(175 days)
Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required.
Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve.
Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.
The provided text describes the acceptance criteria and a study demonstrating the Flexicare Single Use Resuscitator Bags meet these criteria by showing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting recognized standards and performance characteristics comparable to the predicate devices. The "Outcome" column in the table below indicates that the Flexicare device "Passed" each test, implying that it met the respective criteria.
| Test / Characteristic compared | Acceptance Criteria (or Standard Met) | Reported Device Performance (Outcome) |
|---|---|---|
| Visual inspection | Comparison test | Substantially equivalent |
| Valve Function after contamination with vomitus | BS EN ISO 10651-4:2009 | Pass |
| Mechanical shock - Drop testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Immersion in Water | - (Implied to meet performance of predicate / safety standards) | Pass |
| Supplementary Oxygen & Delivered Oxygen Concentration | - (Implied to meet performance of predicate / safety standards) | Pass |
| Expiratory Resistance | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required resistance range) | Pass |
| Inspiratory Resistance | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required resistance range) | Pass |
| Patient Valve Malfunction | - (Implied to meet performance of predicate / safety standards) | Pass |
| Tidal Volume - Minimum Delivered Volume | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required volume range) | Pass |
| Pressure Limitation - Pressure Relief Blow off | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required pressure) | Pass |
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Drop testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Extractables & Leachables | ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2009, ISO 10993-17:2009 | Pass |
| Tubing resistance to gas flow | BS EN 13544-2:2002+A1:2009 | Pass |
| Tensile strength – connector to tubing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Tensile strength – connector to O2 spout | - (Implied to meet performance of predicate / safety standards) | Pass |
| Resistance to kinking | - (Implied to meet performance of predicate / safety standards) | Pass |
| Accelerated Ageing | ASTM F1980 | Pass |
| Particulate Emissions | BS ISO 18562-2 2017 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices) used for each specific test in the "test set". However, it mentions "Verification tests were performed to establish the safety and efficacy of Flexicare's Adult Single Use Resuscitator Bag." and similarly for Pediatric and Infant versions. The tests would likely involve a statistically relevant number of devices to ensure reliability.
The data provenance is from Flexicare Medical Limited, United Kingdom. The study is retrospective in the sense that it compares the newly developed Flexicare device against existing, legally marketed predicate devices (Ambu SPUR II Adult, Pediatric, and Infant Single Patient Use Resuscitators) that have already been cleared by the FDA. The performance testing itself would be prospective for the Flexicare device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. Instead, the ground truth is established by objective measurements against recognized international standards and direct comparison of performance characteristics with legally marketed predicate devices.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method involving human reviewers for the test set. The validation relies on objective laboratory testing against predefined criteria and standards, and direct comparison of measured characteristics with those of predicate devices.
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. This type of study is typically associated with AI/CAD systems for image interpretation, which is not applicable to a manual resuscitator bag. The study is a non-clinical performance and biocompatibility evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone (algorithm-only) study was not done. This device is a manual medical device and does not involve any algorithms or AI for its operation.
7. The Type of Ground Truth Used
The ground truth used for this device's validation is based on:
- Recognized International Standards: Compliance with standards such as BS EN ISO 10651-4:2009, ISO 10993 series, ISO 5356-1:2004, BS EN 13544-2:2002+A1:2009, BS ISO 18562-2 2017, and ASTM F1980.
- Performance Specifications of Legally Marketed Predicate Devices: The performance characteristics (e.g., volume, resistance, force, dead space, stroke volume, pressure relief) of the Flexicare devices are compared directly to those of the Ambu SPUR II predicate devices. The goal is to demonstrate "substantial equivalence," meaning the new device performs as safely and effectively as the predicate.
- Objective Laboratory Measurements: The "Non-clinical Test Results" section explicitly states that "Verification tests were performed to establish the safety and efficacy" including visual inspection, dimensional inspection, internal volume, valve function, drop testing, immersion in water, oxygen concentration, resistances, valve malfunction, tidal volume calculation, O2 tube testing, conical connector compliance, biocompatibility, and particulate emission testing.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).