(357 days)
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.
| Test Category | Specific Test | Acceptance Criterion (Test Method Summary) | Reported Device Performance (Result) |
|---|---|---|---|
| Bench Testing | Label Integrity | Device labels were evaluated to ensure labels are intact and legible after environmental conditioning, distribution simulation and aging. | Pass |
| Bubble Leak | Device packaging was evaluated to detect gross leaks in packaging. | Pass | |
| Pouch Seal Strength | Pouch was evaluated for the mechanical strength of the seal. | Pass | |
| Coating Particulate | The number and size of particles generated during simulated use were measured. | Pass | |
| Dimensional Verification | Dimensional specifications were verified to ensure device meets all the requirements. | Pass | |
| Tip Inspection | Catheter tip was evaluated to ensure the complete retrieval of tip during its removal. | Pass | |
| Surface Integrity | Device visually inspected to ensure surface is free of defects that can cause tissue trauma. | Pass | |
| Heat Shrink Inspection | To ensure heat shrink identifier remains intact and legible after environmental conditioning, distribution simulation and aging. | Pass | |
| Coating Uniformity | To evaluate the devices for uniform coating. | Pass | |
| Simulate Use/Compatibility | The catheter performance was evaluated when used in conjunction with other devices used in standard procedures without sustaining damage or kinks and without causing damage to the other devices. | Pass | |
| Coating Adhesion | To visually categorize the integrity of coating on the device. | Pass | |
| Push/Track | To ensure device is able to be tracked without kink under normal conditions in tortuous anatomy. | Pass | |
| Kink Resistance | The distal shaft of the device was evaluated for kink resistance when subjected to a bend radius of 1.0 cm. | Pass | |
| Liquid Leak Under Pressure | To ensure device does not exhibit leakage of liquid under a minimum pressure of 44 psi for a minimum of 30 seconds. | Pass | |
| Static Burst | To ensure device withstands a minimum pressure of 100 psi prior to burst. | Pass | |
| Tensile Strength - Push Wire | To ensure device meets the required tensile strength between the push wire and catheter body: 15 N pull force minimum. | Pass | |
| Tensile Strength - Distal Section | To ensure device meets the required tensile strength of the distal section of the shaft: 5N pull force minimum. | Pass | |
| Biocompatibility | Cytotoxicity | Biological reactivity Grade 0 on the test article after 48 hrs. incubation with mouse fibroblast. The response on the positive and negative control article extracts confirmed the suitability of the tests. The test article (TA) is considered non-cytotoxic. | Pass |
| Hemolysis (Direct and Indirect) | The test article in direct contact with blood had a hemolytic index of 0.3%, and the test article extract had a hemolytic index of 0.2%. Both the test article in direct contact with blood and the test article extract were non-hemolytic. | Pass | |
| Sterilization | Ethylene Oxide (EO) Residuals | In accordance with ISO 10993-7. | Pass (Implied by Conclusion) |
| Limulus Amoebocyte Lysate (LAL) | In accordance with USP 24 chapter 85 and FDA guidance. | Pass (Implied by Conclusion) | |
| Bioburden Testing | In accordance with relevant standards (not explicitly listed but implied alongside EO residuals and LAL). | Pass (Implied by Conclusion) | |
| Shelf-life | Shelf-life Verification (3 years) | The device will be labeled with an expiration date of 3 years from the date of sterilization. | Pass (Implied by Conclusion) |
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.
§ 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).