Search Results

The SecurAcath is a PICC and is indicated for short and long term use in peripheral vessels to access the central venous system. The catheter may be used for blood sampling and/or infusion therapy. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.

The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 60 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics. The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body.

The provided text describes a 510(k) premarket notification for the SecurAcath Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing devices rather than a detailed clinical study proving performance against specific acceptance criteria with statistical rigor in the way a clinical trial for a new drug or complex diagnostic device might.

Here's an analysis based on the provided text, addressing the requested information where applicable:

Acceptance Criteria and Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format with specific thresholds and corresponding reported device performance. Instead, it makes a general statement about performance.

Note: The acceptance criteria here are inferred from the types of performance testing mentioned and the overall goal of a 510(k) submission, which is to show safety and effectiveness, often by demonstrating substantial equivalence to a legally marketed device. Specific numerical targets for these criteria are not provided in this excerpt.

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document mentions "performance test data is provided in the 510(k) submission," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective). The tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are typically bench or engineering tests, not clinical studies involving human patients.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The performance tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are engineering/bench tests and would not typically involve experts establishing "ground truth" in the clinical sense (like radiologists marking images). The "ground truth" for these tests would be derived from physical measurements and engineering standards.

3. Adjudication method for the test set:

   • Not applicable. As the tests are engineering/bench tests, there wouldn't be an adjudication method in the context of clinical expert review.

4. 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 device is a catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI assistance is irrelevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the mentioned performance tests, the "ground truth" would be based on engineering specifications and measurements conforming to industry standards or internal design requirements. For example, tensile strength would be measured against a predefined breaking point, and dimensions would be verified against blueprint specifications.

7. The sample size for the training set:

   • Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for a physical medical device.

In summary: The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating that the device meets its own product specifications through various performance tests (dimensional, securement, tensile strength) and is substantially equivalent to predicate devices. It does not contain information related to clinical studies, AI performance, or ground truth establishment by experts in the context of diagnostic performance, as these are not relevant to this type of device and submission.

Ask a specific question about this device