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510(k) Data Aggregation
(212 days)
The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing de novo coronary chronic total occlusions (CTO).
The Warrior guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).
R350 Guidewire:
The R350 guidewire is an extended length (350 cm) guidewire with a 0.013″ maximum outer diameter (OD) (0.012" nominal OD). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a polytetrafluoroethylene (PTFE) coating, while the distal 200 cm has a hydrophilic coating.
Spectre Guidewire:
The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014″ diameter and straight shapeable tip. It is available in 200 cm and 300 cm lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating.
Raider Guidewire:
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 200 cm and 300 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Warrior Guidewire:
The Warrior guidewire is a stainless-steel core guidewire with a 0.014" diameter that tapers to a 0.009" diameter distal tip. It is available in 200 cm and 300 cm lengths. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.
Bandit Guidewire:
The Bandit guidewire is a 0.014″ diameter stainless steel core guidewire with a 0.008″ diameter tapered distal tip. It is available in 200 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm length is compatible with a guidewire extension.
The information provided describes the acceptance criteria and a clinical study conducted to demonstrate the safety and effectiveness of several guidewires (R350, Spectre, Raider, Bandit, Warrior guidewires) for use in crossing de novo coronary chronic total occlusions (CTO).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Study Results) |
|---|---|
| Primary Endpoint: Procedure success through discharge or 24 hours post-procedure, whichever came first. | |
| Defined as: | |
| a) Angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access, AND | |
| b) Absence of in-hospital MACE (cardiac death, target lesion revascularization, or post-procedural MI defined as CK-MB ≥ 3x ULN). | Overall Primary Endpoint Met: 75.3% (113/150) |
| Components of Primary Endpoint: | |
| a) Angiographic Visualization of any guidewire distal/proximal to CTO in the true vessel lumen: 94.7% (142/150) | |
| b) Absence of in-hospital MACE: 80.7% (121/150) | |
| The study primary endpoint result (75.3%) met the predetermined performance goal. | |
| Secondary Endpoint: |
- Successful recanalization (angiographic confirmation of crossing CTO and restoring blood flow)
- MACE (In-Hospital and 30-Day)
- Clinically significant perforation
- Technical Success | Successful recanalization: 140 (93.3%)
MACE:
In-Hospital: 29 (19.3%)
30-Day: 0 (0.0%)
Clinically Significant Perforations: 16 (10.7%)
Technical Success: 140 (93.3%) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 150 subjects.
- Data Provenance: Prospective, multi-center, single-arm study. The country of origin of the data is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document describes a clinical study to evaluate the safety and effectiveness of the guidewires but does not specify the number of experts or their qualifications for establishing the ground truth of the outcomes. The endpoints (e.g., angiographic visualization, MACE) would typically be adjudicated by clinical experts, but this detail is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not explicitly state the adjudication method used for the test set. It mentions "in-hospital MACE" as part of the primary endpoint, which would imply clinical events were assessed, but the process of adjudication (e.g., by an independent clinical events committee) is not detailed.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the performance of medical devices (guidewires) in a procedural context, not an AI-assisted diagnostic study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The study evaluates the performance of physical guidewire devices, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was based on clinical outcomes data and angiographic visualization. Specifically:
- Angiographic visualization of guidewire position (distal/proximal to CTO in the true vessel lumen).
- Absence of in-hospital Major Adverse Cardiac Events (MACE), which includes cardiac death, target lesion revascularization, or post-procedural MI (defined as CK-MB ≥ 3x ULN).
- Successful recanalization.
- Clinically significant perforations.
8. The sample size for the training set
This information is not applicable as the document describes a clinical trial for physical medical devices, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a clinical trial for physical medical devices, not an AI model that requires a training set.
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