(363 days)
Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla.
Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla. The products will be available in single and dual lumen configurations, as sterile individual units or in trays along with the components used for insertion.
The provided text describes a medical device, the MIDMARK™ Midline Catheter, and its summary of safety and effectiveness information for FDA clearance (K951620). However, it does not contain any information about acceptance criteria, device performance, sample sizes, expert ground truth, or any clinical studies.
The document focuses on:
- Device identification: Classification name, common name, proprietary name.
- Regulatory information: Establishment registration, classification, substantially equivalent devices.
- Device description: Function, insertion method, optimal tip location, configurations.
- Component specifications: Identical to a previously cleared device (Centermark K920828).
- Performance standards: States "No performance standards have been established by the FDA."
- Packaging and sterilization: Methods used.
- Biocompatibility testing: LAL procedure for non-pyrogenicity.
Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, expert ground truth details, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or training set information.
This document is a regulatory submission summary primarily focused on establishing substantial equivalence to previously cleared devices, not a scientific study report detailing performance data against specific acceptance criteria.
§ 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).