(90 days)
To sample blood or administer drug solutions, blood products, and other fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
The subject catheter is a long term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to the central venous system. It is inserted into the vascular system through a spittable introducer catheter.
The provided text is a 510(k) premarket notification summary for a medical device (intravascular catheter). This type of document is a regulatory submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
The information you are asking for, such as acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications for ground truth, and specific performance metrics like sensitivity/specificity/accuracy, effect sizes for MRMC studies, or standalone algorithm performance, is typically not included in a 510(k) summary for this type of device.
510(k) summaries for devices like catheters often focus on:
- Technological characteristics and how they compare to a predicate device.
- Intended use and indications for use.
- Confirmation of substantial equivalence to an existing device.
- Physical characteristics of the device (materials, dimensions, etc.)
For a device like this intravascular catheter, the "study" demonstrating its safety and efficacy would typically involve:
- Bench testing: To ensure the catheter meets physical and mechanical specifications (e.g., tensile strength, flow rates, material compatibility).
- Biocompatibility testing: To ensure the materials are safe for contact with the human body.
- Sterilization validation: To ensure the device can be consistently sterilized.
- Comparison to the predicate device's established performance.
Therefore, I cannot extract the detailed information requested in your prompt (Table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types) from the provided text because it is not present in a 510(k) summary for this particular device.
The document specifically states: "The proposed catheter differs from the FIRST PICC™ brand catheter in that the stylet and labeling have been modified." This indicates that the safety and efficacy are primarily established by its similarity to the predicate device, rather than detailed performance studies against specific acceptance criteria in the way you might see for an AI/diagnostic device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).