(70 days)
The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation and the VentriClear® II Ventricular Drainage Catheter have been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
The VentriClear® Ventricular Drainage Catheter Set with Cook® Spectrum® Antibiotic Impregnation consists of a VentriClear® Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closed-end configuration with 16 standard and 16 small sideports. The VentriClear® Ventricular Drainage Catheter has markings at 1 cm increments to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.
The VentriClear® II Ventricular Drainage Catheter consists of a VentriClear® II Ventricular Drainage catheter and other components that are used to facilitate the procedure. The VentriClear® II Ventricular Drainage Catheter is a 9 French catheter designed with a radiopaque tip which aids in radiographic recognition and has a closedend configuration with 16 sideports. The VentriClear® II Ventricular Drainage Catheter has markings at 1 cm increments, starting at the 3 cm mark and extending to 33 cm, to aid in determining depth and ease of placement and is 33 cm in length. The VentriClear® II Ventricular Drainage Catheter consists of silicone elastomer impregnated with the antimicrobial agents minocycline and rifampin.
The provided text describes Cook Incorporated's VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation and VentriClear II Ventricular Drainage Catheter. This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously marketed predicate devices.
However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or any other quantifiable performance indicators.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Spectrum® Ventricular Catheter K011812 and VentriClear® II Ventricular Drainage Catheter Set K071640) by comparing device characteristics and indications for use. The only difference noted is the addition of a contraindication for use in pregnant women for both the VentriClear and VentriClear II catheters.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this type of information is not present in the provided text.
The document explicitly states under "Nonclinical Testing": "There were no device changes, so no additional testing was required to support the determination of substantial equivalence to the predicate devices." This further confirms that a new performance study to establish acceptance criteria was not conducted or reported in this submission.
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).