Search Results

The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).

The Medtronic ConfidaTM Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic ConfidaTM Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic ConfidaTM Brecker Guidewire is an external communicating device having limited contact (

This document is a 510(k) summary for the Medtronic Confida™ Brecker Guidewire (K181001), indicating its substantial equivalence to a predicate device. The purpose of this 510(k) is to notify the FDA of a change to the PTFE coating on the core wire section from a low Chromium VI PTFE coating to a Chromium VI-free PTFE coating.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All testing met the specified acceptance criteria," indicating successful compliance without explicitly detailing the specific quantitative or qualitative criteria for each test in this summary.

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., number of guidewires tested for coating adhesion, number of animals for in vivo studies, or cell cultures for in vitro tests).

The data provenance is not explicitly stated in terms of country of origin of the data or whether the studies were retrospective or prospective, beyond the fact that they are non-clinical evaluations performed to demonstrate substantial equivalence.

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

This is a technical device evaluation rather than a study involving expert human interpretation or ground truth establishment in a clinical context (e.g., imaging interpretation). Therefore, information regarding "number of experts," "qualifications of experts," or "ground truth for the test set" as typically understood in AI/clinical studies is not applicable to this submission content. The "ground truth" here is the adherence to established scientific and regulatory safety and performance standards for medical devices, validated through the non-clinical tests listed.

4. Adjudication Method for the Test Set

As mentioned above, this is a non-clinical device evaluation. Therefore, an "adjudication method" in the context of expert consensus (e.g., 2+1, 3+1 for clinical interpretations) is not applicable. The "adjudication" is inherent in the laboratory testing and comparison against pre-defined acceptance criteria for each specific test.

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 done. This type of study is relevant for evaluating the impact of AI on human reader performance in interpreting medical images or data. The current submission is for a physical medical device (guidewire) and focuses on its material and performance characteristics through non-clinical testing.

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

This query is pertinent to AI algorithms. The Medtronic Confida™ Brecker Guidewire is a physical medical device, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's performance is standalone in the sense that its physical properties and biocompatibility are tested directly.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device evaluation is established by validated non-clinical test methodologies and their pre-defined acceptance criteria, which are based on recognized standards (e.g., ISO, USP, ASTM) for biocompatibility and material performance of medical devices. The success of each test (e.g., passing a cytotoxicity assay) serves as its own ground truth for compliance.

8. The Sample Size for the Training Set

This submission pertains to a physical medical device and its non-clinical evaluation, not an AI algorithm requiring a training set. Therefore, the concept of "sample size for the training set" is not applicable.

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

As this document does not concern an AI algorithm, the question of "how the ground truth for the training set was established" is not applicable.

Ask a specific question about this device

The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).

The Medtronic Confida™ Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic Confida™ Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic Confida™ Brecker Guidewire is an external communicating device having limited (

The provided document is a 510(k) summary for the Medtronic Confida™ Brecker Guidewire (K150465). It describes the device and its intended use, and compares it to a predicate device (K132623). The document focuses on establishing substantial equivalence through non-clinical testing.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for each test or detailed quantitative performance data in a table format. Instead, it lists the non-clinical evaluations performed and concludes that the subject device "performs as well as the legally marketed predicate device."

Without specific acceptance criteria metrics and detailed performance results from the provided text, a table like the one requested cannot be accurately generated.

However, the types of non-clinical evaluations performed are listed, suggesting that the criteria for acceptance would be satisfactory outcomes for these tests compared to the predicate device's expected performance or established safety standards.

Inferred Information for a Hypothetical Table:

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

• Sample Size for Test Set: The document does not specify the sample sizes used for each of the non-clinical tests. These typically involve a certain number of samples of the device or its materials subjected to the various assays.
• Data Provenance: Not explicitly stated as retrospective or prospective, or location of data origin (e.g., country). Non-clinical bench and lab testing often does not fit neatly into "retrospective" or "prospective" as clinical studies do. The testing was conducted by Medtronic CoreValve, LLC.

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

This section is not applicable to the provided document. The submission is for a medical device (guidewire) and relies on non-clinical (bench and biocompatibility) testing, not on interpretation of diagnostic images or clinical data by human experts. Therefore, "ground truth" in the context of expert consensus (as asked for in the prompt) is not relevant here.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically used in clinical studies or studies involving multiple human readers for diagnostic interpretation. It is not applicable to the non-clinical evaluations listed for this guidewire. These tests have defined laboratory protocols and pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size.

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms or imaging modalities, especially with human readers, which is not the subject of this 510(k) submission.

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

No, a "standalone algorithm performance" study was not done. The device is a physical medical guidewire, not an algorithm or AI software, so this type of study is not relevant.

7. The type of ground truth used

The "ground truth" for the non-clinical evaluations would be defined by the standardized protocols and reference methods used for each test (e.g., ISO standards for biocompatibility, material testing standards). For example, for cytotoxicity, the "ground truth" is determined by established cell viability assays against negative and positive controls. For coating adhesion, it would be based on validated physical testing methods. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

This question is not applicable. The device is a physical guidewire, not an AI/ML algorithm. Therefore, there is no "training set."

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

This question is not applicable as there is no training set for a physical device.

Ask a specific question about this device