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The Nylus™ PICC is intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus PICC is indicated for dwell times shorter or greater than 30 days. The device has a maximum recommended infusion rating of 5mL/sec.

The Nylus™ PICC is a 5Fr, dual-lumen Peripherally Inserted Central Catheter. The Nylus PICC is a device intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus PICC is indicated for dwell times shorter or greater than 30 days.

The Nylus PICC is made from polyurethane and is approximately 60cm long. It has a reversetapered catheter design, with an injection-molded hub and extension lines with Luer Lock fittings for access attachment. Further, the Nylus PICC has been tested to withstand pressure injection at 5ml/sec with a maximum power injector pressure of 300psi. The catheter's interior and exterior surfaces have been modified by Semprus Sustain™ Technology.

The Semprus Sustain Technology is a proprietary biomimetic polymer surface modification intended to reduce platelet adhesion and thrombus accumulation. The Semprus Sustain Technology does not contain or release any active agents. In vitro and short term, i.e. 4-hour in vivo acute animal studies have demonstrated a reduction in adhered platelets and thrombus accumulation on the surface of the Nylus PICC when compared to an unmodified catheter. Preclinical in vitro and animal models do not necessarily predict clinical performance with respect to thrombus accumulation.

Here's an analysis of the provided 510(k) submission for the Nylus™ PICC, focusing on acceptance criteria and the supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a tabular format as would be typical for a formal performance study against predefined thresholds. Instead, it presents "results" that serve as evidence of the device's performance, particularly regarding the Semprus Sustain™ Technology. The implied acceptance criteria are a significant reduction in platelet adherence and thrombus accumulation compared to unmodified or predicate devices.

2. Sample Sizes and Data Provenance

The submission provides limited detail on specific sample sizes for each test mentioned, particularly for the in vitro studies.

• Test Set Sample Sizes:

  • In vitro bovine blood flow loop: Not explicitly stated how many catheters were tested or the number of replicates.
  • In vitro human blood flow model: Not explicitly stated how many catheters were tested or the number of replicates.
  • In vivo 4-hr canine model: Not explicitly stated how many animals or catheters were used in this "short term" acute animal study.

• Data Provenance:

  • Country of origin: Not specified, but given the submitter's address (Cambridge, MA, U.S.A.) and FDA submission, it's highly likely the studies were conducted in the U.S. or at institutions adhering to international standards.
  • Retrospective or Prospective: These studies are inherently prospective as they involve directed experiments designed to evaluate the device's performance.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment for Test Set: Not applicable in the context of this submission. The ground truth for these studies is the direct measurement of platelet adherence and thrombus accumulation using laboratory techniques and visual assessment (e.g., surface area coverage) in controlled in vitro and in vivo settings. There is no mention of expert consensus being used to establish ground truth for the performance metrics described.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. These were laboratory and animal studies with quantifiable measurements (e.g., percentage reduction, weight, surface area) rather than subjective assessments requiring adjudication among human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The Nylus™ PICC is an implantable medical device, and its performance evaluation focused on its material properties and biological interactions rather than diagnostic accuracy involving human interpretation.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: Not applicable. This device does not involve an algorithm or AI. Its performance is evaluated through direct physical and biological testing.

7. Type of Ground Truth Used

The ground truth used for these performance studies was based on:

• Direct Measurement: Quantifiable metrics like platelet count, thrombus weight, and surface area coverage.
• Laboratory Assays: Specifically designed in vitro blood flow loops.
• Animal Models: An in vivo 4-hour canine model for acute assessment of thrombus accumulation.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of this submission. The device's surface modification (Semprus Sustain™ Technology) is a designed physical property, not an algorithm that learns from data.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set.

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