(127 days)
Codman® BACTISEAL® EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
CODMAN® HAKIM® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The CODMAN® BACTISEAL® Catheter Set and CODMAN® BACTISEAL® EVD Catheter Set are radiopaque catheters packaged with components to facilitate placement and use of the catheters. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.
The provided text from K102589 does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a typical AI/software device would.
This 510(k) submission, K102589, is for a series of physical medical devices (catheters) that are part of shunt systems. The primary purpose of this particular submission is to request a reduction in the frequency of pyrogen testing, not to demonstrate new performance characteristics of the device itself. The document explicitly states:
"The subject of this change is not related to a change to the devices but rather a reduction in the frequency of pyrogen testing; therefore, the technological characteristics of the proposed device are exactly the same as the predicated devices."
And under "Performance Data":
"Control of endotoxin testing has been demonstrated through design and manufacturing controls as demonstrated by the process risk analysis. There were no changes to the device."
Therefore, I cannot provide the requested information for acceptance criteria and a study to prove the device meets acceptance criteria, as this information is not present in the given document. The document describes a regulatory change related to testing frequency for an existing device, not a performance study for a novel device or AI component.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).