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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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(30 days)
The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.
The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm 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. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.
The provided document is a 510(k) summary for the Warrior 14 guidewire, a medical device. It does not describe an AI/ML device or a study comparing AI performance against acceptance criteria. Instead, it details the substantial equivalence determination process for a traditional medical device (a guidewire) based on biocompatibility and bench testing.
Therefore, the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI is not applicable to this document. The document focuses on the physical and material properties of the guidewire and its comparison to a predicate device.
However, I can extract the acceptance criteria and performance data for the guidewire as presented in the document, which are primarily related to safety and performance through bench and biocompatibility testing.
Here's a summary of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance
| Test Category | Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must be non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant. (Based on ISO 10993-1) | Passing results from biomaterial tests demonstrate that the Warrior 14 guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant. |
| Performance - Bench | Device must meet specified criteria for catheter compatibility, coating adherence/integrity, corrosion resistance, dimensional analysis, radiopacity, tensile strength, tip flexibility, tip shapeability, torqueability, and torque strength, and not raise different questions of safety or effectiveness. | The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness. |
| Substantial Equivalence | The device should not raise different questions of safety and effectiveness compared to the predicate device, and be substantially equivalent in technology, materials, and performance. | The technological differences do not raise different questions of safety and effectiveness. The Warrior 14 guidewire is identical to the predicate device in its indications for use and substantially equivalent in technology, materials, and performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "biomaterial tests" and "verification tests" but does not specify the sample sizes (e.g., number of guidewires tested for each bench test) or data provenance. These are typically internal lab tests conducted by the manufacturer.
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)
This information is not applicable as the document describes a physical medical device (guidewire) and its bench/biocompatibility testing, not an AI device requiring expert ground truth for image or data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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 as the document describes a physical medical device (guidewire), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes a physical medical device (guidewire), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" is established by the specified standards (ISO 10993-1) and the observed biological responses. For the bench performance tests, the "ground truth" is the established engineering specifications and measurement results. These do not involve expert consensus in the typical sense of diagnostic interpretation.
8. The sample size for the training set
This information is not applicable as the document describes the testing of a physical medical device (guidewire), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
Ask a specific question about this device
(30 days)
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.
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 190 cm and 300 cm length is compatible with a guidewire extension. 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 provided text is a 510(k) summary for the Raider Guidewire. It outlines the device's indications, technological characteristics, and testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain the kind of detailed information about acceptance criteria or a study design (like sample size for test sets, data provenance, expert demographics, adjudication methods, MRMC studies, or standalone algorithm performance) that you would typically find for an AI/ML medical device.
The Raider Guidewire is a physical medical device (a catheter guide wire), not an AI/ML software device. Therefore, the questions posed in the prompt, which are highly specific to the evaluation of AI/ML diagnostic or predictive algorithms, are not applicable to the information provided in this 510(k) summary.
The document discusses "acceptance criteria" in a general sense through performance testing for mechanical properties and biocompatibility.
Here's the information that can be extracted or inferred from the provided text, while acknowledging that many of your questions cannot be answered because they pertain to a different type of device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria for each test (e.g., "Tensile strength > X Newtons"). Instead, it states that "Device samples passed the following biocompatibility tests" and "The device design has been verified through the following tests." This implies that predefined acceptance criteria were met, but the specific values are not detailed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength acceptable | Verified, Passed |
| Torque Strength acceptable | Verified, Passed |
| Torqueability acceptable | Verified, Passed |
| Tip Flexibility acceptable | Verified, Passed |
| Coating Adherence/Integrity acceptable | Verified, Passed |
| Catheter Compatibility acceptable | Verified, Passed |
| Dimensional Analysis acceptable | Verified, Passed |
| Radiopacity acceptable | Verified, Passed |
| Corrosion acceptable | Verified, Passed |
| Cytotoxicity acceptable | Passed |
| Sensitization acceptable | Passed |
| Irritation acceptable | Passed |
| Acute Systemic Toxicity acceptable | Passed |
| Material Mediated Pyrogenicity acceptable | Passed |
| Hemolysis acceptable | Passed |
| Complement Activation acceptable | Passed |
| Thrombogenicity acceptable | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. For mechanical and biocompatibility testing of a physical device, samples are typically manufactured batches tested in a lab setting, not "test sets" in the AI/ML sense. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of testing.
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):
This information is not applicable/provided. "Ground truth" in the context of this device refers to objective measurements derived from physical and chemical tests, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. Adjudication methods are relevant for human interpretation tasks, not for the objective testing of physical device properties.
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/provided. MRMC studies and AI assistance are relevant for AI/ML diagnostic devices, not for a guidewire.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable/provided. This refers to AI algorithm performance, which is not relevant for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on objective measurements from standard mechanical, material, and biological tests (e.g., tensile strength testing, chemical assays for biocompatibility, dimensional measurements). It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic system would be evaluated.
8. The sample size for the training set:
This information is not applicable/provided. Training sets are for AI/ML models. This device is a physical product.
9. How the ground truth for the training set was established:
This information is not applicable/provided. (See #8).
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