(65 days)
The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
The subject Arrow Seldinger Arterial Catheterization Devices consist of either an introducer needle or catheter-over-needle assembly, spring wire guide, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a luer hub with dust cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique.
The provided text describes a 510(k) summary for the Arrow Seldinger Arterial Catheterization Device, which is a medical device and not an AI/ML powered device. Therefore, the information requested regarding acceptance criteria and study details for an AI-powered device (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device (K093050) through nonclinical bench testing, rather than proving performance against specific acceptance criteria for an AI/ML algorithm.
Here's a summary of the nonclinical testing performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a non-AI medical device and the document describes nonclinical bench testing for substantial equivalence rather than an AI performance study, there isn't a direct "acceptance criteria" table with numerical performance metrics for an algorithm. Instead, the "acceptance criteria" can be inferred from the "applicable requirements" of the referenced ISO standards, and the "reported device performance" is that the device met these requirements, thus supporting substantial equivalence.
| Acceptance Criteria (Inferred from ISO Requirements) | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1 | Testing conducted, supporting substantial equivalence. |
| Surface: Extraneous Matter and External Surface (ISO 10555-1) | Met applicable requirements. |
| Resistance to Kink (ISO 10555-1) | Met applicable requirements. |
| Peak Tensile Force (ISO 10555-1) | Met applicable requirements. |
| Air Leakage (ISO 10555-1) | Met applicable requirements. |
| Liquid Leakage (ISO 10555-1) | Met applicable requirements. |
| Surface: Extraneous Matter and Defects (ISO 11070) | Met applicable requirements. |
| Guide wire Fracture (ISO 11070) | Met applicable requirements. |
| Guide wire Flexure (ISO 11070) | Met applicable requirements. |
| Guide wire Tensile (ISO 11070) | Met applicable requirements. |
| Needle Point (ISO 11070) | Met applicable requirements. |
| Peak Tensile Force (ISO 11070) | Met applicable requirements. |
| Strength of Union of Needle Tube and Needle Hub (ISO 11070) | Met applicable requirements. |
| Guide wire Stiffness | Testing conducted, supporting substantial equivalence. |
| Guide wire Interface | Testing conducted, supporting substantial equivalence. |
| Simulated Blood Withdrawal | Testing conducted, supporting substantial equivalence. |
| Pressure Monitoring | Testing conducted, supporting substantial equivalence. |
| Penetration Force | Testing conducted, supporting substantial equivalence. |
| Radio Detectability | Testing conducted, supporting substantial equivalence. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes bench testing for a physical medical device, not a test set for an AI algorithm.
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 an AI algorithm is not relevant here. The "ground truth" for a physical device would be compliance with engineering specifications and ISO standards, which is evaluated through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to establishing ground truth for AI model evaluation, which is not being done here.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. For the device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1, ISO 10555-1, ISO 11070) and internal design specifications.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).