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510(k) Data Aggregation
(134 days)
BENCHMARK BMX81 Access System
The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The BENCHMARK BMX81 Access System is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra Select Catheter, and a Dilator. The BMX81 Delivery Catheter can be used individually with a 0.038 in [0.97 mm] guidewire or together with the Penumbra Select Catheter to access the desired anatomy.
BMX81 Delivery Catheter:
The BMX81 Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque markerband on the distal end and a Luer hub on the proximal end. The BMX81 Delivery Catheter dimensions are included on the individual device label. The BMX81 Delivery Catheter is compatible with introducer sheaths appropriately sized for the outer diameter of BMX81 Delivery Catheter. The BMX81 Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft. The hydrophilic coating length is 18 cm.
Penumbra Select Catheter:
The Penumbra Select Catheter is a single lumen, braid-reinforced, variable stiffness 5F catheter with a radiopaque distal end and a Luer hub on the proximal end. The Penumbra Select Catheter is available in tip shapes (SIM, H1, or BER). The Penumbra Select Catheter tip shape and dimensions are included on the individual device label. The Penumbra Select Catheter is compatible with the BMX81 Delivery Catheter.
Dilator:
The Dilator is a single lumen, radiopaque catheter with a tapered distal end and a Luer hub on the proximal end. The Dilator is compatible with the BMX81 Delivery Catheter. The Dilator facilitates the percutaneous entry of the BMX81 Delivery Catheter by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
The BENCHMARK BMX81 Access System is a single-use, ethylene oxide (EO) sterilized system.
This document describes the premarket notification (510(k)) for the BENCHMARK BMX81 Access System. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this regulatory submission.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility | |
| Cytotoxicity (MEM Elution) | Grade = 0 (Reactivity None) |
| Sensitization | NS Extract: Grade = 0, SSO Extract: Grade = 0 |
| Irritation (Intracutaneous Reactivity) | NS Extract: Difference = 0.0, SSO Extract: Difference = 1.0 (BMX81) / 0.1 (Dilator) |
| Systemic Toxicity (Acute Systemic Injection) | No evidence of systemic toxicity (no deaths, no signs of toxicity, no weight loss > 10%) |
| Systemic Toxicity (Material Mediated Pyrogen) | Non-pyrogenic (no single animal had an individual rise in body temperature ≥ 0.5 °C) |
| Hemocompatibility (In-vitro Thrombogenicity) | Thromboresistant (Assays #1, #2, #3) |
| Hemocompatibility (Prothrombin Time (PT)) | Test article coagulation times are statistically similar to predicate |
| Hemocompatibility (Partial Thromboplastin Time (PTT)) | Test article coagulation times are acceptable |
| Hemocompatibility (Complement Activation) | Test article concentrations of SC5b-9 are statistically similar to predicate at exposure time point |
| Hemocompatibility (Hemolysis, indirect contact) | Hemolytic Index = 0.00% |
| Hemocompatibility (Hemolysis, direct contact) | Hemolytic Index = 0.21% (BMX81) / 0.00% (Dilator) |
| Performance Testing | Met all established requirements |
| Visual and Dimensional Inspection | Met acceptance criteria |
| Particulate Testing | Met acceptance criteria |
| Friction Testing | Met acceptance criteria |
| Simulated Use Testing | Met acceptance criteria |
| Radiopacity Testing/Markerband Visibility | Met acceptance criteria |
| Hub Air Aspiration Testing | Met acceptance criteria |
| Burst Pressure Testing | Met acceptance criteria |
| Tensile and Elongation Testing | Met acceptance criteria |
| Corrosion Testing | Met acceptance criteria |
| Liquid Leakage Testing | Met acceptance criteria |
| Kink Resistance | Met acceptance criteria |
| Torsion Testing in Simulated Use Model | Met acceptance criteria |
| Catheter Tip Stiffness Testing | Met acceptance criteria |
| Shelf Life | Met established requirements |
| Sterilization (ISO 11135+A1 and ISO 10993-7) | Met established requirements |
| Packaging | Met established requirements |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI/ML device. This document pertains to a medical device (catheter system) for which performance is evaluated through bench testing and biocompatibility. The concept of a "test set" in the context of AI/ML performance evaluation does not directly apply. The tests described were conducted on physical samples of the device and its components. The provenance of the data is from internal testing conducted by Penumbra, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for an AI/ML device. The ground truth in this context is established by standardized laboratory testing methods and regulatory guidelines (e.g., ISO standards for biocompatibility), not by expert human interpretation of data for diagnostic purposes.
4. Adjudication method for the test set:
- Not applicable for an AI/ML device. The performance evaluation involves laboratory tests with defined quantitative or qualitative outcomes (e.g., Grade = 0 for cytotoxicity, "Pass" for non-pyrogenic), which do not typically require adjudication in the way medical image interpretation might.
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:
- No, an MRMC comparative effectiveness study was not done. This is a medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical catheter system, not an algorithm.
7. The type of ground truth used:
- The ground truth for this medical device's performance evaluation is based on established scientific and engineering principles, international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization), and predefined acceptance criteria for physical and mechanical properties. For example, for biocompatibility, it's the absence of cytotoxicity, pyrogenicity, or certain reactivity according to the specific ISO test methods.
8. The sample size for the training set:
- Not applicable for an AI/ML device. The concept of a "training set" is relevant for machine learning models, not for traditional medical devices like a catheter system.
9. How the ground truth for the training set was established:
- Not applicable for an AI/ML device.
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