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• Pulmonary resuscitation during respiratory and/or cardiac arrest.
• Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II BLS device. The device is totally pneumatic in its function therefore 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 CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore 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 CAREvent BLS* is an automatic time cvcled 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 Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate equivalent to that selected on the tidal volume/frequency control. 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 with a flowrate equivalent to that selected on the tidal volume/frequency control. 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.

The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of independent minute volume and frequency controls. adjustable pressure relief, 60/100% air/oxygen mix and the ability to select the manual flowrate with a flowrate equivalent to that selected on the minute volume control. An additional alarm feature has also been added to warn of low input pressure. 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, automatic frequency settings and 12 minute volume settings which are both adjusted 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 with a flowrate equivalent to that selected on the minute volume control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm (adjustable from 20 to 60 cmH20), which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.

The CAREvent ALS 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 Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/frequency control. 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 with a flowrate equivalent to that selected on the tidal volume/frequency control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. 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.

The provided text describes several medical devices, all named "CAREvent" followed by different designations (BLS, ALS, ATV). The common theme across all descriptions is that performance data was assessed based on non-clinical testing against the international standard ISO 8382-1988. The conclusion for each device states that "The testing undertaken verified that the CAREvent [Device Name], when compared with the performance of the device to which substantial equivalence is claimed, performed within specification."

Given the nature of the provided text (a 510(k) submission summary), detailed acceptance criteria in the format of specific numerical thresholds and performance metrics are not explicitly presented. Instead, it relies on demonstrating equivalence to predicate devices and compliance with an international standard.

Here's an attempt to structure the information based on the provided text, acknowledging the limitations inherent in these types of documents:

Acceptance Criteria and Study Details for CAREvent Resuscitators/Ventilators

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to predicate devices and compliance with a standard, rather than presenting specific numerical acceptance limits for performance parameters (e.g., tidal volume accuracy, frequency accuracy, pressure relief settings).

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify a numerical sample size for the test set. It broadly refers to "significant amount of non-clinical test data."
• Data Provenance: The testing was "non-clinical" and likely performed by or for the manufacturer (O-Two Systems International Inc. in Mississauga, Ontario, Canada). The data is retrospective in the sense that it's submitted after the testing was completed. The country of origin for the data is Canada (manufacturer's location) for the testing, referencing an international standard (ISO 8382-1988) which is not country-specific.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable: The studies described are non-clinical, likely bench testing or engineering verification. There is no mention of expert-established ground truth in the context of human physiological data or interpretations. The "ground truth" here would be the specified performance parameters of the device and the requirements of the ISO standard.

4. Adjudication Method for the Test Set

• Not Applicable: Given the non-clinical nature of the testing, an adjudication method for a test set (e.g., clinical outcomes, image interpretation) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No: The document does not mention any clinical studies involving human readers or comparative effectiveness studies with or without AI assistance. The testing is non-clinical.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes (Implied): The "assessment of performance data" is implicitly a standalone evaluation of the device's technical specifications and functionality against a standard and a predicate, without human-in-the-loop performance being a primary measure. The devices are pneumatic and mechanical, not algorithmic in the modern AI sense.

7. The Type of Ground Truth Used

• Engineering Specifications and International Standards: The ground truth for this device's performance is based on its engineering design specifications, the functional requirements outlined for resuscitators/ventilators, and the specific requirements of the international standard ISO 8382-1988. The performance of the legally marketed predicate devices also served as a reference point for equivalence.

8. The Sample Size for the Training Set

• Not Applicable: These are mechanical/pneumatic devices, not AI/machine learning algorithms. Therefore, there is no "training set" in the computational sense. The design and development process for such devices would involve iterative testing and refinement, but not a distinct "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: As there is no training set, this question is not relevant. The device design and manufacturing processes are validated against engineering principles and regulatory standards.

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