(26 days)
The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.
The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is as follows.
• 6 French
• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.
The provided text is a 510(k) summary for the VISTA BRITE TIP and ENVOY Guiding Catheters. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting on a clinical study where the device performance is measured against such criteria.
Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria is not present in the provided document.
Here's why and what information is available:
- Type of Submission: This is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance characteristics to the predicate. It does not usually require new clinical studies to establish safety and effectiveness from scratch, especially for Class II devices like this one.
- Lack of Performance Criteria and Study: The document explicitly states: "The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards." This indicates that there are no pre-defined quantitative performance criteria that the device must meet in a specific study format. Instead, the focus is on a comparison to an already approved device.
- Basis for Equivalence: The "Summary of Substantial Equivalence" section states: "The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalent to the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters." This implies that the device's characteristics (design, materials, intended use) are similar enough to existing, approved devices that no new performance study with acceptance criteria is deemed necessary for market clearance.
In summary, the document does not contain the information you requested because its purpose is to demonstrate substantial equivalence, not to report on a study meeting specific performance acceptance criteria.
§ 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).