(234 days)
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood products, drug administration and blood sampling.
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is composed of a peripherally inserted central venous catheter, obturator, wire guide, Peel-Away® introducer, access needle, syringe, catheter securement device, thumb scalpel, drape, and tape measure. Additional set configurations may also include a dilator, gauze, Lidocaine, Monoject needles, and other convenience accessories. The catheter is available in a single (3.0, 4.0, 5.0 French) or dual lumen (7.0 French) configuration with lengths of 50 and 60 centimeters. The catheter shaft is manufactured from silicone radiopaque tubing, which is connected to a silicone winged manifold. Proximally, the winged manifold is attached to one or two silicone extension tubes with a pre-molded acetal hub. Additionally, removable polypropylene clamps are attached to each extension tube. The obturator is manufactured from stainless steel and has a hydrophilic coating. It is designed to fit in the catheter and is manufactured with a proximal Luer hub that can be locked into the proximal hub of the corresponding catheter. The wire guide is manufactured with either stainless steel or a nitinol mandril with a platinum tip. The introducer is composed of a radiopaque tetrafluoroethylene (TFE) Peel-Away® sheath and a polyethylene dilator matched for transitional fit. The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is sterilized by ethylene oxide and intended for one-time use.
The provided text describes a 510(k) premarket notification for a medical device and evaluates its substantial equivalence to predicate devices, rather than presenting a study proving a device meets acceptance criteria for an AI or imaging diagnostic tool. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or cannot be extracted from this document.
However, I can provide the acceptance criteria and performance data for the physical device based on the bench testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Silicone Peripherally Inserted Central Venous Catheter Set/Tray) |
|---|---|
| Catheter Tensile Testing (per applicable ISO standards) | Met the acceptance criteria. |
| Catheter Liquid Leakage | Catheters did not leak. |
| Catheter Air Leakage (per BS EN ISO 10555-1) | Catheters met the air leak requirements. |
| Catheter Kink Radius (flow rate impact during kinking) | Flow rate was not impacted. |
| Catheter Gravity Flow Rate | Catheters have an acceptable flow rate for the clinical application. |
| Catheter Radiopacity | Devices are visible in the radiographic image. |
| MR Testing (per ASTM F2503) | Catheters are MR Conditional. |
| Dimensional Verification | Test specimens' dimensions are within specified tolerances, and markings are clearly marked on shrink tube. |
| PICC Set Components Compatibility | PICC set components are compatible. |
| Obturator Corrosion (per Annex B of ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Obturator Hub-to-Wire Tensile | Devices met the acceptance criteria. |
| Wire Guide Corrosion (per Annex B of ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Wire Guide Tensile (per BS EN ISO 11070:2014, Annex H) | Predetermined acceptance criteria were met. |
| Wire Guide Fracture (per Annex F of BS EN ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Wire Guide Flex (per Annex G of BS EN ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Peel-Away Introducer Hub-to-Shaft Tensile | Devices met the acceptance criteria. |
| Biocompatibility (per ISO 10993-1 and FDA guidance - cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility) | Demonstrated biocompatibility. |
| Sterilization Validation (per ISO 11135-1:2007, BS EN 556-1:2001) | Established method used to validate the sterilization cycle is consistent; complies with BS EN 556-1:2001. |
| Sterility Assurance Level (SAL) | 10-6 |
| EO Residual Level (per ISO 10993-7:2008) | EO (Average Daily Dose): ≤ 4 mg; ECH (Average Daily Dose): ≤ 9 mg |
| Bacterial Endotoxin Test Method (LAL) | Maximum testing limit being 20 EU/device (recommended for blood contacting devices). |
| Shelf-Life (three-year equivalency by accelerated methods) | Successful testing of performance characteristics on devices aged to a minimum of three-year equivalency. |
Details Not Applicable or Not Provided in the Document:
- Sample size used for the test set and the data provenance: The document refers to "test specimens" for bench testing, but specific sample sizes for each test are not provided. The data provenance is Cook Incorporated's internal testing. This is not clinical data, but rather engineering and materials testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes physical device testing, not a diagnostic or AI-driven medical device requiring expert ground truth for a test set.
- 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. This is not an AI or diagnostic imaging 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): For the physical device performance tests, the "ground truth" refers to established engineering standards (e.g., ISO, ASTM, BS EN) and their respective acceptance criteria.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”