(266 days)
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 4, 2018
Spartan Micro, Inc. % Vikki O'Connor Regulatory Affairs Consultant Ambriel Associates, Inc. 411 Walnut Street. Unit 9236 Green Cove Springs, Florida 32043
Re: K180653
Trade/Device Name: Spartan eCoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG. KRD Dated: November 1, 2018 Received: November 5, 2018
Dear Vikki O'Connor:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180653
Device Name Spartan eCoil™ System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: Spartan eCoil™ System
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:
| Submitter / Owner: | Spartan Micro Inc.3167 SkywayCourtFremont, CA 94539Phone: (512) 270-8501 |
|---|---|
| Contact Person | Ms. Vikki M. O'ConnorRegulatory Affairs ConsultantPhone: 1-207-214-8535Email: vikki0730@yahoo.com |
| Date Prepared | November 2, 2018 |
| Trade Name | Spartan eCoil™ System |
| Proposed Class | Class II |
| Classification Nameand Number | 882.5950 - Neurovascular Embolization Device870.3300 - Vascular Embolization Device |
| Common Name | Neurovascular Embolization Device |
| Product Code / Panel | HCG, NeurologyKRD, Cardiovascular |
| Predicate Device | Micro Therapeutics Inc. Axium Prime Detachable CoilSystem - K162704 |
| Special Controls | Class II Special Controls Guidance Document:Vascular and Neurovascular Embolization Devices |
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| Performance Data | The following performance testing was performed toestablish substantial equivalence:* Visual and Dimensional Inspection;* Simulated Use Flow Model Testing;* Magnetically Induced Displacement Force;* Magnetically Induced Torque;* RF Heating;* MR Artifact Evaluation;* Corrosion Resistance;* Fatigue Resistance;* Torsional Resistance;* Friction (Pull / Push)Sterilization, biocompatibility, packaging andaccelerated aging data were also collected.No clinical or animal testing was performed, as thesubject device has a similar safety profile and asimilar effectiveness profile when compared to thepredicate device. In addition, there is no change in theindications for use or the fundamental scientifictechnology of the device that requires additionaltesting. |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Device Description | 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. |
|---|---|
| Indications for Use | The Spartan eCoil™ System is indicated for theendovascular embolization of intracranial aneurysmsand other neurovascular abnormalities, such asarteriovenous malformations and arteriovenousfistulae. The Spartan eCoil™ System is also indicatedfor arterial and venous embolizations in the peripheralvasculature. |
| Summary ofTechnologicalCharacteristics | The Spartan eCoil™ System is designed to deliver,deploy and detach embolic coils of various sizes,shapes and profiles and to embolize or occlude bloodflow in vascular abnormalities of the neurovascular andperipheral vessels. As such, the system is constructedof implant grade materials. The system comes in 57different configurations, two (2) shape configurationsand a range of primary and secondary diameters andcoil lengths. The Spartan eCoil™ System is designedto work with market available microcatheters withminimum working inner diameters of at least 0.017".The Delivery Wire includes a radiopaque marker usedas a positioning reference. |
| Conclusion | Based on the indications for use, technologicalcharacteristics, materials, required performancetesting, principles of operation, anatomical site, safetycharacteristics and comparison to the predicatedevice, Spartan's eCoil™ System has been shown tobe substantially equivalent to the legally marketedpredicate device. |
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Device Comparison
The table below provides a comparison of the subject device and the currently cleared predicate Axium device line.
