(26 days)
The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.
The Modified Concentric Microcatheter is a single lumen, braided, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use.
Here's an analysis of the provided text regarding the Modified Concentric Microcatheter, focusing on acceptance criteria and the study proving it:
Summary of Device and Regulatory Status:
The Modified Concentric Microcatheter is a Class II diagnostic intravascular catheter (21 CFR 870.1200) seeking 510(k) clearance. Its intended use is for selective placement of fluids, devices, or agents in peripheral, coronary, and neuro vasculature during diagnostic/therapeutic procedures. The submitter claims substantial equivalence to the Concentric Microcatheter (K091961) based on identical technological characteristics (design, materials, function, physical properties, composition).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Tests | ||
| Kink Resistance | Device should sufficiently resist kinking when flexed. | "the device's ability to withstand kinking when flexed was successfully evaluated." |
| Leak Resistance | Device should prevent leaks during high pressure and vacuum. | "the device's leak resistance when subjected to both high pressure and vacuum was successfully evaluated." |
| Flexibility Testing | Device should be able to navigate tight bends. | "the device's ability to navigate tight bends was successfully evaluated." |
| Flow Testing | Device should allow for adequate infusion of fluids. | "the device's ability to infuse fluids was successfully evaluated." |
| Tensile Testing | Device should maintain mechanical integrity under tensile loads. | "the device's mechanical integrity under tensile loads was successfully evaluated." |
| Torque Testing | Device should maintain mechanical integrity when subjected to torsion. | "the device's mechanical integrity when subjected to torsion was successfully evaluated." |
| Biocompatibility | Must meet established biocompatibility standards. | "the following biocompatibility tests were leveraged" (from predicate device): Hemocompatibility/Coagulation, Cytotoxicity, Systemic Toxicity, Hematocompatibility/Hematology, Sensitization, Irritation/Intracutaneous Reactivity, Pyrogen/Systemic Toxicity. |
Note on Acceptance Criteria: The provided document does not explicitly state quantitative acceptance criteria (e.g., "kink resistance must exceed X Newtons" or "leakage must be less than Y mL/min"). Instead, it uses qualitative terms like "successfully evaluated" or "demonstrate that it performs as designed." This is common in 510(k) summaries where the focus is on demonstrating equivalence to a predicate device, implying that the acceptance criteria are met if the new device performs comparably to the predicate device, which has already established safety and efficacy.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for any of the tests (e.g., how many catheters were tested for kink resistance).
- Data Provenance: The data provenance for the functional tests is implied to be from the manufacturer's internal testing ("results of verification and validation conducted on the Modified Concentric Microcatheter"). For biocompatibility, it states that tests were "leveraged" from the predicate device, meaning they relied on existing data for the same materials previously approved. The country of origin and whether the data is retrospective or prospective are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) to this specific submission. This document describes a 510(k) submission for a medical device (catheter), not an AI/Software as a Medical Device (SaMD). The tests are physical and material-based, not diagnostic accuracy assessments relying on expert interpretations or ground truth.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reasons as above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by human readers where there might be disagreement, which is not the case for device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable (N/A). This is a medical device (catheter) submission, not an AI/SaMD submission. No MRMC study was conducted, and there is no AI component or human reader assistance involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable (N/A). This is a medical device (catheter) submission. There is no algorithm or software being tested in a standalone capacity.
7. The Type of Ground Truth Used
The "ground truth" for the functional tests is the objective physical performance of the catheter according to engineering standards and specifications. For biocompatibility, the ground truth is established by validated biological test methods and accepted safety standards, leveraging previous test results for identical materials. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic or prognostic devices.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This is a medical device (catheter) submission, not an AI/machine learning product. Therefore, there is no "training set" in the context of data used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reasons as above. There is no training set or associated ground truth for an algorithm in this device submission.
§ 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).