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The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in/0.018 in (0.36 mm/0.46 mm) guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheter are 40 cm, 80 cm and 135 cm.

This document describes the Boston Scientific Corporation Sterling™ OTW PTA Balloon Dilatation Catheter (K053116).

1. Acceptance Criteria and Reported Device Performance

The submission relies on demonstrating substantial equivalence to predicate devices (Ultra-soft™ SV Balloon Dilatation Catheters K021735 and K050389) through bench testing and biocompatibility testing. The document states: "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen."

However, the provided text does not explicitly list specific quantitative acceptance criteria (e.g., specific thresholds for burst pressure, flexibility, etc.) nor does it report detailed quantitative performance data of the Sterling™ OTW PTA Balloon Dilatation Catheter against such criteria. The document states that the testing demonstrated conformance to requirements and raised no new safety or performance issues, implying satisfactory performance against internal or recognized standards for these types of devices.

Without specific performance metrics and acceptance thresholds, a table for this section cannot be fully populated from the given text.

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

The document indicates that "Bench testing" was performed. This typically refers to laboratory testing of physical samples of the device.

• Sample Size for Test Set: The exact sample size used for the bench testing is not specified in the provided 510(k) summary.
• Data Provenance: The data is described as "Bench testing," meaning it was generated in a controlled laboratory environment, likely by the manufacturer (Boston Scientific Corporation). This is a form of prospective data collection for the purpose of demonstrating device performance. The country of origin of the data is not explicitly stated but can be inferred to be the United States, given the submitter's address and the FDA submission.

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

This submission describes a medical device (a balloon dilatation catheter), not a diagnostic algorithm that requires expert-established ground truth from medical images or clinical data. Therefore, the concept of "experts used to establish the ground truth for the test set" is not applicable in the context of this 510(k) submission for a physical device. Ground truth for a physical device is typically established through engineering specifications, material properties, and standardized functional performance tests.

4. Adjudication Method for the Test Set

As this is a physical medical device submission relying on bench testing, the concept of an "adjudication method" involving human experts (like 2+1 or 3+1 for diagnostic interpretations) is not applicable. Device performance is assessed against predefined engineering specifications and testing protocols.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
The device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve a MRMC study to assess human reader performance with and without AI assistance. The submission focuses on the safety and performance of the device itself, not on improving human diagnostic capabilities.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study (algorithm only) was not done.
This is a physical medical device, not a software algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.

7. Type of Ground Truth Used

The "ground truth" for the performance of this physical medical device is established by:

• Engineering specifications: The device is designed to meet specific physical and functional parameters (e.g., balloon diameter, length, burst pressure, trackability, pushability, inflation/deflation times).
• Performance standards: Testing is conducted against recognized industry standards and regulatory requirements for PTA balloon catheters.
• Biocompatibility standards: Materials are tested to ensure they are safe for contact with the human body.

In this context, ground truth is based on objective physical and chemical measurements rather than expert consensus on medical conditions, pathology results, or clinical outcomes data in the traditional sense of a diagnostic study.

8. Sample Size for the Training Set

This submission is for a physical medical device. It does not involve machine learning algorithms or AI, and therefore, there is no "training set" in the context of data used to train an algorithm. Performance is assessed through physical testing of manufactured devices.

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

Since there is no "training set" for an algorithm, this question is not applicable.

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