(269 days)
The SA Ve II™ series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe 11™ series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.
The SAVe II™ and SAVe II™ Basic ventilators are battery powered compressors to deliver automated, controlled positive pressure breaths with ambient air for up to 10 hours. It is designed to augment the capabilities of first responders by supplementing Bag Valve Mask (BVM) manual ventilation delivery with an automated solution that can be rapidly deployed by minimally skilled providers in environments where compressed oxygen is unavailable or ill-advised.
To support use in emergency situations, the SA Ve II™ is portable and easy to carry. Rapid initial setup is enabled by default ventilator settings based on adult patient's height, ranging from 4'6'' to 6'6" weighing at least 45 kg, organized in a circular-shaped graphic. To mitigate the risk of patient injury, airway pressure is monitored and users are alerted to potentially dangerous low and high pressure situations. Immediate patient injury due to high pressure is avoided by a pressure cut-off that triggers an exhalation if inspiratory pressure exceeds device settings. Rapid troubleshooting is enabled by visual alarm indicators located together at the bottom of the unit that identifies the most likely cause of the triggered alarm.
Here's a breakdown of the acceptance criteria and the study method for the AutoMedx SAVe II™ and SAVe II™ Basic devices, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria with specific acceptance thresholds. The "acceptance criteria" are implied by the features and performance characteristics of the predicate devices. The reported device performance aligns with these characteristics.
| Feature/Characteristic | SAVe II™ Acceptance Criteria (based on Impact Model 754 K931473) | SAVe II™ Reported Performance | SAVe II™ Basic Acceptance Criteria (based on AutoMedx SAVe™ K071221) | SAVe II™ Basic Reported Performance |
|---|---|---|---|---|
| Indications for Use | Short-term ventilatory support for adults during CPR or ARF in pre-hospital, field hospital, and transport settings. | Identical | Short-term ventilatory support for adults during CPR or ARF in pre-hospital, field hospital, and transport settings. | Identical |
| Patient Population | Adult, Pediatric, Infants (Predicate) | Adult Patients weighing >45 kg | Patients weighing >45 kg (Predicate) | Adult Patients weighing >45 kg |
| Operating Principle | Battery-powered ventilator with internal compressor, software-controlled | Identical | Battery-powered ventilator with internal compressor, software-controlled | Identical |
| Breath Type | Volume-targeted, Time-cycled, Pressure limited | Identical | Volume-targeted, Time-cycled, Pressure limited | Identical |
| Main Ventilation Mode | Assist Control | Identical | Assist Control | Identical |
| Air Source | Ambient / Oxygen | Identical | Ambient / Oxygen | Identical |
| TV [mL/breath] | 0 - 3000 (Predicate) | 200 - 800 (increments of 50) | 600 (fixed) (Predicate) | 300 - 700 (increments of 100) |
| RR [br/min] | 1 to 150 (Predicate) | 8 - 20 | 10 (fixed) (Predicate) | 10 (fixed) |
| Inspiratory Flow [L/min] | Up to 60 (Predicate) | Up to 27 | Up to 17 (Predicate) | Up to 27 |
| I:E Ratio | 1:1 to 1:599 (Predicate) | Fixed at 1:3 or 1:2 | Fixed at 1:2 (Predicate) | Fixed at 1:3 or 1:2 |
| PIP Limit [cmH2O] | 15 - 100 (Predicate) | 10 - 60 | 38 (Predicate) | 30 (fixed) |
| PEEP [cmH2O] | 0 - 20 (Predicate) | Internal: 0 - 10 | 0 (Predicate) | 0 (fixed) |
| Supplemental Oxygen (FIO2) | 21 - 100% | Identical | 21 - 60% (Predicate) | 21 - 100% |
| Alarms | Startup Self-Test, Circuit Disconnect, Over Pressure / Blockage, External Power Indicator, Low Battery, Detect Spontaneous Breath, Excessive PEEP, I:E Ratio Exceeded | All present, plus Device Temperature Too High | Startup Self-Test, Circuit Disconnect, Over Pressure / Blockage, External Power Indicator, Low Battery, Detect Spontaneous Breath, Device Temperature Too High, Excessive PEEP | All present |
| Weight [lbs] | 13.0 (Predicate) | 2.6 | 3.1 (Predicate) | 2.6 |
| Display/User Interface | Rotary Switches, LEDs, Graphic Display (Predicate) | Membrane Panel, LEDs, 7-Segment Displays, Increment/Decrement Buttons | Rotary Switch, LEDs (Predicate) | Membrane Panel, LEDs, 7-Segment Displays |
| Battery Duration | 3 hrs (internal pump) / 12 hrs (external gas) (Predicate) | 10 hrs @TV=600,RR=10,PEEP=5 | 5.5 hrs @TV=600,RR=10,PEEP=0 (Predicate) | 10 hrs @TV=600,RR=10,PEEP=0 |
| External Power Supply | Input: 90 – 265 VAC / 47 – 400 Hz | |||
| Output: 12 VDC (Predicate) | Input: 100 - 240 VAC / 50 - 60 Hz | |||
| Output: 16.8 VDC | Input: 100 - 240 VAC / 47 - 63 Hz | |||
| Output: 15 VDC (Predicate) | Input: 100 - 240 VAC / 50 - 60 Hz | |||
| Output: 16.8 VDC |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing rather than studies involving human subjects or real-world data.
- Sample Size: Not specified in terms of numerical units like "cases" or "patients." The testing involved "a complete set of performance testing to the device specifications" and "comparative bench testing to the predicate."
- Data Provenance: Not applicable in the traditional sense of clinical data. The data is generated from non-clinical bench testing performed by the manufacturer, AutoMedx, Inc. The nature of this testing does not involve country of origin in the context of patient data. It is prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for bench testing is established by the device's technical specifications and the performance of the predicate device. It does not involve expert image interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human readers or interpretation where adjudication would be necessary. Performance is measured against engineering specifications and comparison to the predicate's technical characteristics.
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 MRMC comparative effectiveness study was done. This medical device (a ventilator) is not an AI-assisted diagnostic or interpretive tool where human reader performance would be a primary metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary evaluation involved standalone bench testing of the device's performance against its specifications and comparison to predicate devices' technical characteristics. This is an "algorithm only" performance (referring to the device's internal software controlling ventilation parameters), without a human in the loop for interpreting the device's output in the way one would for an AI diagnostic tool. Instead, the device itself delivers the therapy.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on:
- Device specifications: The SAVe II™ and SAVe II™ Basic were tested to ensure they met their own predefined performance requirements.
- Predicate device characteristics: The performance of the SAVe II™ models was compared against the known characteristics and performance of the predicate devices (Impact Instruments - Uni-Vent Model 754 - K931473 and AutoMedx - SAVe™ - K071221). Substantial equivalence was claimed if the device performed comparably or better (e.g., in terms of battery life or alarms).
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set" in the context of data-driven model development. The device's operation is based on pre-programmed logic and control algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).