(468 days)
The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
The Bendit21 Microcatheter is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle. The total working length of the Bendit21 Microcatheter is 157 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser -cut patterns along the 36 cm distal section. The laser cuts give the Bendit21 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable using the proximal Steering Handle. The device includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm from the tip. The distal portion of the catheter shaft (75 cm) is covered with a hydrophilic coating. Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit21 lumen can accommodate compatible guidewires (≤ 0.018 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle. The Bendit21 Microcatheter is compatible with the following types of therapeutic devices: Embolization particles with maximum particle size of 500 µm, Coils with maximum coil wire size of 0.018", Stents/Stent Retrievers/Flow Diverters.
This document is an FDA 510(k) summary for the Bendit21 Microcatheter, demonstrating its substantial equivalence to a predicate device. It is not an AI/ML device, therefore, the information requested about AI/ML specific criteria (such as training data, ground truth establishment methods for training data, expert adjudication, MRMC studies, and standalone performance) cannot be provided from this document.
However, based on the provided text, here's a breakdown of the acceptance criteria and the studies conducted for the Bendit21 Microcatheter:
The acceptance criteria for the Bendit21 Microcatheter are demonstrated through various in vitro bench tests and animal testing, confirming its safety, performance, and substantial equivalence to the predicate device. The general acceptance criterion for all tests is that the device must Pass, meaning its performance met pre-defined acceptance criteria, or it was comparable to the predicate device.
1. A table of acceptance criteria and the reported device performance:
Since specific quantitative acceptance limits for each metric are not explicitly stated in a table format with performance results, I will create a table summarizing the Test Name, the General Acceptance Criteria (inferred from "Results" column), and the Reported Device Performance.
| Test Name | General Acceptance Criteria (inferred) | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspections | No visual evidence of foreign matter, surface defects, or sharp edges; All measurements meet pre-defined acceptance criteria. | Pass. No visual evidence of foreign matter, surface defects or sharp edges. All measurements met the pre-defined acceptance criteria. |
| Kink Resistance | Demonstrates kink resistance in accordance with test acceptance criteria. | Pass. The microcatheter demonstrated kink resistance in accordance with the test acceptance criteria. |
| Simulated Use (Pushability, Retractability, Torsional Strength) | Successfully navigated through tortuous model without damage; met pre-defined acceptance criteria for forces. | Pass. All samples were successfully navigated through the tortuous model without damage and met the pre-defined acceptance criteria for forces. |
| Peak Tensile Force Along the Catheter Shaft | Tensile force to break for all samples met pre-defined acceptance criteria. | Pass. Tensile force to break for all samples for all junctions met the pre-defined acceptance criteria. |
| Air Leakage | No evidence of air leakage. | Pass. No evidence of air leakage. |
| Liquid Leakage | No evidence of liquid leakage. | Pass. No evidence of liquid leakage. |
| Priming Volume | Priming volume met pre-defined acceptance criteria. | Pass. Priming volume for all samples met the pre-defined acceptance criteria. |
| Fatigue (Tip Deflection and Tip Rotation) | Exceeded pre-defined number of tip deflection and tip rotation cycles without damage. | Pass. All samples exceeded the pre-defined number of tip deflection and tip rotation cycles without damage in both test configurations. |
| Torque Strength (Torque to Failure) | Exceeded the minimum number of cycles set by the test acceptance criterion before failure. | Pass. All samples exceeded the minimum number of cycles set by the test acceptance criterion before failure. |
| Torque Transmission | All measurements met pre-defined acceptance criteria. | Pass. All measurements met the pre-defined acceptance criteria. |
| Flow Rate | All measurements met pre-defined acceptance criteria. | Pass. All measurements met the pre-defined acceptance criteria. |
| Pressure Injection Flow Rate | Withstood applied injection pressures under test conditions without damage. | Pass. All samples withstood the applied injection pressures under the conditions of the testing without damage. |
| Burst Pressure | Withstood applied static pressure under test conditions without damage. | Pass. All samples withstood the applied static pressure under the conditions of the testing without damage. |
| Interventional Device Compatibility | Able to deliver all therapeutic devices using acceptable delivery force and without visible damage. | Pass. All samples were able to deliver all therapeutic devices used in the testing using acceptable delivery force and without any visible damage to the microcatheter. |
| Tip Deflection Force | All measurements met pre-defined acceptance criteria. | Pass. All measurements met the predefined acceptance criteria. |
| Tip Flexibility | Comparable to the predicate device. | Pass. Tip flexibility was comparable to the predicate device. |
| Particulate Characterization | Particulate generation was acceptable and comparable to the predicate device. | Pass. Particulate generation was acceptable and comparable to the predicate device. |
| Coating Integrity | Demonstrated acceptable coating integrity before and after simulated use. | Pass. All samples demonstrated acceptable coating integrity before and after simulated use. |
| Coating Length | Met pre-defined acceptance criteria. | Pass. The coating length for all samples met the pre-defined acceptance criteria. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size for In Vitro Bench Testing: "Sample sizes for all tests were established to demonstrate 95%/90% confidence/reliability in the test results." The exact number for each test is not specified, but this statement indicates a statistically sound sample size was used for each.
- Sample Size for Animal Testing: Not explicitly stated as a number of animals, but refers to "a porcine vascular model" where "Interventionalists used both the Bendit21 and the predicate Headway 21 microcatheters on opposite sides of the same animal." This suggests a comparative study design within each animal.
- Data Provenance: The document implies the data was generated prospectively during the development and testing phase for FDA submission. The country of origin of the data is not explicitly stated, but the submitter (Bend It Technologies Ltd.) is located in Petach Tikva, Israel. The testing itself would likely have occurred in laboratories or facilities globally that comply with regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a medical device (microcatheter), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "ground truth" and "experts establishing ground truth" in the AI/ML sense (e.g., radiologist consensus for image labeling) does not directly apply.
For this device:
- Ground Truth for Bench Testing: Established by standardized test methods (e.g., ISO standards, internal test methods) and objective measurements.
- Ground Truth for Animal Testing: Established through direct observation during procedures ("Interventionalists used..."), angiography for vessel patency, and post-mortem gross pathology and histologic evaluation of targeted vessels and downstream organs.
- Experts: "Interventionalists" are mentioned as performing the animal studies. Their specific qualifications (e.g., "vascular surgeon with X years of experience") are not detailed, but it's implied they are qualified professionals for such procedures. For pathology and histology, the "ground truth" would be established by veterinary pathologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable in the context of this traditional medical device study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human subject data, particularly in imaging studies where multiple readers interpret cases and disagreements need resolution (common in AI/ML performance evaluation). For a physical medical device, performance is measured against objective laboratory standards or physiological responses in animal models.
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 traditional medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and material properties, and it is intended for use by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As discussed in point 3, the "ground truth" for this device's performance evaluation was primarily based on:
- Objective Measurement against Pre-defined Specifications: For in vitro bench tests (e.g., dimensions, forces, flow rates, cycle counts before failure).
- Pathology and Histology: For animal testing (assessment of vessel damage, inflammation, etc.).
- Physiological Observations/Outcomes: In animal testing (e.g., animal's overall clinical status, occurrence of vasospasm, vessel patency through angiography).
8. The sample size for the training set:
Not applicable. This is a traditional 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, for the same reasons as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).