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510(k) Data Aggregation
(57 days)
The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
The 10F Sheath and Dilator Set is designed for single use and intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The 10F Sheath and Dilator Set consists of a 10F reinforced Introducer Sheath and a matching 10F radiopaque Dilator.
The 10F Introducer sheath is a coil reinforced sheath with a Platinum Iridium radiopaque marker band. The sheath has a hemostasis valve and a side port with stopcock. The 10F dilator is made of radiopaque, non-reinforced material with an atraumatic tip to minimize blood loss. The device does not include any coating.
The provided document describes a 510(k) premarket notification for the "10F Sheath and Dilator Set" and establishes its substantial equivalence to a predicate device based on in vitro performance testing and technological characteristics. It does not include information about an AI-powered device or a study proving that an AI device meets acceptance criteria. Thus, I cannot populate the requested table or answer the questions related to AI device performance.
However, I can extract the acceptance criteria and the study performed for the 10F Sheath and Dilator Set (a non-AI medical device).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Radiopacity | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Visual | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Dimensional | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Simulative Use | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Leakage (Sheath and Dilator) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Kink Test (System) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Tensile (Sheath and Dilator) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Luer testing | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Shipping Qualification | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Biocompatibility | According to ISO 10993-1:2020 for an external communicating, circulating blood device with limited duration <24hrs. | |
| - Cytotoxicity | (Implicit standard per ISO 10993-5) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Sensitization | (Implicit standard per ISO 10993-10) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Irritation or Intracutaneous Reactivity | (Implicit standard per ISO 10993-23) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Material Mediated Pyrogenicity | (Implicit standard per ISO 10993-11) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Acute Systemic Toxicity | (Implicit standard per ISO 10993-11) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (In-vitro Blood Loop Assay) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (Complement Activation Assay, SC5b-9 Method) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (Heparinized Platelet and Leukocyte Count Assay) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (Partial Thromboplastin Time (PTT) Assay) | (Implicit standard per ISO 10993-4) | Performed with comparison article following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
| - Hemocompatibility (ASTM Hemolysis Assay, Direct and Extract Methods) | (Implicit standard per ISO 10993-4) | Performed following approved protocols under GLP, in compliance with FDA GLP, 21 CFR Part 58. |
Study Information for 10F Sheath and Dilator Set:
Since this document pertains to a traditional medical device (sheath and dilator set) and not an AI/software device, the following points regarding AI studies are not applicable.
- Sample size used for the test set and the data provenance: Not applicable to this type of device. The tests mentioned are bench-top (in vitro) and biocompatibility tests on device components. No "test set" in the context of diagnostic performance, images, or patient data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not involved.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance is established by meeting predefined engineering specifications, industry standards (e.g., ISO 10993), and regulatory requirements for physical and biological properties.
- The sample size for the training set: Not applicable. This device does not have a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
Summary of the study conducted for the 10F Sheath and Dilator Set:
The study involved a series of non-clinical (bench-top) performance tests and biocompatibility tests. The non-clinical tests included:
- Radiopacity
- Visual inspection
- Dimensional analysis
- Simulative Use
- Leakage (Sheath and Dilator)
- Kink Test (System)
- Tensile (Sheath and Dilator)
- Luer testing
- Shipping Qualification
The biocompatibility testing was conducted according to ISO 10993-1:2020 for an external communicating, circulating blood device with limited duration (<24 hours). These tests included Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, and Hemocompatibility assays (In-vitro Blood Loop, Complement Activation, Heparinized Platelet and Leukocyte Count, Partial Thromboplastin Time (PTT), and ASTM Hemolysis). All biocompatibility studies were performed under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58.
The results of these tests demonstrated that the Argon Medical Devices, Inc. 10F Sheath and Dilator Set met the acceptance criteria and was substantially equivalent to the predicate device (Flexor® Check-Flo® Introducer Set) in terms of safety and performance for its intended use.
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