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510(k) Data Aggregation
(220 days)
SecurePortIV™ 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 also providing a moisture barrier. SecurePortV™ is intended to be used with a transparent film dressing on short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.
SecurePortIV Catheter Adhesive is a sterile, professional liquid cyanoacrylate-based adhesive containing a two monomeric formulation (2-octyl cyanoacrylate and butyl 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 liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes. It is intended to be used in conjunction with a transparent film dressing.
This document describes the premarket notification for the "SecurePortIV Catheter Securement Adhesive" (K170505). However, the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report demonstrating the device meets specific acceptance criteria. The information provided is descriptive of the device and comparative to predicates.
Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly present in the provided text. I will extract what I can and note where information is missing.
Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in the format of defined metrics and thresholds that the SecurePortIV device must pass. Instead, it presents a comparison table (Table 1) against predicate and reference devices, aiming to show comparable or superior performance to establish substantial equivalence. The "Acceptance Criteria" here are implicitly that the SecurePortIV performs "as well or better than" the legally marketed predicate/reference devices across various characteristics.
| Characteristic | Implicit Acceptance Criteria (based on comparison) | Reported Device Performance (SecurePortIV) |
|---|---|---|
| Indications for Use (IFU) | Comparable functionality to predicate/reference device, with specific claims. | Film forming securement and sealant at vascular access catheter skin entry. Holds catheter to skin to reduce movement/migration/dislodgement. Protects skin entry site by creating sealant that immobilizes surface bacteria, prevents entry, and provides moisture barrier. Intended for use with transparent film dressing on short-term and long-term vascular access catheters (peripheral IVs, PICCs, CVCs). |
| Adhesion Strength/Securement | Statistically equal or significantly greater than commercial transparent adhesive dressings; no pullout failures under challenge. | In vitro: Adhesion strength values statistically equal or significantly greater than several commercially available transparent adhesive dressings from 3 minutes to 7 days. In vivo (dog study): Presented significant shear pull out force challenge (100g) with no pullout failures in any test point for 6 hours (SecurePortIV alone and in combination with transparent film dressing). |
| Moisture Barrier | Provides a film barrier to moisture penetration, comparable to predicate. | Provides a film barrier to moisture penetration. Activity shared with reference product (seal repellant). |
| Anti-bacterial Activity | Immobilization of bacteria, equivalently effective against gram positive and gram negative bacteria (compared to predicates). | Immobilization of bacteria. Identical to primary predicate; different anti-bacterial to secondary predicate, but all equivalently effective against gram positive and gram negative bacteria. |
| Protection Duration | 5 days to skin sloughing, comparable to predicate. | 5 days to skin sloughing. (Identical to predicate). |
| Packaging Material | Identical to predicate. | Primary - Barex. Identical ampoule material reservoir to predicate. |
| Viscosity | < 200 cps, identical values for each component. | < 200 cps. Same values for each component separately (identical to predicate). |
| Set Time | Identical to predicate. | Identical to predicate and same values for identical formula. |
| Shelf-life | 24 months, identical to predicate component. | 24 months. Supported by accelerated aging and real-time evaluations. Identical shelf-life for each predicate component. |
| Biocompatibility | Pass standard biocompatibility tests, identical results to predicate. | Passed tests per ISO 10993-1:2009 (Bacterial Reverse Mutation, Intracutaneous, Muscle Implantation, In Vitro Cytotoxicity, Mouse Peripheral Blood Micronucleus, Skin Irritation, Genotoxicity (In Vitro Chromosomal Aberration), Maximization Sensitization Study). Results identical to predicate. |
| Flexibility | No ripples, no cracks, no chips. Identical to predicate. | No ripples, no cracks, no chips. Identical to predicate. |
2. Sample sizes used for the test set and the data provenance
- Securement (In vitro): "several different commercially available transparent adhesive dressings" were used for comparison, but the number of tests or samples per test is not specified.
- Securement (In vivo): One "animal dog study" was conducted. The number of dogs or test sites on the dogs is not specified.
- Biocompatibility: Standard ISO tests were conducted. The sample sizes for these specific tests are not detailed.
- Provenance: All studies described appear to be pre-market, in-house, or contract lab studies conducted to support the 510(k) submission. The country of origin for the animals or human data (as there is none specified) is not provided. The studies are most likely prospective as they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document as it pertains to expert independent review of the device's performance against a "ground truth." The studies described are primarily performance and comparison tests, not AI model validation studies requiring expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved. The studies described are laboratory and animal performance tests.
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
- This information is not applicable and not provided. The device is a physical medical device (catheter securement adhesive), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable and not provided. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device is established through physical performance measurements (e.g., adhesion strength, flexibility, moisture barrier) and biological testing (biocompatibility, anti-bacterial activity) against established industry standards and comparison to legally marketed predicate devices. For the in vivo securement study, the ground truth was the objective observation of "no pullout failures" under a specified force.
8. The sample size for the training set
- This information is not applicable and not provided. The device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable and not provided. As above, no training set for an AI model is involved.
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