(2 days)
- Pulmonary resuscitation during respiratory and/or cardiac arrest.
- Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
The Autovent 1000 is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve. This device is identical in terms of features to the Genesis® II Adult/Child resuscitator -510K #: K932170. The range of automatic settings of the device have been extended and chosen to provide the output requirements of the latest AHA recommendations and in the removal of the demand breathing function. An automatic/manual on/off control has been added which is separate from the frequency/volume control as in the predicate device. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO, which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
Below is a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific numerical acceptance criteria. However, it does state the standard against which the performance was evaluated.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit) | Reported Device Performance |
|---|---|---|
| Pneumatic Power | Requires compressed gas supply (air or oxygen) between 50 and 90 psi. | Device is pneumatically powered, requiring compressed gas supply of either air or oxygen and a regulated output between 50 and 90 psi. |
| Ventilation Mode | Automatic time-cycled ventilation. | Device is a time-cycled ventilator. |
| Automatic Settings | Range of automatic settings for tidal volume and frequency. | 12 pre-set automatic settings where both tidal volume and frequency are adjusted simultaneously. |
| Manual Control | Ability for operator to control patient's breathing parameters manually. | Manual button provided for operator to control patient's breathing parameters. |
| Over-pressure Protection | Over-pressure alarm with audible signal and venting. | Over-pressure alarm (pre-set to 60 cmH2O) provides audible signal and vents remaining tidal volume to atmosphere. |
| Performance Standard (Overall) | Performance within specifications of ISO 8382-1988 for automatic resuscitators. | Testing verified the Autovent 1000 performed within specification when compared to the predicate device and the ISO 8382-1988 standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in terms of number of patients or cases. Instead, it refers to "a significant amount of non-clinical test data." The data provenance is not specified beyond being "non-clinical test data," implying laboratory or bench testing. There is no mention of country of origin for this data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The "ground truth" for the test set appears to be the performance specifications outlined in the international standard ISO 8382-1988 and the performance of the predicate device (Genesis® II Adult/Child). There's no indication of clinical experts establishing ground truth for individual cases.
4. Adjudication Method for the Test Set
Not applicable. The performance was assessed against an international standard and a predicate device's specifications, not through adjudication by multiple experts on a test set of patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical testing and comparison to a predicate device's specifications and an international standard, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance assessment of the device itself. "Algorithm only" is not a direct fit as this is a mechanical device, but the testing performed evaluates the device's intrinsic mechanical performance without human intervention as part of the performance measurement, beyond operating it for the test.
7. The Type of Ground Truth Used
The ground truth used was:
- International Standard: ISO 8382-1988 for automatic resuscitators.
- Predicate Device Specifications: The performance characteristics of the GENESIS® II Adult/Child resuscitator (510K #: K932170).
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical resuscitator, not an AI or algorithm-based system that requires a "training set" in the conventional machine learning sense. The development likely involved engineering design and iterative testing, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The design and development would have been guided by engineering principles, industry standards (like ISO 8382-1988), and the functional requirements for a resuscitator, rather than by establishing ground truth from a data set for training an algorithm.
§ 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).