(266 days)
The Maxtec MaxCap Neo and MaxCap Ped are indicated to provide a semi-quantitative visualization of the CO2 in the patient airvay. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg
Environment of Use: Hospital, sub-acute, pre-hospital, transport.
The proposed MaxCap Neo and MaxCap Ped are comprised of several components:
- . Housing with standard 15 mm / 22 mm fittings to connect to the ventilator assist device and a face mask or endotracheal tube
- . Colorimetric litmus media which has been treated with chemical to detect the presence of CO2 by a change in pH
The Maxtec MaxCap Neo and MaxCap Ped devices are semi-quantitative CO2 detectors that use a colorimetric, pH-sensitive dye to visualize CO2 in a patient's airway. The devices are intended for use as an adjunct in patient assessment.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric, but rather lists specifications and performance data for the proposed devices and compares them to predicate and reference devices. We can infer the acceptance criteria from the context of these comparisons and discussions of "similar" or "lower" than predicates.
| Feature / Acceptance Criteria (Inferred) | Reported Device Performance (MaxCap Neo and MaxCap Ped) |
|---|---|
| Color change accuracy | Tested and performed |
| Color change response time | Tested and performed |
| Drop test | Tested and performed |
| Duration of Use | Up to 6 hours |
| Flow Resistance / Back Pressure | MaxCap Neo: 5.0% CO2 - Yellow |
| Means of communicating meaning of color changes | Matching Colored Label on the Outside of the device |
| Means of detecting patient exhalation | Color change |
| Breathes to effect color change |
§ 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).