(175 days)
The Arrow Antimicrobial Pressure Injectable PICC is indicated for short-term or longterm 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 injector equipment used with the Arrow Antimicrobial Pressure Injectable PICC may not exceed 300 psi. Antimicrobial 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. Antimicrobial effectiveness was evaluated using in vitro methods, and no correlation between in vitro and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
The Arrow Antimicrobial Pressure Injectable 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 is available in 4.5 Fr. single lumen and 5.5 Fr. double lumen configurations with usable lengths of 40 - 55 cm. The catheters 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 antimicrobial technology.
The catheters will be packaged sterile in both nursing and radiology The canoters will be passfigurations will include components to facilitate insertion. .
The Arrow Antimicrobial Pressure Injectable PICC underwent extensive nonclinical (bench, in vitro, and in vivo animal) testing to demonstrate its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Air Leakage during aspiration | No air leakage in the form of an air bubble in the syringe connected to the PICC after the first 5 seconds when tested per BS EN ISO 10555-1:1997 Annex D. All catheters must pass to achieve a 5% LTPD with 95% confidence. | Pass |
| Collapse Resistance | Catheter shall not collapse during aspiration as evidenced by water being able to be pulled out of the catheter when vacuum is applied by a minimum of a 10 cc syringe. The extension line clamps, if present, shall be in the fully constrained position. All catheters must pass to achieve a 5% LTPD with 95% confidence. | Pass |
| Liquid Leakage under pressure | No liquid leakage in the form of a falling drop of water at 300-320 kPa (43.5 -46.4 psi) for 30 sec when tested per BS EN ISO 10555-1:1997 Annex C. All catheters must pass to achieve a 5% LTPD with 95% confidence. | Pass |
| Force at break - Tensile Testing and Catheter Elongation | 95% confidence level that 95% of the population meets the specification. | Pass |
| Tensile attribute | Requirement per BS EN ISO 10555-1 and 10555-3: - Catheter Body Force at Break ≥ 10N - Blue Flex Tip to Catheter Body Force at Break ≥ 4N - Catheter Body to Juncture Hub Force at Break ≥ 10N - Extension Line to Juncture Hub Force at Break ≥ 15N - Extension Line to Luer Hub Force at Break ≥ 15N - Catheter Body Elongation > 100% | Pass |
| Radio-Detectability | The optical density contrast must be at least 0.1. | Pass |
| Catheter Body Kink | Does not kink at a radius greater than 0.5 inch when tested per BS EN 13868:2002 Annex A under simulated in vivo conditions. This requirement shall be met with 95% assurance. | Pass |
| Central Venous Pressure Monitoring | The average amplitude difference between input and output signals shall be less than or equal to 1 mmHg when tested using a 1 Hz sinusoidal input signal. This requirement shall be met with 95% assurance. | Pass |
| Column Strength and Tip Stiffness | For catheters having a tip of different construction to the catheter body, the tip shall be constructed in accordance with requirement 5.1.6 (identical to ISO 10555-3 Section 4.3) and shall be made of lower durometer material than that of the catheter body. Design of tip shall ensure that the average force required to deflect or compress the tip is no greater than the average force required to deflect or compress the catheter body. | Pass |
| Static Burst Pressure | The maximum internal static pressure during pressure injection shall not exceed the static burst pressure. | Pass |
| Rate Limited Injection Testing | Each pressure injectable lumen shall withstand at least 5 repeat injections without rupture or visually evident yielding of the catheter when injected at the maximum indicated flow rate using 125 mL of contrast media or equivalent (maximum viscosity of 11.8 ± 0.2 cP) at 37 ± 2 °C. | Pass |
| Pressure Limited Injection Testing | The average flow rate of each catheter lumen shall be at least 90% of the maximum indicated flow rate. | Pass |
| Ink Adhesion Testing | The catheter shall remain legible when examined without magnification with exposure to ChloroPrep and Iodine for 1 minute each, then application and removal of semi-permeable adhesive dressing and Biopatch after 7 days. The acceptance criteria for meeting this requirement will be a legible marking. | Pass |
| Step Stress Testing | The catheters shall pass the first 10 injections at the maximum flow rate without visually evident yielding or rupture. | Pass |
| Trim Tool | After trimming with the provided trimming tool and visualized under 2.5X magnification, the indwelling catheter shall terminate at the distal end with a square tip that: Has no points, Produces a clean, smooth surface. With a sample size of n=60, zero failures are required to show a 95% confidence level and LTPD=5%. | Pass |
| Luer Hub Slip | The hub shall meet the following Luer slip requirements with 95% confidence and a LTPD of 10% when tested per BS EN 20594-1:1994, ISO 594-1:1986 Clauses 5.1 through 5.5: Gauging, Liquid Leakage, Air Leakage, Separation force, Stress cracking. | Pass |
| Luer Hub Lock | The hub shall meet the following Luer lock requirements with 95% confidence and a LTPD of 10% when tested per BS EN 1707:1997 Clauses 5.2 through 5.8: Gauging, Liquid Leakage, Air Leakage, Separation force, Unscrewing torque, Ease of Assembly to Male Fitting, Resistance to Overriding Male to Female Luer Connection, Stress cracking. | Pass |
