(27 days)
The Pressure Injectable PICC with Chlorag+ard Antithrombogeaic 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 catherer has been shown to be effective in reducing microbial colonization and thrombus accumulation on cather 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 ascenained. 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 catheres. The Stylet provides stiffess 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 Coasole, 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 catherer 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 cardias 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 catherer tip location.
The CG+ Arrow PICC powered by Arrow VPS Stylet has the following characteristics:
- 5.5 Fr, 2-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 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. To accommodate the VPS stylet, the internal lumen configuration of the predicate Arrow Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology (K112896) has changed from a "Double-D" design to a "Round-Crescent". As a result of the internal lumen design change, the flow rate of the proximal lumen has changed from a maximum rate of 5 ml/sec to 4 ml/sec. The distal lumen flow rate remains the same as the predicate PICC (K112896).
Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than presenting a comprehensive clinical study to establish new performance metrics. Therefore, some of the requested information (like specific acceptance criteria for a novel performance claim, MRMC studies, or detailed ground truth establishment for a large training set) may not be explicitly present or fully detailed as it would be in a clinical trial report.
Acceptance Criteria and Study Details for K123759
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Summary from text) |
|---|---|---|
| PICC Catheter Performance | ||
| Maximum Pressure Injection Rate (Proximal Lumen) | Not explicitly stated as a separate acceptance criterion, but the change from predicate is acknowledged. | Reduced from 5 mL/sec (predicate) to 4 mL/sec (subject device). |
| Maximum Pressure Injection Rate (Distal Lumen) | Must be equivalent to predicate. | Remains 5 mL/sec (same as predicate K112896). |
| Tensile Strength (Catheter) | Not explicitly quantified, but implied to be acceptable for safe use. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Catheter Body Kink Resistance | Not explicitly quantified, but implied to be acceptable for safe use. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Flow Rate (Catheter) | Not explicitly quantified beyond pressure injection, but implied to be acceptable for intended use. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Static Burst Pressure (Catheter) | Not explicitly quantified, but implied to be acceptable for safe use. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Air and Liquid Leakage (Catheter) | Must prevent air/liquid leakage. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Flex Cycling (Catheter) | Must withstand repeated flexing. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Catheter Whip Stability | Must be stable during use. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Catheter Tip Compression Stiffness | Must meet stiffness requirements. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Collapse Resistance (Catheter) | Must resist collapse. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| CVP Monitoring Capability | Must allow for CVP monitoring. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Chlorhexidine Solution Performance | ||
| Chlorhexidine Content | Must meet specifications (formulation, total content, content per surface area). | Specifications remain unchanged from predicate. Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Chlorhexidine Solution Efficacy | Must demonstrate antimicrobial/antithrombogenic properties. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Chlorhexidine Release Rate (Elution) | Must meet specifications. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Solvent Residual | Must be within acceptable limits. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Chemical Degradation | Must be within acceptable limits. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Combined Device Performance (PICC + VPS Stylet) | ||
| Stylet Tensile Strength | Not explicitly quantified, but implied for safe use. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Simulated Use Insertion/Removal | Must allow for successful insertion and removal without damage. | Testing performed to evaluate; subsequent tests (leakage, electrical) verified no damage. |
| Force to Remove Stylet from Catheter | Must allow for appropriate removal force. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Stylet Electrical Testing (after simulated use) | Must maintain electrical integrity. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| Catheter Air and Liquid Leakage (after simulated use) | Must prevent air/liquid leakage. | Testing performed; results led to conclusion of no new safety/effectiveness issues. |
| VPS System (Stylet and Console for tip positioning) | ||
| Guidance for Catheter Tip Location (Blue Bullseye) | When a steady Blue Bullseye is obtained, the catheter tip is in the desired location (lower third of SVC or cavo-atrial junction). | The VPS System (stylet and console) provides real-time catheter tip location information using cardiac electrical activity and blood flow. The Blue Bullseye indicates the desired location. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test beyond "testing was performed." The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices (K103255 and K112896). It refers to the testing as "Nonclinical Testing," which typically involves bench testing, material characterization, and simulated use rather than studies on patient data.
- Data Provenance: The studies mentioned are "Nonclinical Testing" and were likely conducted in a laboratory setting by the manufacturer, Arrow International, Incorporated (Subsidiary of Teleflex, Incorporated). No mention of data from specific countries or whether it was retrospective or prospective clinical data is made, as it appears to be primarily bench/engineering testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Stated: This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies) where human experts determine ground truth. The presented tests are non-clinical, mechanical, and performance evaluations. The "ground truth" would be objective measurements against defined engineering specifications or the performance of the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable / Not Stated: Adjudication methods like "2+1" or "3+1" are used in clinical trials, especially for endpoints requiring human assessment of data. For the non-clinical testing described, results are typically determined by direct measurement, observation, or adherence to test protocols without expert adjudication in the clinical sense.
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
- No: The document describes a medical device (PICC catheter and a stylet for guidance), not an AI system for diagnostic or interpretive purposes. Therefore, an MRMC study or AI assistance effect size is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- No: The device itself is a physical medical instrument (catheter and stylet), not an algorithm. The VPS Stylet uses physiological information for guidance, but it's part of a human-in-the-loop system (the clinician uses the guidance). There's no AI algorithm operating standalone in the context of this device's submission.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" was established based on:
- Engineering Specifications: Adherence to predefined mechanical, material, and performance standards.
- Predicate Device Performance: Demonstrating that the modified device performs equivalently or within acceptable limits compared to the predicate devices (K103255 and K112896).
- Validated Test Methods: Using established methods to measure parameters like tensile strength, flow rates, leakage, chemical composition, and release rates.
8. The Sample Size for the Training Set
- Not Applicable / Not Stated: This device does not involve a "training set" in the context of machine learning or AI. The testing performed is to validate the physical device's characteristics and performance.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Stated: As there is no training set for an algorithm, this question is not relevant to the described device.
§ 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.”