(17 days)
The Artix Balloon Guiding 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. The Artix Balloon Guiding Sheath is also indicated for use as a conduit for retrieval devices.
The Artix Balloon Guiding Sheath is intended for use in the peripheral vasculature.
The Artix Balloon Guiding Sheath 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 procedures. The Artix Balloon Guiding Sheath is packaged with the following components: Artix Balloon Guiding Sheath (8 Fr, 65 cm or 105 cm) Two 8 Fr Introducer Dilators (0.014" and 0.035" guidewire compatibility) Balloon Inflation Syringe, 1 mL Large Bore Syringe, 30 mL 3-way Stopcock
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is not explicitly detailed.
Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and claims that the results met the criteria.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not explicitly detailed in the provided text for individual tests. The general statement is that "all acceptance criteria were met." | Not explicitly detailed in the provided text for individual tests. The general statement is that "all acceptance criteria were met." |
Study Information:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each non-clinical test. The document lists the types of tests performed (e.g., Pouch Seal Peel Test, Simulated Use Cycling, Balloon Fatigue Test, Sheath Kink to Failure, etc.) but does not provide the number of units tested for each.
- Data Provenance: The tests are non-clinical, likely performed in an Inari Medical lab or by a contract testing organization. The document does not specify a country of origin for the data or whether it was retrospective or prospective, as these terms are more applicable to clinical studies. These are laboratory/benchtop tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the non-clinical (benchtop) tests described. Ground truth for these types of tests would be established by predefined engineering specifications, industry standards (e.g., ISO, AAMI), and the performance characteristics of the predicate device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or image interpretation studies where human judgment is involved in establishing ground truth. For non-clinical tests, the criteria are objective and measurable.
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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:
- No. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Therefore, no MRMC study, human reader improvement analysis, or AI assistance was involved since this submission is for a medical device (Balloon Guiding Sheath) and not an AI/Software as a Medical Device (SaMD).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm or SaMD.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" or reference for comparison would be:
- Predetermined engineering specifications: Based on the device's design requirements.
- Relevant industry standards: Such as ISO 10993-1 for biocompatibility and ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 for sterilization.
- Performance of the predicate device: To demonstrate substantial equivalence in key performance characteristics relevant to safety and effectiveness.
- For the non-clinical tests, the "ground truth" or reference for comparison would be:
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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).