(105 days)
The Artix BG balloon thrombectomy sheath is indicated for:
• Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
• Use as a conduit for retrieval devices.
• The non-surgical aspiration of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.
The Artix BG is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic and interventional procedures. The Artix BG also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix BG is packaged with the following components:
• Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm)
• 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility)
• Balloon Inflation Syringe, 1 mL
• Large Bore Syringe, 30 mL
• 3-way Stopcock
The Artix BG is comprised of a single through lumen shaft with four (4) embedded lumens for balloon inflation and deflation, a proximal integrated hemostasis valve to minimize blood loss, a stopcock with flush port, and a balloon port. To assist with insertion of the sheath into the vasculature, a hydrophilic coating covers a portion of the distal sheath shaft. The distal tip of the sheath shaft contains two (2) radiopaque marker bands to aid with angiographic visualization: The distal marker indicates the location of the sheath's tip, while the proximal marker band marks the location of a compliant balloon mounted at the distal end. The balloon provides temporary vascular occlusion during angiographic and interventional procedures.
The provided text is a 510(k) summary for the Inari Medical Artix BG balloon thrombectomy sheath. It describes the device, its indications for use, and a comparison to predicate and reference devices. It also outlines the non-clinical testing performed to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sheath Visual & Dimensional | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Simulated Use Cycling | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Sheath Aspirational Flowrate | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Clot Burden Removal | Not explicitly stated, but implied to meet product specifications. | All acceptance criteria were met. |
| Biocompatibility | Meet biological safety requirements per ISO 10993-1. | Previous passing results for Artix BG (K221846) are applicable. |
| Sterilization | Achieve a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016. | Previous sterilization process (validated per K221846) remains applicable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (Sheath Visual & Dimensional, Simulated Use Cycling, Sheath Aspirational Flowrate, Clot Burden Removal). It only mentions that "verification and validation testing were identified."
The data provenance is not specified regarding country of origin, but it is clear these were pre-market, non-clinical tests as indicated by "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This implies the tests were conducted in a lab setting by the manufacturer, Inari Medical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are non-clinical engineering and performance tests, not studies requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are non-clinical engineering and performance tests, not studies requiring expert adjudication.
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 device is a medical instrument (balloon thrombectomy sheath), not an AI/software as a medical device (SaMD) that would typically undergo MRMC studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was adherence to established product specifications and recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR 28 for sterilization). For tests like "Sheath Visual & Dimensional" or "Sheath Aspirational Flowrate," the ground truth would be the engineering specifications the device was designed to meet.
8. The Sample Size for the Training Set
Not applicable. This device is a medical instrument, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
In summary, the provided document focuses on non-clinical testing to establish substantial equivalence for a medical device (Artix BG balloon thrombectomy sheath). The "study" proving the device meets acceptance criteria consists of various engineering and performance tests, biocompatibility assessments, and sterilization validation. These tests were conducted against pre-defined product specifications and international standards, and all were reported as successfully meeting their respective acceptance criteria.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).