(297 days)
The intensive care ventilator Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight. Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: - In intensive care wards, in recovery rooms and generally for hospital use - During the transfer of ventilated patients within the hospital
Savina 300 is a turbine driven ventilator with a 12.1" color touch screen, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO). Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight in intensive care units, in recovery rooms and generally for hospital use. Savina 300 can also be used during transport of ventilated patients within the hospital. The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides positive pressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes.
Based on the provided text, the device is the Savina 300 intensive care ventilator. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a rigorous clinical trial proving the device meets those criteria, as one might expect for a new AI/software-as-a-medical-device (SaMD) product.
Therefore, many of the requested elements for a study proving acceptance criteria (like specific metrics, sample sizes for training/test sets, expert adjudication details, MRMC studies, and detailed ground truth establishment for AI performance) are not present in this type of submission. This document describes a traditional medical device (a ventilator) and its modifications, with performance demonstrated through non-clinical testing in conformance with recognized standards.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance thresholds for a clinical study, nor does it report specific performance metrics for the device in a clinical context. Instead, it refers to:
- Conformance to FDA recognized standards: This implies that the device's performance meets the requirements outlined in these standards for safety and essential performance.
- Non-clinical testing: "Performance data related to each proposed modification has been tested and evaluated." This suggests bench testing and verification activities.
- Substantial equivalence: The ultimate "performance" goal stated is that the modifications demonstrate the device is substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets requirements of recognized consensus standards. | "Verification and validation testing was conducted in conformance to the FDA recognized standards." (List of standards provided on page 8). |
| New functionalities (ATC, Patient Admission, Leakage Compensation) perform as intended. | "Performance data related to each proposed modification has been tested and evaluated." (No specific numerical performance data is provided in this summary, but it implies successful non-clinical testing results support functionality). |
| Device is substantially equivalent to the predicate device. | "High level summary reports included in this 510(k) demonstrate that the changes to Savina 300 are substantially equivalent to the predicate device." |
| Biocompatibility of breathing gas pathways. | "Biocompatibility evaluation for Savina 300 was conducted in accordance with the International Standard ISO 18562..." (implies successful evaluation). |
| Electromagnetic compatibility. | "The modified Savina 300 has been tested... and has completed a bench-testing which demonstrates electromagnetic immunity test for exposure to radio frequency identification readers." (implies successful testing). |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/not reported. This was demonstrated through engineering and bench testing, not a clinical study with a patient "test set."
- Data provenance: Not applicable. The "data" comes from engineering tests and measurements, not patient data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert image review) is not relevant to the type of testing described for this ventilator. Device performance is evaluated against engineering specifications and standard requirements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no "test set" in the context of clinical data requiring adjudication.
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:
- No. This is not an AI/diagnostic imaging device, and therefore, an MRMC study is not relevant and was not conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a ventilator, a mechanical and electronic medical device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance would be the engineering specifications and requirements of the applicable medical device standards (e.g., ISO 80601-2-12 for critical care ventilators), confirmed through bench testing and validation activities. There is no clinical "ground truth" derived from patient data in this submission summary.
8. The sample size for the training set:
- Not applicable. This is a traditional medical device, not a machine learning model, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
In summary, this 510(k) submission for the Savina 300 ventilator focuses on demonstrating substantial equivalence through non-clinical testing and adherence to recognized standards for device functionality and safety, rather than a clinical study evaluating diagnostic or interpretive performance.
§ 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).