(7 days)
The Medtronic® Launcher Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.
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.
The provided document, K022764, describes the Medtronic 7F Launcher Guide Catheter, its intended use, and its substantial equivalence to a predicate device (Medtronic® 6F Z3 Guide Catheter - K021256). The primary method for demonstrating safety and effectiveness relies on a comparison to the predicate device and the results of in-vitro functional and biocompatibility testing. The document does not describe a study involving human subjects or AI performance analysis.
Here's an analysis of the provided information based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Acute Intracutaneous Reactivity | Passed (tests successfully performed) |
| Acute Systemic Toxicity | Passed (tests successfully performed) |
| Cytotoxicity | Passed (tests successfully performed) |
| Hemolysis | Passed (tests successfully performed) |
| Sensitization | Test in process at the time of submission (implies expectation of passing) |
| Functional Testing: | |
| Hub to shaft tensile | Meets applicable specifications |
| Shaft tensile | Meets applicable specifications |
| Distal tip to shaft tensile | Meets applicable specifications |
| Torque response | Meets applicable specifications |
| Lumen lubricity | Meets applicable specifications |
| Radiopacity | Meets applicable specifications |
| Pressure shaft burst | Meets applicable specifications |
| Hub leak | Meets applicable specifications |
| Tip compression (softness) | Meets applicable specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for each functional or biocompatibility test beyond stating "tests successfully performed." The data provenance is derived from in-vitro laboratory testing of the Medtronic 7F Launcher Guide Catheter's materials and functional components. There is no indication of country of origin for the data or whether it was retrospective or prospective in the context of human data. The testing described is prospective in nature as it evaluates the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on in-vitro testing against predetermined specifications, not on expert-established ground truth from human data. The "experts" would be the scientists and engineers conducting the tests and interpreting results against established ISO 10993 standards for biocompatibility and internal engineering specifications for functional testing. Their qualifications are not specified but are implied to be appropriate for conducting such tests.
4. Adjudication Method for the Test Set
Not applicable. There was no Adjudication method as the study was not based on human readings or interpretations that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was conducted. This submission is for a medical device (catheter), not an AI diagnostic or assistive tool. Therefore, there is no mention of human readers, AI assistance, or effect size improvements related to AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm performance study was done. This document concerns a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Standards Compliance: Biocompatibility testing against ISO 10993 standards.
- Engineering Specifications: Functional testing against internal design and performance specifications for parameters like tensile strength, lubricity, radiopacity, and burst pressure.
- Predicate Device Equivalence: The overall safety and effectiveness are established through substantial equivalence to the legally marketed Medtronic® 6F Z3 Guide Catheter (K021256), implying that if the new device meets the same functional and material requirements, it will perform similarly to a device already deemed safe and effective.
8. The Sample Size for the Training Set
No training set was used. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).