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Per-Q-Cath® Midline Catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. A midline catheter is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.

Per-Q-Cath midlines are silicone or polyurethane open-ended catheters in single or dual lumen configurations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bard Per-Q-Cath® Midline Catheters (K971991):

Summary of Acceptance Criteria and Study for K971991

The provided 510(k) summary for the Bard Per-Q-Cath® Midline Catheters (K971991) explicitly states that no performance testing was done to support this particular submission. The purpose of this submission was solely to change the tip trimming instructions in the Instructions For Use. Therefore, there are no acceptance criteria, device performance data, or studies as typically understood for evaluating the safety and efficacy of a medical device against new technological characteristics.

The submission relied on a comparison of catheter tip trimming instructions from competitors and a literature bibliography to support the change in instructions, implying that the safety and effectiveness of the catheter itself was already established through prior submissions or predicate device comparisons.

Given this, the following information cannot be provided as the requested studies were not conducted for this specific submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. No performance criteria were established or evaluated in this submission.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set was used.
3. 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. No ground truth was established for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set required adjudication.
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: Not applicable. This device is a catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established for performance testing.
8. The sample size for the training set: Not applicable. No training set was used for performance evaluation in this submission.
9. How the ground truth for the training set was established: Not applicable. No ground truth for a training set was established.

Key Statement from the Document:

Section G, "Performance Data (if applicable)," explicitly states: "No performance testing was done. A comparison of catheter tip trimming instructions from various competitors and a literature bibligraphy were sent to FDA to support the change in tip trimming instructions."

This indicates that the FDA's clearance (K971991) was based on the premise that the change in instructions did not alter the fundamental safety or effectiveness of the previously cleared device, rather than on new performance data demonstrating compliance with specific acceptance criteria.

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