(90 days)
The Medtronic 6F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Sherpa NX guiding catheter is intended for used in the coronary or peripheral vascular system.
The 6F Z4 Guide Catheter consists of a luer hub, a strain relief, inner liner, a braided wire, an outer jacket, a sleeve, a tungsten/nylon band, and a soft tip.
The 6F Z4 Guide Catheter design is based on an inner lumen liner of polyethylene material. The new shaft will be comprised of an inner liner of polyethylene, an intermediate layer of Pebax, stainless steel braid wire and a Vestamid outer jacket. The braided wire, intermediate layer and outer jacket materials have been previously used in others Medtronic Guide Catheters.
This document describes a 510(k) submission for the Medtronic 6F Z4 Guiding Catheter, comparing it to a predicate device, the 6F Launcher Guide Catheter (K021256).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not list specific numerical acceptance criteria or detailed performance metrics. It states that the device has been "subjected to performance testing and it has been determined that the 6F Z4 Guiding Catheter is suitable for its intended use."
The comparison is primarily qualitative, focusing on technological equivalence and manufacturing processes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device | "In addition to being technologically equivalent to the predicate devices..." |
| "The 6F Z4 Guiding Catheter design is based on an inner lumen liner of polyethylene material. The new shaft will be comprised of an inner liner of polyethylene, an intermediate layer of Pebax, stainless steel braid wire and a Vestamid outer jacket. The braided wire, intermediate layer and outer jacket materials have been previously used in others Medtronic Guide Catheters." | |
| Suitability for Intended Use | "...it has been determined that the 6F Z4 Guiding Catheter is suitable for its intended use." |
| Manufacturing Processes Equivalence | "The 6F Z4 Guiding Catheter is manufactured under the same Summary of Non-The of 24 Galling Catalonian (sic) processes and equivalent clinical Data, as the 6F Launcher Guiding Catheter; the legally marketed predicate device." |
| Equivalent Indications for Use | "In addition to being technologically equivalent, the indications for use have not changed." (Indications for Use for the 6F Sherpa NX, likely a typo for Z4, are "Provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended for used in the coronary or peripheral vascular system.") |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI device. The submission focuses on device design, materials, and manufacturing process equivalency to a predicate device, along with performance testing (without specifying the nature or scale of this testing). Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of data is not provided for a "test set."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The device is a physical medical device (guiding catheter), not an AI algorithm requiring expert-established ground truth from a dataset. The evaluation is based on engineering principles and comparison to a predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no "test set" or associated "ground truth" to adjudicate in the context of an AI device evaluation.
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:
This information is not applicable. The document describes a physical medical device (a guiding catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical guiding catheter, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. For this type of device submission, "ground truth" would be established through engineering specifications, material testing standards, and predicate device equivalence.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a physical medical 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).