(27 days)
The NMI Microcatheter is intended for use in small vessels and superselective 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 must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.
The NMI 2.8F MC has an outside diameter of 2.8F and has a nominal inside diameter of 0.027" along the entire catheter length. The MC's shaft is a braided reinforced shaft, which 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 proximal end of the MC contains a Luer fitting and strain relief. The device is provided sterile and intended for single procedure use.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of detail as it's a labeling change submission:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this submission (K113638) is for a labeling change only and states that "The NMI 2.8F MC described in this submission is identical in terms of intended use, materials, design, components and technological characteristics to the predicate NMI 2.8F MC cleared under K112124. The change involves a labeling change only."
Therefore, the performance data presented is to demonstrate substantial equivalence to the predicate device, not necessarily against specific new acceptance criteria for the device itself. The document does not provide specific quantitative acceptance criteria or detailed results for these tests. It only lists the types of tests performed.
| Test Category | Reported Device Performance |
|---|---|
| Dynamic Infusion Testing | Not specified beyond indicating the test was performed. |
| Static Burst Testing | Not specified beyond indicating the test was performed. |
| Flow Rate Testing | Not specified beyond indicating the test was performed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the non-clinical tests (Dynamic Infusion, Static Burst, Flow Rate Testing), nor does it provide information about data provenance (e.g., country of origin of the data, retrospective or prospective). Given these are bench tests, "country of origin" for data is generally not applicable in the same way it would be for clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The "ground truth" concept is relevant for studies involving human assessment (e.g., image-based diagnosis) or clinical outcomes. The performance data presented are from non-clinical (bench) tests.
4. Adjudication Method for the Test Set
This information is not applicable. The performance data presented are from non-clinical (bench) tests, which do not involve human adjudication for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a labeling change and relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. It does not involve human readers or AI.
6. If a Standalone Study Was Done
Yes, from the perspective of the "device," the non-clinical tests (Dynamic Infusion, Static Burst, Flow Rate Testing) are essentially standalone performance evaluations of the physical characteristics of the microcatheter. However, "standalone" often implies an algorithm's performance without human intervention, which is not relevant here as this is a physical medical device. The performance data listed (Dynamic Infusion Testing, Static Burst Testing, Flow Rate Testing) represent the device’s inherent physical capabilities.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be established by validated test methods and reference standards for physical and functional properties of catheters (e.g., infusion rate, burst pressure, flow rate). These are objective measurements rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device (microcatheter), not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this device.
§ 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).