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To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

Nitinol or Stainless Steel core wire with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetrafluoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: OUTSIDE DIAMETER: .014" - .035", LENGTHS: 60 cm - 500 cm, TIPS: Straight or shaped with various tip flexibilities., COIL LENGTH: 2cm - 30 cm

This document describes a 510(k) premarket notification for a medical device called "Mandrel Guidewire or M-Wires™." The submission aims to demonstrate the substantial equivalence of the new device iterations to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

The document explicitly states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria for each test and the detailed reported device performance against those criteria are not provided in the given text. It only vaguely mentions "established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."

The general performance claim is: "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the currently marketed devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." However, it does not specify the sample size used for the test set.

Data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

3. Number of Experts and their Qualifications for Ground Truth Establishment:

This information is not applicable as the document describes non-clinical testing of a physical medical device (guidewire) for substantial equivalence, not an AI/ML-based diagnostic device requiring human expert ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Testing involved physical device characteristics and biocompatibility, not expert adjudication of diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable as this submission is for a physical medical device, not an AI-assisted diagnostic tool. No AI component is described.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable as this submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by "established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." This implies objective, measurable standards for physical properties. For biocompatibility, it was based on ISO 10993 series standards.

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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