Search Results

The .035 LOC Guide Wire Extension is intended to provide the necessary length to allow the exchange of one catheter for another while maintaining the position of the guide wire in the artery. After the catheter exchange has been completed, the extension can be detached and the initial wire can be used as a conventional guide wire.

The Abbott branded .035 LOC Guide Wire Extension is 0.035" nominal in diameter and 115 cm long. The distal end consists of a stainless steel hypotube that is attached to a 0.0197" core wire. The proximal end is coated with a polyethylene (PE) jacket. Silicon is used to coat the entire length of the polyethylene tubing.

This 510(k) submission (K083713) is for a "Special 510(k)," which indicates that the device being submitted is a modification of a legally marketed device and that the modifications do not affect its safety or effectiveness. In such cases, extensive new performance studies are often not required if substantial equivalence to the predicate device can be demonstrated through other means.

Therefore, the submission you provided does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, data provenance, expert qualifications, adjudication methods, or MRMC studies.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device based on:

• Identical Intended Use: The device performs the same function.
• Identical Operating Principle: The mechanism of action is unchanged.
• Identical Guide Wire Design: The fundamental design of the guide wire remains the same.
• Identical Manufacturing Processes: The methods of production are consistent.
• Identical Materials: The components are made from the same materials (excluding packaging and labeling).
• Identical Shelf Life: The product's stability duration is the same.
• Identical Sterilization Method: The sterilization procedure is unchanged.

The only changes identified are to branding, packaging, and labeling. These types of changes are generally considered not to impact the fundamental performance or safety of the device itself.

Therefore, I cannot provide the requested information in the format of acceptance criteria and a study to prove it, as the provided document does not contain this type of performance data.

The document states: "No changes were made that could impact product performance. Only branding, packaging and labeling are affected by this submission." This statement is the core of the justification for substantial equivalence in this Special 510(k) submission, rather than a detailed performance study with acceptance criteria.

Ask a specific question about this device