(77 days)
The Arrow® Pessure Injectable Jugalarian Central Catherer™ with Chlorag+ard Antimicrobial and Antithrombagenc Technology is indicated for short-tern access to the central venous system for intrasenous therapy. blood sampling, infusion, pressure injection of contrast media and allows for contrasion The maximum pressure of pressure injector quipment used with the Arrow Pressure Injectable 1900 psi. The marimum pressure injection 110ve rate for the specific lumen heing used for pressure injection is printed on the extension line hub.
Chionageurd Technology treatment on the cathere of the cathere body as well as the entire fibid pathway of the catherer has been shown to be citective in reducing microbial colonization on cathers. Antimierobial cities were evaluated using in ritre and in rive and in rive and in rive and in rive and in rive methods and no correlation between these esting methods and clinical outcome has currently been assertained. It is not intended to be used for the treatment of existing infections.
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheress for use in placement of the cather. intravascular espability for ECG devection and intravascular ultrasound for eatherer guiding and passioning. The VPS Stylet, when used with the VPS Console, provides real-time catherer information by using the patient's physiological (curdize clectrical activity and blow) 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 sherative method to Internation venus cather up placement confirmation in add patients when a steady Blue Bullseye is obtained, NOTE: IT's steady Blue Bullained, standard haspital proctive should be followed to confirm catherer tip location.
Limiting but not contraindiented situations for this receivers where alterations of cardiae thythm change the presentation of the fwave as in atial fibrillation, arrial flutter severe achycardia and pacental venous catherization procedures performed through femoral or suphenous vein access which of the P-vave. 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 JACC powered by Arrow VPS Stylet has the following characteristics:
- . 4.5 French, 1-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
- . 5.5 French, 2-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
- . 6 French, 3-Lumen, 15-35 cm pressure injectable, antimicrobial and antithrombogenic catheter preloaded with VPS Stylet
The CG+ Arrow JACC powered by Arrow VPS Stylet is a CG+ Arrow JACC pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations. The CG+ Arrow JACC devices will also be provided in sterile kit configurations without the Arrow VPS Stylet preloaded in the catheter.
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 coating technology.
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 is designed to be compatible with any catheter with an inner luminal diameter of at least 0.021 inch.
The provided text is a 510(k) summary for the "CG+ Arrow JACC powered by Arrow VPS Stylet." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with defined metrics for the device itself.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI/algorithm performance, cannot be fully extracted from this document in the way it would for a software device with performance claims. The document is primarily a comparison against existing hardware devices.
However, I can provide the information available that most closely aligns with your request, focusing on the verification testing performed.
Summary of Device and its Purpose:
The "CG+ Arrow JACC powered by Arrow VPS Stylet" combines a Central Venous Catheter (CG+ Arrow JACC) with a Vascular Positioning System (VPS) Stylet. The VPS Stylet, used with a console, guides the catheter to the desired location (lower third of the SVC or cavo-atrial junction) using Doppler and intravascular electrocardiogram (ivECG) signals.
1. Table of Acceptance Criteria and Reported Device Performance
As this document is a 510(k) for substantial equivalence of a hardware device (catheter and stylet), it does not present acceptance criteria in the typical format of a standalone performance study for an AI/algorithm, with metrics like AUC, sensitivity, or specificity. Instead, it describes verification testing performed to ensure the device meets engineering and safety specifications, demonstrating equivalence to predicate devices.
The "acceptance criteria" can be inferred from the need for the device to perform "the same" or comparably to its predicates in various tests. The "reported device performance" is a statement that these tests were performed and the device passed, leading to the conclusion of substantial equivalence.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Chlorhexidine Coating Testing: | |
| - Chlorhexidine content (Internal, External, Total Maximum) | - "SAME" as predicate devices for 4.5 and 5.5 Fr catheters. New 6 Fr catheter: Internal Content: 13-36 µg/cm; External Content: 205-309 µg/cm. Total Max Content: "SAME" (Maximum of 22.2 mg/catheter). |
- Testing performed for content. |
| - Chlorhexidine coating efficacy (Antimicrobial, Antithrombogenic) | - "SAME" as predicate device ("Effective in reducing microbial colonization," "Antithrombogenic Efficacy"). - Testing performed for efficacy. |
| - Chlorhexidine release rate (elution) | - Testing performed. |
| - Mechanical Hemolysis | - Testing performed. |
| - Solvent Residual | - Testing performed. |
| - Chemical Degradation | - Testing performed. |
| Catheter Performance Testing: | |
| - Tensile strength | - Testing performed. |
| - Catheter body kink resistance | - Testing performed. |
| - Flow rate (Max infusion rate, Pressure injection capabilities) | - Max infusion rate: 1-Lumen: 5 mL/sec; 2-Lumen: 5 mL/sec; 3-Lumen: 6 mL/sec. - Pressure Injection: 1-Lumen Distal: 5 mL/sec (SAME); 2-Lumen Distal: 5 mL/sec (SAME), Proximal: 4 mL/sec; 3-Lumen Distal: 6 mL/sec, Proximal/Medial: No Pressure Injection. Testing performed. |
| - Static burst pressure | - Testing performed. |
| - Air and liquid leakage | - Testing performed. |
| - Flex cycling | - Testing performed. |
| - Catheter whip | - Testing performed. |
| - Catheter tip compression stiffness | - Testing performed. |
| - Luer hub testing | - Testing performed. |
| - Collapse resistance | - Testing performed. |
| - Central venous pressure monitoring | - Testing performed. |
| Combined Device Performance Testing (Catheter + VPS Stylet): | |
| - Stylet tensile strength | - Testing performed. |
| - Simulated use insertion/removal (Force to remove stylet from catheter) | - Testing performed. |
| - Post-insertion/removal catheter air and liquid leakage | - Testing performed. |
| - Stylet electrical testing | - Testing performed. |
| Overall (from "Conclusions" section): | The results of the risk assessment and resultant testing performed have demonstrated that the proposed design and specification changes do not raise new issues of safety or effectiveness and therefore the subject device is considered substantially equivalent to the cited predicate devices. This implies all tests were passed to demonstrate no new safety/effectiveness concerns. |
No information is provided for the following points as they are generally related to AI/algorithm performance studies, which this document does not contain:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
The document only states that "Antimicrobial efficacies were evaluated using in vitro and in vivo methods" for the Chlorag+ard technology on the catheter, but does not provide details on sample sizes, ground truth, or expert involvement for these specific tests. The VPS Stylet's function is described as providing "real-time catheter information by using the patient's physiological (cardiac electrical activity and blood) information," leading to a "Blue Bullseye" indicator, but no performance metrics for this guidance system itself are provided beyond acknowledging its indication and an alternative method for tip placement confirmation.
§ 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).