(23 days)
Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
The Boston Scientific 6F RunWay Guide Catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of Vestodur to the shaft for added strength, a different blend of Hytrel in the tip, a different colorant used in the shaft, and a different braid pattern using thirty-two 0.001" stainless steel wires, eight 0.002" Stainless Steel wires, and eight 0.002" Tungsten wires to strengthen the catheter for better backup support.
The Boston Scientific RunWay Guide Catheters are designed to provide a pathway through which medical instruments such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. The RunWay catheters will be offered in a 6F outer diameter, available in lengths ranging from 40-125 cm, with optional side holes. The devices are provided sterile and intended for one procedure use only.
The RunWav catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: inner, middle, and outer. The outer laver is composed of three segments.
The outer laver segments one and two consist of various durometers of Amitel. Segment three is a blend of Vestodur 3000 and Arnitel. Vestodur is added to the shaft to strengthen the catheter. The use of varying durometers of Amitel provides specific flexibility zones at the distal end of the catheter. The tip consists of a reinforced portion and a non-reinforced portion.
The provided text describes a medical device (Boston Scientific 6F RunWay Guide Catheter) and its 510(k) premarket notification. However, it does not contain the kind of detailed information typically found in acceptance criteria and study reports for software-based devices, especially in the context of AI/ML.
This document focuses on the mechanical and material properties of a physical catheter, comparing it to a predicate device. It confirms the device's substantial equivalence based on in-vitro testing.
Therefore, for the specific questions you asked about acceptance criteria and studies (especially regarding AI/ML, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance), the provided text does not contain this information.
Here's a breakdown of why this information is missing, based on the provided text:
- No AI/ML Component: The device described is a physical catheter, not a software or AI-driven diagnostic tool. Therefore, concepts like "test set," "training set," "ground truth established by experts," "MRMC studies," or "standalone algorithm performance" are not applicable to this product.
- Focus on Substantial Equivalence: The document is a 510(k) submission, whose primary goal is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is achieved through comparisons of intended use, materials, design, and, in this case, non-clinical (in-vitro) testing of its physical properties.
- Safety and Effectiveness Justification: The "Non-clinical Test Summary" (Section 6.6) states: "Testing and evaluation of the 6F RunWay Guide Catheter consisted of shaft and distal segment tensile and elongation, tip tensile, tip deflection, hub to shaft tensile, pressure shaft burst and leak, torque response, lumen integrity and radiopacity. Biocompatibility, package pouch burst, and product shelf life testing have also been conducted. Test results verified that the 6F RunWay Guide Catheters are adequate for the intended use." This statement serves as the justification for meeting acceptance criteria for a physical device, based on standard engineering and biocompatibility tests.
To directly answer your request based only on the provided text, I must state that the information requested is not present.
If you were expecting this type of information, it suggests the input text might not be relevant to the kind of AI/ML device study you are looking to describe.
§ 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).