(157 days)
The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Vygon PICCs are sterile, single-use, polyurethane PICCs with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties as the predicate device.
The provided document details the Vygon PICCs device, its intended use, and substantial equivalence to a predicate device, focusing on various performance and safety tests. However, the document does not describe an algorithm or AI-driven device, nor does it present acceptance criteria and performance data in the context of such a device.
Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission, as it pertains to a physical medical device (Vygon PICCs) and not a software or AI-based diagnostic/screening tool.
The document primarily focuses on bench testing, sterilization testing, and biocompatibility testing to demonstrate that the Vygon PICCs are substantially equivalent to the predicate device (5 Fr DL PowerPICC® Catheter).
Here's an attempt to extract the relevant information based on the provided document, addressing the prompt's categories where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like a PICC, the "acceptance criteria" are typically the satisfactory completion of standardized tests and meeting the requirements outlined in those standards. The "reported device performance" is whether the device "Passed" each test.
| Test Standard / Requirement | Acceptance Criteria (Implied: "Pass" per standard) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| ISO 9626:2016 (Dimensional) | Meets dimensional specifications | Passed |
| ISO 10555-1:2014 (Conditioning Saline) | Maintains integrity after conditioning | Passed |
| ISO 10555-1:2014 (Leak Test) | No leaks detected | Passed |
| Internal Requirement (Priming Volume) | Meets specified priming volume | Passed |
| ISO 10555-1:2014 (Gravity Flow) | Achieves specified flow rate | Passed |
| ISO 10555-1:2014 (Pump Flow) | Achieves specified flow rate | Passed |
| ISO 10555-1:2014 (Tensile) | Withstands specified tensile force | Passed |
| ISO 10555-1:2014 (Burst) | Withstands specified burst pressure | Passed |
| ISO 10555-1:2014 (Power Injection Conditioning) | Maintains integrity after power injection conditioning | Passed |
| Internal Requirement (Printing Font Size) | Meets specified font size | Passed |
| ASTM F1842-15 (Ink Permanence) | Ink remains permanent | Passed |
| ISO 594-1: 1986 Via / ISO 80369-7:2016 (Luer Taper) | Complies with Luer taper standards | Passed |
| ASTM F1842-15 (Ink Integrity) | Ink integrity maintained | Passed |
| Vygon Internal (Aspiration Flow) | Achieves specified aspiration flow | Passed |
| Vygon Internal (Luer Color/Orientation) | Correct color and orientation | Passed |
| Vygon Internal (Clamp Closure Maintenance) | Clamp maintains closure | Passed |
| Vygon Internal (Clamp and ID Tag Fit) | Clamp and ID tag fit correctly | Passed |
| Vygon Internal (Clamp Actuation) | Clamp actuates correctly | Passed |
| Aged Performance Testing | ||
| ISO 10555-1:2014 (Power Injection Conditioning) | Maintains integrity after conditioning (aged) | Passed |
| ISO 10555-1:2014 (Burst) | Withstands specified burst pressure (aged) | Passed |
| Sterilization Testing | ||
| ASTM F88 / F88M-15 (Seal Strength) | Packaging seal strength maintained | Passed |
| ASTM F2096-11 (Bubble Leak) | No leaks in packaging | Passed |
| ANSI/AAMI ST72:2011 (LAL) | Meets endotoxin limits | Passed |
| ISO 10993-7:2008 (EO Residual) | Meets EO residual limits | Passed |
| Biocompatibility Testing | ||
| ISO 10993-5:2009 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-10 (Sensitization) | Non-sensitizing | Non-sensitizer |
| AAMI/ANSI/ISO 10993-10 (Irritation) | Non-irritating | Non-irritant |
| ISO 10993-11:2006 (Acute Systemic) | Non-toxic | Non-toxic |
| USP37 (Material Mediated Pyrogen) | Non-pyrogenic | Non-pyrogenic |
| ISO 10993-4 (Hemolysis, extract) | Non-hemolytic | Non-hemolytic |
| ISO 10993-4 (Hemolysis, direct) | Non-hemolytic | Non-hemolytic |
| ISO 10993-4 (Complement Activation) | Similar to predicate | Similar when compared to predicate |
| ISO 10993-4 (Partial Thromboplastin Time) | Minimal activator (same as predicate) | Minimal activator (same as predicate) |
| ISO 10993-4 (Dog Thrombogenicity) | Similar to predicate | Equivocal similar |
| AAMI/ANSI/ISO 10993-6 (Implantation) | Non-irritating | Non-irritant |
| ISO 10993-18 (Extractable/Leachable) | Analysis summarized | Summarized in project #MJ16357-BIO01 |
| ISO 10993-17 (Toxicity) | Evaluated satisfactorily | Evaluated in Toxicological Risk Assessment |
2. Sample sized used for the test set and the data provenance:
For a physical device, "sample size" refers to the number of units tested. The document does not explicitly state the sample sizes for each bench, sterilization, or biocompatibility test. The data provenance is internal testing performed by Vygon USA (the submitter). The context implies these are prospective tests conducted on the final device. No country of origin for the data is specified beyond the submitter's location (Lansdale, PA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is subjected to standardized physical and chemical tests, not an assessment requiring expert "ground truth" derived from clinical cases or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or image interpretations. The tests performed are objective, pass/fail criteria based on adherence to international standards and internal requirements.
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-driven device or study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device is compliance with established engineering and biological standards and specifications.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”