(771 days)
Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight.
Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring.
Savina 300 is intended for the following environments of use:
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In intensive care wards, recovery rooms and generally for hospital use
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During the transport of ventilated patients within the hospital
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During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300)
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During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)
Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, 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).
The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.
This document is a 510(k) Summary for the Dräger Savina 300 ventilator, claiming substantial equivalence to previously cleared devices. It does not contain a study proving that the device meets specific acceptance criteria in the way a clinical validation study for an AI/ML software device would. Instead, it demonstrates compliance with recognized performance standards to establish substantial equivalence.
Here's an breakdown based on the information provided, and where certain requested information might not be applicable or present for this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of "acceptance criteria" paired with "reported device performance" in the context of specific outcome metrics like sensitivity, specificity, or accuracy for a diagnostic device.
Instead, the "acceptance criteria" are implied by compliance with listed international and national standards relevant to medical electrical equipment, particularly for lung ventilators. The "reported device performance" is demonstrated by the device's design, functional specifications, and its claim of equivalence to existing devices that have already met these standards.
Here's a summarization of the relevant information provided under "List of Performance Testing" and "Comparison of Technological Characteristics":
| Acceptance Criteria (Implied by Standards & Predicate Equivalence) | Reported Device Performance (as claimed in 510(k) Summary) |
|---|---|
| Safety and Essential Performance (IEC 60601-1) | Complies with IEC 60601-1: 1988 + A1: 1991 + A2: 1995 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2: 2007 |
| Specific Requirements for Lung Ventilators - Critical Care (IEC 60601-2-12) | Complies with IEC 60601-2-12: 2001 |
| Programmable Electrical Medical Systems (IEC 60601-1-4) | Complies with IEC 60601-1-4: 1996 + A1: 1999 |
| Usability (IEC 60601-1-6) | Complies with IEC 60601-1-6: 2006 |
| Alarm Systems (IEC 60601-1-8) | Complies with IEC 60601-1-8: 2006 |
| Risk Management (ISO 14971) | Complies with ISO 14971: 2007, Corrected version 2007-10-01 |
| Reprocessing of Resterilizable Medical Devices (ISO 17664) | Complies with ISO 17664: 2004 |
| Medical Device Software - Software Life Cycle Processes (IEC 62304) | Complies with IEC 62304: 2006 |
| Environmental Conditions and Test Procedures for Airborne Equipment (RTCA-DO 160G) | Complies with RTCA-DO 160G: 2010 (applicable clauses for radiated electromagnetic emissions and mechanical safety) |
| Respiratory Gas Monitors (ISO 21647) | Complies with ISO 21647: 2005 |
| Biological Evaluation of Medical Devices (ISO 10993-1) | Complies with ISO 10993-1: 2009 + Cor. 1: 2010 |
| Ventilators Intended for Use in Critical Care (ASTM F1100-90 (Reapproved 1997)) | Complies with ASTM F1100-90 (Reapproved 1997) |
| Functional Equivalence to Predicate Devices | "The functionality is equivalent to the Infinity Acute Care System Workstation Critical Care and the flight transport indication is equivalent to the Oxylog 3000 Plus." (Page 4) |
| Technological Equivalence to Predicate Devices | "The technological concept of the Savina 300 is equivalent to Savina." (Page 4) |
| Intended Use | "The intended use and the functionalities as the predicate devices remain the same." (Page 11) |
| Ventilation Modes | Savina 300 provides comparable volume-controlled and pressure-controlled ventilation modes, support for spontaneous breathing, and special modes (Pages 5, 8). |
| Monitoring Capabilities | Savina 300 provides equivalent monitoring sensors (flow, pressure, O2, optional CO2) and displayed parameters (airway pressure, MV, VTi, FiO2, etCO2, etc.) to predicates (Pages 9, 10). |
| Environmental Conditions for Operation/Storage | Savina 300 meets or exceeds the environmental specifications of its predicates for temperature, atmospheric pressure, and humidity (Pages 9, 10). |
| Power Supply & Battery Bridging Time | Savina 300 mains power supply and internal battery bridging time (typ. 45 min) are comparable or improved (predicates 30 min, one predicate 4 hours) (Page 10). |
| Gas Supply Requirements | Savina 300 gas supply pressure, peak input flow, dew point, oil concentration, and particle size are within acceptable limits and comparable to predicates (Page 10). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable (N/A) in the context of this 510(k) submission. This document does not describe a clinical validation study involving a "test set" of patient data for evaluating a software algorithm. The "testing" referred to is performance testing against recognized standards for medical devices and a comparison of technical specifications to predicate devices. There is no patient data involved in this type of submission for this device.
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)
This information is N/A. As explained above, there is no "test set" or "ground truth" establishment in the context of expert review for a diagnostic AI/ML device in this submission. The device is a ventilator, and its performance is assessed against engineering standards and comparison to similar devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is N/A. No adjudication method for a test set is relevant to this 510(k) 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
This information is N/A. The device is a ventilator, not a diagnostic imaging device or AI assistance tool for human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is N/A. The Savina 300 is a physical medical device (ventilator) with integrated software, not a standalone algorithm. Its operation involves continuous interaction with a patient under the supervision of trained medical personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is N/A. "Ground truth" in the context of diagnostic accuracy is not relevant to this type of device and submission. The "truth" here is compliance with established performance standards and the functional equivalence of its technical characteristics to predicate devices.
8. The sample size for the training set
This information is N/A. As this is a medical device (ventilator) and not an AI/ML software device trained on data, there is no "training set."
9. How the ground truth for the training set was established
This information is N/A. No training set exists for this device.
§ 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).