(90 days)
The Bactiseal Catheters are indicated 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 Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.
The 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 Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. 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 catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.
This document is a 510(k) summary for modifications made to existing Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheters. The modifications primarily involve updates to MRI labeling and a change in the supplier of clindamycin hydrochloride.
Therefore, the submission focuses on demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than proving the initial efficacy of an entirely new device. This means that a conventional study with specific acceptance criteria, test sets, expert adjudication, and detailed ground truth establishment as typically seen for entirely new AI/CADe devices, is not applicable in this context. The document relies on bench testing and an equivalency assessment to the predicate devices.
Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not applicable" due to the nature of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| MRI Safety Testing (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) | Device meets established MRI safety standards for MR Conditional. | Pass |
| Drug Equivalency Testing (USP standards, USP Monograph for Clindamycin Hydrochloride) | Clindamycin hydrochloride from new supplier is equivalent to current supplier in identity, formulation, concentration, application method, and drug release. | Pass |
| Drug Effectiveness Testing (USP and internal test methods) | Device continues to demonstrate the intended antimicrobial effectiveness. | Pass |
| Sterilization Equivalency Assessment | Sterilization process remains effective with the new clindamycin hydrochloride supplier. | Acceptable |
| Biocompatibility Assessment | New clindamycin hydrochloride supplier does not introduce new biocompatibility issues. | Determined no new issues |
Explanation of Implied Acceptance Criteria: The document states that the testing "utilized well-established methods, including those from FDA consensus standards." For a "Pass" result in such tests, the device must meet the specific criteria outlined in those standards. For drug equivalency and effectiveness, the stated goal is to confirm the new supplier's clindamycin hydrochloride is "equivalent" and "continues to meet the same drug specifications" and efficacy. The biocompatibility assessment "determined that the introduction of the new supplier for clindamycin hydrochloride does not introduce any new issues."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document indicates "All testing was performed on production equivalent devices," but the number of devices or units tested for each benchmark is not provided.
- Data Provenance: Not applicable in the context of clinical data. The tests are benchtop performance tests. The specific labs or countries where these bench tests were conducted are not mentioned.
3. 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. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring adjudication.
5. 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
- Not applicable. This is not an AI/CADe device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense. The "ground truth" for the bench tests would be the established scientific and engineering principles, and the specifications of the predicate device/original drug, against which the modified device's performance is compared. For example, the ground truth for MRI safety is defined by the ASTM standards.
8. The sample size for the training set
- Not applicable. This is not an AI/CADe device, and no training set is mentioned or implied for its development or evaluation.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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).