(126 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.
The provided document describes a medical device called the "Modified Concentric Microcatheter" (K113260) and its substantial equivalence to a predicate device. The document does not contain information about software, AI, or diagnostic performance metrics typically associated with acceptance criteria for such systems. Therefore, most of the requested information regarding AI device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this text.
The acceptance criteria described in this document are primarily related to the physical performance and biocompatibility of the microcatheter.
Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not available:
Acceptance Criteria and Device Performance (for physical and biocompatibility tests)
| Acceptance Criteria (What was evaluated) | Reported Device Performance |
|---|---|
| Kink Resistance | "...successfully evaluated." |
| Leak Resistance (high pressure and vacuum) | "...successfully evaluated." |
| Flexibility Testing (navigating tight bends) | "...successfully evaluated." |
| Tensile Testing (mechanical integrity) | "...successfully evaluated." |
| Torque Testing (mechanical integrity) | "...successfully evaluated." |
| Coating Testing (durability and lubricity) | "...successfully evaluated." |
| Radiopacity (visibility under fluoroscopy) | "...successfully evaluated." |
| Particulate Testing (amount and size of particles) | "...successfully evaluated." |
| Biocompatibility: Sensitization/Maximization | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Cytotoxicity | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Intracutaneous Reactivity | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Systemic Toxicity/Systemic Injection Test | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Systemic Toxicity/Rabbit Pyrogen Test | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Hemocompatibility/Hemolysis | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Hemocompatibility/Complement Activation | "...results for all tests met the predetermined acceptance criteria." |
| Biocompatibility: Hemocompatibility/in vivo Thrombogenicity | "...results for all tests met the predetermined acceptance criteria." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of data for an AI/diagnostic device. Instead, it refers to physical testing of components and biocompatibility testing. No sample sizes are provided for these tests.
- Data provenance (country of origin, retrospective/prospective) is not applicable as there is no data-driven diagnostic component described.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment by experts for a diagnostic performance test, as this is a physical medical device. The "ground truth" for the physical tests would be the established engineering standards and specifications.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies in expert labeling for diagnostic datasets, which is not present here.
-
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:
- No. This is a physical microcatheter, not an AI or diagnostic imaging device. No MRMC study was conducted or relevant to this device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical microcatheter; there is no algorithm, AI, or standalone performance to evaluate.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and biocompatibility tests, the "ground truth" would be the pre-defined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidelines for medical device safety and performance. The document states that "results for all tests met the predetermined acceptance criteria."
-
The sample size for the training set:
- Not applicable. There is no AI algorithm or training set mentioned or relevant to this physical device.
-
How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI algorithm.
Summary regarding AI/Diagnostic Performance:
The provided 510(k) summary for the "Modified Concentric Microcatheter" pertains to a physical medical device. The testing described focuses on its mechanical integrity, material properties, and biocompatibility, demonstrating substantial equivalence to a predicate device. There is no mention or indication of any AI component, diagnostic algorithm, or performance evaluation that would involve radiologists, image analysis, or typical AI acceptance criteria.
§ 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).