(28 days)
The Medtronic® Z3 Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Z3 catheter is intended to be used in the coronary or peripheral vascular system.
The Medtronic® Z3 Guide Catheter is constructed with an inner liner, stainless steel braid, segmented outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Z3 Guide Catheter has a thin lubricious coating. The Z3 Guiding Catheter (6F) has an inner lumen diameter comparable to the predicate devices.
The provided text describes a 510(k) submission for a medical device (Medtronic 6F Z3 Guiding Catheter) and focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, most of the requested information regarding AI device evaluation is not directly available in this document.
However, I can extract the available information and indicate where the document does not provide the requested details.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Specification | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|---|
| Biocompatibility | Acute Intracutaneous Reactivity | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" |
| Acute Systemic Toxicity | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" | |
| Cytotoxicity | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" | |
| Hemolysis | Passed (implicit) | "All materials used for the Medtronic® Z3 Guiding Catheter passed the following tests" | |
| Sensitization | Test in process at time of submission (not yet passed) | "Sensitization (Test in process at the time of this submission.)" | |
| Functional Testing | Hub to Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" |
| Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Segment to Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Distal Tip to Shaft Tensile | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Torque Response | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Lumen Lubricity | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Radiopacity | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Pressure Shaft Burst | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Hub Leak | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" | |
| Tip Compression (Softness) | Meets applicable specifications (implicit) | "Results verified that the Medtronic® Z3 Guiding Catheter meets all of the applicable specifications" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document details in vitro (bench) testing, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable. The tests were performed on the device itself, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI device evaluated with a clinical test set. The ground truth for in vitro tests is established by physical measurement against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (guiding catheter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the ground truth is established by the results of standard ISO 10993 biological tests, which have defined pass/fail criteria. For functional testing, the ground truth is established by engineering specifications and physical measurement.
8. The sample size for the training set
Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set described in this document.
Summary of the Study and Device Performance:
The study described for the Medtronic® Z3 Guiding Catheter is focused on demonstrating substantial equivalence to previously approved predicate devices (Medtronic® 6F Zuma™ Guiding Catheter and Medtronic® 6F Genius™ Guide Catheters) for regulatory clearance. This is typical for a 510(k) submission for conventional medical devices.
The "study" consists of two main types of testing:
- Biocompatibility Tests: These tests, chosen based on ISO 10993 standards for external-communicating devices with circulating blood and limited exposure (≤24 hours), evaluated the material's interaction with biological systems. The reported performance is that all materials passed the acute intracutaneous reactivity, acute systemic toxicity, cytotoxicity, and hemolysis tests. The sensitization test was "in process" at the time of submission.
- Functional Testing: This involved a series of in-vitro physical tests to ensure the catheter's mechanical integrity and performance characteristics. The reported performance is that the device "meets all of the applicable specifications" for tests such as hub to shaft tensile, torque response, lumen lubricity, radiopacity, pressure shaft burst, hub leak, and tip compression.
The document concludes that based on the intended use, design, and in-vitro test results, the Z3 guide catheter is substantially equivalent to the predicate devices. This type of submission does not involve clinical trials or AI performance evaluations, which is why much of your requested information is not present.
§ 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).