Search Results

The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.

The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F.

The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.

This document describes the MedAmicus Coaxial Introducer, a device intended to facilitate the introduction of guide wires or catheters into the vascular system. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance through extensive clinical studies and acceptance criteria as might be expected for a new technology with specific performance metrics. Therefore, the questions related to clinical study design, expert ground truth, effect size with AI, etc., are not directly applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text, focusing on the available information regarding performance and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with specific quantitative thresholds that the device must meet, nor does it present detailed performance metrics as one might find in a clinical trial. Instead, it focuses on demonstrating equivalence to predicate devices through material similarity, manufacturing processes, and limited functional testing.

2. Sample Size for the Test Set and Data Provenance

• Bonding Strength Test: "All samples met the required specifications." The exact sample size is not stated, but it implies a sufficient number were tested to draw this conclusion. The data provenance is internal testing by MedAmicus.
• Biocompatibility Testing: Conducted on "MedAmicus' peelable sheath and dilator that uses identical material to that used in the Coaxial Introducer." The specific sample size for each biocompatibility test (e.g., number of animals for toxicity, number of cells for cytotoxicity) is not provided. The data provenance is internal testing, likely by a contract lab specializing in medical device biocompatibility.
• Sterilization Validation: Spore strips (one million spores of Bacillus var niger) were used in sample product. This refers to the biological indicator for sterilization validation, not patient data.

This submission is not a clinical study involving human patients, so there is no "test set" in that sense or data provenance related to patient cohorts.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a 510(k) submission focused on substantial equivalence to existing devices through material and performance comparisons, not a clinical study requiring expert review of patient data for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no human-reviewed test set or clinical data requiring adjudication.

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

Not applicable. This is not a study comparing diagnostic accuracy or clinical outcomes of the device with and without AI assistance, nor does it involve multiple readers interpreting medical cases.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in medical device AI/diagnostic studies is not directly relevant here. Instead, the "truth" is established through:

• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (MedAmicus K932323 and Boston Scientific K974640).
• Material Equivalence: Verification that the materials used are identical or highly similar to those in already cleared devices, and pass specified biocompatibility tests.
• Functional Testing: Internal testing demonstrating physical properties (e.g., bonding strength) meet specifications and are comparable to predicate devices.
• Sterilization Validation: Adherence to established standards (AAMI method) for achieving sterility.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device