(30 days)
The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic 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 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 methods 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 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 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 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 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 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 catheter tip location.
The CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:
- 4.5 Fr, 1-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 Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology 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.
The provided 510(k) summary (K122545) describes a device, the "CG+ Arrow PICC powered by Arrow VPS Stylet," which is a combination of two previously cleared predicate devices: the Vascular Positioning System (VPS System) Stylet (K103255) and the Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896).
Crucially, this submission is for a combination device, not a new AI/software-as-a-medical-device (SaMD) product. The 510(k) summary explicitly states: "The subject device combines the predicate Arrow VPS Stylet and the Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology; there is no change to the previously cleared devices or their indications for use."
Therefore, the document does not report on a study proving the device meets new acceptance criteria for an AI or SaMD component. Instead, the nonclinical testing performed focused on ensuring that combining the two previously cleared devices did not introduce new safety or effectiveness issues.
Given this context, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/SaMD are not applicable or not present in this document.
However, I can extract the relevant information based on the nature of this 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a combination of pre-approved physical devices, the "acceptance criteria" and "reported device performance" are primarily related to the physical integrity and continued functionality of the combined product. There are no specific performance metrics like sensitivity, specificity, accuracy, or AUC typically associated with AI/SaMD.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Catheter Performance | Passed tests for air and liquid leakage. |
| Stylet Performance | Passed tests for tensile strength, electrical function, and removal. |
| Combined Device Performance | Passed simulated use insertion/removal test. |
| Substantial Equivalence | Demonstrated that combining the two previously cleared devices does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the "test set" in the context of typical AI/SaMD validation (e.g., number of images or patient cases). The testing described is nonclinical, involving engineering and bench testing.
- Sample Size: Not specified in terms of distinct units or cases. The testing would have involved appropriate numbers of devices/components to satisfy engineering test standards for the mentioned performance categories.
- Data Provenance: Not applicable as it's nonclinical, bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for these nonclinical tests would be established by engineering specifications, physical measurements, and adherence to established test protocols. No human expert interpretation of data for ground truthing is described or required for this type of submission.
4. Adjudication Method for the Test Set
Not applicable. Adjudication is not typically part of standard nonclinical engineering bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission does not involve such an AI component.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical catheter and stylet; it is not a standalone algorithm.
7. The Type of Ground Truth Used
For the nonclinical testing, the "ground truth" would be objective engineering measurements and compliance with predetermined physical and mechanical specifications. For example, for air and liquid leakage, the ground truth is "no leakage" beyond an acceptable threshold. For tensile strength, it's maintaining integrity under a specified load.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI/ML algorithm is involved.
In summary, the K122545 submission is for a combined medical device, not an AI or SaMD product. The testing performed focused on ensuring the physical and functional integrity of the combined components, and therefore, the document does not contain the specific details relevant to AI/SaMD performance validation.
§ 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.”