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The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (<30 days) or long-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 injector equipment used with the Arrow 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 pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and 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 treatment of existing infections.

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

• 4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
• 5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
• 6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The CG+ Arrow JACC consists of a non-tapered, radiopaque polyurethane extruded catheter body, a juncture hub, extension lines for each lumen and printed extension line hubs. The extension lines each contain a clamp. 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 material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

The subject device is a CG+ Arrow JACC without a Blue FlexTip that will be provided in sterile kit configurations. A catheter-compatible tunneling device will be offered as an optional kit component. In addition to the catheter tip modification, the printed text on the catheter body and the extension lines has also been modifications, as well as the addition of the tunneling device as an optional kit component, require additions to the recommended procedural technique; procedure steps related to the tunneler and updated graphic representation of the catheter have been included in the instructions for use. All other portions of the catheter design and instructions for use remain unchanged.

The provided text describes a 510(k) premarket notification for a medical device, the ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC). This document outlines the device's characteristics, its comparison to a predicate device, and the nonclinical testing performed to support its substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of quantified numerical targets in the way typically seen for performance evaluation studies (e.g., sensitivity, specificity thresholds). Instead, for this 510(k) submission, the primary acceptance criteria revolve around demonstrating substantial equivalence to a predicate device and confirming that the modifications made do not negatively impact safety or effectiveness. The device performance is reported as "SAME" for most characteristics, indicating that the performance remains consistent with the predicate.

Here's a table summarizing the relevant performance aspects based on the provided text, and the implicit 'acceptance criteria' are that these aspects are substantially equivalent or confirmed to be safe/functional after modifications.

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

The document does not explicitly state "sample sizes" in terms of number of patients or specific items for the nonclinical testing. It only states that "Design verification testing was conducted to mitigate identified risks and is summarized in the submission to support the substantial equivalence of the modified device."

• Test Set Sample Size: Not explicitly stated. The nature of biocompatibility and mechanical testing usually involves a certain number of units or replicates, but these specifics are missing.
• Data Provenance: The testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the data is implied to be where the manufacturer (Arrow International, Inc., subsidiary of Teleflex Inc.) performed their R&D and testing, which is in the USA (Reading, PA). However, this is not formally stated.

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

This type of information (experts, ground truth for a test set) is typically relevant for studies evaluating diagnostic accuracy, where human interpretation is compared against a gold standard. The provided document describes a device modification for a physical medical device (catheter) and the testing outlined is nonclinical (benchtop/in vitro) to demonstrate substantial equivalence in performance and safety characteristics. Therefore, the concept of "experts establishing ground truth" in the clinical imaging sense is not applicable here. The "ground truth" for these tests would be the established scientific methods and engineering specifications for biocompatibility, mechanical properties, etc.

4. Adjudication Method for the Test Set

As the testing is nonclinical and focuses on physical and biological properties rather than human interpretation, a formal "adjudication method" as seen in clinical reader studies (e.g., 2+1, 3+1) is not applicable. The results of the nonclinical tests are compared against predefined engineering specifications or performance of the predicate device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic algorithm or digital health tool on human reader performance. The device in question is a physical central venous catheter, not a diagnostic imaging or AI tool.

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

Not Applicable. This question relates to AI or algorithm performance. The device is a physical catheter, so there is no "algorithm" or standalone software performance to evaluate in this context.

7. The Type of Ground Truth Used

For the nonclinical tests, the "ground truth" would be:

• Biocompatibility: Established ISO standards for biocompatibility (e.g., cytotoxicity, material characterization).
• Mechanical Performance (e.g., tip penetration, detachment force): Engineering specifications, validated test methods, and comparison data from the predicate device.
• Antimicrobial/Antithrombogenic Efficacy: Results from in vitro and in vivo laboratory test methods designed to assess these properties. The document notes that a correlation between these test methods and clinical outcomes has not been ascertained, indicating the ground truth here is the demonstration of efficacy in a controlled lab setting, not necessarily clinical outcome.

