(34 days)
The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.
The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. Throughout catheter insertion, blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization platform with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub. vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device.
The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood.
The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arrow Endurance™ Extended Dwell Peripheral Catheter System:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided here lists various tests performed to demonstrate substantial equivalence, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it states that "Bench testing performed on the Arrow Endurance™ Extended Dwell Peripheral Catheter System supports substantial equivalence of the subject device." The "reported device performance" is implicitly that the device met the requirements of the standards listed.
However, we can infer some performance aspects from the table of technological characteristics and the nonclinical testing section:
| Acceptance Criteria (Inferred from standards/benchmarking) | Reported Device Performance (Implicitly met or stated) |
|---|---|
| Material & Biocompatibility: | |
| Biocompatible (ISO 10993-1) | Tested and found biocompatible |
| Catheter Material: Polyurethane | Polyurethane (same as predicate) |
| Radiopacity: 20% Barium Sulfate | 20% Barium Sulfate (same as predicate where specified) |
| Functional Performance: | |
| Radio-Detectability (ISO 10555, ISO 11070) | Tested and found satisfactory |
| Surface (ISO 10555, ISO 11070) | Tested and found satisfactory |
| Corrosion Resistance (ISO 10555, ISO 11070) | Tested and found satisfactory |
| Freedom from leakage (Air and Liquid) (ISO 10555, ISO 11070) | Tested and found satisfactory |
| Flow rate (ISO 10555, ISO 11070) | Tested and found satisfactory |
| Pressure Injection: Max 325 psi | Capable of 325 psi (higher than one predicate's 300 psi) |
| Tensile Testing (ISO 10555, ISO 11070) | Tested and found satisfactory |
| Blood Containment | Bloodless (seal and extension line) (similar to one predicate) |
| Luer testing (BS EN 20594-1/ISO 594-1 & BS EN 1707) | Tested and found satisfactory |
| Simulated Use testing | Tested and found satisfactory |
| Penetration/Insertion force | Tested and found satisfactory |
| Catheter Kink resistance (BS EN 13868) | Tested and found satisfactory |
| Safety Features: | |
| Sharps Safety Feature performance (CDRH Sharps Guidance, ISO 23908) | Tested and found satisfactory (device has passively-activated needle protection mechanism) |
| Blood Safety Feature: Bloodless | Present (seal and extension line) |
| Sterilization: | |
| Sterilization Method: EO | EO (Ethylene Oxide) |
2. Sample Size Used for the Test Set and Data Provenance
The document provides information on nonclinical (bench) testing. It does not specify the sample sizes used for each of the listed tests (e.g., how many catheters were tested for flow rate, tensile strength, etc.).
There is no mention of a clinical test set for evaluating device performance in humans. The testing described is entirely non-clinical bench testing.
Therefore, "data provenance" in terms of country of origin or retrospective/prospective does not apply here as it's not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The device validation summarized here relies on bench testing and adherence to international standards (ISO, BS EN), not on expert human interpretation of clinical outputs or images. The "ground truth" for these engineering and material tests is defined by the specific requirements and measurement methodologies outlined in the referenced standards.
4. Adjudication Method for the Test Set
This question is not applicable as there is no human interpretation or subjective assessment framework described for the bench tests. Performance is measured against physical or chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission describes nonclinical bench testing to demonstrate substantial equivalence, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a physical medical device (catheter system), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
For the nonclinical testing, the "ground truth" is defined by:
- International and national standards: e.g., ISO 10993-1 (Biocompatibility), ISO 10555 (Sterile, single-use intravascular catheters), ISO 11070 (Sterile, single-use introducers), BS EN 20594-1 (Luer fittings), BS EN 1707 (Luer slip fittings), BS EN 13868 (Catheter kink resistance), ISO 23908 (Sharps injury protection).
- CDRH Sharps Guidance: Specific guidance from the FDA's Center for Devices and Radiological Health regarding sharps safety.
- Engineering specifications and design requirements: As determined by Arrow International for the device's functional aspects like flow rate, tensile strength, and pressure limits.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical device. There is no AI algorithm being trained, therefore no training set is relevant here.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as above.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).