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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 < 45°. | All acceptance criteria were met. Pass |
| MR Testing: Magnetically Induced Torque | Per ASTM F2213-06⁶ (2011). $\tau_{mag} < \tau_{grav}$. | All acceptance criteria were met. Pass |
| MR Testing: Electrical Conductivity | <1 S/m. | All acceptance criteria were met. Pass |
| MR Testing: MR Image Artifacts | Per ASTM F2119-07⁷ (2013). (For information only; no specific acceptance criteria given, implies it was evaluated and data collected). | All acceptance criteria were met. Pass |
| Sterile Barrier - Package Integrity Testing: Peel Strength (Time zero and post-aging) | Per ASTM F88/F88M-15⁸. The peel strength of the pouch seal is ≥ 1.2N/15mm seal width. | All acceptance criteria were met. Pass |
| Sterile Barrier - Package Integrity Testing: Bubble Leak Test (Time zero and post-aging) | Per ASTM F2096-11⁹. No stream of bubbles released from outer pouch during leak testing. | All acceptance criteria were met. Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
The document primarily describes bench testing and biocompatibility testing. For these types of tests, individual samples of the device components or finished product are used.
- Sample Size: Not explicitly stated as a single number across all tests. Each test would have its own sample size, typically a small number of devices or components to demonstrate compliance with specifications. For example, "the test article" for resistance to collapse, flow rate, and leakage implies individual units were tested.
- Data Provenance: The device manufacturer is Cook Ireland Ltd. The testing was performed as per Cook Ireland's design control system and in line with 21 CFR 820.30, including FDA recognized standards. This indicates the testing was conducted internally or by a contracted lab on behalf of Cook Ireland, likely in Ireland. This is prospective testing, as it's directly conducted to demonstrate the performance of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to the type of studies described. The "ground truth" for bench tests and biocompatibility is established by objective measurements and standardized protocols (e.g., measuring force, flow rate, or observing cellular reactions), not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are not clinical trials or image interpretation studies requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed and is not mentioned in the document. The submission focuses on substantial equivalence based on technological characteristics and non-clinical performance data (bench and biocompatibility testing).
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not performed. This device is a physical medical device (catheter set), not an AI algorithm. Therefore, "algorithm only performance" is irrelevant.
7. Type of Ground Truth Used
- Objective Measurement/Standardized Protocols: The "ground truth" for the performance criteria is defined by the objective quantitative or qualitative measurements specified in the referenced international standards (e.g., ISO, ASTM, EN, JIS) and Cook Ireland's design parameters. For biocompatibility, the ground truth is the biological response observed according to the specific test methods outlined in ISO 10993.
8. Sample Size for the Training Set
- This information is not applicable. The document describes a traditional medical device (catheter set) where performance is established through physical and biological testing, not through machine learning or AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as point 8.
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