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The Aveir™ Introducer is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The Aveir™ Introducer is designed to perform as a guiding sheath for introduction of diagnostic or interventional devices. It is intended to provide a conduit into the venous system for insertion of diagnostic or interventional devices. The Aveir™ Introducer has a 25 French (Fr) inner diameter and comes in two lengths - Model LSN25301, 30 cm. and Model LSN25501, 50 cm. The only difference between the two models is the length.

The Aveir™ Introducer comprises the following two components:

1. Introducer sheath with a flush port and a three-way stopcock
2. Dilator

The introducer sheath is coated with a hydrophilic coating and is fitted with a suture loop, a sideport with a three-way stopcock, and a hemostasis valve, which minimizes air introduced and maintains hemostasis during insertion and/or exchange. The sheath contains a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip sheath. The dilator contains a locking mechanism that locks the dilator into the introducer sheath.

The introducer sheath and dilator are supplied sterile (via ethylene oxide) in one package and are intended for single procedure.

This document is a 510(k) Premarket Notification from the FDA regarding the "Aveir Introducer," a medical device manufactured by Abbott Medical. It focuses on demonstrating the substantial equivalence of the Aveir Introducer to previously marketed predicate devices.

Based on the provided text, the document describes performance testing for a medical device (Aveir Introducer) used as an introducer sheath. However, it does not detail acceptance criteria or specific study results in a format typically seen for algorithms or AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity, AUC).

Instead, the "Performance Data" section discusses:

• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance, including tests like cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility (hemolysis, complement activation, thrombogenicity), and particulate matter.
• Bench Testing: Including design verification (physical, dimensional, functional characteristics, hydrophilic coating lubricity and durability) and packaging/shelf life testing.
• Animal Testing: An acute GLP study for usability validation related to implanting or retrieving a leadless pacemaker via the femoral vein.

Therefore, many parts of your request for information about acceptance criteria for an AI/ML system and the detailed study proving its performance cannot be answered from the provided text. The document describes a traditional medical device (catheter introducer) and its non-AI related performance evaluation.

However, I can extract what is implied about "acceptance" in the context of this device's testing:

Acceptance Criteria and Device Performance (Based on available information, not AI/ML specific):

The document states:
"Based on the results of usability validation testing, the Aveir™ Introducer possesses acceptable usability and acceptable residual usability risk based on the observed difficulties and use errors of the participants. All acceptance criteria were met under the conditions of the study. There were no observed use errors that could result in serious patient harm."

And for the overall performance:
"The resulting evidence obtained from the design verification and validation testing demonstrated that the subject device is substantially equivalent to the predicate devices."

While the specific quantitative acceptance criteria for each test (biocompatibility, bench, and animal) are not explicitly stated in a table, the overall conclusion is that the device met its design specifications and criteria.

Table of Acceptance Criteria and Reported Device Performance (Inferred from text):

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