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The PRO-PICC m 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. 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 m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C 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 air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection. Injectable CVC. The PRO-PICC m ™ catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion. The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Medcomp® PRO-PICC ™ CT Peripherally Inserted Central Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "in vitro testing was performed" without specifying the number of units tested.
• Data Provenance: In vitro testing was performed. The country of origin for the testing is not specified, but the submitter is based in Harleysville, PA, USA. The testing is not retrospective or prospective in the clinical sense, as it was lab-based in vitro testing.

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

• No human experts were used to establish ground truth for this in vitro test set. The acceptance criteria are based on engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols, which are objective, measurable performance parameters.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth was established by objective engineering standards and measurements, no human adjudication was required.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. Clinical studies were explicitly not deemed necessary. The device's safety and effectiveness were demonstrated through in vitro testing and comparison to legally marketed predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical catheter, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product.

7. The Type of Ground Truth Used

• Objective Engineering Standards and Measurements: The ground truth for the device's performance was established using objective measurements against established international engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols. These standards define the acceptable range for physical and chemical properties (e.g., burst pressure, flow rate, leakage).
• Biocompatibility Standard: For biocompatibility, the ground truth was meeting the requirements of ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This refers to a physical medical device, not a machine learning algorithm. Therefore, there is no "training set." The design and materials are based on existing, cleared predicate devices and engineering principles.

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

• Not applicable. As there is no "training set" in the context of this device, this question is not relevant. The device's design is informed by established engineering principles and prior validated devices.

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The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. 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 m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C 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 air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

The provided document, K072509, is a 510(k) premarket notification for a medical device, the PRO-PICC™ CT catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy through clinical trials with specific acceptance criteria in the manner of a new drug or a highly innovative device.

Therefore, the study design and acceptance criteria outlined would be for in vitro (bench) testing designed to show the device performs similarly to or within acceptable limits compared to the predicate device, or to established industry standards (ISO). There are no clinical studies described, nor are there any AI components involved.

Here's a breakdown of the requested information based on the provided text, with a recognition that many items are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was performed to "assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol." It does not provide specific numerical acceptance criteria or results, but rather a statement of compliance.

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

• Sample Size for Test Set: Not explicitly stated for specific in vitro tests. Typically, in vitro testing for device performance involves a specified number of samples (e.g., 5-10 devices per test condition) to demonstrate consistency and compliance with standards.
• Data Provenance: The document refers to "in vitro testing" and internal engineering protocols. This indicates the testing was conducted prospectively in a laboratory setting by the manufacturer (Medcomp®). There is no mention of country of origin for the data as it's not patient data.

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

• Not applicable. This device submission relies on in vitro engineering testing against established standards, not expert-derived ground truth based on patient data. There are no experts reviewing test images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this is an in vitro device performance study, not a study involving human interpretation of data requiring 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 physical medical catheter, not an AI or imaging analysis tool. No MRMC study was conducted.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by international standards (ISO 10555-1, 10555-3, 10993) and the manufacturer's internal engineering protocols. These standards specify acceptable limits for various physical and material properties (e.g., burst pressure, flow rates, biocompatibility), which form the basis of the "ground truth" for demonstrating device safety and reliable performance.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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