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Cross-Pilot™ Turbo Elite® Support Catheters are intended to guide and support Spectranetics laser catheters during access of the vasculature and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating. Predicate devices of this type with similar intended uses have been classified into Class II. The support catheters are single-use and provided in sterile packaging.

Acceptance Criteria and Study for Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Spectranetics Cross-Pilot™ Turbo Elite® Support Catheter to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on "substantial equivalence" rather than specific numerical acceptance criteria. The performance is assessed through comparative laboratory testing against identified predicate devices.

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

• Sample Size: The document does not explicitly state the specific number of units tested for each physical dimension, infusion rate, or burst pressure test. It refers to "samples produced under routine manufacturing conditions" for device integrity and functionality.
• Data Provenance: All testing appears to be retrospective and conducted in-house by Spectranetics Corporation, Inc. The country of origin for the data is implicitly the United States, given the company's location.

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

Not applicable. This submission is for a medical device (support catheter) based on physical and functional equivalence to predicate devices, not on diagnostic or prognostic performance requiring expert interpretation of results. The "ground truth" is defined by the technical specifications and performance of the predicate devices and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no subjective interpretation of results requiring adjudication. The assessment is based on objective measurements and comparison to established specifications or predicate device performance.

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

Not applicable. This device is a support catheter, not an imaging or diagnostic device requiring human reader interpretation or comparative effectiveness studies of human performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Predicate Device Performance: The established physical dimensions, infusion rates, burst pressure, and technical characteristics of the legally marketed predicate devices (Terumo 5Fr Radifocus Optitorque and Asahi Angiographic Catheters).
• Industry Standards: Compliance with relevant ISO and ANSI/AAMI standards for biocompatibility (ISO 10993-1:2003), sterilization (ANSI/AAMI/ISO 11135:1994), and intravascular catheters (ISO 10555-1).
• In-house Requirements: Spectranetics' own established internal requirements for device integrity and functionality.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this device.

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