(29 days)
The CATHTONGTM II PICC Catheter is intended for short or long-term peripheral access to the central yenous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 3.0 mL/sec for 3F and 5.0 mL/sec for 4F single lumen catheters. The maximum pressure of power injection with the CATHTONG™ II PICC Catheter may not exceed 325 psi. The CATHTONG™ II PICC Catheter is indicated for adult patients.
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The provided text is an FDA 510(k) clearance letter for the CATHTONG™ II PICC Catheter. It does not contain information about acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications as typically found in a clinical study report or a detailed summary of safety and effectiveness.
The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the catheter and provides specific maximum flow rates and injection limits for different catheter sizes (3F and 4F single lumen) and a maximum pressure of power injection (325 psi). These specifications look like they are part of the acceptance criteria that need to be met by the device.
To answer your request, a study proving the device meets these acceptance criteria would typically involve:
- Bench testing: To verify the flow rates and pressure limits under various conditions.
- Biocompatibility testing: To ensure the materials are safe for human contact.
- Sterilization validation: To confirm the sterility assurance level.
- Performance testing: To demonstrate the catheter's ability to maintain patency and integrity under simulated use.
- Clinical data (if required for substantial equivalence): This could involve a review of existing data of the predicate devices or, in some cases, limited clinical data if the technological characteristics are significantly different.
Since the provided text is only the FDA's clearance letter, these details are not available within the given document. Therefore, I am unable to fill out the table and provide the requested information about the study design, sample sizes, ground truth establishment, expert qualifications, or MRMC data.
The document only provides the following directly relevant to acceptance criteria, which appear to be performance specifications:
| Catheter Size | Maximum Flow Rate | Injection Limit Setting | Reported Device Performance |
|---|---|---|---|
| 3F Single Lumen | 3.0 mL/sec | 325 psi | 3.0 mL/sec (specified) |
| 4F Single Lumen | 5.0 mL/sec | 325 psi | 5.0 mL/sec (specified) |
| All Catheters | - | 325 psi | 325 psi (specified) |
All other requested information is not present in the provided text.
§ 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.”