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The Cardiometrics FloWire 300 Doppler Guide Wire and the Cardiometrics FloWire XT 300 Doppler Guide Wires are intended for use in all blood vessels, including both coronary and peripheral arteries, to measure blood flow velocities during diagnostic angiography and/or interventional procedures. The FloWire may be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood flow velocity measurements are obtained to provide hemodynamic information for the diagnosis and treatment of coronary or peripheral artery disease.

Device Description

The FloWire 300/ FloWire XT 300 Doppler Guide Wire is a steerable guide wire with a ultrasound transducer mounted in a housing at the tip of the radiopaque tip coil. The FloWire 300/ FloWire XT 300 utilizes a coaxial design, has a nominal outer diameter of .014" throughout the entire length of the guide wire, and is approximately 300 cm in length. The FloWire 300/ FloWire XT 300 is constructed from a core wire, tapered at the distal end. Two different taper configurations are available, one is for the standard FloWire 300 Doppler Guide Wire, while the second configuration is for the FloWire XT 300 Doppler Guide Wire. The FloWire XT 300 Doppler Guide Wire has increased column strength in the distal segment of the wire just proximal to the tip of the wire, while retaining the floppy characteristics of the tip itself; the increased column strength provides additional support for tracking interventional devices, such as atherectorny devices, lasers and stents. External to the core wire is a hypotube, proximal and tip coils, and the transducer housing. The hypotube extends from the conductive bands at the proximal end of the FloWire 300/FloWire XT 300 Doppler Guide Wire to the proximal coil. The distal tip is available in three different stiffnesses: floppy or flex. In addition, the FloWire 300/FloWire XT 300 Doppler Guide Wire is coated to provide lubricity for tracking interventional devices, such as balloon dilatation catheters. The FloWire 300/FloWire XT 300 Doppler Guide Wire connects to the FloMap/FloMap II Instrument via the Rotary Connector Cable and Patient Cable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the FloWire 300/FloWire XT 300 Doppler Guide Wire. This submission is for a modification to an existing device (lengthening the guide wire), rather than a completely new device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not presented in the traditional sense of a clinical trial proving a new device's efficacy against a set of performance metrics.

Instead, the submission focuses on substantial equivalence to a previously cleared predicate device. This means the primary "acceptance criterion" is demonstrating that the modified device performs equivalently and safety to the original, shorter FloWire/FloWire XT Doppler Guide Wire, and that the changes do not raise new questions of safety or effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence: Maintain intended use, function, materials, performance, and sterilization method as predicate device.	The FloWire 300/FloWire XT 300 is demonstrated to be substantially equivalent to the currently marketed FloWire/FloWire XT Doppler Guide Wire with regard to intended use, function, materials, performance, and sterilization method. The only modification is the length (175 cm to 300 cm), which is addressed through testing.
Biocompatibility: Meet requirements for "Externally Communicating Devices, Circulating Blood, Limited Contact" (ISO-10993).	Materials used were tested for biocompatibility and meet the requirements of FDA BlueBook Memorandum #G95-1 ("Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"). These results support the safety of the device.
Mechanical Performance: Maintain structural integrity and mechanical properties as per FDA guidance for guide wires.	Bench testing of the FloWire 300/FloWire XT 300 Doppler Guide Wire was conducted according to the FDA guidance document "Coronary and Cerebrovascular Guide Wire Guidance" (January 1995). Evaluations included: `Turns-to-Failure Torque Response`. Other tests (joint tensile strength, coating/particulate, radiopacity) were not re-performed as materials/dimensions/processes are identical to the predicate device, and prior results apply.
Acoustic Performance: Equivalent to predicate device.	Acoustic performance testing was performed to assure the performance of the FloWire 300/FloWire XT 300 Doppler Guide Wire was equivalent to the performance of the FloWire/FloWire XT Doppler Guide Wire. (Specific metrics not provided in this summary).
Manufacturing Quality: Compliance with Good Manufacturing Practices.	A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820). The FDA verifies this through periodic QS inspections.

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

Sample Size: Not explicitly stated in terms of a "test set" of patients or cases. The testing was primarily bench testing (mechanical and acoustic). For bench testing, sample sizes are typically determined by engineering and statistical methods to ensure representativeness and confidence in the results, but these details are not provided in this summary.
Data Provenance: The data provenance is from bench testing performed by the manufacturer, Cardiometrics, Inc., in the United States (Mountain View, California). This is retrospective in the sense that it's performed on manufactured devices for the purpose of the 510(k) submission, not on patient data from a prospective clinical trial.

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

This information is not applicable as the provided text describes bench testing (mechanical and acoustic performance) and biocompatibility, not a study requiring expert-established ground truth for patient outcomes or diagnoses. The "ground truth" here is the physical and functional properties of the device as measured against engineering specifications and regulatory guidelines.

4. Adjudication Method for the Test Set

This information is not applicable as the provided text describes bench testing, not a study requiring adjudication of clinical outcomes or diagnoses.

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

This information is not applicable. The device is a Doppler guide wire, not a diagnostic imaging AI system. The submission does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical instrument (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, performance standards (e.g., FDA guidance documents), and comparison to the established performance of the predicate device. For biocompatibility, the ground truth is established by the ISO-10993 standard.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a learning algorithm that requires a training set.

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

This information is not applicable for the reasons stated in point 8.

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