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The Arrow Pressure Injectable JACC with Chlorag+ard Antithrombogenic Technology is indicated for short-term (30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Pressure Injectable JACC may not exceed 300 psi (2068.4 kPa), The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathyav of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness were evaluated using in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treating infections.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in palients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Chlorag ard Antimicrobial and Antithrombogenic Technology has the following characteristics:

• . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter with or without preloaded VPS stylet
• 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic . catheter with or without preloaded VPS Stylet
• 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic ● catheter with or without preloaded VPS Stylet

The subject device is a CG+ Arrow JACC with or without pre-loaded Arrow VPS Stylet and will be provided in sterile kit configurations. The modifications subject to this submission are additions to the recommended procedural technique to clarify that the catheter devices can be trimmed or cut to the appropriate length based on the specific patient's anatomy.

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-Lumen and 2-Lumen catheters and 6 mL/sec for the 3-Lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag+ard technology. There are no modifications subject to this premarket notification related to the geometric or material design of the devices modified in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

The provided text is a 510(k) summary for Arrow International, Inc.'s CG+ Arrow JACC devices. It aims to demonstrate substantial equivalence to a predicate device, focusing on a modification to the recommended procedural technique (catheter trimming instructions).

Here's an analysis of the acceptance criteria and supporting study information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for performance metrics in the way one might expect for a formal clinical trial or algorithm validation. Instead, the focus is on demonstrating substantial equivalence to a predicate device after a modification to a procedural technique. The "performance" being evaluated is essentially the continued safety and functional equivalence of the modified device.

Important Note: The document explicitly states that "no correlation between these testing methods and clinical outcome has currently been ascertained" for the antimicrobial efficacy. This means while the device has shown antimicrobial activity in lab/animal settings, there isn't clinical evidence in this document proving it translates to reduced infections in humans.

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

The document does not provide specific sample sizes for test sets in a traditional sense. The "testing" mentioned is primarily design verification testing and risk analysis related to the modification (catheter trimming). There is no mention of a patient-based test set with specific sample sizes.

• Data Provenance: The testing mentioned ("internal method", "in vitro and in vivo test methods") points to internal laboratory or animal studies, likely conducted by the manufacturer (Arrow International, Inc./Teleflex Inc.). There is no mention of country of origin for data or whether it's retrospective or prospective clinical data.

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

This information is not provided. Given the nature of the submission (510(k) for a procedural modification to an existing device), the "ground truth" for the verification testing would be based on engineering specifications, material science, and established safety standards rather than expert clinical consensus on a patient test set.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no mention of a test set that would require expert adjudication in the context of this submission. The "adjudication" would be performed by the manufacturer's internal quality and regulatory teams, and subsequently by the FDA reviewers, applying regulatory standards to the provided test results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This submission is for a medical device (catheter) with guidance (VPS Stylet), not an AI-powered diagnostic imaging system that would typically involve human "readers" and AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The "VPS Stylet" is a guidance system used by a human operator during a medical procedure, not a standalone AI algorithm.

7. The Type of Ground Truth Used

For the aspects evaluated:

• Catheter Trimming Compatibility & Functional Performance: The "ground truth" would be engineering specifications, established mechanical/material properties, and successful demonstration of absence of adverse effects from trimming through design verification testing.
• Antimicrobial & Antithrombogenic Efficacy: The "ground truth" was established through in vitro and in vivo test methods.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of an "AI algorithm" or a "training set" in this 510(k) submission.

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

This information is not applicable/not provided as there is no "training set" mentioned.

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