Duet External Drainage and Monitoring System (EDMS)

The Duet External Drainage and Monitoring System (EDMS) is a gravity-driven system for temporarily draining cerebrospinal fluid (CSF) from the brain's lateral ventricles or lumbar spine into an external collection bag. It also monitors intracranial pressure (ICP) and CSF chemistry in patients with severe head injury, subarachnoid hemorrhage, hydrocephalus, and related conditions to reduce ICP or manage infected shunts.

The subject device features a 75 ml graduated drip chamber (versus 50 ml in predicate), a 4-way rotating pole-mounted pressure scale (versus fixed side-by-side scales), MR Conditional safety status (versus MR Unsafe), and a 3-year shelf life (versus 2 years). Both use gravity-based drainage, ethylene oxide sterilization, and the same patient line tubing design with green stripe identification.

Biocompatibility assessment followed FDA guidance on ISO 10993-1 for biological evaluation of medical devices, evaluating cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subacute/subchronic toxicity, and indirect hemolysis. Testing of microbial barrier efficiency demonstrated 99.9% Bacterial Filtration Efficiency (BFE).

The subject device is substantially equivalent because it shares identical indications for use, intended use, fundamental operating principle (gravity-driven external drainage), and biocompatibility category with the Becker predicate (K200456). Design differences—such as larger drip chamber volume, rotating scale display, improved shelf life, and MR Conditional status—represent refinements that do not alter the basic function or safety profile. All performance testing passed, demonstrating the device performs as designed and is suitable for its intended use with no new risks introduced.