(32 days)
The Artix BG balloon thrombectomy sheath is indicated for:
- · 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.
- · Use as a conduit for retrieval devices.
- · Use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
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 aspirate thrombi and emboli from the peripheral vasculature, facilitate the insertion and guidance of an intravascular catheter into selected peripheral blood vessels, 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 is also 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 provided text is a 510(k) summary for the Inari Medical Artix BG device. This document is a regulatory submission for medical devices to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.
Crucially, this document does not describe a study proving the device meets acceptance criteria in the context of comparing its performance to a defined set of clinical or technical metrics for a novel technology.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (Inari Medical, Artix BG K223000) based on a device modification (addition of two alternate suppliers for the PTFE liner). Therefore, the "acceptance criteria" and "study" described in the prompt are not applicable in the way they would be for a direct performance validation of a new device.
Here's an breakdown based on the information provided, highlighting why it doesn't fit the typical "acceptance criteria and study" mold for a new device's performance:
1. Table of acceptance criteria and the reported device performance:
This document doesn't provide a table of acceptance criteria and device performance in the sense of clinical metrics (e.g., sensitivity, specificity, accuracy, or a specific functional performance threshold for a new technology).
Instead, the document's "acceptance criteria" is implicitly demonstrating that the modified device (Artix BG with new PTFE suppliers) performs equivalently to the predicate device (the original Artix BG). The "reported device performance" is that the modified device "continues to apply" to previous performance test results.
- Acceptance Criteria (Implied): The modified device must perform equivalently to the predicate device, as demonstrated through non-clinical testing. This means:
- No change in intended use, design, fundamental scientific technology, or principles of operation.
- Meeting biocompatibility requirements per ISO 10993-1.
- Maintaining sterility assurance level (SAL) of 10-6.
- Reported Device Performance:
- "As there were no proposed design changes, previous performance test results that demonstrated that all acceptance criteria were met continue to apply; therefore, the device conforms to established product specifications."
- Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis)) were completed and passed.
- Sterilization using EtO to achieve SAL of 10-6 was validated.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific non-clinical tests. The statement "previous performance test results that demonstrated that all acceptance criteria were met continue to apply" implies reliance on prior testing of the original Artix BG device. For the biocompatibility tests, typically a sufficient number of samples are used to meet the standards (e.g., ISO 10993-1), but the exact numbers are not provided.
- Data Provenance: Not specified. The document is a regulatory submission to the FDA, likely based on internal company testing or contracted lab testing. It's not clinical data (retrospective or prospective) in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This document refers to non-clinical (laboratory/bench) testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of outcomes. Biocompatibility and sterility testing follow established international standards and protocols, not expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This applies to clinical studies or studies involving human assessment of data. The testing mentioned in this document is non-clinical.
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:
- N/A. This is a non-clinical device modification submission, not an AI or imaging diagnostic study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A (for clinical ground truth). The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization) that define what constitutes a "passing" or "acceptable" result for each test.
8. The sample size for the training set:
- N/A. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- N/A. This is not an AI or machine learning device.
Summary of the "Study" provided in the document:
The "study" or rather the evidence provided to support substantial equivalence after the modification (new PTFE suppliers) primarily consists of:
- Non-Clinical Testing: The document states that "previous performance test results...continue to apply" due to "no proposed design changes" affecting those aspects.
- Biocompatibility Testing:
- Tests conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis).
- Proof: Passing results demonstrated meeting biological safety requirements per ISO 10993-1.
- Sterilization Validation:
- Method: EtO sterilization to achieve a sterility assurance level (SAL) of 10-6.
- Proof: Validated process in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.
Conclusion from the document:
"The Artix BG has the same intended use/indications for use and principles of operation as the predicate. The testing provided supports the Artix BG's substantial equivalence to the predicate device."
§ 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).