Search Results

The AccuDrain™ External CSF Drainage System is indicated for draining and monitoring of cerebrospinal fluid (CSF) from the lateral ventricles of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), monitor intracranial pressure, to monitor cerebrospinal fluid, and provide temporary CSF drainage for patients with infected hydrocephalic shunts.

The AccuDrain™ External Drainage Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. The patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. An antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. The antimicrobial vent used on the AccuDrain™ systems will allow better drainage of the CSF to the drainage bag and will resist occlusion after contact with CSF.

The Integra LifeSciences Corporation's AccuDrain™ External CSF Drainage System 510(k) summary provides information on the device's substantial equivalence to predicate devices, but does not describe specific acceptance criteria with numerical targets or a detailed study proving the device meets those criteria in the way typically expected for a performance study with detailed metrics.

Instead, the submission focuses on demonstrating safety and equivalence through:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document does not specify sample sizes for the testing mentioned (MR safety, vent occlusion, strength, leakage, drainage, package integrity).
• The data provenance (country of origin, retrospective/prospective) is not mentioned. These appear to be in-house engineering and bench tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This type of information is not applicable as the "testing" described is primarily mechanical/material performance and safety, not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method:

• Not applicable for the type of testing performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not performed or mentioned. The device is a medical device for draining CSF, not an imaging or diagnostic AI tool that would typically involve human reader performance comparison.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone algorithm performance study was not performed or mentioned. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for the tests mentioned are based on engineering specifications and established testing methodologies for material properties, fluid dynamics (drainage), and sterility/safety (vent occlusion, package integrity, MR safety definitions). For example, MR safety is defined by the CDRH Magnetic Resonance Working Group.

8. Sample Size for the Training Set:

• Not applicable. This medical device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

Summary of Device Performance and Equivalence:

The 510(k) submission for the AccuDrain™ External CSF Drainage System focuses on demonstrating substantial equivalence to legally marketed predicate devices (Hermetic Plus™, Integra NeuroSciences EDS, Codman® EDS3TM). The "studies" mentioned are primarily bench testing to ensure the device performs as intended and is safe, without raising new issues compared to its predicates. The claim of "MR safe" and resistance of the antimicrobial vent to occlusion are key safety aspects highlighted. The submission concludes that the device's design does not raise new safety and effectiveness issues, thereby supporting substantial equivalence.

Ask a specific question about this device