(30 days)
The SecurAcath Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a standalone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SecurAcath device:
Based on the provided text, the device is a catheter securement device, and the submission is a Special 510(k) for a device that is substantially equivalent to a previously cleared predicate device (K092306). Special 510(k)s typically involve modifications to a company's own legally marketed device for which design control activities have been completed. This means the focus of the submission is often on demonstrating that the changes do not raise new questions of safety or efficacy and that the device still meets its established performance specifications.
Due to the nature of a Special 510(k) and the content provided, the level of detail regarding acceptance criteria and a deep statistical study may be less extensive than for a novel device or a Traditional 510(k) where new clinical data might be required.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Verification | Device "meets all product specifications" |
| Securement Reliability | Device "is able to secure catheters to insertion sites" |
| Material Equivalence | Device "uses the same material as its predicate device" |
| Specification Equivalence | Device "meets similar specification as its predicate devices" |
| Functional Performance | "Test results demonstrate that the device functions as intended." |
Note: The provided text does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, specific pull-out force resistance values). Instead, it makes general statements about meeting specifications and demonstrating intended function. This is common for Special 510(k) submissions where the changes are often minor and the primary goal is to ensure the modified device performs comparably to the predicate.
Study Details
Based on the provided text, a comprehensive clinical study with human subjects, a test set, and ground truth established by experts, as typically seen for AI/ML devices or novel therapies, was not performed or reported in this 510(k) summary. The evaluation primarily relied on non-clinical performance testing to demonstrate substantial equivalence to the predicate device.
Here's why some requested sections cannot be filled:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The text refers to "Performance tests" including "dimensional verification" and "securement reliability." These are laboratory-based engineering tests, not clinical studies with a patient test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. Ground truth, in the context of expert consensus on patient data, is not relevant for the type of engineering performance tests described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are used in clinical studies when multiple human readers interpret data, which is not described here.
- 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:
- No. This is not an AI/ML device, nor is it a device that directly assists human readers in interpreting clinical data. Therefore, an MRMC study is not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (catheter securement), not an algorithm or AI system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications. The "ground truth" for the performance tests would be the established engineering specifications and design requirements that the device was tested against (e.g., a specific pull-out force standard).
- The sample size for the training set:
- Not applicable / Not provided. As this is not an AI/ML device, a "training set" in that context does not exist. The development and testing would follow standard engineering design and verification principles.
- How the ground truth for the training set was established:
- Not applicable / Not provided. See above.
§ 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.”