(119 days)
The Chartis System is indicated for use by bronchoscopists during a diagnostic bronchoscopy in adult patients in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is a re-useable piece of capital equipment that displays the patient information.
The Chartis™ Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Catheter lumen during spontaneous respiration.
The provided document, K111522 for the Chartis Catheter, is a Special 510(k) submission. Special 510(k)s are used for modifications to a manufacturer's own legally marketed device where the modification does not affect the intended use or alter the fundamental scientific technology of the device.
Therefore, the "acceptance criteria" and "study" described in such a submission typically focus on demonstrating that the modifications to the device do not raise new questions of safety or effectiveness and that the modified device performs equivalently to the predicate device. It is not a study to prove initial clinical effectiveness or diagnostic accuracy in the way an AI/ML device might be evaluated.
Based on the provided text, here's a breakdown of the information requested, with an emphasis on what's available and what's not for a Special 510(k):
1. A table of acceptance criteria and the reported device performance
The document states: "Verification and validation test results support the performance characteristics of the modified device and show equivalence to the currently marketed predicate device."
This implies that the acceptance criteria for this Special 510(k) were based on demonstrating equivalence of the modified device to the predicate device in terms of performance characteristics. Specific quantitative criteria and detailed performance results are not provided in this summary. Instead, the general conclusion is that the modified device meets the implied acceptance criteria of equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a Special 510(k) focused on minor material, packaging, and shelf-life changes, the "test set" would likely refer to engineering and bench testing rather than a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided. This 510(k) is not about diagnostic accuracy where expert ground truth would be established. It's about demonstrating that modifications to an existing device (Chartis Catheter) do not negatively impact its performance or raise new safety/effectiveness concerns.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies for diagnostic devices to establish ground truth or resolve discrepancies, which is not the purpose of this Special 510(k).
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
This information is not applicable and therefore not provided. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and therefore not provided. This 510(k) is not about establishing ground truth for a diagnostic condition but rather confirming equivalence of the modified catheter to its predicate.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is a physical medical device (catheter), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As above, this is a physical device, not an AI/ML algorithm requiring a training set with established ground truth.
In summary, for K111522 Chartis Catheter (a Special 510(k)):
The core of this submission is demonstrating that minor changes to materials, packaging, and shelf-life of the Chartis Catheter do not raise new types of safety or effectiveness questions and that the modified device remains substantially equivalent to its predicate. The "performance data" refers to verification and validation tests for these modifications, not a clinical study to establish diagnostic accuracy or clinical effectiveness against a "ground truth" in the way an AI/ML device would. The detailed specifications of these tests (e.g., sample size, specific criteria, methodologies) are not included in this summary document but would have been part of the full 510(k) submission.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).