8. The Sample Size for the Training Set

Not Applicable. The device is a physical catheter; there is no "training set" in the context of machine learning or AI models.

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

Not Applicable. As there is no training set, this question is not relevant.

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The Arrow Pressure Injectable JACC with Chlorag+ard Antithrombogenic Technology is indicated for short-term (<30 days) or long-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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The Pressure Injectable PICC with Chlorag+ard Antithrombogeaic Technology is indicated for short-term 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 catheter 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 catherer has been shown to be effective in reducing microbial colonization and thrombus accumulation on cather surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these test methods and clinical outcome has currently been ascenained. 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 catheres. 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 Coasole, 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 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 catherer 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 patients where alterations of cardias 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 or saphenous 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 catherer tip location.

The CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

• 5.5 Fr, 2-Lumen, 40-55 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
  The CG+ Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow CG+ PICC 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. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based solution technology. Studies have shown the technology to possess both antimicrobial and antithrombogenic properties.

The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch.

For user convenience, Arrow has created the CG+ Arrow PICC powered by Arrow VPS Stylet in which the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is provided pre-loaded with the Arrow VPS Stylet. To accommodate the VPS stylet, the internal lumen configuration of the predicate Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) has changed from a "Double-D" design to a "Round-Crescent". As a result of the internal lumen design change, the flow rate of the proximal lumen has changed from a maximum rate of 5 ml/sec to 4 ml/sec. The distal lumen flow rate remains the same as the predicate PICC (K112896).

Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than presenting a comprehensive clinical study to establish new performance metrics. Therefore, some of the requested information (like specific acceptance criteria for a novel performance claim, MRMC studies, or detailed ground truth establishment for a large training set) may not be explicitly present or fully detailed as it would be in a clinical trial report.

Acceptance Criteria and Study Details for K123759

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test beyond "testing was performed." The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices (K103255 and K112896). It refers to the testing as "Nonclinical Testing," which typically involves bench testing, material characterization, and simulated use rather than studies on patient data.
• Data Provenance: The studies mentioned are "Nonclinical Testing" and were likely conducted in a laboratory setting by the manufacturer, Arrow International, Incorporated (Subsidiary of Teleflex, Incorporated). No mention of data from specific countries or whether it was retrospective or prospective clinical data is made, as it appears to be primarily bench/engineering testing.

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

• Not Applicable / Not Stated: This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies) where human experts determine ground truth. The presented tests are non-clinical, mechanical, and performance evaluations. The "ground truth" would be objective measurements against defined engineering specifications or the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable / Not Stated: Adjudication methods like "2+1" or "3+1" are used in clinical trials, especially for endpoints requiring human assessment of data. For the non-clinical testing described, results are typically determined by direct measurement, observation, or adherence to test protocols without expert adjudication in the clinical sense.

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: The document describes a medical device (PICC catheter and a stylet for guidance), not an AI system for diagnostic or interpretive purposes. Therefore, an MRMC study or AI assistance effect size is not applicable.

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

• No: The device itself is a physical medical instrument (catheter and stylet), not an algorithm. The VPS Stylet uses physiological information for guidance, but it's part of a human-in-the-loop system (the clinician uses the guidance). There's no AI algorithm operating standalone in the context of this device's submission.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" was established based on:
  • Engineering Specifications: Adherence to predefined mechanical, material, and performance standards.
  • Predicate Device Performance: Demonstrating that the modified device performs equivalently or within acceptable limits compared to the predicate devices (K103255 and K112896).
  • Validated Test Methods: Using established methods to measure parameters like tensile strength, flow rates, leakage, chemical composition, and release rates.

8. The Sample Size for the Training Set

• Not Applicable / Not Stated: This device does not involve a "training set" in the context of machine learning or AI. The testing performed is to validate the physical device's characteristics and performance.

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

• Not Applicable / Not Stated: As there is no training set for an algorithm, this question is not relevant to the described device.

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