Search Results

The Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

The Q Distal Access Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.

The medical device described, the Q Distal Access Catheter, is not an AI/ML powered device, therefore, the requested information regarding AI/ML related aspects (such as effect size, standalone performance, training set details, and expert qualifications for ground truth) is not applicable. The provided text details the non-clinical performance testing for a physical medical catheter.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Q Distal Access Catheter are derived from various non-clinical performance tests, including bench testing and biocompatibility testing. The "Results" column from the provided tables serves as the reported device performance, indicating that the device "Pass"ed each criterion.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific bench or biocompatibility test. The evaluation involved "design verification testing" and "additional biocompatibility testing." The provenance of the data is from internal testing conducted by MIVI Neuroscience, Inc., as part of their 510(k) submission. This is considered retrospective for the purpose of the submission, as the tests were performed to demonstrate compliance of an already designed and manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as the Q Distal Access Catheter is a physical medical device, not an AI/ML powered device that relies on expert interpretation for "ground truth" establishment in its performance evaluation. The "ground truth" in this context refers to established engineering specifications, material science standards, and biocompatibility guidelines.

4. Adjudication Method for the Test Set

This question is not applicable for a physical medical device. The "adjudication method" concept is typically used for subjective assessments in clinical or AI/ML studies where human interpretation of ambiguous data is involved. For engineering and scientific testing of a physical device, results are typically objective and determined by established protocols and measurement techniques.

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 question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not have a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Q Distal Access Catheter's performance evaluation is based on a combination of:

• Design Specifications: Predefined engineering requirements and dimensional tolerances for the catheter.
• Established Industry Standards: Such as ISO 11135:2014 for sterilization, ISO 10993-7 for biocompatibility residuals, ASTM F756 for hemolysis, and USP 24 chapter 85 for bacterial endotoxins.
• Visual and Mechanical Inspection Criteria: Standardized methods to assess physical integrity, coating uniformity, and functional performance.
• Physiological Response Criteria: For biocompatibility, established thresholds for cytotoxicity and hemolysis.

8. The Sample Size for the Training Set

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. The Q Distal Access Catheter is a physical medical device and does not involve an AI/ML training set.

Ask a specific question about this device

· Merlin Aspiration Catheter
As a part of the Merlin Aspiration System, the Merlin Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi in the peripheral arterial system.
· High Flow Tubing
As a part of the Merlin Aspiration System, the High Flow Tubing is indicated to connect the guide catheter to an aspiration pump.

The Merlin Aspiration System is comprised of two devices:

• Merlin Aspiration Catheter
• High Flow Tubing
  The Merlin Aspiration Catheter is introduced through a guide catheter or long sheath into the peripheral vasculature and guided over a guidewire to the site of primary occlusion. The Merlin Aspiration Catheter is used in conjunction with an aspiration pump, which is connected to High Flow Tubing. These devices are visible under fluoroscopy.
  Merlin Aspiration Catheter
  The Merlin Aspiration Catheter consists of single lumen, coiled construction, variable stiffness shaft with radiopaque markers on distal and proximal end of the catheter portion for angiographic visualization. The Merlin Aspiration Catheter is identical in design to the MIVI Q Distal Access Catheter (K192558).
  High Flow Tubing
  The MIVI High Flow Tubing is a sterilized and disposable (onetime use) product consisting of high-pressure PVC tubing with end fittings and an on/off switch. The MIVI High Flow Tubing connects an aspiration pump to a reperfusion catheter, providing a means for introducing vacuum during procedures. The MIVI High Flow Tubing has a flow valve that allows the physician to start and stop the flow of aspiration.

The provided text describes the MIVI Merlin Aspiration System and its premarket notification (K213771) to the FDA, demonstrating substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, reported device performance (in quantitative metrics), human reader studies, or detailed information about the ground truth establishment in the manner typically associated with studies proving device performance against acceptance criteria for AI/ML-based devices.

The provided text focuses on the mechanical and material performance of a medical device (aspiration catheter and tubing), not an AI/ML diagnostic or therapeutic device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the content provided.

The document instead provides information about engineering bench testing, animal testing, and biocompatibility, which are standard for physical medical devices.

Here's a summary of the information that is available, formatted to address the relevant parts of your request, and explicitly stating where information is not applicable (N/A) based on the nature of the device described:

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

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are implied by the "established criteria" that the device was tested against. The "reported device performance" is simply that the device "Met established criteria" for each test. Specific quantitative criteria and performance values are not provided in this summary.

Information for AI/ML Device Evaluation (Not Applicable for this Device)

The following points are primarily relevant for AI/ML-based medical devices, which the Merlin Aspiration System is not. Therefore, specific details for these points are Not Applicable (N/A) based on the provided text. The device is a physical aspiration system, and its evaluation focuses on mechanical performance, biocompatibility, and animal testing.

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

• N/A. This device is a physical medical device (aspiration system), not an AI/ML device that uses a "test set" of data in the common sense for diagnostic or prognostic purposes. Performance was evaluated through bench testing and animal testing.
• For animal testing: 8 animals (porcine carotid, renal, and subclavian vasculature). This is prospective testing in an animal model.

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)

• N/A. Ground truth establishment for a "test set" of data points is not relevant for the physical device performance testing described.

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

• N/A. Not relevant for the type of device testing described.

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

• N/A. This is a physical medical device, not an AI-assisted diagnostic or therapeutic tool.

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

• N/A. This is a physical medical device, not an algorithm.

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

• N/A. For the bench testing, the "ground truth" would be established engineering specifications and physical measurements. For animal testing, it would be direct observation of the device's performance in vivo concerning safety and effectiveness in removing emboli/thrombi.

8. The sample size for the training set

• N/A. This device is not an AI/ML product developed using a training set.

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

• N/A. Not applicable as there is no training set for this physical device.

Ask a specific question about this device