the AI/CADe sense is established or used for this type of device. Performance is generally verified against engineering specifications, simulated physiological models, and recognized standards.
8. The sample size for the training set
- Not Applicable / Not Available. This device does not involve a "training set" as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. As there is no training set, this question is not relevant.
Summary of Relevant Information from the Document:
While the document does not fit the structure of an AI/CADe device submission, it does discuss device performance in terms of compliance with standards and equivalence:
- Performance Standards: The iVent™ 201 portable ventilator complies with several voluntary standards: ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-112/3, IEC 60601-1, IEC 60601-2-12, IEC 60601-1-2, CAN/CSA-C22.2 No.601.1, ISO 9919, EN 865 (section 6).
- Statement on Performance: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use."
- Substantial Equivalence: The primary "proof" of meeting safety and effectiveness is through demonstration of substantial equivalence to a predicate device (iVent™ cleared under K053270). This equivalence is based on having the same intended use, environment for use, patient population, similar design, same technology, and identical materials, with only a "clarification to the indications statement without changing the scope."
Essentially, for this device, the "acceptance criteria" are the relevant voluntary standards and the ability to demonstrate substantial equivalence to a predicate device already deemed safe and effective by the FDA. The "study" proving it meets these "criteria" is the non-clinical testing mentioned and the formal argument for substantial equivalence presented in the 510(k) submission.
§ 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).