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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.

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The Amplatz Goose Neck Snare is a Class II device intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

The Amplatz Goose Neck Snare consists of a braided nitinol loop attached to a solid core nitinol guidewire. The plane of the loop is perpendicular to the host wire. The loop is covered with a gold-plated tungsten coil to enhance radiopaque. The shaft of the snare consists of a solid continuous Nitinol core wire shaft. The loop snare is delivered in a multi-purpose catheter. The catheter has a radiopaque marker band at its distal tip. The package configuration consists of a compact spiral configuration, using hoops to contain the snare and catheter. These spiral hoops are then double pouched in Tyvek/mylar pouches.

The provided 510(k) summary for the Amplatz Goose Neck Snare (K972511) does not contain a detailed study report that includes acceptance criteria and performance data in the format requested.

The document states: "The Amplatz Goose Neck Snare received clearance for market based on functional and safety testing detailed in the original premarket notification K901502." This means the detailed study information regarding acceptance criteria and performance would be found in the K901502 submission, which is not provided in this document.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the information given. The current document is a summary of the 510(k) application for a new version of the device, referencing the original clearance for the testing.

The document focuses on establishing substantial equivalence to a predicate device (MICROVENA Amplatz Goose Neck Snare, K901502) based on design and intended use, rather than presenting new performance data from a specific study for K972511.

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