(259 days)
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
- Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
- CPAP with Pressure Support .
- Adaptive Bi-Level for either NIV or invasive ventilation. ●
The iVent101 ventilator is suitable for use in institution, home and portable settings.
The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets . Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiO2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen.
All the operator actions are performed on the LCD touch-screen on the front panel, allows, 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.
The iVent101 can use external AC or DC power supply and contains an integrated battery.
The iVention is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
The iVent101 is capable of providing the following types of ventilatory support:
- Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
- CPAP with Pressure Support
- Adaptive Bi-Level for either NIV or invasive ventilation. .
The iVent101 is a continuous ventilator intended to provide continuous or intermittent ventilatory support for patients requiring mechanical ventilation, including infants (from 5 kg) through adults. It supports various ventilatory modalities and can be used in institutional, home, and portable settings.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." Therefore, there are no specific, quantitative acceptance criteria provided in the document in terms of performance metrics (like accuracy, sensitivity, or specificity for a diagnostic device, or specific flow/pressure tolerances for a ventilator). Instead, the device's conformance to established voluntary standards is used as evidence of its safety and effectiveness.
Acceptance Criteria (Voluntary Standards met) Reported Device Performance ASTM F 1100-90 (Critical Care Ventilators) Complies with standard ASTM F 1246-91 (Home Care Ventilators) Complies with standard Draft Reviewer guidance for ventilators (July 1995) Complies with standard ISO 10651-2 (Home Care Ventilators) Complies with standard ISO 10651-6 (Usability of Medical Electrical Equipment) Complies with standard IEC 60601-1 (General Safety for Medical Electrical Equipment) Complies with standard IEC 60601-2-12 (Safety of Lung Ventilators) Complies with standard IEC 60601-1-2 (Electromagnetic Compatibility) Complies with standard IEC 60601-1-8 (Alarm Systems) Complies with standard UL 60601-1 (General Safety for Medical Electrical Equipment) Complies with standard The overall reported device performance conclusion is: "The iVent101 performs as intended according to its performance specification. The iVent101 is substantially equivalent to the predicate devices."
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Sample size used for the test set and the data provenance:
No human or animal test set data is described or used. The evaluation relies on compliance with engineering and safety standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth was established by experts for a test set in the context of clinical performance data.
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Adjudication method for the test set:
Not applicable.
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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. This is a medical device (ventilator), not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (ventilator), not an algorithm for diagnosis or interpretation.
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The type of ground truth used:
Not applicable. Clinical ground truth (e.g., pathology, outcomes data) was not used as there were no clinical studies. The "ground truth" for the device's performance in this context is its adherence to the specified technical requirements and voluntary industry standards.
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The sample size for the training set:
Not applicable. This is a medical device (ventilator), not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" demonstrating the device meets its "acceptance criteria" (which are defined by adherence to voluntary standards and substantial equivalence to predicate devices) is a series of non-clinical performance tests.
The document states: "Due to comprehensive scientific literatures, performance tests per ASTM 1246-91, ASTM 1100-90, IEC and ISO standards, VersaMed believes that clinical studies are not required to determine the safety and efficacy of the device."
Therefore, the proof consists of:
- Engineering and Performance Testing: The device underwent internal performance tests to ensure it met its own engineering specifications and complied with the listed voluntary international and national standards (ASTM, ISO, IEC, UL). These tests would verify aspects like air delivery accuracy, pressure control, alarm functionality, electrical safety, electromagnetic compatibility, and usability, all as specified in those standards.
- Substantial Equivalence Argument: The core of the submission relies on demonstrating substantial equivalence to four predicate devices (LTV1200, iVent201, PLV Continuum II, Legendair XL2). This argument posits that because the iVent101 has the same intended use, environment for use, patient population, and employs the same technology (internal compressor, software algorithms for breath delivery) as legally marketed, safe, and effective devices, it is also safe and effective. No specific data from the predicate devices is provided beyond their identification.
§ 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).