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510(k) Data Aggregation
(45 days)
KENDALL CO2NFIRM NOW CO2 DETECTOR
Used to assist verification of tube location during oral or nasal placement of a gastric tube in adults.
The Kendall CO2nfirm NOW™ CO2Detector is a disposable device that is used during the oral or nasal placement of a gastric tube to preliminarily determine if the tube is properly placed by detection of CO2
Based on the provided 510(k) summary for the Kendall C02nfirm NOW™ C02 Detector, here's an analysis of the acceptance criteria and supporting study information:
The Kendall C02nfirm NOW™ C02 Detector is a disposable device used to assist in the verification of gastric tube placement by detecting CO2.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria or specific performance metrics for the Kendall C02nfirm NOW™ CO2 Detector. Instead, it relies on demonstrating equivalence to predicate devices and meeting industry standards.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices (Easy Cap® CO2 detector, Pedi-Cap® CO2 detector) in technological characteristics, construction, materials, detector chemistry, and sensitivity. | The proposed device has the same technological characteristics as the predicate devices. "Both the proposed and predicate devices function by colorimetric detection of CO2 in air. The construction and materials of the devices, as well as the detector chemistry and sensitivity are identical between the proposed and predicate devices." |
| Adherence to industry accepted criteria for such devices as defined in EN1615:2000 and ISO 594, Parts 1&2. | "Testing was conducted to demonstrate that the design of the proposed device... met the industry accepted criteria for such devices as defined in EN1615:2000 and ISO 594, Parts 1&2." (No specific performance data against these standards is provided in the summary.) |
| Modified inlet/outlet ports to accommodate new intended use (gastric tube placement). | "The inlet and outlet ports of the proposed device have been modified to accommodate the new intended use." (Implied successful modification, no specific performance data given.) |
| Modified device printing to replace quantitative scale with qualitative (yes/no) scale. | "The device printing has been modified to replace the quantitative scale with a qualitative (yes/no) scale." (Implied successful modification, no specific performance data given.) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on a specific "test set" in terms of subject or patient data. The non-clinical testing described focuses on demonstrating design equivalence to predicate devices and adherence to industry standards for device construction and function. It does not mention a clinical study involving human subjects or patient data. Therefore, there's no information on sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set with human subjects or patient data is described, there is no mention of experts being used to establish ground truth in this context. The evaluation appears to be purely technical and comparative against existing devices and standards.
4. Adjudication Method for the Test Set
Given the absence of a clinical test set and expert review for ground truth, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance. The device is a diagnostic tool, not an AI-powered image analysis system.
6. Standalone Performance Study
The summary describes "Nonclinical Testing" conducted to demonstrate design equivalence and adherence to industry standards. This can be considered a form of standalone testing in the sense that the device itself was tested for its physical and functional characteristics. However, it's not a standalone clinical performance study in the way it's typically understood for diagnostic algorithms (e.g., performance metrics like sensitivity, specificity on a clinical dataset). The testing described is more about the intrinsic properties of the device (colorimetric detection, materials, construction) rather than its diagnostic accuracy in a clinical setting.
7. Type of Ground Truth Used
For the nonclinical testing, the "ground truth" implicitly used would be:
- Predicate Device Performance: The established functionality and performance of the Easy Cap® CO2 detector and Pedi-Cap® CO2 detector.
- Industry Standards: The requirements and specifications outlined in EN1615:2000 and ISO 594, Parts 1&2.
The summary does not mention pathology, outcomes data, or expert consensus in a clinical context as ground truth.
8. Sample Size for the Training Set
No training set is mentioned. This device is a passive, colorimetric CO2 detector, not a machine learning or AI-driven system that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable. The device's function is based on a well-understood chemical principle, not on learned patterns from a dataset.
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