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The Pressure Injectable PICC with Chlorag+ard Antithrombogenic Technology is indicated for shortterm or long-term peripheral 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 injection equipment used with the pressure injectable PICC may not exceed 300 psi.

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

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffess 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 VPS System guidance indicator shows a Blue Bullseye, the catherer tip is in the desired location.

The VPS System is indicated for use as 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 Bullseve is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in patients 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 purpose of this premarket notification is to propose design and material modifications to the subject device: the Arrow Vascular Positioning System (VPS) stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS . The Arrow Vascular Positioning System (VPS) Stylet PLUS (hereafter referred to as Arrow VPS Stylet PLUS) is designed for use with a VPS Console to guide market available central catheters to the desired location, which is the lower third of the superior vena cava (SVC) or at the cavo-atrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS already loaded into a central catheter. (The Arrow VPS Stylet PLUS and the Arrow VPS Stylet PLUS included in the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS are exactly the same stylet.)

The subject device, the Arrow VPS Stylet PLUS has the following characteristics:

• 6 ft overall length

This document describes the premarket notification (K153487) for the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS. It details modifications made to the device and the nonclinical testing performed to demonstrate substantial equivalence to a predicate device (K141618).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it lists the nonclinical tests performed and their results, which were all "PASS". The implicit acceptance criterion for each test is that the device must pass it.

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

The document describes nonclinical testing (bench testing and biocompatibility) rather than a clinical study with a "test set" from patients. Therefore, information about patient sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided. The tests were performed on the device itself.

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

Not applicable. This was nonclinical testing, not a study involving human interpretation of data where expert consensus would establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was nonclinical testing.

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

No. This document describes nonclinical, bench, and biocompatibility testing to demonstrate substantial equivalence of a modified medical device to a predicate device. It is not an MRMC comparative effectiveness study, nor does it involve human readers or AI assistance.

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

No. This document pertains to a physical medical device (catheter and stylet), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established by adherence to specified international standards and guidances (e.g., ISO 10555-1, BS EN ISO 11070, ASTM F640-07, ISO 10993-1, IEC 60601 series). These standards define the test methods and criteria for acceptable functional and safety performance (e.g., tensile strength, corrosion resistance, biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm study requiring a training set. The modifications are to a physical medical device.

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

Not applicable. This is not an AI/algorithm study requiring a training set.

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