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The PRO-PICC® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. For blood sampling, infusion or therapies use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC catheter is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® PRO-LINE® CT Power Injectable CVC (K053345) and PRO-PICC® CT (K081904) catheter line. The PRO-PICCo CT catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent and fluid communication. Female luer connectors provide the connection for intravenous administration. The power iniectable extension lines are purple in color to differentiate it from non-power injectable catheters. The extensions are also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection. The dual lumen catheter has one purple colored clamp and one natural colored clamp allowing units to designate power injection on one side and infusion; blood withdraw and pressure monitoring on the other although both lumens are capable of power injection.

The PRO-PICC catheter is available in additional French sizes and either a single or double lumen. The catheter has a usable length of 50cm to 60 cm depending on French size with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp PRO-PICC CT device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria for a new device type. Therefore, explicit, quantitative, and standalone acceptance criteria in the typical sense (e.g., "sensitivity must be > X%") are not present.

Instead, the acceptance criteria are implicitly met by demonstrating that the PRO-PICC CT is substantially equivalent to established predicate devices in terms of:

Important Note: The document explicitly states: "Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food, Drug and. Cosmetic Act. Testing is based upon internal engineering testing methods." This reinforces that quantitative, pre-defined FDA-mandated performance metrics for the specific function of "power injection" were not applicable as acceptance criteria in this submission.

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

• Sample Size: Not applicable. This submission relies on substantial equivalence and bench testing, not a clinical study with a "test set" of patients or data in the way an AI/ML device would.
• Data Provenance: Not applicable. The "data" refers to engineering bench test results and biocompatibility testing of materials, not clinical data from specific geographic regions.

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

• Number of Experts: Not applicable. There is no "ground truth" establishment by external medical experts for a clinical test set in this 510(k) submission.
• Qualifications of Experts: Not applicable. The evaluation is based on engineering testing and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no "test set" requiring adjudication by multiple readers or experts.

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:

• MRMC Study: No. This device is a physical catheter, not an AI/ML-driven diagnostic or assistive tool for human readers.

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

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

7. The Type of Ground Truth Used:

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's acceptable performance is primarily derived from:
  • Predicate Device Performance: The established safety and effectiveness of the existing predicate devices (K053345, K081904, K070996).
  • Bench Test Results: Internal engineering testing demonstrating the device meets its design specifications and performs as intended, consistent with the predicates.
  • Biocompatibility Standards: Compliance with ISO 10993 for materials used.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

In summary, the provided document details a traditional 510(k) submission for a physical medical device (catheter) that demonstrates substantial equivalence to predicate devices through bench testing and material biocompatibility, rather than through clinical studies with defined test sets, expert-driven ground truth, or AI/ML performance metrics.

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