(52 days)
CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.
The BACTISEAL Endoscopic Ventricular Catheter is designed to be placed with an endoscope, which functions as the stylet. The endoscope will enable visualization of catheter placement. The tip of the catheter has been slit to allow passage of the endoscope through the catheter tip.
The BACTISEAL ventricular and peritoneal catheters are made of radiopaque (bariumimpregnated) silicone tubing and are subjected to a treatment process by which the tubing is impregnated with rifampin and clindamycin hydrochloride.
The ventricular catheter has an inner diameter of 1.4 mm and an outer diameter of 2.7 mm. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A right angle adapter is included.
A 120 cm peritoneal catheter is included in the Bactiseal Endoscopic Ventricular Kit along with the ventricular catheter described above. The peritoneal catheter has an inner diameter of 1.0 mm and an outer diameter of 2.2 mm. The catheter can be trimmed to length as needed.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary for the CODMAN® BACTISEAL® Endoscopic Ventricular Catheter:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Device allows passage of an endoscope through the slit. | "Bench testing demonstrated that the slit design allows passage of an endoscope through the slit." |
| Design Conformance | Conforms to its design specifications. | "The Bactiseal Endoscopic Ventricular Catheter conforms to its design specifications..." |
| Intended Use | Performs according to its description and intended use. | "...device performs according to its description and intended use..." |
| Safety & Effectiveness | Supports the safety and effectiveness of the device. | "...supports the safety and effectiveness of the device." |
| Substantial Equivalence | Substantially equivalent to commercially distributed devices for the same intended use. | "...is substantially equivalent to the commercially distributed devices for the same intended use." |
| Material Equivalence | Technological characteristics are the same as the predicate device (Codman® Bactiseal® Catheters). | "The technological characteristics of the proposed devices are the exact same as the Codman® Bactiseal® Catheters predicate device." |
| Design Equivalence | Design modification (slit) is the same as the ventricular catheter in the predicate (Codman® Neuroguide Endoscopic Placement Catheter). | "The design modification adds a slit to this device which is the same as the ventricular catheter in the predicate Codman® Neuroguide Endoscopic Placement Catheter." |
Study Details
Here's a summary of the study details based on the provided document:
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Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "Bench testing" but does not specify a sample size for the test set, nor does it provide details on data provenance (country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. The study described is bench testing, not a clinical study involving experts establishing ground truth for a test set of clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This information is irrelevant for the described bench testing.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not conducted. This device is a medical catheter, not an AI-based diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a medical catheter and does not involve an algorithm or AI. The performance validated was the physical function of the catheter.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance was the physical demonstration and observation that "the slit design allows passage of an endoscope through the slit." This is a purely functional physical test.
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The sample size for the training set:
- Not applicable / Not provided. This device is a physical medical device, not a machine learning model, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not relevant.
§ 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).