(71 days)
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) 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.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Catheter Length | Maintain previous range or justify new range. | 35 cm only (changed from 15-35 cm) |
| Catheter OD | Substantially equivalent to predicate. | SAME (4.5, 5.5, and 6 Fr) |
| Number of Lumens | Substantially equivalent to predicate. | SAME (1, 2, and 3 Lumen) |
| Internal Lumen Configuration | Functional equivalence to predicate. | One configuration removed (2 Lumen - Round-Crescent), others are SAME. Justification implicit that removed configuration is not necessary for equivalence. |
| Pressure Injection Capabilities | Maintain flow rates and pressure limits. | SAME. Max pressure injector equipment not to exceed 300 psi (2068.4 kPa). Flow rates match predicate. |
| Catheter body material | Substantially equivalent to predicate. | SAME (Radiopaque polyurethane) |
| Catheter Juncture Hub Material | Substantially equivalent to predicate. | SAME (Blue polyurethane) |
| Catheter Tip Design and material | Safe and functionally equivalent to predicate (especially when trimmed). | Non Blue FlexTip; blunt tip (integral with and same material as the catheter body and equivalent to a trimmed predicate CG+ Arrow JACC). This is a modification. |
| Catheter trimmable? | Maintain existing functionality. | SAME (Yes) |
| Extension Line Material | Substantially equivalent to predicate. | SAME (Clear polyurethane) |
| Extension Line Hub Material | Substantially equivalent to predicate. | SAME (Distal - Pink polyurethane, Proximal - White Polyurethane, Medial - Blue Polyurethane) |
| Printing Ink | Substantially equivalent to predicate. | SAME (2405 Black Ink and White Ink) |
| Sterilization | Substantially equivalent to predicate regarding sterility and method. | SAME (Provided Sterile. Sterilized by Ethylene Oxide.) |
| Antimicrobial Efficacy | Effective in reducing microbial colonization on catheter surfaces (as demonstrated by in vitro and in vivo methods). | Effective in reducing microbial colonization on catheter surfaces. (Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods, but no correlation between these testing methods and clinical outcome has currently been ascertained.) |
| Antithrombogenic Efficacy | Effective in reducing thrombus accumulation on catheter surfaces. | Effective in reducing thrombus accumulation on catheter surfaces. |
| Tunneler Compatibility | Safe and functionally compatible when used as an accessory. | Can accommodate a tunneler accessory which is specifically designed for use with the catheter to facilitate the tunneled insertion technique. This is an addition. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Biocompatibility (Tunneler Device) | No cytotoxicity, corrosion resistance, appropriate tip penetration, no extraneous matter. | Testing performed for Cytotoxicity (L929 MEM Elution O), Corrosion Resistance, Tip Penetration, and Extraneous Matter. Results are summarized as supporting substantial equivalence. |
| Tunneler device/Catheter Compatibility | Tunneler detaches from catheter without damage to catheter. | Testing performed for Tunneler detachment force from catheter and Catheter not damaged by tunnel disconnection. Results are summarized as supporting substantial equivalence. |
| Catheter Priming Volume | Accurate data for labeling purposes. | Determined for labeling purposes only. |
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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”