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Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty of narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.

The proposed Symmetry Balloon Dilatation Catheter is substantially equivalent to the existing Symmetry Balloon Dilatation Catheter cleared by FDA under premarket notification K060959 (April 12, 2006). Symmetry has the same intended use, scientific technology, design, materials (with the exception of the Pebax resin used in the shaft), sterilization method, and packaging materials as the applicable predicate device.

The vendor is discontinuing the supply of the current Pebax resin, which is used in the shaft of the device; therefore a new resin is being supplied.

This document is a 510(k) summary for a medical device called the "Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheter" from Boston Scientific. It is a submission to the FDA seeking clearance to market this device as substantially equivalent to a predicate device.

The study presented here is focused on demonstrating the substantial equivalence of a modified version of an existing device to its predicate. The primary change is the material used for the shaft (a new Pebax resin). This is not an AI/algorithm-driven device, so many of the requested criteria related to AI studies (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the device's technical performance and regulatory acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify sample sizes for "test sets" in the context of image analysis or algorithm validation, as this is a physical medical device. The "testing" mentioned refers to bench testing and biocompatibility studies of the physical device. The provenance of this data is from internal testing conducted by Boston Scientific.

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

Not applicable. This is not an AI/algorithm-driven device requiring expert ground truth for image analysis.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/algorithm-driven device requiring ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

Not applicable in the context of AI studies. For the physical device, the "ground truth" would be established through engineering specifications, validated test methods, and compliance with relevant industry standards for material properties, functional performance, and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device with a training set.

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

Not applicable. This is not an AI/algorithm-driven device with a training set.

Summary of the Study and Acceptance:

The study described here is purely focused on demonstrating substantial equivalence for a minor material change in the shaft of an existing balloon dilatation catheter.

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion for this 510(k) submission is that the modified device (Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters with the new Pebax resin) is as safe and effective as the predicate device (Symmetry Balloon Dilatation Catheter K060959 cleared April 12, 2006). This is demonstrated by showing that the indications for use, scientific technology, design, materials (except for the specified resin change), sterilization method, and packaging materials are essentially the same or that any differences do not raise new questions of safety or effectiveness.
• Study Proving Acceptance: Boston Scientific conducted bench testing and biocompatibility testing. The results of these tests indicated that the changes (specifically the new Pebax resin in the shaft) did not introduce any new safety or performance issues. The report explicitly states, "No new safety or performance issues were raised during the device testing." This positive outcome of the non-clinical tests allowed the FDA to determine that the device is substantially equivalent to the predicate. The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

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