(131 days)
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of invividuals who require mechanical ventilation. 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, FiG2, 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, allowing 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 iVentiol 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 provided 510(k) summary for the iVent101 ventilator does not contain the detailed information required to fulfill all sections of your request. This document focuses on demonstrating substantial equivalence to a predicate device and safety/effectiveness related to the ventilator's operational characteristics, rather than clinical study data involving human or expert evaluation for specific performance metrics like those for an AI/diagnostic device.
However, I can extract the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific performance metrics and acceptance criteria for clinical performance as one would see for a diagnostic or AI device are not available. The document describes the intended function of the device and its operational parameters. The demonstration of "safety and effectiveness" for this type of device typically involves engineering tests, electrical safety, biocompatibility, and bench testing to ensure it delivers specified ventilatory support, not a clinical trial with acceptance criteria for diagnostic accuracy.
What might be considered "performance" for this device type (and implicitly, its acceptance criteria) relates to its ability to deliver specified ventilatory parameters accurately and reliably. The provided text states:
"Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiG2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen."
This implies that the device is designed to measure and present these parameters accurately. However, specific acceptance criteria (e.g., "Tidal Volume accuracy within ±5% of set value") and reported numerical performance against those criteria are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This 510(k) summary does not describe a clinical study with a "test set" in the context of evaluating a diagnostic algorithm's performance on patient data. The evaluation would have involved engineering and bench testing, for which sample sizes of patients or specific characteristics of "data provenance" (like country of origin of data, retrospective/prospective) are not relevant or provided in this type of submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. As there is no clinical study described for establishing diagnostic "ground truth," experts for this purpose are not mentioned. Evaluation for a ventilator involves engineers and medical professionals verifying the device's technical performance and safety.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No adjudication method for a clinical test set is described as there isn't a clinical test set in the context of diagnostic accuracy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a MRMC comparative effectiveness study, which is typically performed for imaging or diagnostic AI algorithms to compare human performance with and without AI assistance. This device is a ventilator, not a diagnostic tool in that sense.
6. Standalone Performance Study (Algorithm Only)
Not applicable/Not provided. This is not an AI algorithm. Its performance is inherent in its hardware and software delivering ventilatory support. Its 'standalone' performance is literally its ability to function as a ventilator as described.
7. Type of Ground Truth Used
Not applicable/Not provided in the typical sense of a diagnostic device. For a ventilator, "ground truth" would be the accurately measured physiological parameters (e.g., actual tidal volume delivered, actual pressure achieved) compared against the device's readings and settings. This is typically established through high-precision calibration equipment and bench testing, rather than expert consensus, pathology, or outcomes data related to diagnostic accuracy.
8. Sample Size for the Training Set
Not applicable/Not provided. As this is not an AI/ML device in the context of pattern recognition or diagnostics, there is no "training set" in the conventional sense. The device's software is developed and validated through traditional engineering processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. No training set, therefore no associated ground truth establishment process in the context of AI/ML.
In summary, the K092135 510(k) document is for a medical device (a ventilator) whose performance is evaluated against engineering specifications, electrical safety standards, and functional capabilities, not against clinical diagnostic accuracy metrics that would involve a test set, ground truth establish by experts, or AI algorithms. The sections requested are highly relevant for AI/ML diagnostic devices, but not for traditional therapeutic or support devices like the iVent101 ventilator based on the provided 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).