| Characteristics | Subject DeviceSpartan eCoilSystemK180653 | Predicate DeviceAxium PrimeK162704 | Rationale forDifferences /Comments |
|---|---|---|---|
| FDA Classification | Class II | Class II | Same |
| FDA ProductCode | HCG, KRD | HCG, KRD | Same |
| FDA Regulation | 882.5950,870.3300 | 882.5950,870.3300 | Same |
| Special Guidance | Guidance forIndustry and Staff-Class II SpecialControls GuidanceDocument:Vascular andNeurovascularEmbolizationDevices | Guidance forIndustry and Staff-Class II SpecialControls GuidanceDocument:Vascular andNeurovascularEmbolizationDevices | Same |
| Characteristics | Subject DeviceSpartan eCoil SystemK180653 | Predicate DeviceAxium PrimeK162704 | Rationale forDifferences /Comments |
| Indications forUse | The Spartan eCoilTM System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Spartan eCoilTM System is also indicated for arterial and venous embolizations in the peripheral vasculature. | The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolization in the peripheral vasculature. | Same |
| User Population | Patients withvascularabnormalitiesandhemorrhagicvascular trauma | Patients withvascularabnormalitiesandhemorrhagicvascular trauma | Same |
| Technical Method | Providesscaffolding,packaging, and anembolic reaction invascular anatomy | Providesscaffolding,packaging, and anembolic reaction invascular anatomy | Same |
| Target Area | Neurovascularand peripheralvascularanatomy | Neurovascularand peripheralvascularanatomy | Same |
| Method of Supply | Inserted in a rigidHDPE Hoop, in aTyvek Pouch,placed in a shelfcard, in a shippingcarton | Stored withinDispenser Coil, inTyvek pouch, in ashipping carton | SimilarSpartan utilizesa shelf card (i.e.,Cardboardcarton) to holdeach TyvekPouch |
| Implant Design | Alloy coil withatraumatic tip andvarious shapesand sizes toaccommodatedifferent arterialspaces. | Alloy coil withatraumatic tip andvarious shapesand sizes toaccommodatedifferent arterialspaces. | Same |
| DetachmentMechanism | Mechanicalrelease inducedby exposinginternal releasewire, to free asphericalcomponentpreviouslycaptured by amechanicalinterferencefeature. | Mechanicalrelease inducedby exposinginternal releasewire, to free asphericalcomponentpreviouslycaptured by amechanicalinterferencefeature. | Same |
| Number of Models | 57 | 140 | Subject devicefalls within therange ofmodelofferings asthe currentlycleared predicatedevice models. |
| Sterilization (EOResiduals andBioburden) | Ethylene Oxide -Pass | Ethylene Oxide -Pass | Same |
| Implant Shape | Helix and 360 | Helix and 3D | Subject deviceshape is similarto the predicate |
| Device Size /Range PrimaryDiameter | 0.0110" - 0.0145" | 0.0108" – 0.0145" | Subject devicesize range fallswithin thecurrently cleared |
| predicatedevice size range | |||
| Device Size /RangeSecondaryDiameter | 3mm – 25mm | 1mm – 25mm | Subject devicesize range fallswithin thecurrently clearedpredicatedevice size range |
| Size RangeLength (in sheath) | 5.5cm - 50cm | 1cm - 50cm | Subject devicesize range fallswithin thecurrently clearedpredicate devicesize range |
| Characteristics | Subject DeviceSpartan eCoilSystemK180653 | PredicateDeviceAxium PrimeK162704 | Rationale forDifferences /Comments |
| Visual PositioningAides | RadiopaqueMarker and Flouro-Saver Marker | RadiopaqueMarker | The subjectdevicecontains anadditionalFlouro-SaverMarker fordevicevisibility. |
| Stretch ResistantMember | Yes | Yes | Same |
| CatheterCompatibility | Micro catheterswith a minimumI.D. of.017" | Micro catheterswith a minimumI.D. of.017" | Same |
| Materials (Implant Coil) | |||
| Primary Coil | 92% Platinum 8%Tungsten Alloy | 92% Platinum 8%Tungsten Alloy | Same |
| Stretch ResistantMonofilament | Polypropylene | Polypropylene | Same |
| Coil Shell | 92% Platinum 8%Tungsten Alloy | 92% Platinum 8%Tungsten Alloy | Same |
