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The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

Device Description

The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.

AI/ML Overview

This document describes the acceptance criteria and study that proves the Micrus Ascent Occlusion Balloon Catheter meets these criteria, supporting its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Study Results)	Type of Study
Balloon cycling and fatigue	Modified device met acceptance for balloon cycling and fatigue. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Balloon burst diameter and volume changes	Modified device met acceptance for balloon burst diameter and volume changes. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Coating integrity of the balloon	Modified device met acceptance for coating integrity of the balloon. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Pressure at the design diameter of the balloon	Modified device met acceptance for pressure at the design diameter of the balloon. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Inflation and deflation functions	Modified device met acceptance for inflation and deflation functions. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Trackability of the device in a simulated tortuous anatomy	Modified device met acceptance for trackability in a simulated tortuous anatomy. (Specific quantitative results or thresholds not provided in the summary.)	In-vitro test
Adequacy and acceptability of the preparation method	The preparation method was adequate and acceptable in both in-vitro and in-vivo settings. (In-vivo study demonstrated this.)	In-vitro and In-vivo (porcine model)
Device deployment effectiveness	The device deployed effectively and as expected in an animal model. (Specific quantifiable measures of effectiveness not provided, but deemed acceptable by physicians in the in-vivo study.)	In-vivo (porcine model)
Trackability meeting physicians' acceptance	The trackability of the device met physicians' acceptance during the in-vivo study. (Qualitative assessment by medical professionals.)	In-vivo (porcine model)
Balloon stability in position after placement	The balloon remained stable in position after placement in the animal model. (Stability was observed and deemed acceptable in the in-vivo study.)	In-vivo (porcine model)

2. Sample Size Used for the Test Set and Data Provenance

In-vitro tests: The exact sample size for each in-vitro test is not specified in the summary, but multiple tests were conducted across various performance aspects.
In-vivo study: The test set for the in-vivo study consisted of 7 devices in a porcine model.
Data Provenance: The data provenance is from in-vitro laboratory testing and an in-vivo animal study (porcine model). This is prospective data generated specifically for the 510(k) submission. No country of origin is explicitly stated, but it can be inferred the testing was conducted by or for Micrus Endovascular Corporation, based in San Jose, CA, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For the in-vivo study, the summary states that "the trackability of the device met physicians' acceptance" and "the device deployed effectively and as expected." This implies subjective assessment by medical professionals.

Number of experts: Not explicitly stated, but the phrasing "physicians' acceptance" suggests more than one, or at least a general consensus attributed to medical professionals involved in the study.
Qualifications of those experts: Not explicitly stated, but it can be inferred they were veterinarians or medical researchers with expertise in animal models and catheter deployment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "physicians' acceptance" in the in-vivo study seems to refer to a qualitative observation and concurrence, rather than a structured adjudication process for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This was a substantial equivalence submission for a modified device, focusing on demonstrating performance against established benchmarks and the predicate device's performance, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" is not applicable. The studies assessed the physical device's performance characteristics.

7. The Type of Ground Truth Used

In-vitro tests: The ground truth for in-vitro tests was based on engineering specifications, design parameters, and established industry standards for catheter performance (e.g., balloon burst pressure, cycling durability, coating integrity).
In-vivo study: The ground truth for the in-vivo study was based on direct observation, successful deployment, stability, and "physicians' acceptance" within the porcine model, indicating successful functionality in a biological system.

8. The Sample Size for the Training Set

This device did not involve machine learning or AI algorithms requiring a training set. The term "training set" is not applicable in this context.

9. How the Ground Truth for the Training Set Was Established

As there was no training set (see point 8), this question is not applicable.

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