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The Cardio Flow Peripheral Guide Wire is intended for temporary placement in peripheral vasculature the placement and exchange of diagnostic and therapeutic devices during percutaneous intravascular procedures. This guidewire device is intended for peripheral vascular use only.

The Cardio Flow Peripheral Guide Wire (Guidewire), Model GW1001 is a 304V stainless steel mandrel guidewire with a fixed distal spring coil. The distal coil is radiopaque to fluoroscopy. The coil is medium-stiffness in load-force and the distal end is coated in hydrophobic silicone to facilitate tracking. The Guidewire has a maximum outer diameter of 0.36 mm (0.014-inch). The GW1001 Guidewire has overall nominal length of 325 cm.

The Cardio Flow Peripheral Guide Wire (Model GW1001) underwent several non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Asahi Astato XS 20 Guide Wire (K103057).

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench evaluations and non-clinical performance tests. This implies that physical samples of the Cardio Flow Peripheral Guide Wire were tested in a laboratory setting.

• Sample Size: Not explicitly stated for each individual test. However, it is standard practice for such tests to use a statistically significant number of samples to ensure robust results.
• Data Provenance: The tests were conducted internally by or on behalf of Cardio Flow, Inc., likely at their facilities or a contracted testing lab, following established international and FDA-recognized standards. There is no mention of country of origin for test data, but the company is based in Mahtomedi, MN, USA. The data is prospective for the device under review.

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

Not applicable. This was a physical device performance study, not a study requiring expert clinical assessment for ground truth. The "ground truth" for these tests is defined by the objective performance criteria specified in the referenced standards (e.g., ISO, ASTM, FDA guidance).

4. Adjudication Method for the Test Set

Not applicable, as this was a physical device performance study, not a clinical study involving human judgment that would require adjudication.

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

Not applicable. This device is a medical guidewire, not a diagnostic AI system that evaluates medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical medical guidewire, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this type of device performance testing is established by objective engineering and performance specifications defined in recognized national and international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges, thresholds, or qualitative outcomes (e.g., "Pass/Fail") for various physical and material properties.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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