(99 days)
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
| Test | Acceptance Criteria (based on implied compliance with standards/guidance) | Reported Device Performance |
|---|---|---|
| Corrosion Resistance | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Dimensional Verification | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Kink Resistance | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Lubricity | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Particulate Evaluation | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Radiopacity | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Silicone Coating Integrity | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Simulated Use (Compatibility) | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Tensile Strength | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Tip Flexibility | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Tip Pull | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Torque Strength | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Torqueability (Torque Response) | Compliance with FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 10, 2019) | Pass |
| Flex Resistance | Resistant to damage by flexing in accordance with ISO 11070:2014 Annex G criterion, between two cylindrical mandrels with diameters equal to 20 times the guidewire diameter. | Pass |
| Fracture Resistance | Shall not fracture or fail when tested in accordance with ISO 11070:2014 Annex F criterion, test article wrapped around a mandrel with a diameter 10 times larger than the guidewire outside diameter. | Pass |
| Tip Load | Guidewire tip load buckling force inducing buckling deformation with a 20 mm gauge length from the distal tip is documented. (Implied acceptance is demonstration of acceptable force for intended use) | Pass |
| Sterility | Sterilization validated according to ANSI/AAMI/ISO 11135:2014 with a minimum sterility assurance level (SAL) of 10-6. | Pass |
| Sterile barrier integrity | Post terminal sterilization simulated distribution, seal peel (per ASTM F88), and bubble emission testing (per ASTM F2096) results demonstrate integrity. | Pass |
| Biocompatibility | Compliance with ISO 10993-4, -5, -10, -11 (for Cytotoxicity, Complement Activation, Intracutaneous Reactivity, Sensitization, Material Mediated-Pyrogenicity, Acute Systemic Toxicity, and Standard in Vivo Thrombogenicity in Canine), ASTM F756 (for Hemolysis), and ASTM F2888 (for Heparinized Platelet and Leukocyte Count). | Pass |
| Shelf life (2 years) | Confirmation of device functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16. | Pass |
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.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.