(261 days)
The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours.
The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules.
The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the patient's breathing circuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport.
The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors.
The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only.
The Bluepoint Medical disposable Airway Gas Sampling Products offered in this submission are specified for use with compatible GE Healthcare side stream respiratory gas modules and patient monitors utilizing these modules.
The Airway Gas Sampling Products include two product series:
- . Disposable Airway Gas Sampling Sets with airway adapter and integrated side stream TPE gas sampling lines
- . Disposable Airway Adapter with female Luer Connector and without sample line
The Airway Gas Sampling Sets are offered in both Adult/Pediatric and Infant airway sizes. Two lengths of the Adult/Pediatric size are offered: 3m/10ft, and 2m/7ft. The Infant size is offered in 2m/7ft.
The Airway Gas Sampling Sets are constructed with the following features:
- . Rigid clear medical grade plastic airway adapter designed for connection to patient breathing circuit
- . TPE (thermoplastic elastomer) gas sampling lines with moisture management properties that support their specified use duration of up to 72 hours
- . Molded male Luer connector for attachment to GE Healthcare respiratory gas modules
The Airway Adapter without sample line is offered in an Adult/Pediatric size, and includes a molded female Luer connector for attachment of a clinician-selected gas sample line.
All devices are disposable and labeled for single patient use.
The provided text describes the acceptance criteria and the studies performed for the Bluepoint Medical Airway Gas Sampling Products, but it does not contain information typically associated with AI/ML device studies, such as training sets, test sets, expert adjudication, or MRMC studies. This is a medical device clearance, not an AI/ML software clearance.
Based on the document, here's the information regarding the acceptance criteria and a detailed description of the studies:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | The devices met the acceptance criteria for biocompatibility and acceptable risk, as evaluated against ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 18562-1, ISO 18562-2, ISO 18562-3, and a comprehensive inhalation risk assessment in accordance with ISO 10993-17. |
| Performance Testing (Accuracy) | For CO2 and O2, total system response time (per ISO 80601-2-55) was |
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).