(85 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 thin lubricious coating.
Acceptance Criteria and Device Performance Study for Medtronic Vascular Guide Catheters
This document outlines the acceptance criteria and the study conducted to demonstrate that the modified Medtronic Vascular 5F and 8F Launcher Guide Catheters meet these criteria and perform similarly to their predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Bench Testing | 1. Visual Analysis (Sink Mark, Flash, Short Shot, Discoloration) | No significant visual defects (e.g., sink marks, flash, short shots, discoloration) on the luer hub that would affect function or aesthetics. | Met: Bench testing included visual analysis for sink mark, flash, short shot, and discoloration on the luer hub (due to new material change). The summary states that "no new safety or effectiveness issues were raised during the testing," implying acceptable visual quality. |
| 2. Visual Analysis (Luer Taper ISO 594-1 Gauge) | Luer taper dimensions meet ISO 594-1 standards. | Met: Bench testing included visual analysis of the luer taper using ISO 594-1 gauge. The summary states that "no new safety or effectiveness issues were raised during the testing," implying compliance with the luer taper standard. | |
| 3. Dimensional Analysis (Hub Shaft ID) | Hub shaft inner diameter within specified tolerance. | Met: Bench testing included dimensional analysis of the hub shaft ID. The summary states that "no new safety or effectiveness issues were raised during the testing," implying acceptable dimensions. | |
| 4. Hub/Shaft Tensile | Hub-to-shaft bond strength exceeds a specified minimum tensile force. | Met: Bench testing included hub/shaft tensile strength tests. The summary implies sufficient tensile strength, as "no new safety or effectiveness issues were raised during the testing." | |
| 5. Leak | No leakage at specified pressure or vacuum. | Met: Bench testing included leak tests. The summary implies no significant leakage, as "no new safety or effectiveness issues were raised during the testing." | |
| 6. Luer Hub Leak and Aspiration Test | No leakage or aspiration when connected to other devices, at specified pressures/vacuums, demonstrating secure connection. | Met: Bench testing included luer hub leak and aspiration tests. The summary implies no significant leakage or aspiration, as "no new safety or effectiveness issues were raised during the testing." | |
| 7. Visual Analysis (Hub Inside Inspection for Exposed Wires) | No exposed wires inside the hub that could compromise device integrity or patient safety. | Met: Bench testing included visual analysis of the hub inside for exposed wires. The summary implies no exposed wires, as "no new safety or effectiveness issues were raised during the testing." | |
| Biocompatibility | Cytotoxicity Testing | No evidence of cytotoxic effects. | Met: "Cytotoxicity Testing was performed as a screening test for this device modification." The overall conclusion states that "no new safety or effectiveness issues were raised during the testing," indicating acceptable biocompatibility. |
| Overall Performance | Substantial Equivalence | The modified devices perform similarly to the predicate devices and raise no new safety or effectiveness issues. | Met: "Medtronic Vascular has demonstrated that the modified 5F Launcher and 8F Launcher Guide Catheters are substantially equivalent to the predicate devices," based on the nonclinical data. "No new safety or effectiveness issues were raised during the testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for each bench test conducted. However, the tests are implied to have been performed on a sufficient number of samples designated for quality and performance evaluation.
- Data Provenance: The data is presented as "Nonclinical Data," which includes bench and biocompatibility testing. The data is generated internally by Medtronic Vascular as part of their regulatory submission for a Special 510(k). The context strongly suggests this is prospective testing conducted specifically for this device modification. The country of origin for the data is not explicitly stated, but it is a US-based company submitting to the FDA, implying the tests were likely conducted in the US or under US regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "ground truth" in the diagnostic or image interpretation sense, which typically requires expert consensus for classification. Instead, the "ground truth" is primarily established by adherence to engineering specifications, recognized standards (e.g., ISO 594-1), and pre-defined acceptance criteria for physical and biological properties. Therefore:
- Number of Experts: Not applicable in the traditional sense of diagnostic expert consensus. The "ground truth" for the performance characteristics is derived from engineering and regulatory standards.
- Qualifications of Experts: The "experts" would be the engineers, technicians, and regulatory specialists within Medtronic Vascular responsible for designing, conducting, and interpreting these tests, ensuring compliance with relevant standards and internal specifications. Their qualifications would typically include degrees and experience in biomedical engineering, materials science, quality assurance, and regulatory affairs, but these specific qualifications are not detailed in the summary.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly those involving human readers interpreting medical images or clinical outcomes, to resolve discrepancies. For bench and biocompatibility testing, the results are objectively measured against predefined acceptance criteria. Any inconclusive or borderline results would likely lead to re-testing or deeper investigation by the testing team, rather than an adjudication process involving multiple independent reviewers.
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.
- Reason: The device under review is a guide catheter, a physical medical device, not a diagnostic imaging algorithm, and the study focuses on changes to its physical characteristics (luer hub material). MRMC studies are designed to assess the performance of diagnostic systems where multiple human readers interpret multiple cases, often with and without AI assistance. This study is a nonclinical, bench, and biocompatibility study.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted, and the device is a physical catheter, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" performance evaluation was done, as the testing assessed the intrinsic physical and biological properties of the modified catheter without human intervention in its analysis or interpretation. However, this isn't an "algorithm only" study, as the device is mechanical, not an algorithm. The bench tests and biocompatibility tests evaluate the device's inherent characteristics.
7. The Type of Ground Truth Used
The ground truth used for this study is a combination of:
- Expert Consensus (Engineering/Regulatory Standards): The acceptance criteria themselves are established based on industry standards (e.g., ISO 594-1 for luer taper), regulatory guidance from the FDA, and internal engineering specifications for device functionality and safety. These standards and specifications represent the "ground truth" for successful device performance.
- Objective Measurements: The test results (e.g., dimensional measurements, tensile strength, leak test pressures, cytotoxicity readings) are objective measurements compared against these predefined numerical or qualitative criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The nonclinical testing performed (bench and biocompatibility) is analogous to verification and validation testing for a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set exists for this type of device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).