(28 days)
The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.
The Amplatz Goose Neck Snare kit (Snare device) contains the snare, snare catheter, snare introducer, and torque device. The snare is made of a nitinol cable and a gold-plated tungsten loop. The preformed snare loop can be introduced through catheters without risk of snare deformation because of the snare's superelastic construction. The snare catheter contains a platinum-iridium, radiopaque marker band.
The provided text describes a 510(k) premarket notification for the Amplatz™ Goose Neck Snare Kit and does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is for a traditional medical device (a snare kit) and primarily focuses on its substantial equivalence to a predicate device, along with verification and validation testing for its physical and biocompatibility properties.
Specifically, the document lists:
- Biocompatibility tests: ISO MEM Elution, Guinea Pig Maximization Sensitization Test, Intracutaneous Irritation Test, Acute Systemic Injection Test, Materials Mediated Rabbit Pyrogen, ASTM Hemolysis Assay - Direct Contact Method, Complement Activation SC5b-9 Assay, ISO Standard Thrombogenicity in Canine, ISO Standard Thrombogenicity in Ovine.
- Design Verification tests: Snare Catheter Length, Snare Catheter OD, Snare Catheter Tip OD, Guide Catheter Compatibility.
- Packaging Validation tests: Visual Inspection (Gross Physical Damage to Package System), Visual Inspection (Label Legibility and Adhesion), Visual Inspection (Carton), IFU / eIFU Leaflet (Legibility), Visual Inspection (Device), Visual Inspection (Sterile Barrier Seal Integrity and Width), Package Integrity (Bubble Test), Peel-Open/Aseptic Presentation, Seal Strength Test.
- Shelf Life tests: Catheter Visual Inspection, Snare Catheter Tip Configuration, Snare Catheter ID and OD, Snare Catheter Length, Snare OD, Functional (general), Catheter Shaft Tensile Strength, Hub Bond Tensile Strength, Snare Catheter Tip OD, Guide Catheter Compatibility.
- Sterilization tests: Sterilization validation per ISO 11135 (overkill half cycle approach), Sterilization Residuals Testing.
These are standard engineering and safety tests for a physical medical device, not performance criteria for a software or AI/ML-driven device. The document explicitly states: "Animal testing was not required for the determination of substantial equivalence. Clinical testing was not required for the determination of substantial equivalence." This further indicates that no human clinical or AI/ML performance study, as typically described by your prompt's questions, was conducted or reported in this submission.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).