| Catheter Securement | The catheter shall include a feature that enables the catheter to be secured to the patient's skin. Demonstrate a 95% confidence level and LTPD=5% by having the suture holes for all catheters fit over the Securement posts with zero failures and the retainer wings from all catheters lock. | Pass |
| First Article Inspection | Distance markings: If provided, shall indicate distance from the distal end. From the first mark, distance between marks shall not exceed 5cm. (BS EN ISO 10555-3: 1997 Section 4.4 and JIS T 3218:2005, Section 5.7). Multilumen identification: Identification of each lumen shall be apparent to the user (BS EN ISO 10555-3:1997, Item 4.5 and JIS T 3218:2005, Item 5.8). French size: Shall be printed on the integral juncture hub or in a location that can be seen after insertion. Manufacturer/tradename: Shall be printed on the integral juncture hub or in a location that can be seen after insertion. | Pass |
| Clamp Closure Efficacy | The clamp closure capability shall be such that when the clamps are in the fully constrained position, there shall be no flow through the lumen being tested when tested in accordance with BS EN ISO 10555-3 Annex A or JIS T 3218 Annex C. | Pass |
| Flow restriction after clamping | The extension lines shall not be permanently deformed from the use of extension line clamps during the maximum expected clamp duration of the catheter to the point where a restriction in the extension line decreases the gravity flow through the catheter below the minimum gravity flow rate requirement (i.e. 90 mL/hr). | Pass |
| In vitro efficacy testing - external antimicrobial treatment | The antimicrobial agent release rate will be sufficiently slow to provide efficacy against gram (+), gram (-) and fungi for a minimum of 7 days. Efficacy will be based upon a minimum 4 log reduction of adherent biomass (microbial colonization) when compared to the initial inoculum concentration. | Pass |
| In vitro efficacy testing - internal antimicrobial treatment | The antimicrobial agent release rate will be sufficiently slow to provide efficacy against gram (+), gram (-) and fungi for a minimum of 7 days. Efficacy will be based upon a minimum 4 log reduction of adherent biomass (microbial colonization) when compared to the initial inoculum concentration. | Pass |
| In vivo animal infection study | The product shall exhibit efficacy against Staphylococcus aureus at minimum 7 days for in-vivo studies. Efficacy will be based upon a minimum 4 log reduction of adherent biomass (microbial colonization) when compared to the initial inoculum concentration. | Pass |
2. Sample size and data provenance for the test set
The document does not explicitly state the exact sample sizes for each test in the provided "Summary of Verification Activities." However, it specifies confidence levels and LTPD (Lot Tolerance Percent Defective) for several tests, indicating sample-based testing.
For example:
- Air Leakage, Collapse Resistance, Liquid Leakage: "All catheters must pass to achieve a 5% LTPD with 95% confidence."
- Force at break: "There must be a 95% confidence level that 95% of the population meets the specification."
- Catheter Body Kink, Central Venous Pressure Monitoring: "This requirement shall be met with 95% assurance."
- Trim Tool: "With a sample size of n=60, zero failures are required to show a 95% confidence level and LTPD=5%."
- Luer Hub Slip/Lock: "with 95% confidence and a LTPD of 10%".
- Catheter Securement: "Demonstrate a 95% confidence level and LTPD=5%".
The data provenance is from nonclinical testing, including bench testing, in vitro testing, and in vivo animal infection studies. No specific country of origin is mentioned for the data, but the testing was performed by Arrow International, Inc. (a subsidiary of Teleflex Inc.) in the USA. These are laboratory studies, not clinical (human) studies.
3. Number of experts and qualifications for ground truth
Not applicable. This submission describes nonclinical "bench" and "in vitro/in vivo animal" testing. There is no mention of experts establishing ground truth for a test set in the context of human data or diagnoses. The "ground truth" for these tests comes from objective measurements and predefined engineering or biological criteria.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for human data (e.g., medical imaging) to establish ground truth. The tests described are objective nonclinical measurements.
5. Multi-reader multi-case (MRMC) comparative effectiveness study
No MRMC study was done. This is a 510(k) summary for a medical device (PICC catheter), focusing on nonclinical safety and performance, not diagnostic effectiveness with human readers.
6. Standalone (algorithm only without human-in-the-loop performance)
This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable. The device's performance was evaluated inherently "standalone" in bench, in vitro, and in vivo animal tests against predefined criteria.
7. Type of ground truth used
The ground truth used for these nonclinical studies is based on:
- Objective physical measurements: Electrical resistance, force at break, optical density, flow rates, pressure measurements, mechanical integrity assessments (e.g., kink resistance, leakage).
- Standardized protocols and specifications: Adherence to ISO standards (ISO 10555-1, 10555-3), BS EN standards (BS EN 13868, BS EN 20594-1, BS EN 1707), JIS T standards (JIS T 3218), and FDA Guidance documents.
- Biological efficacy criteria: For antimicrobial tests, a "minimum 4 log reduction of adherent biomass (microbial colonization)" compared to initial inoculum concentration. This is a predefined microbiological efficacy threshold.
8. Sample size for the training set
Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical 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.”