Search Results

The Bendit17 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 Bendit®17 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 Bendit®17 Microcatheter is 151 cm. It is comprised of two Nitinol hypo tubes that are connected at their distal ends, with proprietary laser-cut patterns along the 38 cm distal section. The laser cuts give the Bendit®17 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 10 mm section is steerable and includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm proximally from the tip. The distal portion of the catheter shaft (100 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 Bendit®17 lumen can accommodate compatible guidewires (≤ 0.014 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.

The Bendit®17 is compatible with the following types of therapeutic devices:

• Embolization particles with maximum particle size of 400 µm
• Coils with maximum coil wire size of 0.014''
• Stents/stent retrievers/intrasaccular flow disruption devices compatible with microcatheters with inner diameter of 0.017''

N/A

Ask a specific question about this device

VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.

VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.

The VIA® Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the radiopaque marker bands using fluoroscopic techniques (VIA17 Microcatheter has 2 radiopaque marker bands. VIA 21, 27 and 33 Microcatheters have one radiopaque tip marker band). Diagnostic and interventional devices can be delivered through the lumen of the catheter to the treatment site. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories.

The provided FDA 510(k) summary for the VIA® Microcatheter does not contain the specific information required to answer all parts of your request, as it pertains to a medical device's 510(k) clearance rather than a diagnostic AI algorithm study. This document focuses on demonstrating substantial equivalence to a predicate device through performance testing (biocompatibility and bench testing), not on a clinical effectiveness study with human readers and AI assistance.

Therefore, for aspects related to AI performance, human expert adjudication, effect size with AI assistance, and large-scale training/test sets for an AI algorithm (questions 2-9), the information is not applicable or not provided in this document.

However, I can extract the acceptance criteria and reported performance for the device itself (the VIA® Microcatheter) based on the provided bench testing data.

Acceptance Criteria and Reported Device Performance (Based on Bench Testing)

Note: Some tests (Coating Integrity, Catheter Torque Strength, Flow Rate, Dead Space) were reported "For characterization only," implying they were not subject to specific pass/fail acceptance criteria for this submission but were measured to understand device properties.

Study Details (for the VIA® Microcatheter, not an AI study)

1. A table of acceptance criteria and the reported device performance:

   • See table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: The document does not specify exact sample sizes for each bench test. For biocompatibility tests, specific numbers of animals (e.g., 17 male Hartley Guinea Pigs, 3 female New Zealand White Rabbits, 20 female Albino Swiss Mice, 2 Canine) are mentioned, but these are for biological testing, not for evaluating an AI algorithm on a medical dataset.
   • Data Provenance: Not applicable for device performance bench testing in the context of AI. The tests are laboratory-based.

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):

   • Not applicable. This is not an AI study requiring expert ground truth for medical images.

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

   • Not applicable. This is not an AI study requiring expert adjudication.

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 MRMC study was done. This document outlines the premarket notification for a physical medical catheter, not an AI-powered diagnostic tool.

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

   • Not applicable. This is not an AI algorithm.

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

   • For biocompatibility testing, the "ground truth" is defined by biological responses in test organisms and in vitro systems, evaluated against established ISO standards and criteria for non-toxicity, non-sensitization, non-irritation, non-hemolysis, etc.
   • For bench testing, the "ground truth" is adherence to predefined engineering and functional specifications or standards (e.g., ISO 10555-1:2014, ISO80369-7:2016).

8. The sample size for the training set:

   • Not applicable. There is no training set for an AI algorithm in this document specific to the device's performance evaluation.

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

   • Not applicable. There is no AI training set.

Ask a specific question about this device

The PG Pro microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The PG Pro Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the catheter hub is used for the attachment of accessories.

The provided text is for a 510(k) premarket notification for the "PG Pro Microcatheter". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria for an AI/ML type of medical device through a clinical study.

Therefore, the text does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size and data provenance for a test set.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for the training set was established.

Instead, the document describes:

• Device Description: The PG Pro Microcatheter is a single lumen catheter designed for introducing over a guidewire to access small, tortuous vasculature for infusing diagnostic and therapeutic agents in the peripheral vasculature.
• Predicate Device: Headway 27 Microcatheter (K142449). A reference device (Headway 17 Microcatheter, K101542) is also listed.
• Comparisons: The document includes a detailed "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" (Table 1) comparing the PG Pro Microcatheter to its predicate and reference devices across properties like Indications For Use, Principle of Operation, Material(s), Proximal ID/OD, Distal ID/OD, Number of Marker bands, Coating, Effective Length, Tip Configuration, Guidewire Compatibility, Method of Supply, and Accessories. The table highlights differences such as the PG Pro being intended only for peripheral vasculature, using a Tungsten coil vs. stainless steel, having a different range of effective lengths, being straight configuration only, being compatible with larger guidewires, and not including a shaping mandrel.
• Performance Data (Non-Clinical):
  • Biocompatibility testing: Conducted according to ISO10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility, as it is considered a limited (<24 hour) circulating blood contacting device.
  • Bench testing: A comprehensive list of tests was performed, including surface contamination, physical attributes, force at break, leakage (liquid, air), static and dynamic burst, durability and lubricity of hydrophilic coating, simulated use in flow model, catheter flow rate, kink resistance, stiffness, flexural fatigue, particulate testing, catheter dead space, torque strength, hub testing, corrosion testing, and radio detectability.
  • Animal Study: An acute large animal study was conducted with n=3 animals. The study assessed the device's safety profile, compatibility with therapeutic agents, and tissue response, concluding that the PG Pro Microcatheter performed similarly to the predicate device (Headway 27 Microcatheter).
• Conclusion: The PG Pro Microcatheter is considered substantially equivalent to the identified predicate based on performance, intended use, design, materials, principle of operation, and overall technological characteristics. The nonclinical data, verification, and validation testing support this conclusion and demonstrate the device should perform as intended.

In summary, this document is a 510(k) submission for a physical medical device (microcatheter) and relies on benchmarking against a predicate device, along with non-clinical (bench and animal) testing to demonstrate substantial equivalence, not the evaluation of an AI algorithm against specific performance criteria.

Ask a specific question about this device