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510(k) Data Aggregation
(56 days)
The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a lubricious coating. The inner lumen of the Sherpa Guide Catheters is an HDPE liner.
This document is a 510(k) summary for Medtronic's 5F and 6F Launcher® Guide Catheters and 5F and 6F Sherpa® Guide Catheters. It describes the device, its intended use, and its substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | No new safety or effectiveness issues during evaluation and testing, demonstrating substantial equivalence to predicate devices. | "No new safety or effectiveness issues were raised during the evaluation and testing. Current testing demonstrates that the 5F and 6F Launcher and Sherpa Guide Catheters are safe, effective and are substantially equivalent to the predicate devices." |
| Biocompatibility | Modified devices remain biocompatible and compliant to ISO 10993. | "The current biocompatibility testing supports the biological safety, as no new materials or processes are being introduced into the design, and no additional biocompatibility tests were deemed necessary. Therefore, the modified 5F and 6F Launcher and Sherpa Guide Catheters remain biocompatible and compliant to ISO 10993." |
| Technological Characteristics | Technological characteristics are identical to predicate devices (Luer hub, outer jacket, wire braided shaft, distal segments, soft tip). | "The technological characteristics of the subject medical devices 5F and 6F Launcher and Sherpa Guide Catheters are identical to the predicate devices." (Details provided for each characteristic like Luer hub, outer jacket, etc.) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical investigation has been performed on the modified device." This indicates that there was no "test set" in the traditional sense for clinical performance. The evaluation for this 510(k) was based on non-clinical data and a comparison of technological characteristics to predicate devices. The data provenance is not applicable as no human-subject testing occurred.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As stated above, no clinical investigation was performed, and therefore no ground truth was established by human experts for a test set.
4. Adjudication Method for the Test Set
Not applicable. No clinical investigation or test set requiring adjudication occurred.
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 device is a guiding catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related improvement metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument, not a software algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering testing and established standards, primarily demonstrating that the modified device's characteristics and performance are substantially equivalent to existing, legally marketed predicate devices. This includes:
- Non-clinical performance data: Indicating no new safety or effectiveness issues.
- Biocompatibility testing: Compliance to ISO 10993.
- Technological characteristics comparison: Verification that features like the Luer hub, outer jacket, wire braided shaft, distal segments, and soft tip are identical to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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