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510(k) Data Aggregation
(59 days)
This device is used for temporary endoscopic drainage of the pancreatic duct through the nasal passage by use of an indwelling catheter.
The Nasal Pancreatic Drainage Set consists of a drainage catheter, nasal transfer tube and drainage connecting tube. The drainage catheter has flaps, side ports and a touby-borst connector. The drainage catheter flaps are located at the distal end of the catheter. The flaps help prevent migration hereby helping the drainage catheter to remain in the desired position. The side ports, also located the distal end of the drainage catheter, these help assist in drainage of pancreatic fluid. The touhy borst connector allows connection of the drainage catheter to the drainage connection tube; it also allows the drainage catheter to be flushed. The drainage connection tube allows the drainage catheter to be connected to a drainage collection bag. In the middle of the drainage connecting tube is a three way stopcock; this allows a flow through the drainage connecting tube during the procedure. The nasal transfer tube enables the drainage catheter to be threaded through the oral cavity and out through the nostril. The drainage catheter contains radiopaque material which allows the user to ensure the drainage catheter is accurately positioned using fluoroscopically.
The provided document describes the acceptance criteria and performance data for the Cook Nasal Pancreatic Drainage Set (K171623), as determined through bench testing and biocompatibility evaluations.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility Evaluation | Conducted in accordance with FDA's "Use of International Standard ISO 10993-1" (June 16, 2016) and ISO 10993-1:2009. Includes Cytotoxicity, Intracutaneous, Sensitization, Acute Systemic Toxicity, Systemic Toxicity, 4-week muscle implantation, Genotoxicity (Mouse Lymphoma Assay), Genotoxicity (Bacterial Reverse Mutation Study). | Successfully completed (no specific pass/fail for each individual test reported, but overall conclusion is "successfully completed"). |
| Dimensional Verification & Simulated Use Testing (Time Zero and post-aging) | Dimensional verification as per the design parameters of the device. For simulated use testing, the device performs in line with the instructions for use. | All acceptance criteria were met. Pass |
| Drainage Catheter: Resistance to Collapse (Time Zero and post-aging) | Per EN 1617:1997¹. The test article does not collapse when exposed to a pressure not less than -10kPa for a period not less than 60 sec. | All acceptance criteria were met. Pass |
| Drainage Catheter: Flow Rate (Time Zero and post-aging) | Per EN 1618:1997². Minimum flow rate of 4 ml/min. | All acceptance criteria were met. Pass |
| Drainage Catheter: Tensile Testing (Time Zero and post-aging) | Per JIS T 3243³, EN 1618:1997², and EN 1617:1997¹. There shall be no breaks and cracks when subjected to a force of 4.9 N (5 Fr and 7 Fr catheters). Minimum force of 10N (7 Fr catheters). | All acceptance criteria were met. Pass |
| Leakage Testing | Per EN 1618:1997². At a test pressure of not less than 10kPa, there is no leakage from the test articles including their connection to a drainage collection bag. | All acceptance criteria were met. Pass |
| Radiopacity Testing | Per ASTM F640-12⁴. The drainage catheter is visible under fluoroscopy. Visibility of the Drainage catheter is equal to or greater than the visibility of the user-defined standard. | All acceptance criteria were met. Pass |
| MR Testing: Magnetically Induced Displacement Force | Per ASTM F2052-15⁵. Deflection Angle |
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