(26 days)
The Medtronic 8F Sherpa NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 8F Sherpa NX guiding catheter is intended for use in the coronary or peripheral vascular system.
The 8F Sherpa NX guide catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary (transition) segment, a primary segment, primary (transition) segment, tungsten marker band. a segment sleeve and a soft tip. The 8F Sherpa NX Guide Catheter design is based on a four layer design with an inner liner of polyethylene.
This submission K060418 is for a guiding catheter, not an AI device. Therefore, the questions related to AI device performance are not applicable.
The 510(k) summary indicates that the device's substantial equivalence is based on:
- Technological equivalence to predicate devices (7F Sherpa NX Guide Catheter K042489 and 8F Launcher Guide Catheter K023402).
- Performance testing to demonstrate suitability for its intended use.
- Manufacturing conditions, processes, and materials being similar to predicate devices.
- Indications for use remaining unchanged from predicate devices.
Since this is a traditional medical device and not an AI-powered one, the requested information about acceptance criteria for AI devices, test set details, expert ground truth, MRMC studies, standalone performance, training set, etc., are not presented in this document.
The document states: "The 8F Sherpa NX Guiding Catheter has been subjected to performance testing and it has been determined that the 8F Sherpa NX Guiding Catheter is suitable for its intended use. Summary of Non-The 8F Sherpa NX Guiding Catheter is manufactured under clinical Data: the same conditions, using the similar processes and equivalent materials, as the 7F Sherpa NX Guiding Catheter; and 8F Launcher Guiding Catheter, the legally marketed predicate devices."
This implies that the acceptance criteria for this device would have been related to the physical and functional performance of the catheter (e.g., burst pressure, tensile strength, kink resistance, lubricity, torqueability, trackability, etc.) to ensure it is safe and effective for its intended purpose of providing a pathway for other therapeutic devices. However, the specific acceptance criteria and the detailed results of these performance tests are not provided in this 510(k) summary. The summary only states that such testing was performed and confirmed suitability for use, consistent with predicate devices.
§ 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).