(28 days)
The CATHTONG™ II PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrastration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 5.0 mL/sec for 5F dual 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.
Not Found
The provided document does not contain information about the acceptance criteria and study proving device performance in the context of an AI/ML powered device.
The document is an FDA 510(k) clearance letter for a medical device called the "CATHTONG™ II PICC Catheter." This is a physical, interventional medical device, not an AI/ML software device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC).
- Sample size for a test set or training set.
- Data provenance for AI/ML models.
- Number of experts used to establish ground truth for AI/ML.
- Adjudication methods for AI/ML ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone performance of an algorithm.
- Type of ground truth used for AI/ML training/testing.
The information in the document pertains to the regulatory clearance of a physical medical catheter, including its indications for use, maximum flow rates, and injection limits. These are performance specifications for a hardware device, not evaluation metrics for an AI/ML algorithm.
§ 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.”