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510(k) Data Aggregation
(266 days)
Spartan eCoil System
The Spartan eCoil™ System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The System is also indicated for arterial and venous embolizations in the peripheral vasculature.
The Spartan eCoil™ System is a mechanically detachable embolic coil system that consists of an embolic coil (the Spartan eCoil™) attached to a delivery wire with a fluoroscopic marker band and the system is housed in an introducer sheath. The system is provided sterile and requires no additional equipment to be employed by the user.
The Spartan Micro, Inc. Spartan eCoil™ System is a neurovascular embolization device. The provided text from the 510(k) summary indicates that no clinical or animal testing was performed for this device to prove its acceptance criteria because it was deemed substantially equivalent to a predicate device (Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704). Therefore, the acceptance criteria are met through bench testing and assessments that confirm its performance is similar to or better than the predicate device, and through biocompatibility and sterilization testing.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since no specific numerical acceptance criteria are explicitly stated for each test (e.g., "tensile strength must be >X Newtons"), the performance is generally reported as "Pass" or "Equivalent" when compared to the predicate device or a minimum acceptable specification limit.
| Acceptance Criteria / Test Name | Reported Device Performance | Comments / Rationale for Equivalence |
|---|---|---|
| Bench Testing | ||
| Coil Tensile Study | Pass | All tensile strengths must be equal to or greater than the minimum spec. A minimum confidence and reliability level of 95% and 95% respectively must be demonstrated. |
| eCoil Anchor Bond | Pass | Test the Coil to anchor component bond joint and determine the tolerance limit of the tensile strength of the bond joint from the anchor component to the eCoil joint. A confidence and reliability interval of 95%/95% is required. |
| Coil Deformation | Pass, Equivalent | Observed the average resultant force of the test articles as compared to the predicate. The first loop is compressed to a deformation distance of 20% of the coil's loop OD. The peak force is recorded. |
| Tab Compression and Rebound Study | Pass | Evidence from direct observation that the lock tab returns to its unfolded position when the lock component is removed. |
| Deformation Force | Pass | The first loop is compressed to a deformation distance of 20% of the coil's loop OD. The peak force is recorded. |
| Tip Buckling | Pass, Equivalent | Delivery wire tip buckling forces are equal or better than the tip buckling forces produced by the predicate delivery wire. |
| Hypotube Weld and Tension Strength | Pass | Test the weld tensile strengths of the cannula weldment component of the delivery wire. |
| Pusher Tensile | Pass | Determine tensile strength of the DEC Tube. Must be equal to or greater than 250 g. |
| Friction in Catheter | Pass, Equivalent | Test the friction load in the micro catheter and compare it to the predicate. |
| Friction in Sheath | Pass, Equivalent | Test the friction load in the introducer sheath (must not buckle during advancement) as compared to the predicate. |
| Release Wire Tensile | Pass | Test the delivery wire to ensure the ultimate tensile strength of the release wire can withstand the frictional force required to initiate a detachment of the Spartan eCoil Implant. |
| Marker Radiopacity | Pass, Equivalent | Compare the radiopacity of the radiopaque marker to the predicate device. |
| Physician Use Testing | Pass | Device navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm to assess stability, neck coverage, conformability, softness and smoothness of delivery. |
| Stretch Resistant Polypropylene Tensile Test | Pass | Pull monofilament (tension) to failure. |
| Corrosion / Corrosion Resistance (ASTM F2129-17, F3044-14) | Pass | N/A |
| MRI Compatibility (ASTM F2119-07, 2182-11a, F2213-06, F2052-15, ASTM 2503/IEC 62570) | Pass | Determine the safety and MR system scanning parameters. |
| Visual and Dimensional, First Loop OD Post Sterilization, Fatigue and Knotting, Label Verification, Pusher Dimensions, Detachment Reliability | Pass | All devices met acceptance criteria. Testing to prove outputs equal inputs. Dimensions measured and key characteristics inspected. |
| Biocompatibility | ||
| Cytotoxicity (MEM Elution Using L-929 Mouse Fibroblast Cells) | Pass | Non-cytotoxic |
| Sensitization (Guinea Pig Maximization Sensitization) | Pass | Non-sensitizer |
| Irritation (Intracutaneous Reactivity Test) | Pass | Non-irritant |
| Acute Systemic Toxicity (Acute Systemic Injection Test) | Pass | No acute systemic toxicity |
| Hemocompatibility (Thrombogenicity, Direct/Indirect Hemolysis, SC5b-9 Complement Activation) | Pass (Acceptable) | Acceptable compared to a comparator control. |
| Material Mediated Pyrogenicity (Rabbit Pyrogen Test) | Pass | Non-pyrogenic |
| Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma Assay, Chemical Characterization and Toxicological Risk assessment) | Pass | Non-mutagenic/clastogenic and acceptable toxicological risk assessment. |
| Carcinogenicity (Chemical Characterization and Toxicological Risk assessment) | Pass | Acceptable carcinogenicity risk assessment. |
| Implantation (Intramuscular Implantation Test in Rabbits) | Pass | No significant difference comparing to the comparator. |
| Sub-Acute / Sub-Chronic (14-day, 14 repeat dose intravenous and intraperitoneal Toxicity Study in Mice) | Pass | No systemic toxicity and acceptable toxicological risk assessment. |
| Sterilization | ||
| Bacterial Endotoxin (USP 85 / ASTM ST72) | Pass | N/A |
| EO Residuals (10993-7:2008 (R) 2012 Part 7) | Pass | N/A |
| Pyrogen (Mediated Rabbit Pyrogen) | Pass | Non-pyrogenic |
| Package Integrity | ||
| Dye Penetration Test (ASTM F1929-15) | Pass | N/A |
| Bubble Testing (ASTM F2096) | Pass | N/A |
| Environmental Conditioning (ASTM D4332) | Pass | N/A |
| Shelf Life | ||
| Accelerated Aging (ASTM F1960) | Pass | Justifies 1-year shelf life |
2. Sample sized 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 specific sample sizes used for each bench test. For the animal study (implantation in rabbits, sub-acute/sub-chronic toxicity in mice), the sample sizes are not provided either.
The data provenance is not mentioned. Given it's a 510(k) submission to the FDA, it is expected that the studies adhered to relevant US regulations and standards, but the country of origin of the actual testing is not specified. All tests were non-clinical (bench and animal, where specified) and are essentially prospective studies conducted specifically for this 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 there was no clinical study involving human patients to establish a medical ground truth (e.g., disease presence). The "ground truth" for the performance and biocompatibility tests was based on established engineering specifications, ASTM standards, ISO standards (for biocompatibility), and comparison to the predicate device's known performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there were no subjective clinical assessments requiring adjudication. The tests conducted were objective physical, mechanical, and biological evaluations against defined standards or comparisons.
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 Spartan eCoil™ System is a physical medical device (an embolization coil), not an AI/software device. There were no human readers or AI involved in evaluating its performance in the context of effectiveness against a disease or condition.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the evaluation of this device was established based on:
- Engineering specifications and standards: Many bench tests refer to "minimum acceptable specification limit" or comparison to "accepted values."
- ASTM and ISO standards: For material properties, corrosion, MRI compatibility, and biocompatibility testing.
- Predicate device comparison: Performance parity or superiority to the legally marketed predicate device (Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704) was a primary "ground truth" for substantial equivalence.
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning model.
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