(202 days)
The Q 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 MIVI Q 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 catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q 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 catheter contains a pin vise threaded on the control wire, which may be used to advance the catheter.
Acceptance Criteria and Study for MIVI Q Distal Access Catheter
This document describes the acceptance criteria and study proving the MIVI Q Distal Access Catheter meets these criteria, based on the provided FDA 510(k) summary (K192558).
It's important to note that this device is a medical catheter and not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, data provenance) are not directly applicable in the context of this traditional medical device submission. The study focuses on bench testing (non-clinical performance testing) to demonstrate substantial equivalence to a predicate device, rather than clinical trials or AI model validation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Criterion (Pass/Fail) | Reported Device Performance (Result) |
|---|---|---|
| Dimensional Verification | Device meets specified dimensional requirements. | Pass |
| Corrosion Resistance | Exposed metallic components show no signs of corrosion. | Pass |
| Tensile Strength – Pin Vise | Adequate device tensile strength. | Pass |
| System Compatibility / Simulated Use | Successful simulated use testing with "worst case" dimensional stack up. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For medical devices undergoing bench testing, samples are typically chosen based on statistical methods to ensure representativeness and confidence in the results, though the exact numbers are not detailed in this summary.
- Data Provenance: This is bench testing conducted by the manufacturer, MIVI Neuroscience, Inc., at their facilities. It is inherently prospective for the specific design verification of the modified device. Country of origin for the data is implicitly the United States, given the company's location (Eden Prairie, Minnesota).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For this type of medical device submission focused on physical properties and performance, "ground truth" is established by engineering specifications, validated test methods, and industry standards, not by expert medical consensus on human-generated data. The "experts" would be the engineers and quality control personnel designing and executing the tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective and quantitative (e.g., measuring dimensions, observing corrosion, measuring tensile strength). There is no "adjudication" in the sense of resolving disagreements between human observers. The outcomes are determined by adherence to pre-defined engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The MIVI Q Distal Access Catheter is a physical medical device (catheter) with no AI/ML components or human diagnostic interpretation associated with its direct function.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, this is not applicable. The MIVI Q Distal Access Catheter is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing is based on:
- Engineering Specifications: Pre-defined dimensional requirements, material properties, and functional performance targets derived from the device's intended use and comparison to the predicate device.
- Industry Standards: Relevant ISO or ASTM standards governing medical device testing (though not explicitly listed in this summary, they are implicitly followed in such submissions).
- Predicate Device Performance: The established performance and safety profile of the legally marketed predicate device (MIVI Mi-EXT Extension Catheter, now branded as the MIVI Q Distal Access Catheter K163233) serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
§ 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).