(179 days)
KIMVENT* MICROCUFF* Endotracheal Tubes for Adults are indicated for airway management by nasal or oral intubation of the trachea in adult patients.
The Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults are available in sizes 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0 mm. They are available as Magill and made with an ultra-thin polyurethane cuff, referred to as the MicroCuff*.
The provided text describes a 510(k) submission for the "Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults." It focuses on demonstrating substantial equivalence to a predicate device through bench testing.
Here's an analysis of the acceptance criteria and study information, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Claim/Benchmark) | Reported Device Performance |
|---|---|
| Superior tracheal seal for a wider range of trachea sizes and cuff sealing pressures compared to leading PVC cuffed tubes. | The Microcuff tube with its cylindrical shaped polyurethane cuff provides a superior tracheal seal for a wider range of trachea sizes and cuff sealing pressures compared to leading PVC cuffed tubes. (Stated as a claim, supported by benchtop testing.) |
| Reduce microaspiration by at least 95% when compared to the Covidien Hi-Lo PVC cuffed tube. | KimVent* Microcuff* Endotracheal Tubes reduce microaspiration by at least 95% when compared to the Covidien Hi-Lo PVC cuffed tube. (Stated as a claim, supported by benchtop testing.) |
| Reduce microaspiration by at least 93% when compared to the Covidien TaperGuard tube with a tapered PVC cuff. | KimVent* Microcuff* Endotracheal Tubes reduce microaspiration by at least 93% when compared to the Covidien TaperGuard tube with a tapered PVC cuff. (Stated as a claim, supported by benchtop testing.) |
| At 10 cm H2O cuff pressure, demonstrate less microaspiration compared to the Covidien TaperGuard tube. | At 10 cm H2O cuff pressure, the Microcuff* tube demonstrated 96% less microaspiration compared to the Covidien TaperGuard tube. (Stated as a claim, supported by benchtop testing.) |
| Perform the same function as the predicate device (Adult Cuffed ET Tubes; Standard cleared under K050803). | Bench testing has demonstrated that the modified Kimberly-Clark* KimVent* Microcuff* Endotracheal Tubes for Adults performs the same function as the predicate device. Functional test results met acceptance criteria. (General statement of equivalence and meeting acceptance criteria.) |
| Any minor differences between the modified device and the predicate device would have positive impact to safety or efficacy. | Bench testing has demonstrated that any minor differences between the modified device and the predicate device would have positive impact to safety or efficacy. (General statement of positive impact from differences.) |
| Safe and effective for use in humans. | Functional test results met acceptance criteria and demonstrate that the device is safe and effective for use in humans. (Conclusion based on functional tests.) |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "bench testing" and "benchtop testing" to support its claims. However, it does not specify the sample size used for these tests. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective) as it's a bench test, not a clinical study with human or animal subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As the testing appears to be purely mechanical/benchtop, it wouldn't typically involve experts establishing a ground truth in the same way a diagnostic algorithm (e.g., for radiology) would. The "ground truth" here would be the physical measurements and observations from the bench tests.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Bench testing generally does not involve adjudication methods like those used in clinical studies with human evaluators. The "adjudication" would be inherent in the standardized test methods and measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no MRMC comparative effectiveness study mentioned in this document. The device is a medical product (endotracheal tube), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an endotracheal tube, not an algorithm, so "standalone algorithm performance" is irrelevant.
7. The Type of Ground Truth Used
The ground truth for the "performance data" mentioned (tracheal seal, microaspiration reduction) was established through bench testing/experimental measurements. This involves controlled laboratory settings to quantitatively assess the physical characteristics and performance of the endotracheal tubes. It's based on objective, quantifiable data rather than expert consensus, pathology, or outcomes data in the traditional sense.
8. The Sample Size for the Training Set
There is no "training set" as this is a medical device (endotracheal tube) and not an AI/machine learning model that requires training data.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set mentioned or implied for this type of medical device submission.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).