| DetachSubassembly | Cobalt Chromium– MP35N AlloyCobalt Chromium– 35N LT AlloyPt (92%) / W (8%) | SS 316LVM | Subject deviceutilizes CobaltChromium,which performedadequately interms ofcorrosionresistance, MRIcompatibility,and materialstrength whencompared to thepredicatedevice. |
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| Materials (Delivery System) | |||
|---|---|---|---|
| Unibody | SS 304 | SS 304 | Same |
| Outer Jacket | PET | PTFE | Subjectdeviceutilizes PETto laminatethe deliverywire. |
| Marker Coil | 92% Platinum 8%Tungsten Alloy | 92% Platinum 8%Tungsten Alloy | Same |
| Lumen Stop | N/A | SS 304 | Subject devicedoes not use thiscomponent in theimplant. |
| Inner Liner | PTFE | PTFE | Same |
| Coupler Tube | N/A | SS 304 | Subject devicedoes not use thiscomponent in theimplant. |
| Actuator Interface | |||
| Actuator Interface | N/A | SS 304 | Subject devicedoes not use thiscomponent in theimplant. |
| Release Wire | SS 304 | SS 304 | Same |
| Retainer Ring | N/A | SS 304 | Subject devicedoes not use thiscomponent in theimplant. |
| Break Indicator | PET Shrink Tubing | PET Shrink Tubing | Same |
| Positive LoadIndicator | N/A | PET Shrink Tubing | Subject devicedoes not use thiscomponent in theimplant. |
| Introducer Sheath | Nylon 12 | Polypropylene /HDPE | Subject devicesutilizes Nylon12 for retentionof the SpartaneCoil Systemwhenpackaged. |
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| Test | Test Method | Test Results | Comments | ||||
|---|---|---|---|---|---|---|---|
| Bench Testing | |||||||
| Coil Tensile Study | Compare theaccepted valuesto the minimumacceptablespecificationlimit. All tensilestrengths mustbe equal orgreater than theminimum spec.Further, aminimumconfidence andreliability level of95% and 95%respectively mustbe demonstrated. | Pass | N/A | ||||
| eCoil AnchorBond | Test the Coil toanchor componentbond joint anddetermine thetolerance limitof the tensilestrength of thebond joint fromthe anchor | Pass | N/A | ||||
| component tothe eCoil joint. Aconfidence andreliability intervalof 95%/95% isrequired. | |||||||
| Coil Deformation | Test to attain acoil deformationforce andobserve theaverage resultantforce of the testarticles ascompared to thepredicate. Thefirst loop iscompressed to adeformationdistance of 20%of the coil's loopOD. The peakforce isrecorded. | Pass | Equivalent | ||||
| Tab Compressionand ReboundStudy | Test to provideevidence fromdirect observationthat the lock tabreturns to itsunfolded positionwhen the lockcomponent is | Pass | N/A | ||||
| removed. | |||||||
| Deformation Force | The first loop is compressed to a deformation distance of 20% of the coil's loop OD. The peak force is recorded. | Pass | N/A | ||||
| Tip Buckling | Test to prove the delivery wire tip buckling forces are equal or better than the tip buckling forces produced by the predicate delivery wire. | Pass | Equivalent | ||||
| Hypotube Weldand TensionStrength | Test the weld tensile strengths of the cannula weldment component of the delivery wire. | Pass | N/A | ||||
| Pusher Tensile | Determine tensile strength of the DEC Tube. Must be equal to or greater than 250 g. | Pass | N/A | ||||
| Friction in | Test the friction | Pass | Equivalent | ||||
| Catheter | load in the microcatheter andcompare it tothe predicate. | ||||||
| Friction in Sheath | Test the frictionload in theintroducer sheath(must not buckleduringadvancement) ascompared to thepredicate. | Pass | Equivalent | ||||
| Release WireTensile | Test the deliverywire to ensure theultimate tensilestrength of therelease wire canwithstand thefrictional forcerequired to initiatea detachment ofthe Spartan eCoilImplant. | Pass | N/A | ||||
| MarkerRadiopacity | Test the deliverywire radiopaquemarker andcompare theradiopacity of theradiopaquemarker to thepredicate device. | Pass | Equivalent | ||||
