(90 days)
The CSI is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
The RCIS consists of a 5-7F spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch. Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Each introducer also has a radiopaque distal tip to aid the physician is correct placement of the device. The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.
The provided text does not contain information about acceptance criteria, device performance, or any studies involving test sets, training sets, or expert evaluations.
The document is a 510(k) summary for a Reinforced Catheter Introducer System (RCIS) and the FDA's clearance letter for the device. It focuses on establishing substantial equivalence to a predicate device, as required for 510(k) submissions.
Key information provided:
- Device: Reinforced Catheter Introducer System (RCIS) (5-7F)
- Manufacturer: Thomas Medical Products, Inc.
- Predicate Device: Thomas Medical Products, Inc., Reinforced Catheter Introducer System - K081341
- Comparison Basis: The submission states that the "technological characteristics of the device are identical to those of the predicate devices" and that they have "identical intended use / indications for use."
- Indications for Use: The RCIS is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
- Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Therefore, I cannot fulfill the request as the necessary data regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment are not present in the provided text. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) submission document.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).