(264 days)
The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.
The provided document is a 510(k) clearance letter from the FDA for a medical device (Codman Libertís™ EVD Catheter). It describes the device, its intended use, a comparison to a predicate device, and summaries of nonclinical testing.
However, the question asks for details related to acceptance criteria and studies that prove a device meets acceptance criteria, specifically those typically associated with AI/software medical devices. This document does not describe an AI/software medical device; it describes a physical medical device (a catheter for draining CSF). Therefore, much of the information requested in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) study," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of device and are not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, and sterilization validation, which are standard for physical medical devices.
Here's an attempt to answer the applicable parts of your request based on the provided text, and explicitly state where information is not available or not applicable.
Description of Acceptance Criteria and Proving Device Meets Criteria
The Codman Libertís™ EVD Catheter is a physical medical device. Its acceptance criteria are primarily demonstrated through a battery of nonclinical performance bench tests, biocompatibility testing, and sterilization validation, to show that it is substantially equivalent to a legally marketed predicate device. The performance criteria are generally considered a "Pass" or "Fail" based on established standards and internal methods.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria values but rather states a "Pass" or "Fail" for each test. The acceptance criterion for each test is implicitly that the device performs as expected according to the specified standard or internal method.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Evaluation of Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 | Meets specifications of ASTM F647 and ISO 7197 for EVD catheters. | Pass |
| Evaluation of Aged Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 (T = 12 months) | Meets specifications of ASTM F647 and ISO 7197 for EVD catheters after 12 months simulated aging. | Pass |
| Functional/Mechanical Performance of Codman Libertís EVD Catheters | Meets predefined functional and mechanical performance specifications. | Pass |
| Functional/Mechanical Performance of Aged Codman Libertís EVD Catheters (T = 12 months) | Meets predefined functional and mechanical performance specifications after 12 months simulated aging. | Pass |
| MRI Compatibility Assessment of Codman Libertís EVD Catheters per ASTM F2503 | Meets specifications of ASTM F2503 for MRI compatibility (Note: Catheter is MR Conditional, Trocar and Stylet are MR-Unsafe, as noted in labeling). | Pass |
| Antimicrobial Efficacy of Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use | Demonstrates sufficient Zone of Inhibition against specified bacteria after 28 days of simulated use to show antimicrobial efficacy. | Pass |
| Antimicrobial Efficacy of Aged Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use (T = 12 months) | Demonstrates sufficient Zone of Inhibition after 12 months simulated aging and 28 days of simulated use. | Pass |
| Antibiotic Content Testing of Codman Libertís EVD Catheters | Contains the specified levels of antibiotics (rifampicin and clindamycin hydrochloride). | Pass |
| Residual Solvents Testing of Codman Libertís EVD Catheters | Levels of residual solvents are within acceptable limits. | Pass |
| Libertís EVD Catheters with Bactiseal® and Endexo® Technology – Summative Usability Study | Meets user-related safety and effectiveness requirements, indicating the device can be used safely and effectively by its intended users. | Pass |
| Product Shelf Life Testing per ASTM F1980 and ISO 11607-1 | Maintains integrity and performance over its stated shelf life (12 months) as per ASTM F1980 and ISO 11607-1. | Pass |
| Biocompatibility Testing per ISO 10993-1 | Demonstrates biocompatibility in accordance with ISO 10993-1 for medical devices in contact with the body. | Pass |
| Sterilization Validation (Electron Beam) | Achieves a sterility assurance level (SAL) of 10-6. | Pass |
2. Sample size used for the test set and the data provenance
The document states, "All testing was performed on production equivalent devices." However, it does not specify the sample size for any of the individual bench tests.
Data provenance (e.g., country of origin of the data, retrospective or prospective) is not applicable in the traditional sense for these bench tests, which are conducted in a laboratory setting to evaluate physical properties and performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to this type of medical device (physical catheter). "Ground truth" in this context would refer to established engineering standards, material specifications, and validated test methods, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
This concept is not applicable to this type of medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers (e.g., radiologists) to resolve disagreements in interpretation, which is not relevant for bench testing of a physical device.
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
No MRMC comparative effectiveness study was done, as this is a physical medical device (catheter), not an AI/software device. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable since the device is a physical catheter, not a software algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests of this physical device consists of:
- Established industry standards (e.g., ASTM F647, ISO 7197, ASTM F2503, ISO 10993-1, ASTM F1980, ISO 11607-1).
- Internal predefined functional and mechanical specifications.
- Validated laboratory methods for chemical content, antimicrobial efficacy (Zone of Inhibition), and sterility assurance (SAL 10-6).
- Usability requirements for the Summative Usability Study.
8. The sample size for the training set
This concept is not applicable as this is a physical medical device, not an AI/software device that would involve a "training set."
9. How the ground truth for the training set was established
This concept is not applicable for the same reason as above.
§ 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).