(88 days)
The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis.
The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.
The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients.
This 510(k) submission (K974642) is for a medical device called the COMBICATH Catheter, which is a physical device for sampling bronchoalveolar secretions, not an AI or software-driven diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable.
The performance described is purely related to functional and safety testing of a physical device.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Results) |
|---|---|
| Functionality of the device under conditions similar to normal usage | Successful |
| Conformance to product specifications | Successful |
| Safety of the device | No issues raised regarding safety |
| Effectiveness of the device | No issues raised regarding effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a quantitative "sample size" in terms of number of catheters or patients for the functional and safety testing. It mentions "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." The data provenance is not explicitly stated but implies testing conducted by the manufacturer, Plastimed Laboratoire Pharmaceutique, as part of their product development and regulatory submission. It is likely prospective testing related to device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a physical device. Ground truth as typically understood for diagnostic AI (e.g., presence or absence of a disease) is not relevant here. The "ground truth" during testing would be whether the device physically functioned as intended and met specifications.
4. Adjudication Method for the Test Set
Not applicable. This is a physical device. Adjudication methods are typically used for evaluating human or AI interpretations of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the functional and safety performance of a physical sampling catheter, not on the interpretation of medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing was its functional performance and adherence to engineering specifications. This includes successful capture of bronchoalveolar secretion samples, material compatibility, and overall device integrity during simulated use, as well as meeting manufacturing and design specifications.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.