| Physician UseTesting | The device wasnavigated througha tortuousbenchtop modeland deployed intoa simulatedsilicone aneurysmin order to assessstability, neckcoverage,conformability,softness andsmoothness ofdelivery. | Pass | N/A | ||||
| Stretch ResistantPolypropyleneTensile Test | Pull monofilament(tension) to failure. | Pass | N/A | ||||
| Corrosion /CorrosionResistance | Tested as perASTM F2129-17,F3044-14 | Pass | N/A | ||||
| MRI Compatibility | ASTM testing todetermine thesafety and MRsystem scanningparameters forpatients that willhave this device.F2119-07, 2182-11a, F2213-06,F2052-15, ASTM2503/IEC 62570 | Pass | N/A | ||||
| Visual andDimensional, FirstLoop OD PostSterilization,Fatigueand Knotting,LabelVerification,PusherDimensions,DetachmentReliability | Testing to proveoutputs equalinputs.Dimensions weremeasured and keycharacteristics ofthe implant coilwere inspected. | Pass | All devicesmetacceptancecriteria. | ||||
| Biocompatibility | |||||||
| eCoil Implant (permanent implant with direct blood contact) and eCoil DeliverySystem (limited (≤ 24 hrs)) contact with blood | |||||||
| Cytotoxicity | MEM Elution UsingL-929 MouseFibroblast Cells | Pass | Non-cytotoxic | ||||
| Sensitization | Guinea PigMaximizationSensitization | Pass | Non-sensitizer | ||||
| Irritation | IntracutaneousReactivity Test | Pass | Non-irritant | ||||
| Acute SystemicToxicity | Hemocompatibility | Acute SystemicInjection Test | Thrombogenicityassessment, Directand Indirect Hemolysistests, and SC5b-9ComplementActivation testcomparing subjectdevice data with acomparator control | Pass | Pass | No acutesystemictoxicity | Acceptable |
| Material MediatedPyrogenicity | eCoil Implant (permanent implant with direct blood contact) | Rabbit Pyrogen Test | Pass | Non-pyrogenic | |||
| Genotoxicity | -BacterialMutagenicity Test(Ames Assay)-In Vitro MouseLymphoma Assay- ChemicalCharacterization andToxicological Riskassessment | Pass | Non- mutagenic/ clastogenic andAcceptabletoxicological riskassessment | ||||
| Carcinogenicity | ChemicalCharacterization andToxicological Riskassessment | Pass | Acceptablecarcinogenicityriskassessment | ||||
| Implantation | IntramuscularImplantation Test(Rabbits) withHistopathology | Pass | Nosignificantdifferencecomparing tothecomparator |
Table 1: Test Results
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| Control. | |||||
|---|---|---|---|---|---|
| Sub-Acute/ Sub-Chronic | 14-day, 14 repeatdose intravenous andintraperitonealToxicity Study inMice, withHistopathology- ChemicalCharacterization andToxicological Riskassessment | Pass | No systemictoxicity andAcceptabletoxicologicalriskassessment | ||
| Animal Studies | |||||
| Animal Studies | Substantial equivalence ofthe subject device has beenestablished to the predicatedevice through the results ofthe bench testing that wasperformed as well as thetesting that was adoptedfrom thepredicate device. | N/A | N/A | ||
| Sterilization | |||||
| BacterialEndotoxin | USP 85 / ASTMST72 | Pass | N/A | ||
| EO Residuals | 10993-7:2008 (R)2012 Part 7 | Pass | N/A |
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| Pyrogen | Mediated RabbitPyrogen | Pass | Non-pyrogenic |
|---|---|---|---|
| Package Integrity | |||
| Dye PenetrationTest | ASTM F1929-15Standard TestMethod forDetecting SealLeaks in PorousMedicalPackaging | Pass | N/A |
| Bubble Testing | ASTM F2096 | Pass | N/A |
| EnvironmentalConditioning | ASTM D4332 | Pass | N/A |
| Shelf Life | |||
| Accelerated Aging | ASTM F1960 | Pass | Justifies 1-year shelf life |
| Clinical Study | |||
| Clinical Study | No clinical studywas performedas substantialequivalence ofthe subjectdevice has beenestablished to thepredicate devicethrough theresults of thebench testingthat wasperformed. | N/A | N/A |
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).