(28 days)
The Pressure Injectable PICC with Chierobial and Antitrombogenic Technology is indicated for short-erm or long-erm 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 injection equipment used with the pressure injectable PCC cathere may not exceed 300 psi.
Chlorageard Technology treament on the cather of the cather fluid pathway of the cather ins been shown to be effective in reducing microbial colonization on cather surfaces. Antimicrobial and antitrombial and antithrombogenic effectiveness were evaluated using in viro test methods and no correlation between these est methods and clinical outcome has currently been ascerained. It is not intended to be used for the treatment of existing intections or vein thrombosis.
The VPS Stylet and Console are indicated for guidening for central venous cathers. The Stylet provides stiffiess for use in placement of the catherer, intravascular conding and intravascular ultrasond for cathere guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time cather in lormation by using the patient's physiological (cardias electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Dullseye, 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 contraction of in adult patients when a steady Blue Bullsey. If a stedy Blue Bullseye is not oblained, standard hospital practice should be followed to confirm catheter tip location.
Limiting but not contraindicated situations for this technique of earlier there allerations of cardiac the presentation of the Pwave as in attial fibrillation, arial flutter, severe achyandian driven rhythm, and in central venous catherization procedures performed through femoral or saphenous vein access which change the presents, who are easily identifiable prior to central venous catherer 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:
- 6 Fr, 3-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 6 mL/sec. The external catheter body and the internal fluid path of the device are treated with Chlorhexidine based coating 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.
The number of lumens has increased from 2 to 3 and as a result the subject device is French size has increased from 5.5 to 6 French. In order to identify the third lumen, an additional colorant and ink were used. Additionally, the internal lumen configuration of the predicate (K123759) has changed from a "Round-Crescent" to a "Round-Split-Crescent". The "Round-Split-Crescent" internal lumen design modification resulted in an increased flowrate in the distal lumen from a maximum of 5 ml/sec. (The proximal and medial lumen are not pressure injectable on the subject device.) The increased surface area on the subject device's 6 French 3-L catheter design resulted in a 3.8 mg increase in the maximum allowable chlorhexidine content as compared to the predicate device (the content per surface area remains unchanged).
The provided text is a 510(k) summary for the "CG+ Arrow PICC powered by Arrow VPS Stylet." It describes the device, its intended use, technological characteristics, and nonclinical testing performed. However, it does not detail specific acceptance criteria or the study that explicitly proves the device meets those criteria in the format requested.
The document states that the new device (6 French, 3-Lumen) is "substantially equivalent" to a predicate device (K123759, 5.5 French, 2-Lumen) due to minor modifications that do not raise new safety or effectiveness concerns. The nonclinical testing performed primarily verified that these modifications (increased lumen count, size, and associated chlorhexidine content increase) did not negatively impact performance or safety.
Therefore, many of the requested sections (e.g., specific acceptance criteria, reported performance against those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance details, and ground truth establishment) cannot be directly extracted from this document as it focuses on demonstrating substantial equivalence based on nonclinical testing rather than clinical efficacy against defined acceptance criteria.
Missing Information:
- Specific quantitative acceptance criteria for device performance.
- A comparative study demonstrating the device meets explicit acceptance criteria.
- Sample sizes for test sets where clinical performance is evaluated.
- Data provenance for such clinical tests.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Details of any MRMC comparative effectiveness study, including effect size.
- Details of any standalone algorithm performance study.
- Type of ground truth used (clinical outcomes, pathology, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
Information Extracted from the Document (where applicable to the questions):
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with specific quantitative targets and reported performance against them in the context of clinical efficacy or accuracy. Instead, it relies on demonstrating that modifications to the predicate device did not negatively impact existing performance characteristics based on nonclinical testing.
Nonclinical Testing Performed & Verification:
| Test Category | Specific Tests | Conclusion (demonstrates equivalence/no new concerns) |
|---|---|---|
| Chlorhexidine Coating | Chlorhexidine content testing, chlorhexidine coating efficacy, chlorhexidine release rate (elution), mechanical hemolysis, solvent residual, chemical degradation. | The increased surface area resulted in a 3.8 mg increase in maximum allowable chlorhexidine content, but the content per surface area remained unchanged, and efficacy was verified as unaffected. |
| Catheter Performance | Tensile, catheter body kink, flow rate, static burst pressure, air and liquid leakage, flex cycling, catheter whip, catheter tip compression stiffness, luer hub testing, collapse resistance, central venous pressure monitoring. The distal lumen's flow rate increased from 5 ml/sec due to the lumen design change. | These tests verified the physical and functional integrity of the catheter. The increased flow rate in the distal lumen was a result of the design change, not a specific acceptance criterion mentioned. |
| Combined Device Performance | Stylet tensile, simulated use insertion/removal test, force to remove stylet from catheter. Post-simulated use tests: catheter air and liquid leakage, stylet electrical testing. | These tests verified the safe and effective interaction between the catheter and the VPS Stylet after simulated use, ensuring no damage and continued stylet function. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is "Nonclinical Testing," implying laboratory-based or bench testing, not clinical studies with human subjects or patient data.
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)
This information is not applicable as the document describes nonclinical, laboratory-based testing rather than studies requiring expert ground truth for clinical diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes nonclinical, laboratory-based testing.
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
This information is not applicable. The device is a physical medical device (PICC catheter and stylet system) and not an AI-powered diagnostic or assistive tool for human readers in the context of image interpretation. The VPS Stylet aids in guidance during catheter placement using physiological signals, not in reading or interpreting clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the context of an algorithm's diagnostic performance. The VPS Stylet and Console system does provide "real-time catheter tip information" and a "guidance indicator (Blue Bullseye)" based on "physiological (cardiac electrical activity and blood flow) information." This can be seen as standalone guidance performance, where the system provides an indicator of desired tip location without human interpretation of raw physiological signals. However, the document does not present a formal study of its standalone "accuracy" against a gold standard for tip placement in terms of a specific performance metric. Instead, it states the VPS System is "indicated for use as an alternative method to fluoroscopy or chest x-ray for confirmation... when a steady Blue Bullseye" is obtained, inferring its standalone guidance capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical testing, the "ground truth" or reference was likely defined by engineering specifications, material standards, and validated laboratory test methodologies. For the VPS Stylet's function of guiding catheter tip placement, the implicit ground truth for its "Blue Bullseye" indication would be the actual anatomical location of the catheter tip (e.g., lower third of SVC or cavo-atrial junction), which can be confirmed by "standard hospital practice" such as fluoroscopy or chest x-ray. However, the document does not detail studies comparing the Blue Bullseye to such gold standards, but rather states its indication as an alternative method.
8. The sample size for the training set
This information is not provided and is likely not applicable as this is not an AI/ML-based device that would typically have a separate "training set" in the conventional sense. The "training" for such a system would involve engineering development and calibration of the physiological sensing and analysis algorithms.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.”