(25 days)
The NMI Microcatheter is intended for use in small vessels and supreselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products delivered through the microcatheter must be used in accordance with the original manufacturer's instruction for use. The catheter is not intended for use in coronary or neuro- vasculature.
The proposed MC is offered in two French size configurations. The first configuration has an outside diameter of 3.0F/2.8F (tapers proximally to distally) and has a nominal inside diameter of 0.027" along the entire catheter length. The second configuration has an outside diameter of 3.0F/2.4F (tapers proximally to distally) and has a nominal insider diameter of 0.021" along the entire catheter length.
Both MC configurations consist of a shaft and proximal hub assembly. The radiopaque shaft transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located 1mm from the catheter's distal end to identify the location of the distal tip under fluoroscopic visualization. The distal end of the catheter's outer surface is hydrophilic coated. The microcatheter is provided with a shaping mandrel and a rotating hemostatic valve. The microcatheter kit additionally includes a guidewire, a guidewire insertion tool and a torque device.
The provided document does not describe a study involving AI or machine learning. It pertains to a 510(k) premarket notification for a medical device called the "NMI Microcatheter" and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance.
However, I can provide the acceptance criteria and performance data for the physical device as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Characteristic | Reported Device Performance (Summary from Document) |
|---|---|---|
| Physical Performance | Coating performance | Demonstrated substantial equivalence through non-clinical tests. |
| Trackability | Demonstrated substantial equivalence through non-clinical tests. | |
| Pressure testing | Demonstrated substantial equivalence through non-clinical tests. | |
| Dimensional verification | Demonstrated substantial equivalence through non-clinical tests. | |
| Radiopacity | Demonstrated substantial equivalence through non-clinical tests. | |
| Kink resistance | Demonstrated substantial equivalence through non-clinical tests. | |
| Flow rate | Demonstrated substantial equivalence through non-clinical tests. | |
| Tip shapability | Demonstrated substantial equivalence through non-clinical tests. | |
| Compatibility tests | Demonstrated substantial equivalence through non-clinical tests. | |
| Particulate generation | Demonstrated substantial equivalence through non-clinical tests. | |
| Luer performance | Demonstrated substantial equivalence through non-clinical tests. | |
| Biocompatibility | Biocompatibility per ISO 10993-1 | Demonstrated substantial equivalence through non-clinical tests. |
Study Proving Device Meets Acceptance Criteria:
The document describes a series of non-clinical tests conducted to demonstrate that the NMI Microcatheter is "substantially equivalent" to specified predicate devices (Boston Scientific Renegade Hi-Flo Microcatheter K000177 and Boston Scientific Renegade STC Microcatheter K023861). The study's conclusion is based on "comparison of technological characteristics and the results of non-clinical tests."
Missing Information (Not applicable to this document as it's not an AI/ML study):
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).