(21 days)
Codman® BACTISEAL® EVD Catheter Set and Codman® BACTISEAL® Clear EVD Catheter Set are 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.
The CODMAN® BACTISEAL® EVD Catheter Set and CODMAN® BACTISEAL® Clear EVD Catheter Set are 1.9 mm inner diameter ventricular catheters packaged with components to facilitate placement and use of the ventricular catheter. Both products 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 describes a 510(k) submission for the CODMAN® BACTISEAL® EVD Catheter Set and CODMAN® BACTISEAL® Clear EVD Catheter Set. This submission asserts substantial equivalence to a predicate device and relies on bench testing. The information required for a detailed study description of acceptance criteria for a medical AI/CADe device is not present in this document because the device is not an AI or CADe device. Instead, it is a physical medical device (catheter set).
Therefore, I cannot provide the requested information in the format specified because the device and its submission process do not align with the typical evaluation strategies for AI or CADe systems.
Specifically, the document states:
- "Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device."
- "All test results demonstrated the substantial equivalence of the product to the commercially distributed devices for the same intended use."
- "The technological characteristics of the proposed device are the exact same as the predicate device."
This indicates that the "study" for this submission was bench testing, focused on verifying the physical and functional aspects of the catheter set to demonstrate its equivalence to a previously approved device. There is no mention of AI, CADe, image analysis, or clinical performance metrics that would require expert review, ground truth establishment in the context of an AI study, or human-in-the-loop performance.
§ 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).