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510(k) Data Aggregation
(136 days)
The Magic Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The Magic Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
The subject device is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. Magic catheters are available in 1.8 and 1.5Fr and 165 and 155 cm in length and are available with an "olive" tip configuration.
This document is a 510(k) summary for the Magic® Infusion Catheter, indicating its substantial equivalence to a predicate device. It primarily focuses on demonstrating that changes to materials and coating do not affect safety and effectiveness. As such, the information typically found in studies for AI/ML devices or diagnostic tools (like acceptance criteria tables, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) is not applicable here.
Here's a breakdown of the available information based on your request, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance:
The document describes several tests performed on the Magic Infusion Catheter, particularly regarding the changes to its materials and coating. It states that these tests demonstrate biocompatibility and material integrity.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility (Hydrophilic Coating) | Non-cytotoxic, non-hemolytic, non-pyrogenic, non-mutagenic, non-sensitizing, non-irritating | Testing demonstrated that the Magic catheter with the hydrophilic coating was non-cytotoxic, non-hemolytic, non-pyrogenic, non-mutagenic, non-sensitizing and non-irritating, "attesting to the catheter with the new coating's biocompatibility." |
| Biocompatibility (Polyamid Shaft) | Non-cytotoxic, non-hemolytic, non-pyrogenic, non-allergenic, non-toxic, non-irritating | Testing on the catheter including the Polyamid section of the shaft demonstrated that the catheter was non-cytotoxic, non-hemolytic, non-pyrogenic, non-allergenic, non-toxic, and non-irritating. |
| Material Change (Tip Marker - Platinum) | Material properties are well understood and change is not significant. | Change of the material in the catheter's tip marker is not a significant change as the properties of the new material (platinum) is well understood. |
| Other Physical Tests (General Catheter) | Not explicitly stated, but implied to meet performance similar to predicate. | Testing on the Magic catheter including biocompatibility, joint strength, shaft tensile strength, tip tensile strength, tip flexibility, static rupture strength, dynamic rupture strength, and flow rate. (Specific performance values or direct comparison to criteria for these are not provided in the summary.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document refers to "Testing" but does not detail the number of units or samples used for each test.
- Data Provenance: Not specified. This is a technical performance study, not a clinical data study, so "country of origin" of data or "retrospective/prospective" does not apply in the typical sense for medical imaging or diagnostic devices.
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):
- Not Applicable. This is a physical device testing summary, not a study involving expert readers or ground truth in the context of diagnoses or image interpretation. The "ground truth" here is based on laboratory test results and material properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication method is described as this is not a study assessing diagnostic performance or subjective interpretations.
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:
- Not Applicable. This is not an AI/ML device or a diagnostic device where MRMC studies would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Test Results and Material Properties. The "ground truth" for the device's performance is derived from standardized laboratory tests for biocompatibility, material strength, flexibility, rupture strength, and flow rate, as well as the known properties of the materials used (e.g., platinum).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
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