(162 days)
The Medtronic guide catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.
Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.
The provided document is a 510(k) summary for the Medtronic Launcher Guide Catheter. It outlines the product's description, intended use, and substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance/Conclusion |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility Assessment | 1) Cytotoxicity
2) Sensitization
3) Intracutaneous Reactivity
4) Material-Mediated Pyrogenicity
5) Hemocompatibility
6) Acute Systemic Toxicity | Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and demonstrated no safety or effectiveness concerns. |
| Product Performance Evaluation (Dimensional & Performance) | 1) Inner Diameters (shaft, tip, & hub)*
2) Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)
3) Total Segment Length
4) Effective Length*
5) Exposed Tip Length
6) Luer Connector Performance*
7) Leak Resistance*
8) Draw-through stiffness of primary and secondary curve
9) Shaft bending stiffness & bending kink resistance (Body temperature and room temperature)
10) Arch bending stiffness & bending kink resistance (Body temperature and room temperature)
11) Shaft & distal segment crush resistance
12) Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation
13) Curve retention after simulated seating
14) Peak shaft & segment tensile load
15) Peak soft tip tensile load
16) Soft tip stiffness
17) Peak hub/shaft tensile load*
18) Internal lubricity | Necessary tests performed met the acceptance criteria and demonstrated that there are no safety or effectiveness concerns. The performance testing, along with biocompatibility testing, demonstrated substantial equivalence to the predicate device. Specific standards used for some tests are noted: ISO 594-1, ISO 594-2, EN ISO 80369-7 for Luer Connector Performance; ISO 10555-1 for Leak Resistance and Peak Hub/Shaft Tensile Load. |
Note: Tests marked with an asterisk () were specifically highlighted as being performed on the subject device to demonstrate substantial equivalence for modifications in this premarket notification.*
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical and biocompatibility tests. It broadly mentions "Summary of Nonclinical Data/Performance Testing" and "Product Performance Evaluation". Given the nature of these tests for medical devices, they would typically involve a statistically relevant number of samples to ensure robust results, but the exact numbers are not provided in this summary.
The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Medtronic Vascular. No information regarding country of origin of the data or whether it was retrospective or prospective is mentioned (as these terms usually apply to clinical studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings are used to establish a definitive diagnosis or outcome. For non-clinical performance and biocompatibility testing, the "ground truth" is established by adherence to recognized international standards and engineering principles, with results evaluated against predefined acceptance criteria derived from these standards or predicate device performance. Experts involved would be engineers, scientists, and toxicologists specializing in medical device testing and regulatory compliance, but their specific numbers or detailed qualifications are not typically included in a 510(k) summary (beyond general statements about adherence to guidance documents like ISO 10993-1).
4. Adjudication Method for the Test Set
This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials where multiple experts assess cases and their disagreements need to be resolved to establish a ground truth. For the non-clinical tests described, the "adjudication" is inherent in the test methodology and adherence to international standards and acceptance criteria. Any deviations or failures would be investigated and resolved according to quality system procedures.
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
No MRMC comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or imaging tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance and biocompatibility testing is established by:
- Adherence to International/Recognized Standards: Such as ISO 594-1, ISO 594-2, EN ISO 80369-7, ISO 10555-1, and FDA Guidance "Use of International Standard ISO 10993-1".
- Predicate Device Performance: The subject device's performance is compared to the predicate device, aiming to demonstrate substantial equivalence by showing that any differences in characteristics do not raise different questions of safety and effectiveness.
- Engineering Specifications and Design Requirements: The tests verify that the device meets its own engineering specifications for parameters like dimensions, strength, flexibility, and resistance to various stresses.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" in the context of this device. Training sets are used in machine learning and AI model development.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.
§ 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).