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The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.

The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is available in four French sizes (6 through 9 Fr) with multiple distal stem configurations and lengths. SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices.

The provided text describes a 510(k) summary for the SCHNEIDER GUIDER Softip® Guiding Catheters. This submission focuses on demonstrating substantial equivalence to predicate devices based on design and indications for use, rather than conducting a detailed performance study with specific acceptance criteria as you would find for a novel device or AI/software.

Therefore, much of the requested information about acceptance criteria, study design, and ground truth is not explicitly present or applicable to this type of regulatory submission. The document emphasizes mechanical testing in simulated environments to ensure the device's functionality, not clinical performance metrics.

Here is an attempt to address your points based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) for a medical device like this catheter, acceptance criteria are often implied by comparison to a legally marketed predicate device. The primary "study" is a demonstration of substantial equivalence through design comparison and mechanical testing, rather than a clinical trial with performance metrics like sensitivity, specificity, or accuracy.

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

• Sample Size: Not specified. The description mentions "simulated aortic and carotid anatomy with appropriate interventional devices," but does not explicitly state the number of catheters tested or the number of simulated procedures performed.
• Data Provenance: The origin of the simulated anatomy data is not specified (e.g., country of origin). The testing was an internal evaluation by the manufacturer, not a clinical study on human subjects, so the terms "retrospective" or "prospective" do not directly apply to patient data.

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

• This information is not provided. Given that the testing was mechanical in simulated anatomy, "experts" in the sense of clinical reviewers establishing ground truth for disease states or outcomes are not applicable. The "ground truth" here would be the physical properties and functionality of the catheter itself, assessed by engineers or technical personnel.

4. Adjudication Method for the Test Set

• Not applicable. There's no indication of independent review or adjudication for the mechanical testing results beyond the manufacturer's own internal reports.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No. This device is a physical medical instrument (guiding catheter), not an AI or software algorithm. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. As stated above, this is not an AI/algorithm device.

7. The Type of Ground Truth Used

• The "ground truth" was based on mechanical performance and design equivalence to predicate devices. Specifically, it involved whether the "force needed for insertion is acceptable" in simulated anatomical models and whether the design features matched the predicate. It did not involve expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of data used to train an algorithm. Any "training" would refer to the historical data and design principles used to develop the catheter, which is not quantified.

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

• Not applicable. Since there's no training set for an AI algorithm, this question doesn't apply.

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The SCHNEIDER GUIDER® Softip® guiding catheter is designed for the intravascular introduction of interventional devices.

The SCHNEIDER GUIDER® guiding catheter is manufactured in four French sizes (6 through 9 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.

The submission for the SCHNEIDER GUIDER® Softip® guiding catheter (K981413) does not describe an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for device performance in the context of AI/ML is not applicable.

The submission is for a conventional medical device, a guiding catheter, and focuses on demonstrating substantial equivalence to a predicate device through comparison of design and verification of materials.

Here's an analysis based on the provided text, focusing on what is present:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (as per AI/ML prompt, but not applicable to this submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device submission involving physical testing, not a dataset for AI/ML.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for AI/ML algorithms is not relevant here.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Study Description (for the conventional device):

The study was a design control activity to demonstrate the equivalence of the modified SCHNEIDER GUIDER® Softip® guiding catheter (with new stem material) to the original, currently marketed predicate device. The "study" involved a series of engineering and material performance tests.

• Tests Conducted: Biocompatibility, tip tensile pull, pressure injection leak test, and shape recovery.
• Objective: To verify that the change in stem material did not adversely affect the safety and effectiveness of the device, thereby proving its substantial equivalence to the predicate device.
• Conclusion: The tests indicated that the modified catheters are equivalent to the currently marketed ones and are safe for the intended use.

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The SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.

The SCHNEIDER GUIDER guiding catheter is manufactured in five French sizes (6 through 10 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.

This document describes a 510(k) summary for a medical device, specifically a guiding catheter. It focuses on demonstrating equivalence to predicate devices through in vitro performance tests and biocompatibility, rather than clinical study results involving human performance or diagnostic accuracy. Therefore, many of the requested categories related to human-in-the-loop performance, expert ground truth, and training data for AI models are not applicable.

Here's the information that can be extracted or inferred from the provided text, formatted to address your request as much as possible:

1. A table of acceptance criteria and the reported device performance

Note: The document states "The results of these tests indicated that the SCHNEIDER GUIDER Softip® guiding catheters are equivalent to the previously approved predicate devices and are, therefore, safe for the intended use." This implies that the acceptance criteria for each test were to demonstrate equivalence to the predicate devices and that these criteria were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the in vitro tests.
• Data Provenance: In vitro performance tests. The document does not specify country of origin for the internal testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The study involved in vitro performance tests comparing the device to predicate devices, not subjective assessments by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No human adjudication was involved in these in vitro performance tests.

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

• Not applicable. This summary describes the regulatory submission for a physical medical device (guiding catheter), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth: For the in vitro performance tests, the "ground truth" or reference was the performance characteristics of the previously approved predicate devices. For biocompatibility, the ground truth was adherence to ISO 10993-1 recommendations.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; there is no training set in the context of this submission.

9. How the ground truth for the training set was established

• Not applicable.

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