(150 days)
The SPECTRUM® Ventricular Catheter is intended 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 device will be supplied sterile and is intended for one-time use.
The SPECTRUM® Ventricular Catheter is a 9 Fr catheter nominally 33 cm in length. The catheter has a closed-end configuration with nominally 16 sideports, and has markings at 1 cm increments to aid in determining depth of placement. The SPECTRUM® Ventricular Catheter is impregnated with an antimicrobial combination of minocycline and rifampin which may reduce the risk of catheter related infection during use. Based on HPCC analysis, the average amount of minocycline on the catheter is approximately 5 mg (159 Φg/cm), and the average amount of rifampin on the catheter is approximately 4 mg (116 @g/cm). Components supplied with the SPECTRUM® Ventricular Catheter include a pre-loaded stainless steel stylet, a stainless steel tunneling trocar, and proximal fittings, which are included to facilitate placement and use of the Ventricular Catheter.
The SPECTRUM® Ventricular Catheter is a medical device intended for short-term external drainage of fluid from the ventricular cavity of the brain to relieve elevated intracranial pressure or fluid volume. The information provided outlines the device's characteristics, intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices and ensure its safety and efficacy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state numerical acceptance criteria in a typical "Pass/Fail" format. Instead, it describes various tests and a clinical study designed to demonstrate that the SPECTRUM® Ventricular Catheter performs as intended and is as safe and effective as predicate devices. The "reported device performance" is essentially the successful completion of these tests and the favorable outcomes of the clinical study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Successfully passed Dermal Sensitization, Cytotoxicity, 7 Day Muscle Implantation with Histopathology, Intracutaneous Toxicity, Systemic Toxicity, Hemolysis, Genotoxicity, and a Two Week Brain Implantation Study. |
| Physical Performance | Successfully passed physical performance testing. |
| Antimicrobial Efficacy | Successfully passed HPLC analysis, zone of inhibition testing, and susceptibility testing. |
| Clinical Efficacy (Reduced Catheter-related Infection) | In a clinical study, the SPECTRUM® Ventricular Catheter group showed a significantly lower incidence of catheter-related infection (1.3%) compared to the standard non-coated catheter group (6.8%) (p |
§ 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).