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SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.

The SecurePortIV Advanced Catheter Securement Adhesive underwent various tests to demonstrate its safety and effectiveness, leading to its clearance based on substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each individual test related to catheter adhesion, sealant effectiveness, or bacterial immobilization. The tests are described generally, indicating they were qualitative "Pass" results compared to the predicate device.

For the Clinical (Securement Time), the result for the subject device is 14 seconds compared to the predicate's 143 seconds. However, the sample size or methodology for obtaining these times is not detailed in the provided text.

The data provenance is internal to Adhezion Biomedical, LLC, and appears to be from non-clinical (laboratory/bench) studies. There is no mention of specific country of origin or whether these studies were retrospective or prospective, but given they are performance tests against acceptance criteria, they are inherently prospective for this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given document. The document describes non-clinical performance and biocompatibility testing, which typically rely on standardized methods and laboratory assessments rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies when multiple reviewers assess subjective data (e.g., medical images). Since the provided data focuses on non-clinical performance and biocompatibility parameters, an adjudication method is not applicable and therefore not mentioned.

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

There is no mention of an MRMC comparative effectiveness study being conducted or its results in the provided document. The study focuses on direct performance comparisons and biocompatibility rather than human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This device is not an AI algorithm; it's a physical medical device (an adhesive). Therefore, the concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not applicable. The performance criteria are for the device itself.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on:

• Established laboratory performance standards: For adhesion, sealant penetration, and bacterial immobilization, the device's performance was compared to that of the legally marketed predicate device.
• Standardized ISO and USP guidelines: For biocompatibility testing (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, systemic toxicity, implantation; USP <85> for pyrogenicity).
• Quantitative measurements: For securement time, a specific time (14 seconds) was measured and reported.

8. Sample Size for the Training Set

This question is not applicable as the device is a physical medical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is a physical medical product, not an AI algorithm.

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