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The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The BNLE Hydrophilic Jacketed Peripheral Guidewire is available in 150 cm - 260 cm lengths and in 0.018" - 0.035" diameter ranges. The hydrophilic coated guidewire consists of a nickel-titanium alloy core wire and tungsten infused polyurethane jacket in configurations of wire stiffness and tip shape. The finished guidewire is placed in a dispenser hoop and Tyvek pouch. Five (5) Tyvek pouches are placed into a shelf box with an IFU, and 26 shelf cartons are placed into a shipper box. Labels are placed on the Tyvek pouch and shelf box. The finished product is EO sterilized.

The provided text is a 510(k) summary for a medical device (BNLE Hydrophilic Jacketed Peripheral Guidewire). It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have acceptance criteria related to accuracy metrics like sensitivity, specificity, or AUC, nor does it involve expert readers establishing ground truth.

Instead, this document details the substantial equivalence of a physical medical device (a guidewire) to a predicate device. The "performance testing" described is for the physical and biological characteristics of the guidewire itself, not for an algorithm's performance.

Therefore, most of the requested information (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, AI-related ground truth types) is not applicable to this document.

However, I can extract the acceptance criteria and performance as described for this physical device.

Acceptance Criteria and Device Performance (for a physical medical device - Guidewire)

Since this document pertains to a physical medical device (a guidewire) and not an AI/diagnostic algorithm, the "acceptance criteria" discussed are related to the device's physical and biocompatibility characteristics. The document doesn't provide specific numerical acceptance criteria or performance metrics for each test, but it states the overarching conclusion that the device "met all predetermined acceptance criteria."

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation for "Pass": The document states: "BNLE Hydrophilic Peripheral Jacketed Guidewire met all predetermined acceptance criteria and raised no new concerns regarding safety or efficacy." This implies that for each listed test, the device's performance fell within the acceptable range defined by the manufacturer for demonstrating substantial equivalence. Specific numerical ranges or results for each test are not provided in this summary.

2. Sample size used for the test set and the data provenance:

• This information is not applicable as this is a physical device, not an AI/diagnostic algorithm using a "test set" of patient data.
• The tests are performed on samples of the manufactured guidewire itself. The sample size for each specific physical or biocompatibility test is not detailed in this 510(k) summary.
• Data provenance for a physical device refers to the conditions under which the tests were conducted (e.g., lab conditions, animal models for biocompatibility). These specifics are not detailed in this public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable for a physical medical device. "Ground truth" in this context would be established by validated test methods and standards (e.g., ISO, ASTM standards), not by human experts interpreting images or data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This concept is for resolving discrepancies in expert interpretations of data, which is not relevant to the testing of a physical guidewire.

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:

• Not applicable. This is a framework for evaluating diagnostic AI algorithms involving human readers, which is not the subject of this 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This refers to the evaluation of an AI algorithm's performance on its own, which is not relevant to a physical guidewire.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For physical devices, "ground truth" is typically established by:
  • Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) and internal design specifications.
  • Physical Measurements: Direct measurements of device dimensions, strength, flexibility, etc., against predefined specifications.
  • Chemical Analysis: Verification of material composition.
  • Biological Response in vitro/in vivo: Assessment of biocompatibility based on established biological assays (e.g., cytotoxicity, sensitization, hemolysis) and animal studies (e.g., thrombogenicity in canine).

8. The sample size for the training set:

• Not applicable. This refers to the data used to train machine learning models, which is not relevant to this physical device.

9. How the ground truth for the training set was established:

• Not applicable for the same reason as above.

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The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.

The BNLE Access Guidewires are available in 40 cm to 80 cm lengths and in the 0.018" – 0.021" diameter range. The BNLE Access Guidewires are available with Nitinol or Stainless Steel (SS) shafts and in configurations with SS coils or radiopaque Tungsten coils.

The BNLE Access Guidewires consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A micro-coil is wound with a lumen that is then placed over the tapered distal section. The distal end is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The micro-coil will provide tip radiopacity in designated models. The finished guidewire is placed in a protective polymer dispenser hoop for either sterile packaging in a labeled Tyvek pouch or shipped in bulk non-sterile condition to use with in a procedure tray by a customer.

The provided text is a 510(k) summary for the BNLE Access Guidewire, a medical device classified as a catheter guide wire (Product Code: DQX, Regulation Number: 21 CFR 870.1330). This document focuses on demonstrating substantial equivalence to a predicate device, the VSI Guidewire (K112631), rather than outlining a study to prove acceptance criteria for a new AI/ML-driven device.

Therefore, the following information, typically requested for AI/ML device studies, is not available in the provided text:

• Acceptance Criteria and Reported Device Performance Table: The document explicitly states "BNLE Access Guidewire raised no new concerns regarding safety or efficacy" and aims to prove "substantially equivalent" rather than meeting specific performance metrics against a predefined acceptance criterion.
• Sample size used for the test set and data provenance: No information on a test set (clinical or otherwise for performance evaluation) is provided. The testing described is primarily mechanical and material-based.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set requiring expert ground truth.
• Adjudication method for the test set: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is a conventional medical device, not an AI-assisted one.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, the document does list the performance testing conducted to support the substantial equivalence claim for the BNLE Access Guidewire:

Performance Testing Items:

• Simulated Use/Device Compatibility
• Corrosion
• Kink Resistance
• Tip Flexibility
• Radiopacity
• Tensile
• Dimensional
• Visual Inspection
• Reverse Bend / Flex
• Fracture Resistance
• Torqueability
• Torque Strength
• Shelf Life

Biocompatibility Testing (per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device):

• Cytotoxicity L929 MEM Elution
• Maximum Sensitization
• Irritation Intracutaneous Reactivity
• Systemic Toxicity
• Material Mediated Pyrogen
• Hemolysis Extract and Direct Contact
• ASTM Partial Thromboplastin
• Complement Activation Assay
• Thrombogenicity in Canine
• Chemical Characterization

The study described here is a premarket notification (510(k)) which aims to demonstrate that the new device (BNLE Access Guidewire) is substantially equivalent to a legally marketed predicate device (VSI Guidewire K112631) in terms of design, materials, sterilization, principles of operation, performance, and indications for use. The performance testing outlined above was conducted to support this claim of substantial equivalence and ensure the new device performs as designed and is suitable for its intended use, posing no new concerns regarding safety or efficacy compared to the predicate.

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