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The Pressure Injectable M/29TM is a Peripherally Inserted Catheter Device which is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling and pressure injection applications such as contrast media injection.

The maximum flow rate for Flexicath Pressure Injectable midline catheter may not exceed 5ml/sec.

Flexicath's M/29™ Pressure Injectable device is actually the very same device cleared under K080793 (FirmGrip - Peripherally Inserted Catheter) and K092629 (same device with the addition of the Safety Needle Mechanism (SNM).

It is also similar to Arrow's Pressure Injectable PICC and has the very same claim (use with pressure injection of up to 300psi or 5ml/sec flow rate). Other aspects of Arrow's device are not relevant to our M/29 catheter (such as: antimicrobial claim; being used as PICC and; time duration exceeding 29 days).

The main addition in Flexicath M/29 Catheter within this submission is to allow high pressure applications at up to 300psi or 5ml/sec flow rate.

No redesign of M/29 catheter or engineering modifications took place in order to comply with this pressure and flow rate definition. The components' list and materials remain the same as in Flexicath's predicate devices indicated above. The mode of operation of Flexicath's M/29 also remain the same but with the addition of meeting the pressure injection claim for up to 300psi or 5ml/sec.

The indication for use was revised in order to reflect the additional claim for pressure injection.

Several minor other modification (not relevant to the pressure injection), are presented in our submission. The changes are:

• a) A color change of the friction unit: from natural to pink colorant in order to make it more visible.
• b) A 10cm length catheter unit assembly was added in addition to the current length exists.
• c) The single unit package was changed from a pouch to a hard (rigid) blister.
• d) A luer cap was added separately within the blister package as an accessory to close the catheter's female luer connection when open.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. However, it states:

"All tests' acceptance criteria were met."

The primary performance claim for the M/29™ Pressure Injectable catheter is the ability to withstand high-pressure applications.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly mentions "non-clinical performance data" and "tests results."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. This device is a physical medical device (catheter), and its performance evaluation primarily relies on engineering and physical testing, not interpretation by medical experts in the context of imagery or diagnostic data.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-based ground truth establishment or adjudication is mentioned for this type of medical device's performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical medical device (catheter) and the submission focuses on its mechanical performance for pressure injection. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images or data. There is no mention of human readers or AI assistance in this context.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Not applicable. This device is not an algorithm or an AI system. It is a physical catheter. The performance described is inherent to the device itself.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical performance data appears to be established through:

• "Flexicath's legally marketed device specification and applicable standards."
• "Arrow's predicate device information as a 'gold standard'" for pressure injection performances.

This implies that the ground truth is based on established engineering standards and performance characteristics of a previously cleared, comparable device.

8. Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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