(144 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 line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, 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. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each microcatheter.
The provided submission describes a medical device, the "Modified Concentric Microcatheter," which is a line extension to an existing product. The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with acceptance criteria for a new AI/software device. Therefore, many of the requested categories related to AI/software performance evaluation (e.g., effect size with human readers, standalone performance, ground truth establishment for training) are not applicable to this document.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study, tailored to the context of a medical device submission demonstrating substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list quantitative acceptance criteria in a tabular format with corresponding performance metrics for the Modified Concentric Microcatheter. Instead, it describes various tests and states that the device successfully met the evaluation for each. The acceptance criteria generally seem to be "successful evaluation" or "meets its intended use" for each test. The performance is reported qualitatively as "successfully evaluated."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Withstand kinking when flexed | Kink Resistance: successfully evaluated |
| Withstand leak when subjected to both high pressure and vacuum | Leak Resistance: successfully evaluated |
| Navigate tight bends | Flexibility Testing: successfully evaluated |
| Maintain mechanical integrity under tensile loads | Tensile Testing: successfully evaluated |
| Maintain mechanical integrity when subjected to torsion | Torque Testing: successfully evaluated |
| Durability and lubricity of the device coating | Coating Testing: successfully evaluated |
| Satisfactory dimensions (as verified) | Dimensional verification testing: performed |
| Visibility under fluoroscopy | Radiopacity Testing: successfully evaluated |
| Meets intended use (in a simulated environment) | Design Validation Simulated Use Testing: successfully evaluated |
| Biocompatibility (relying on predicate device data) | Biocompatibility: met pre-determined acceptance criteria |
| Sterilization (relying on predicate device data) | Sterilization: met pre-determined acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes (number of devices or tests performed) for each specific test. It simply mentions that tests were "performed" or "evaluated."
For the Design Validation Simulated Use Testing, it states "testing was performed in a porcine model." This indicates the use of an ex vivo or in vivo animal model. Data provenance is implied to be from internal testing by Concentric Medical, Inc. The timing of testing is prospective to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the submission is for a medical device (microcatheter) and not an AI/software device requiring expert interpretation for ground truth. The "ground truth" for this device relates to its physical and functional performance, which is assessed through engineering and simulated-use testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the testing described pertains to the physical and mechanical properties of a microcatheter, not to the interpretation of images or data that would necessitate an adjudication method among experts.
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 is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through:
- Engineering specifications and standards: For physical and mechanical properties (kink resistance, leak resistance, flexibility, tensile strength, torque, coating).
- Dimensional measurements: For shaft diameters and length.
- Fluoroscopic visibility standards: For radiopacity.
- Functional assessment in a simulated environment: In the porcine model to confirm intended use.
There is no "expert consensus" or "pathology" in the diagnostic sense, nor is there "outcomes data" presented in this 510(k) summary, as it's a pre-market submission focused on substantial equivalence.
8. The sample size for the training set
This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).