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510(k) Data Aggregation
(27 days)
The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.
The Spartan MC 0165™ is a sterile single-use microcatheter device. On the proximal end is a Luer connector for infusion of diagnostic agents. The microcatheter has a single lumen of 0.0165" ID, has a flexible and variable stiffness composite body, and 2 radiopaque marker bands on the distal tip for visualization under fluoroscopy. It comes with a sterile stainless steel shaping mandrel to shape the distal portion of the catheter.
The Spartan MC 0165™ is a microcatheter device. The provided text describes several performance studies conducted to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Coating Lubricity (Friction Force) | Acceptable friction force under simulated use conditions similar to the predicate device. | The Spartan MC 0165™ was found to have acceptable friction force under simulated use conditions similar to the predicate device. |
| Hub Functional & Dimensional | Meet ISO 594-1:1986-06-15 and ISO 594-2:1998-09-01 requirements. | The Spartan MC 0165™ met the acceptance criteria for hub functional and dimensional requirements. |
| Torque Strength | Acceptable torsional strength similar to the predicate device during simulated use. | The Spartan MC 0165™ exhibited acceptable torsional strength similar to the predicate device. |
| Tensile | Meet ISO 10555-1:2013 Annex B requirements. | The Spartan MC 0165™ met the acceptance criteria for tensile strength. |
| Air Aspiration | Meet ISO 10555-1:2013(E) Annex D requirements for air leakage. | The Spartan MC 0165™ met the acceptance criteria for air aspiration. |
| Liquid Leak | Meet ISO 10555-1:2013(E) Annex C requirements for liquid leakage. | The Spartan MC 0165™ met the acceptance criteria for liquid leakage. |
| Particulate and Coating Integrity | Meet acceptance criteria for particulate generation and coating integrity, and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate. |
| Tip Shape | Retain steam-shaped tip shape and be substantially equivalent to the predicate device. | The Spartan MC 0165™ met the acceptance criteria for tip shapeability and was found substantially equivalent to the predicate. |
| Stiffness | Meet acceptance criteria for catheter stiffness and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for catheter stiffness and was found substantially equivalent to the predicate. |
| Kink Resistance | Withstand bends and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate. |
| Radiopacity | Be visible under fluoroscopy and be substantially equivalent to the predicate device. | The Spartan MC 0165™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate. |
| Corrosion | Meet ISO 10555-1:2013(E) Annex A requirements. | The Spartan MC 0165™ met the acceptance criteria for corrosion resistance. |
| Static Burst Pressure | Meet ISO 10555-1:2013(E) Annex F requirements. | The Spartan MC 0165™ met the acceptance criteria for static burst pressure. |
| Torque Response | Meet acceptance criteria for torque response and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for torque response and was found substantially equivalent to the predicate. |
| Buckling | Meet acceptance criteria for tip deflection and buckling, and be substantially equivalent to the predicate. | The Spartan MC 0165™ met the acceptance criteria for tip deflection and buckling, and was found substantially equivalent to the predicate. |
| Design Validation | Meet requirements for which it was designed and tested in a challenging use setting. | The Spartan MC 0165™ met the requirements for which it was designed and tested. |
| Dimensional Testing | Meet device specifications. | The Spartan MC 0165™ met the dimensional requirements. |
| Visual Inspection | Meet visual inspection requirements. | The Spartan MC 0165™ met the visual inspection requirements. |
| Dead Space Volume | Dead space volume to be measured and reported in labeling. | The Spartan MC 0165™ dead space volume was measured and is reported in the labeling. |
| Pressure Flow Testing with Contrast Media | Flow rates and pressures for various solutions to be evaluated and reported in labeling. | The Spartan MC 0165™TM pressure-flow performance was evaluated, and flow rates and pressures of various saline and contrast media solutions are reported in the labeling. |
| Sensitization (Kligman Maximization Test) | Classified as a non-sensitizer (0% sensitization). | Spartan MC 0165 elicited no reaction at the challenge (0% sensitization), classified as a non-sensitizer. |
| Genotoxicity (Mouse Lymphoma Mutagenesis Assay) | Non-mutagenic (IMF of Test Article < GEF of $126 \times 10^{-6}$). | The IMF of Test Article for all conditions was less than the GEF of $126 \times 10^{-6}$, considered non-mutagenic. |
| Genotoxicity (Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay) | No statistically significant increase in revertant colonies compared to negative controls. | Neither of the test article extracts induced a statistically significant increase in the number of revertant colonies as compared to the negative controls. Non-genotoxic. |
