(86 days)
The Mercury Medical Mini StatCO2™ End Tidal CO2 Detector is to provide a semi-quantitative visualization of the CO2 in the patient airway. 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.
The Mercury Medical Mini StatCO2™ uses the same technology as the Nellcor Pedi-CAP™ (K944400). The Mini StatCQ2™ End Tidal CO2 Detector is a "Single Patient Use" only device. The device assists in verification of tube placement during endotracheal or nasotracheal intubation. It may be used on intubated patients to detect approximate ranges of end tidal CO2 when clinically significant. The device consists of a housing unit made with material of polycarbonate, filter media consisting of 3M Filtrete GSB30 and Bregas C-it Indicator, 510(k) K000520 mounted to the housing.
The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics for the Mini StatCO2™ device.
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the Mini StatCO2™ is substantially equivalent to the predicate device, Nellcor Pedi-CAP™ (K944400), and shares the same technology and technical characteristics.
- Non-Clinical Data: The "Non-Clinical Data" section states that "Performance and specifications of the modified device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 -Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm." This indicates the device meets certain industry standards for physical characteristics, but not overall performance metrics like sensitivity or specificity for CO2 detection.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert details, or study methodologies as these details are not present in the provided text.
§ 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).