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The 6 Fr. Triple Lumen Pressure Injectable Peripherally Inserted Central Catheter is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.

Device Description

The Pressure Injectable Peripherally Inserted Central Catheters have the following characteristics:

Radiopaque polyurethane catheters
6 Fr Triple Lumen BlueFlex® Tip
Usable length of catheters are 40 cm to 55 cm
Catheters are provided in sterile kit configurations
The 6 Fr BlueFlex® Tip catheter is labeled for "6 ml/sec, pressure injectable" on the Luer hub to facilitate the proper use of the device

AI/ML Overview

The provided document is a 510(k) summary for Arrow International's Pressure Injectable Peripherally Inserted Central Catheter (PICC). This document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical and mechanical properties, not clinical performance or diagnostic accuracy. Therefore, many of the requested categories related to clinical studies, human readers, and ground truth are not applicable or cannot be extracted from this type of regulatory document.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Liquid Leakage Under Pressure	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Air Leakage During Aspiration	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Air Leakage Under Pressure	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Catheter and Blue Flex Tip Stiffness	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Catheter Collapse	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Tensile Testing	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Catheter Radiopacity	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Non-Pressure Injectable Lumen Static Burst Pressure	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Repeat Pressure Injection	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Static Burst Pressure under power injection	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.
Central Venous Pressure Monitoring	Not explicitly stated, but implied to meet performance criteria of FDA recognized standards and guidance.	Met performance criteria.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of bench tests conducted by Arrow International, Inc., as described in the "Performance tests" section of the 510(k) summary. These tests are physical and mechanical characterizations of the device and are not clinical trials.

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

Test Set Sample Size: Not explicitly stated for each test. Regulatory bench tests typically involve a statistically relevant number of units, but the exact count isn't provided.
Data Provenance: The data is from in-house bench testing conducted by Arrow International, Inc. The country of origin is implicitly the USA, where the company is located. The tests are prospective in the sense that they were conducted on the new device model to demonstrate its performance.

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

This information is not applicable as the evaluation involved physical/mechanical bench testing, not image analysis or clinical diagnosis requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved physical/mechanical bench testing, not image analysis or clinical diagnosis 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

This information is not applicable. The device is a physical medical catheter, not an AI or diagnostic imaging device involving human readers.

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

This information is not applicable. The device is a physical medical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these physical performance tests is based on engineering specifications, industry standards, and regulatory guidance. For example, a "burst pressure" test would have an engineering specification for the minimum pressure the device must withstand without failure.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of physical medical device bench testing.

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

This information is not applicable. There is no "training set" in the context of physical medical device bench testing.

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