(59 days)
Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.
Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.
The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).
The provided text is a 510(k) Summary for the Exodus Drainage Catheters. This document details the substantial equivalence of new drainage catheters to previously marketed predicate devices. It focuses on device description, intended use, technological characteristics, and performance data to demonstrate safety and effectiveness.
However, it does not include the type of study that would typically generate acceptance criteria and performance metrics for a diagnostic AI device. The document describes physical and chemical performance tests for a physical medical device (catheter), not a digital or AI-based diagnostic tool.
Therefore, I cannot fulfill your request for specific acceptance criteria and study details related to an AI device's performance based on the provided text. The information required (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not available in this type of FDA submission for a catheter.
Here's how I would describe the current information, acknowledging its limitations for an AI device:
Based on the provided K152069 510(k) Summary for the Exodus Drainage Catheters, the device is a physical medical device (catheter), not an AI-based diagnostic tool. Therefore, the information requested regarding acceptance criteria and study details for an AI device's performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not applicable or available in this document.
The document details performance testing for the physical attributes and biological compatibility of the catheter.
1. Table of Acceptance Criteria and Reported Device Performance (for a physical catheter):
The 510(k) summary lists the types of performance tests conducted for the Exodus Drainage Catheters to demonstrate substantial equivalence to a predicate device (K093392). While specific quantitative acceptance criteria and detailed reported performance values are not explicitly stated in this high-level summary, the document indicates that the results "demonstrate safety and effectiveness of the proposed device and substantial equivalence."
| Acceptance Criteria Category | Types of Performance Testing Reported | General Outcome (as stated in document) |
|---|---|---|
| Material Properties & Strength | Tensile Testing | Demonstrated safety and effectiveness |
| Device Integrity | Catheter Surface, RO Marker Band Scrape Test, Fluid Leak Testing, Aspiration Strength, Catheter Column Strength, Suture Force to Pigtail | Demonstrated safety and effectiveness |
| Visibility & Functionality | Radiopacity Testing, Flow Rate Testing, Coating Lubricity, Pigtail Diameter | Demonstrated safety and effectiveness |
| Biocompatibility | Biocompatibility Testing per ISO 10993-1 | Acceptable for its intended use |
| Compatibility | Catheter Compatibility | Demonstrated safety and effectiveness |
2. Sample size used for the test set and the data provenance: Not applicable. This summary describes physical testing of devices, not a study involving a "test set" of patient data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for patient images/data is not relevant to the physical and biological testing of a catheter.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving reader adjudication of diagnostic output.
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: Not applicable. This document pertains to a physical medical device (catheter) and does not describe an AI system's performance or human-AI interaction.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device and testing. The "ground truth" for catheter performance relates to established engineering standards, material specifications, and biological safety standards (e.g., ISO 10993-1).
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
§ 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.