(233 days)
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The specific features of the product include:
- . Breathing system under microprocessor control.
- · User interface under microprocessor control. Uses "hyman interface" features associated with touch screen and graphical user interface technology. The specifics of the particular touch screen technology and its suitability to medical applications is covered in more detail in the principle of operation section.
- · Integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual, stand alone compressor for each ventilator. The product will also be offered in a configuration without the blower in which case it will operate from a wall air supply.
- · Ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical grade, oxygen gas source, including medical grade gas cylinders with suitable regulators.
- · Ability to operate on a re-chargeable primary battery for 30 minutes (nominal).
- · Ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours.
- · Provide high product quality and reliability. ESPRIT has been designed using Highly Accelerated Life Testing (HALT), coupled with Environment Stress Screening (ESS) during manufacturing. Studies have shown that these techniques greatly eliminate reliability problems and are integral to the reliability of the product.
The Esprit Critical Care Ventilator (K981072) demonstrates substantial equivalence to predicate devices through a series of environmental and performance tests. The provided documentation does not detail specific acceptance criteria in numerical thresholds for clinical performance or any associated study proving the device meets those criteria with statistical significance. Instead, the focus is on engineering performance and safety standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on complying with various environmental and electrical safety standards, as well as meeting performance characteristics comparable to legally marketed predicate devices. The document does not provide specific numerical performance metrics but asserts that the device meets the requirements of the referenced standards and produces the flows and pressures detailed in the comparative analysis.
| Test / Criterion | Basis / Standard | Reported Device Performance |
|---|---|---|
| Dielectric Strength | IEC 601-1, Clause 20 | Not specified, but implied compliance through testing. |
| Leakage Current | IEC 601-1, Clause 19 | Not specified, but implied compliance through testing. |
| Radiated and Conducted Electromagnetic Emissions | CISPR 11 | Not specified, but implied compliance through testing. |
| Magnetic Field Emissions | RE101 of MIL-STD 461D at 7 cm | Not specified, but implied compliance through testing. |
| Electrostatic Discharge | IEC 801-2 | Not specified, but implied compliance through testing. |
| Radiated Electromagnetic Fields Susceptibility | IEC 801-3 | Not specified, but implied compliance through testing. |
| AC Voltage Fluctuation: Steady State, Dropout, Slow Sags and Surges | IEC 801-11 | Not specified, but implied compliance through testing. |
| AC Voltage Fluctuation: Fast Transient Bursts | IEC 801-4 | Not specified, but implied compliance through testing. |
| AC Voltage Fluctuation: Fast Surges | IEC 801-5 | Not specified, but implied compliance through testing. |
| Conducted Electromagnetic Energy Susceptibility | MIL-STD-461D, CS114 | Not specified, but implied compliance through testing. |
| Magnetic Fields Susceptibility | RS101 (Army) of MIL-STD-461D | Not specified, but implied compliance through testing. |
| Quasi-static Electric Fields Susceptibility | Reviewer Guidance for Premarket Notification Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Random Vibration | Reviewer Guidance for Premarket Notification, Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Shock | Test conditions based on IEC 68-2-27 | Not specified, but implied compliance through testing. |
| Ingress of Liquids | IEC 601-1, Clause 44.6, and IEC 529 | Not specified, but implied compliance through testing. |
| Temperature/Humidity | Reviewer Guidance for Premarket Notification Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Surface Temperature | Reviewer Guidance for Premarket Notification Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Ventilator Requirements | "Draft Reviewer Guidance for Ventilators, July, 1995" | Device meets the requirements (details in Section 7). |
| Performance Characteristics (Flows and Pressures) | Comparative Analysis to Predicate Devices (Section 8) | Device produces the flows and pressures (details in Section 8). |
| Waveform Performance | Comparative Analysis to Predicate Devices (Section 8.3) | Compared to 7200 Ventilator predicate device (details in Section 8.3). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes environmental and lab testing for the device. It does not refer to a "test set" in the context of patient data or clinical trials for evaluating diagnostic or predictive performance. The testing appears to be primarily engineering validation. Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), is not applicable in the typical sense for AI/diagnostic devices. The testing is likely conducted on various units of the Esprit ventilator itself to ensure adherence to specified standards.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the studies described are engineering and performance validation tests, not clinical evaluations requiring expert consensus for ground truth establishment.
4. Adjudication Method
This information is not applicable for the type of testing described (environmental and performance validation). There is no mention of human adjudication for defining a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not performed or described. The submission focuses on device equivalence through engineering and performance comparisons, not on comparing human reader performance with or without AI assistance.
6. Standalone Performance
The device itself is a standalone mechanical ventilator. The described testing (environmental, performance, and comparison to predicate devices) effectively assesses the standalone performance of the ventilator in terms of its engineering and functional characteristics. There is no mention of an algorithm 'only' performance in the context of a diagnostic AI.
7. Type of Ground Truth Used
The "ground truth" in this context is adherence to established engineering standards, regulatory guidance for ventilators, and the performance characteristics of legally marketed predicate devices. This is based on objective measurements and comparisons against these defined benchmarks. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the declared studies.
8. Sample Size for the Training Set
This information is not applicable. The Esprit Ventilator is a mechanical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).