(268 days)
Use to assist verification of tube placement during endotracheal intubation. Use on intubated patients to detect approximate ranges of end-tidal CO2 when clinically significant.
The subject device, when connected between an endotracheal tube and a breathing device, detects approximate ranges of end-tidal CO2 by color comparison in patients. The detector may be used during patient transport or in any location where intubations are performed. It may be used for up to 2 hours. The subject device is non sterile and is intended for single use.
The provided text describes the 510(k) summary for the Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector and Nellcor™ PEDCICAP Pediatric Colorimetric CO2 Detector. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a full-fledged study as would typically be done for a novel device or AI/ML-based diagnostic.
Therefore, many of the requested elements (like a test set sample size, expert consensus for ground truth, MRMC study, effects size of human readers, training set details) are not applicable (N/A) because the submission relies on bench testing and biocompatibility testing to establish substantial equivalence by comparing the device's characteristics to a legally marketed predicate, rather than a clinical performance study with human subjects interpreting results.
Here's how the available information maps to your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance are primarily that its technological characteristics are comparable to a predicate device and that any differences do not raise new questions of safety or effectiveness. The reported "performance" is demonstrated through bench testing and biocompatibility.
| Criterion Type | Acceptance Criteria (Bench Test/Spec) | Reported Device Performance (as per comparison table and summary) |
|---|---|---|
| Intended Use | Similar to predicate: To detect approximate ranges of end-tidal CO2. | Same as predicate. |
| Indications for Use | Similar to predicate: Assist verification of tube placement during endotracheal/nasotracheal intubation; detect approximate ranges of end-tidal CO2 when clinically significant on intubated patients. | Similar to predicate. |
| Patient Population | Nellcor™ EASYCAP II: Patients > 15 kg (33 lb). | |
| Nellcor™ PEDCICAP: Patients 1-15 kg (2.2-33 lb). (Predicate: 1-15 kg). The adult device (EASYCAP II) has a different patient population than the predicate (Pedi-CAP pediatric). | Nellcor™ EASYCAP II: Different (Adult). Justification: Intended for adult patients. | |
| Nellcor™ PEDCICAP: Same as predicate. | ||
| Duration of Use |
§ 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).