(267 days)
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 Libertís™ Shunt Catheter includes a ventricular and distal (peritoneal) drainage catheter that are used as part of a cerebrospinal fluid (CSF) shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system. The ventricular catheter diverts excess CSF from the ventricles of the brain through the valve. After passing through the valve, the excess CSF is drained through the distal catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters have Endexo® polymer, a surface modifying macromolecule, blended into their base silicone. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. The Libertís™ Shunt Catheter has 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 ink markings on the silicone tubing to aid in positioning of the catheter.
The catheters are packaged with two accessories, a stylet and a right-angle adapter. The stylet is used to help introduce the ventricular catheter into the brain's ventricles. The right-angle adapter is used to fixate the ventricular catheter to the cranium.
This document is a 510(k) clearance letter for a medical device, specifically a shunt catheter. It does not describe an AI medical device or software. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility testing, rather than performance studies of an AI algorithm.
However, I can provide the acceptance criteria and performance information that is present in the document, which pertains to the physical and biological characteristics of the shunt catheter.
Acceptance Criteria and Device Performance (for the physical device, not an AI algorithm):
Since the provided document is for a medical device (shunt catheter) and not an AI/software device, the questions related to AI-specific criteria (e.g., sample size for test/training sets of AI, expert adjudication, MRMC studies, standalone algorithm performance, type of ground truth for AI) are not applicable.
The acceptance criteria here refer to the performance of the physical device as demonstrated through various bench and biocompatibility tests. The document states that all tests were "Pass," implying that the device met the pre-defined acceptance criteria for each test.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|
| Evaluation of Safety and Performance per ISO 7197 and ASTM F647-94 | Complies with the safety and performance requirements of these standards. | Pass |
| Functional/Mechanical Performance per ASTM F647-94 and ASTM D412-16 | Complies with the functional and mechanical performance requirements of these standards. | Pass |
| MRI Compatibility per ASTM F2053-20 | Meets MRI compatibility standards (specifically, "MR-safe" designation). | Pass |
| Antimicrobial Efficacy – Zone of Inhibition (ZOI) per internal methods | Demonstrates adequate zone of inhibition as per internal methods. | Pass |
| Antibiotic Content Analysis using High-performance Liquid Chromatography (HPLC), per internal methods | Meets specified antibiotic content levels as per internal methods. | Pass |
| Residual Solvents Testing via Headspace Gas Chromatography – Flame Ionization Detection (HS GC-FID), per FDA guidance "Q3C – Tables and List Guidance for Industry" | Meets specified limits for residual solvents. | Pass |
| Usability Evaluation and Design Validation per IEC 62366-1 | Complies with usability and design validation requirements of IEC 62366-1. | Pass |
| In vitro flow loop thrombogenicity test | Observed significantly less thrombus deposition compared to the predicate device. | Observed significantly less thrombus deposition on Codman Libertis Distal Shunt Catheter with Bactiseal and Endexo Technology compared to predicate device |
| Cytotoxicity per ISO 10993-5:2009 | No cytotoxic effects. | Pass |
| Sensitization per ISO 10993-10:2021 | No sensitization reactions. | Pass |
| Irritation per ISO 10993-10:2021 and ISO 10993-23:2021 | No irritation. | Pass |
| Acute Systemic Toxicity per ISO 10993-11:2017 | No acute systemic toxicity. | Pass |
| Pyrogenicity per ISO 10993-11:2017 | No pyrogenic effects. | Pass |
| Subacute/Subchronic Toxicity per ISO 10993-6:2016 and ISO 10993-11:2017 | No subacute/subchronic toxicity. | Pass |
| Genotoxicity per ISO 10993-3:2014 | No genotoxic effects. | Pass |
| Implantation per ISO 10993-6:2016 | Acceptable tissue response upon implantation. | Pass |
| Chronic Toxicity per ISO 10993-11:2017 | No chronic toxicity. | Pass |
| Hemocompatibility per ISO 10993-4:2017 | Hemocompatible. | Pass |
| Carcinogenicity per ISO 10993-3:2014 | No carcinogenic effects. | Pass |
| Sterilization Validation (E-beam) per ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2 | Achieves a sterility assurance level (SAL) of 10-6. | Achieved SAL of 10-6 |
| Shelf Life | At least 1 year. | 1 year |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify general "sample sizes" in terms of patient data or typical "test sets" as one would for an AI model. Instead, it refers to "production equivalent devices" used for the various bench and biocompatibility tests. The specific number of devices or replicates for each test is not detailed.
- Data Provenance: The data is generated from laboratory studies and bench testing performed on the physical device. This is not clinical patient data. The provenance for this type of testing is typically the manufacturer's internal testing facilities or contract labs. No country of origin for data or retrospective/prospective nature is applicable as this is not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This pertains to an AI/software device. The "ground truth" for a physical device is established by objective measurements and standardized test methods, not expert consensus on data interpretation.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
- Not applicable. This pertains to an AI/software device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, not applicable. This pertains to an AI/software device evaluating human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. This pertains to an AI algorithm; the device is a physical shunt catheter.
7. The Type of Ground Truth Used
- For the performance bench tests and biocompatibility tests, the "ground truth" is defined by established international (ISO, ASTM) and FDA-recognized consensus standards, as well as pre-defined internal test methods and specifications. For instance, a "Pass" for biocompatibility means the device met the criteria specified in the relevant ISO 10993 standards. For thrombogenicity, the ground truth was a statistically significant reduction in thrombus deposition compared to the predicate device.
8. The Sample Size for the Training Set
- Not applicable. This pertains to an AI/software device. No training set is involved for validating a physical medical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This pertains to an AI/software device.
§ 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).