(29 days)
Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
The proposed Multipurpose Drainage Catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has as a pigtail configuration. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and a Trocar.
This 510(k) summary (K111315) describes a Multipurpose Drainage Catheter. The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CAD/software device (e.g., performance metrics like sensitivity, specificity, AUC).
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices. For a physical medical device like a catheter, "performance data" typically refers to engineering tests and biocompatibility, not clinical efficacy studies with specific performance metrics against a ground truth.
Here's how to interpret the available information in the context of your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or report device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) because this is a physical medical device, not a diagnostic or AI-driven one.
The "performance data" mentioned in section H refers to:
- Results of performance testing: These would typically involve engineering tests to ensure the catheter meets design specifications related to strength, flexibility, flow rates, durability, etc. The document states these "demonstrate safety and effectiveness of the proposed device and substantial equivalence."
- Biocompatibility testing: Performed in accordance with ISO 10993-1, which "demonstrate the proposed device is acceptable for its intended use."
Table of Acceptance Criteria and Reported Device Performance (as applicable for this device type):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Safety & Biocompatibility: Device materials are non-toxic, non-irritating, and suitable for human contact. | Biocompatibility testing performed per ISO 10993-1 demonstrated the proposed device is acceptable for its intended use. |
| Functional Performance: Catheter's physical properties (e.g., flexibility, strength, flow, pigtail formation) meet design specifications and are comparable to predicate devices. | Results of performance testing demonstrate safety and effectiveness of the proposed device and substantial equivalence to predicate devices. (Specific quantitative results are not provided in this public summary). |
| Sterility: Device can be terminally sterilized and maintain sterility until use. | (Implied by medical device regulations and 510(k) process, but not explicitly detailed in this summary.) |
| Ease of Use/Design Features: Design allows for intended drainage function and connection to fluid collection. | Device consists of a flexible tube with open distal tip, drainage holes, lubricious surface, pigtail configuration, and a Luer lock hub for connection to a fluid collection device. Accessories include stiffening cannulas and a trocar, similar to predicate devices. |
Other Information:
Given the nature of this physical medical device and the type of 510(k) submission, the following information is not applicable or not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable for engineering and biocompatibility testing. There isn't a "test set" of clinical cases in the way there would be for an AI device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical interpretation is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/CAD/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical integrity, material properties, and biocompatibility, verified by engineering standards and lab tests.
- The sample size for the training set: Not applicable (no training set for a physical device).
- How the ground truth for the training set was established: Not applicable.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.