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Per-Q-Cath PICCs are indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

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

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, there is no performance data or study conducted to establish acceptance criteria for the Per-Q-Cath® PICCs. This submission (K971990) specifically states:

"No performance testing was done. A comparison of catheter tip trimming instructions from various competitors and a literature bibliography were sent to FDA to support the change in tip trimming instructions."

The submission is solely to change the tip trimming instructions in the Instructions For Use. No changes were made to the catheters themselves, and therefore, no new performance data was generated or required for this specific 510(k) submission. The device's substantial equivalence is based on its prior established safety and effectiveness, and the current submission only pertains to an instructional change, not a design or performance change.

Therefore, most of the requested information regarding acceptance criteria and a study to prove the device meets these criteria cannot be extracted from the provided text because such a study was explicitly stated as not performed.

However, I can still address the relevant points based on the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no performance testing was done for this specific 510(k) submission. Therefore, there are no acceptance criteria or reported device performance metrics established by a study within this document. The submission's focus is on a change to instructions, not a change to the device itself or its performance.

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

Not applicable. No test set was used as no performance testing was conducted.

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

Not applicable. No test set or ground truth establishment relevant to device performance was performed for this submission.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. No performance study of any kind was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device (catheter) and not an AI algorithm. No standalone performance study was conducted.

7. The Type of Ground Truth Used

Not applicable. No performance testing was conducted that would require establishing a ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a medical device and not an AI algorithm. No training set was used.

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

Not applicable. No training set was used.

Summary of the K971990 Submission's Nature:

The K971990 submission for the Per-Q-Cath® PICCs is a 510(k) notification for a minor change specifically related to a change in "tip trimming instructions" in the Instructions For Use. The submission explicitly states that "No performance testing was done" and "No changes were made to the catheters." The basis for substantial equivalence for this change was a comparison of competitor trimming instructions and a literature bibliography. This type of submission falls under a category where new performance data or clinical studies are not typically required because the change is administrative or pertains to instructions without altering the device's fundamental design, material, or intended use in a way that would impact its safety or effectiveness profile.

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