(148 days)
The Vygon Multicath Expert Catheter is intended for use in patients who require Short-term (less than 30 days) I.V. iherapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters are manufactured with a Pellethane-based AgION™ antimicrobial. The AglON™ uses silver as the antimicrobial agent.
The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial function. The polyurethane catheters are impregnated with the silver ion-based antimicrobial agent AgION™ and are available in 2-, 3-, 4-, or 5-lumen catheters. Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antiseptic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.
The Vygon Multicath Expert Catheter is cleared via the 510(k) pathway, which means it demonstrates substantial equivalence to predicate devices rather than fulfilling specific acceptance criteria in a clinical study. The provided document does not contain details about a study with acceptance criteria and a reported device performance as would be expected for a de novo device or a device with new indications requiring clinical efficacy data.
Instead, the submission focuses on demonstrating that the only change—the addition of the AgION™ silver ion-based antimicrobial agent—does not adversely affect the safety and efficacy of the device compared to its predicate.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for an AI device) are mentioned because this is a 510(k) submission for a physical medical device (intravascular catheter) with an antimicrobial coating. The "acceptance criteria" are implied by the regulatory requirements for showing substantial equivalence.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-irritant and non-toxic materials. | Biocompatibility testing of the material demonstrates it is non-irritant and non-toxic. |
| Performance: Changes do not affect safety or efficacy compared to predicate. | Performance testing demonstrates that the changes do not affect safety or efficacy. |
| Risk Assessment: Compliance with ISO 14971. | Risk Assessment was conducted in compliance with ISO 14971. |
| Antimicrobial Functionality (AgION™): Release of silver ions for broad antimicrobial spectrum. | "Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains." "Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy." (This describes the technology characteristic, not necessarily a formal performance metric from a study within this submission). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of an AI/algorithm-driven device. The evaluation of the Multicath Expert is based on:
- Biocompatibility testing: This typically involves in vitro and sometimes in vivo animal studies, but the sample sizes are not specified here.
- Performance testing: This refers to mechanical and functional testing (e.g., flow rates, tensile strength) to ensure the catheter's core functionality is maintained despite the coating. Sample sizes for these engineering tests are not provided.
- Risk assessment: An analytical process, not a data-driven test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not an AI/algorithm device requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Not applicable. This is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used:
Not applicable in the AI/algorithm sense. The "ground truth" for this device's safety and efficacy is derived from:
- Biocompatibility standards: established methods for evaluating biological harm.
- Performance specifications: engineering and functional requirements for catheters.
- Predicate device's known safety and efficacy: the established performance of the already-marketed Multicath (K870067).
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" for this type of device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).