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The BridgePoint Medical Entera guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The Entera guidewires are not to be used in cerebral blood vessels.

The Entera is a conventionally constructed 0.014" diameter single use disposable guidewire that consists of a full length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes coaxially positioned coils, constructed of stainless steel and Pt/W for visibly under fluoroscopy. The coils are fixed to the stainless core via silver alloy solder and are optionally coated with silicone (Lake Region Medical MDX). The distal tip of the guidewire is supplied in a straight or angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0032" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the Entera rounded tip.

This document is a 510(k) summary for a medical device called the BridgePoint Medical Entera™ Percutaneous Coronary and Peripheral Guidewire. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results is generally not present in this type of regulatory submission.

Specifically, the document does not contain any information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details of a study proving the device meets acceptance criteria.
3. Number of experts, their qualifications, or adjudication methods for ground truth because no such study addressing acceptance criteria is described.
4. A multi-reader multi-case (MRMC) comparative effectiveness study, nor effects of AI assistance.
5. Standalone algorithm performance, as this is a physical medical device, not an AI algorithm.
6. The type of ground truth used, as no study requiring ground truth is detailed for performance assessment.
7. Sample size for a training set or how ground truth was established for a training set, as these concepts relate to AI/ML models, which this device is not.

The document states that the BridgePoint Medical Entera™ Guidewire is "substantially equivalent" to existing predicate devices (Lake Region PTCA guidewire/Triumph, Cordis/Brivant, Ltd. Regatta Steerable Guidewire, and Asahi PTCA Guidewire Confianza Pro). The arguments for substantial equivalence are based on:

• Intended Use: All devices are designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA/PTA.
• Method of Operation: The Entera is a conventionally constructed guidewire.
• Technical Aspects:
  • It is a 0.014" diameter single-use disposable guidewire with a full-length stainless steel shaft, proximal PTFE coating, and a taper-ground distal portion for flexibility.
  • The distal portion includes coaxially positioned coils of stainless steel and Pt/W for fluoroscopic visibility.
  • The coils are fixed via silver alloy solder and can be silicone-coated.
  • The distal tip can be straight or angled, transitioning to a rounded tip.
  • Key difference and justification for equivalence: The Entera has a 0.0032" diameter, 0.007" long narrowed extension on its distal tip, unlike the standard 0.014" distal tip of the Triumph. However, this narrowed tip is stated to be "substantially equivalent" to the narrowed distal tip geometries of the Cordis Regatta (which has a non-conventional "wedge shaped" tip substantially less than 0.014") and the Asahi Confianza Pro (which tapers to 0.009" diameter).
  • The distal-most portion of the Entera core wire (under the distal coil) has a round cross-section, while the Triumph has a flattened/ribbon cross-section.
  • The Entera and Triumph are manufactured by the same company (Lake Region Medical) and use the same component materials with "very similar physical attributes (flexibility, radiopacity, etc.)."

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a study designed to explicitly meet predefined performance acceptance criteria.

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