(21 days)
The intended use of the Arrow VPS Stylet PLUS and VPS Console (together the VPS System) is to quickly and accurately 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 Catheters powered by Arrow VPS Stylet PLUS permit venous access to the central circulation through a peripheral vein, with the guidance of the VPS system.
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 cather , intravascular capability for ECG delection and intravascular ultrasound for catheter guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catherer in location information by using the patient's physiological (cardiae 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 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 contraincied situations for this technique are in patients where allerations of cardias the presentation of the P-waye 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 Pwave. 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 Pressure Intectable PICC with Chlorag+ard Aniithombogenic Technology is indicated for short-lerm or long-term peripheral access to the central venous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure of 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 entire fluid patiway of the catheler has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheler surfaces. Antimicrobial and antitlersmoogenic effectiveness were evaluated using in viro and in vive test methods and no correlation between these test methods and clinical outcome has currently been asseriained. It is not intented 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 intravascular ultrasound for catherer guiding and positioning. The VPS Style, when used with the VPS Console, provides real-time catheter ip location information by using the patient's physiological (cardial 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 allemative 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 patientions of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachyeardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the Pwave. 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 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 cavoatrial junction. The CG+ Arrow PICC powered by Arrow VPS Stylet PLUS provides the user with an Arrow VPS Stylet PLUS aiready 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 a 510(k) submission for the Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS. It is a submission for substantial equivalence to previously cleared devices, meaning the focus of the study is to demonstrate that the new device performs as well as the predicate device(s), rather than establishing new clinical effectiveness. Therefore, the information provided below is extracted based on the nature of this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission seeking substantial equivalence for a medical device that has minor changes from existing predicate devices, the "acceptance criteria" are typically defined by demonstrating that the modified device performs comparably to the predicate device and meets established engineering and biocompatibility standards. Clinical performance is generally not evaluated with new efficacy endpoints unless the changes introduce new risks or intended uses. In this case, the acceptance criteria are largely implied by the PASS results in the nonclinical testing, indicating the device meets the set standards for each test.
| Acceptance Criteria (Implied by Test) | Reported Device Performance |
|---|---|
| Mechanical strength (Tensile, Torque, Tip Flexibility, Flexing, Fracture) | PASS |
| Corrosion resistance | PASS |
| Component compatibility & grip strength (Marking accessory, Tuohy-Borst Adapter) | PASS |
| Leak integrity (Tuohy-Borst) | PASS |
| Physical characteristics met | PASS |
| X-ray Detectability | PASS |
| Electrical Performance (Hi-Pot, Continuity, Doppler Bandwidth, Capacitance, Sensitivity, Sensitivity Stability) | PASS |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Hemocompatibility) | PASS |
| Electrical Safety and Electromagnetic Compatibility | PASS |
| Catheter Compatibility (Simulated Use Insertion/Removal, Force to Remove stylet) | PASS |
| Substantial Equivalence to Predicate Device | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a 510(k) submission for substantial equivalence based on nonclinical testing, there is no "test set" of clinical data in the typical sense (i.e., a set of patient data used to evaluate clinical accuracy or performance metrics against a ground truth). The testing conducted was primarily bench testing and laboratory testing on the device itself.
- Sample Size: The document does not specify exact sample sizes for each nonclinical test (e.g., how many stylets were tested for tensile strength). These are typically determined by engineering and quality control standards.
- Data Provenance: The data is generated from laboratory and bench testing performed on the Arrow VPS Stylet PLUS and the CG+ Arrow PICC powered by Arrow VPS Stylet PLUS. The origin of the data is the manufacturer's internal testing. It is not patient or country-specific. The testing was performed after preconditioning with Et.O sterilization, ISTA simulated environmental conditions, and one year of accelerated aging.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this submission. "Ground truth" in the context of expert consensus is typically relevant for studies evaluating diagnostic accuracy or clinical outcomes where human experts interpret data. This 510(k) submission focuses on demonstrating the device's technical specifications and safety through nonclinical testing, not on clinical interpretation or an AI algorithm's performance against human experts.
4. Adjudication Method for the Test Set
This section is not applicable as there was no clinical test set requiring adjudication by experts. The "adjudication" in this context would be the successful completion of each nonclinical test according to predefined engineering and safety standards, as indicated by the PASS results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the impact of an AI system on human reader performance, which is not the focus of this 510(k) submission for mechanical and electrical device changes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described (Arrow VPS Stylet PLUS) is a physical medical instrument used to guide catheters and provides real-time information to a "VPS Console." While the VPS Console likely contains algorithms to process the ivECG and Doppler signals, this submission focuses on the stylet itself. Therefore, a "standalone algorithm performance" study in the context of AI models is not relevant or described in this document. The electrical performance tests (Hi-Pot, Continuity, Doppler Bandwidth, Capacitance, Sensitivity, Sensitivity stability) assess the functionality of the device's signal-sensing components, which are essential for the console's operation.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical testing performed can be defined as:
- Engineering Specifications and Standards: Each test (e.g., tensile strength, electrical performance, biocompatibility) has predefined, objective acceptance criteria (e.g., a minimum tensile strength, a specific range for electrical resistance, absence of cytotoxic effects) based on international standards (e.g., ISO, ASTM, IEC) and the manufacturer's own design specifications.
- Predicate Device Performance: A key aspect of "substantial equivalence" in a 510(k) is demonstrating that the new device performs "as well as" the predicate device(s). Therefore, the performance characteristics of the legally marketed predicate devices serve as an implicit "ground truth" or benchmark for comparison in the nonclinical testing.
8. The Sample Size for the Training Set
This section is not applicable. This submission describes a physical medical device and its nonclinical testing to demonstrate substantial equivalence, not the development or training of an AI algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for an AI algorithm.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).