| Cytotoxicity (L929 MEM Elution Test) | Non-cytotoxic (no cultures with greater than Mild reactivity - Grade 2). | The test article meets the requirements of the test and there were no cultures treated with the test article that showed greater than a Mild reactivity (Grade 2). Considered non-cytotoxic. |
| Irritation/Intracutaneous Reactivity | Not show a significantly greater biological reaction than control sites (mean score difference = 0). | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article (mean score difference = 0). Non-irritant. |
| Acute Systemic Toxicity | Not induce a significantly greater biological reaction than control extracts. | The extracts of the test article did not induce a significantly greater biological reaction than the control extracts. No systemic toxicity. |
| Pyrogenicity (Rabbit Pyrogen Test) | Temperature increase for test animals not to exceed test limit (0.0 °C observed). | The temperature increase for all test animals was 0.0 °C and did not exceed the test limit. The control animal also showed 0.0 °C. Non-pyrogenic. |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | Hemolysis above negative < 5%. | For direct and indirect contact testing, hemolysis above negative were 0.13% and 0%, respectively, both < 5%. Non-hemolytic. |
| Hemocompatibility (Unactivated Partial Thromboplastin Time Test) | No statistically significant decrease between UPTT of plasma exposed to test article and controls. | There was no statistically significant decrease found between the Unactivated Partial Thromboplastin Time (UPTT) of the plasma exposed to the test article and that of the plasma exposed to both the negative control article and the untreated control. Hemocompatible. |
| Hemocompatibility (SC5B-9 Complement Activation Test) | No statistically significant increase between SC5b-9 concentrations in plasma exposed to test article and controls. | There was no statistically significant increase found between the SC5b-9 concentrations in the plasma exposed to the test article and that of the plasma exposed to both the negative control article and untreated control. Hemocompatible. |
| Hemocompatibility (In Vitro Blood Flow Loop) | Thrombus Formation Score of zero (Minimal to nonexistent thrombus formation). | All devices tested received a Thrombus Formation Score of zero which means Minimal to nonexistent thrombus formation (1% or less). Not Thrombogenic. |
| Sterilization | Achieves a Sterility Assurance Level of 10-6. | EO sterilization validation testing performed to ISO 11135:2014, following an overkill (half cycle) approach, achieved a Sterility Assurance Level of 10-6. |
| Shelf Life | Safe and effective after at least 1 year (after accelerated aging and simulated shipping). | Accelerated aging (55 °C, 38 days for 1-year equivalent) and simulated shipping were performed, and devices remained safe and effective. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The results are presented as general compliance (e.g., "The Spartan MC 0165™ met the acceptance criteria"). However, standard testing protocols for medical devices typically involve a representative sample size to ensure statistical validity.
- Data Provenance: The studies are "non-clinical bench testing" and "biocompatibility evaluation." This indicates controlled laboratory experiments using specific test methodologies (e.g., ISO standards, simulated use conditions). The data is generated prospectively under these controlled conditions. The testing was performed in vitro (bench, simulated models, and various biological assays) and in vivo for some biocompatibility tests (e.g., Kligman Maximization Test, Mouse Lymphoma Mutagenesis Assay, Rabbit Pyrogen Test, Rabbit Blood Hemolysis Test, Systemic Injection Test). There is no mention of country of origin for the data, but the standards cited are international (ISO) and US (USP).
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. These are performance tests for a physical medical device, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" is defined by the acceptance criteria of the referenced ISO standards and specific test protocols.
4. Adjudication method for the test set:
Not applicable. These are objective performance tests with predefined pass/fail criteria based on standards and test methods. There is no subjective interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This is a performance evaluation of a physical medical device (microcatheter), not a diagnostic or AI-assisted system that would typically involve a multi-reader multi-case study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used:
The ground truth is established by the specified international and national standards (e.g., ISO 594, ISO 10555, ISO 10993, USP) and predefined acceptance criteria within the Spartan Micro, Inc. test protocols. For comparative tests, the predicate device's performance also serves as a benchmark for "substantial equivalence."
8. The sample size for the training set:
Not applicable. This is a physical medical device undergoing performance testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device undergoing performance testing, not a machine learning model.
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