(103 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 guidewire 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 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 and 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, 18, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
Here's a breakdown of the acceptance criteria and study information for the Arrow Endurance™ Extended Dwell Peripheral Catheter System, based on the provided document:
This document describes a 510(k) submission for a product line extension of an already cleared device, not an entirely new device with a standalone performance study in the traditional sense of evaluating an AI or diagnostic algorithm. Therefore, many of the typical questions for AI/algorithm performance (like sample sizes for test sets, ground truth establishment for training sets, MRMC studies, etc.) are not applicable in this context. The core of this submission is demonstrating substantial equivalence to a previously cleared predicate device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on meeting established international standards and demonstrating functional equivalence to the predicate device. The "reported device performance" is essentially the successful completion of these tests.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria / Standard | Demonstrated Performance / Status |
|---|---|---|
| Biocompatibility | ISO 10993-1, -3, -4, -5, -6, -7, -10, -11, -12 | Testing completed / Device is biocompatible. |
| Physical and Functional Performance (ISO 10555 & 11070 Requirements) | Radio-Detectability | Testing completed / Device is radio-detectable. |
| Surface | Testing completed / Meets surface requirements. | |
| Corrosion Resistance | Testing completed / Device is corrosion-resistant. | |
| Freedom from leakage (Air and Liquid) | Testing completed / Device is free from leakage. | |
| Flow rate | Testing completed / Meets flow rate specifications. | |
| Pressure Injection | Testing completed / Withstands 325 psi. | |
| Tensile Testing | Testing completed / Meets tensile strength requirements. | |
| Blood Containment | Testing completed / Effectively contains blood. | |
| Luer Testing | BS EN 20594-1 (ISO 594-1) & BS EN 1707 | Testing completed / Meets Luer connection standards. |
| Simulated Use | Not specified standard, but indicated as a test | Testing completed / Performs as intended in simulated use. |
| Penetration/Insertion Force | Not specified standard, but indicated as a test | Testing completed / Meets penetration/insertion force requirements. |
| Sharps Safety Feature | CDRH Sharps Guidance and ISO 23908 | Testing completed / Safety feature performs as intended. |
| Catheter Kink Resistance | BS EN 13868 | Testing completed / Device is kink-resistant. |
Study Details (as applicable to a 510(k) of this nature)
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an algorithm's performance with a specific number of patient cases. Instead, it refers to bench testing performed on physical samples of the new catheter configurations (18 gauge and 22 gauge, 6cm and 8cm lengths).
- Data Provenance: The testing was conducted by Arrow International, Inc.
- The nature of the testing is retrospective in the sense that physical samples were manufactured and then subjected to various engineering and biological tests. It is not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study involving human interpretation of data where ground truth is established by experts (e.g., radiologists). The "ground truth" for these tests is defined by engineering specifications, international standards (ISO, EN), and regulatory guidance (CDRH).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human interpretations or disagreements to resolve, no adjudication method is used.
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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:
- Not Applicable. This device is a peripheral catheter system, a physical medical device, not an AI or diagnostic tool. Therefore, no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of the catheter is based on engineering specifications, established international standards (ISO, EN), and regulatory guidance (CDRH Sharps Guidance). For example, passing particular flow rate tests, achieving specific tensile strength, or demonstrating a certain level of biocompatibility according to defined protocols and limits.
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of machine learning for this physical device.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an algorithm, this question is not relevant.
§ 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).