(266 days)
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.
The catheters will be packaged sterile in kits that will include components to facilitate insertion.
The provided text is a 510(k) summary for a medical device (Arrow® Pressure Injectable Midline Catheter) and does not describe acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets said criteria. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, and sterilization/packaging testing.
Therefore, most of the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.
However, I can extract the information that is present about the device's characteristics and the types of non-clinical tests performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria (e.g., "Pass if flow rate >= X mL/s") or specific reported performance values resulting from the tests. Instead, it indicates that "Non-clinical testing related to the device changes has been completed to support the substantial equivalence." This implies that the device met the internal and standard-based requirements for these tests to demonstrate equivalence, but the precise thresholds and results are not detailed.
| Test Category | Standard / Description | Implied Performance (Met) |
|---|---|---|
| Luer Hub Testing | BS EN ISO 80369-7: 2016 (Sub-atmospheric pressure air leakage, Stress Cracking/Fluid Leakage, Resistance to separation (axial load, unscrewing, overriding)) | Met requirements of standard |
| Labeling | BS EN ISO 10555-1: 2013 (Catheter Nominal Effective Length, Catheter outside diameter, Pressure Injection Gravity flow Rate, Visual Inspection, Surface Quality) | Met requirements of standard |
| Mechanical Testing | BS EN ISO 10555-1: 2013 (Force at Break – Juncture Hub & Catheter Body, Force at Break - Luer Hub & Extension Line, Catheter Body Elongation, Liquid Leakage under Pressure, Air Leakage during Aspiration, Priming Volume Pump Flow Rate, Pressure Injection Flow rate & Repeat Injection, Static Burst under Pressure Injection) | Met requirements of standard |
| Radiopacity | ASTM F640-20 | Met requirements of standard |
| Catheter Body Kink | BS EN ISO 13868: 2002 | Met requirements of standard |
| Collapse Resistance | Internal Test Method | Met internal requirements |
| Blood Draw | Internal Test Method | Met internal requirements |
| Extension Line Clamp Closure Efficacy | Internal Test Method | Met internal requirements |
| Clamp Force | Internal Test Method | Met internal requirements |
| Biocompatibility | BS EN ISO 10993-1: 2020 (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute/Subacute Systemic Toxicity, Hemocompatibility, Genotoxicity, Chemical Characterization) | Met requirements of standard |
| Sterilization Evaluation | ANSI/AAMI/ST72:2019 (Bacterial Endotoxin), BS EN ISO 10993-7: 2008 (Ethylene Oxide Residuals) | Met requirements of standard |
| Preconditioning | ISTA 3A, ASTM D4169 (Shipping, Distribution Simulation) | Met requirements of standard |
| Package Protection Testing | BS EN ISO 11607-1: 2020 | Met requirements of standard |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and biological performance testing, not AI/ML model testing with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here. The "ground truth" for these tests would be defined by the technical specifications of the standards (e.g., a specific pressure, flow rate, or biological response).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML device. For this device, the "ground truth" for testing is established by recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) and internal company test methods, which define acceptable parameters for physical and chemical properties, functionality, and biocompatibility.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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).