(426 days)
The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids.
The BIOTEO Drainage Catheter Set (Seldinger Type), BT-PDS-series percutaneous drainage catheter with hydrophilic coating, are percutaneous drainage catheters used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a pigtail or close loop and drainage holes.
The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator should use Seldinger Technique to provide access.
The document is a 510(k) summary for the BIOTEQ Drainage Catheter Set (Seldinger Type), K210419. This document pertains to a medical device (catheter set) and not an AI/ML powered device. As such, information regarding AI/ML specific criteria such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and not present in the provided text.
Therefore, I cannot provide a response for the requested information as it is not contained in the provided document. The document describes non-clinical performance data for substantial equivalence with a predicate device, focusing on sterilization, shelf-life, biocompatibility, and general performance testing against various ISO and ASTM standards.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.