(194 days)
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
The provided document is a 510(k) Pre-Market Notification for the Optima Coil System. It focuses on demonstrating substantial equivalence to a predicate device through performance bench testing, animal testing, biocompatibility studies, sterilization validation, and shelf-life/packaging testing. It does not contain information about studies involving human readers, AI assistance, or expert-established ground truth which are typically associated with performance evaluations of diagnostic or AI-driven medical devices.
Therefore, I cannot provide information for points 1-9 as they are not applicable to the content of this document. The document describes a medical device (neurovascular embolization coil system) and its mechanical, material, and biological performance, not an AI or diagnostic tool.
The "device performance" mentioned in the document refers to how the physical device (the coil system) performs in various mechanical and biological tests, not its accuracy in diagnosing or interpreting medical conditions.
Here's an explanation of why the requested information isn't present in the document:
- Acceptance Criteria and Reported Device Performance (Table): The document lists "Test Method Summary" and "Results" for various tests (e.g., Corrosion Resistance, MRI Compatibility, Biocompatibility). The acceptance criterion for all these tests is implicitly "All test samples passed testing", which is consistently reported as the result. However, the exact numerical acceptance ranges or thresholds are not detailed for each specific test, only the pass/fail outcome.
- Sample Size (Test Set) and Data Provenance: Sample sizes are not explicitly stated for individual bench tests. For animal testing, it mentions "acute porcine model" but not the number of animals. Biocompatibility studies specify "3 Rabbits" for a 4-week implantation and "4 Rabbits" for a 13-week implantation. No data provenance in terms of country of origin is mentioned. All studies appear to be prospective lab/animal studies.
- Number of Experts and Qualifications (Ground Truth): Not applicable. This document does not describe studies that require human experts to establish ground truth, as it's not a diagnostic or AI-driven device.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance: The "device performance" shown is standalone performance of the physical device via bench and animal testing.
- Type of Ground Truth: For the mechanical and biological tests, the "ground truth" is defined by established scientific and engineering principles, international standards (e.g., ISO, ASTM), and the requirements for a safe and effective medical device. For example, for biocompatibility, the ground truth is that the device should not be cytotoxic, sensitizing, irritant, etc., as determined by standardized biological assays.
- Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.
- Ground Truth for Training Set: Not applicable.
In summary, the provided text details the regulatory submission for a physical medical device. The types of evaluations described are standard for such devices (mechanical, material, biological safety), and do not involve AI performance metrics or human reader studies.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
February 18, 2018
Blockade Medical, LLC (d.b.a. Balt USA) Rebecca K. Pine Official Correspondent 18 Technology Drive, Suite 169 Irvine, California 92618
Re: K172390
Trade/Device Name: Optima Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: January 18, 2018 Received: January 19, 2018
Dear Rebecca K. Pine:
We have reviewed your 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Image /page/1/Picture/6 description: The image contains the text "Carlos L. Pena -S FDA". The text is arranged horizontally, with "Carlos L. Pena" appearing first, followed by "-S", and then "FDA". The text is in a sans-serif font and is black. The background is white.
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) K172390
Device Name Optima Coil System
Indications for Use (Describe)
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and 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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Optima Coil System 510(k) Summary
This 510(k) summary for Optima Coil System is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance. The 510(k) Program: Evaluating substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Blockade Medical, LLC (d.b.a. Balt USA) 18 Technology Dr. Ste 169 Irvine, CA 92618
Contact person: Rebecca K Pine Phone: (760) 809-5178 Date prepared: February 12, 2018
DEVICE [807.92(a)(2)]
Name of the device: Optima Coil System Common of usual name: Neurovascular embolization device Classification name: Neurovascular embolization device Vascular embolization device Regulatory Class: Class II Product Code: HCG KRD Submission Type: Traditional 510(k) Regulation Number: 21 CFR 882.5950 Reviewing Product Branch: Division of Neurological and Physical Medicine Devices (Office of Device Evaluation, CDRH)
PREDICATE DEVICE [807.92(a)(31)]
Barricade Embolization Coil System (K151760)
DEVICE DESCRIPTION [807.92(a)(4)]
The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
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INDICATIONS FOR USE [807.92(a)(5)]
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(a)(6)]
The technological characteristics of the Optima Coil System is highly analogous to the technological characteristics of the Barricade Embolization Coil System previously cleared (K151760) version of the device, as shown below:
| BarricadeEmbolization CoilSystem (K151760)(Predicate Device) | Optima Coil System(Subject Device) | Effect onsubstantialequivalence | |
|---|---|---|---|
| Principle of Operation | Facilitatesendovascularembolization ofintracranialaneurysms and othervascularabnormalities | SAME | None. Identical |
| System components | Coil (implant)Delivery systemDetachmentcontroller | SAME | None. Identical |
| Coil delivery mechanism | Pusher | SAME | None. Identical |
| Methodofsupply(coil/delivery system) | Sterile, single use | SAME | None. Identical |
| Coil (implant) | |||
| Main Coil Material | Platinum/Tungstenalloy | SAME | None. Identical |
| Primary Coil Diameter | 0.010"-0.014" | SAME | None. Identical |
| Coil Secondary diameter | 1.0mm - 15mm | 1mm-24mm | None. Anincrease indiameter range hasno effect on theintendedperformance of thedevice. |
| Coil Wire Diameter | 0.00125"-0.003" | 0.00125"-0.0035" | Minor increase(0.0005") indiameter range has |
| no effect on theintendedperformance of thedevice | |||
| Secondary Shapes | Complex/Helical | SAME | None. Identical |
| Coil Types | Framing, Filling,Finishing | Framing, Filling,Finishing (standard, soft,super soft, 18) | None. Identical.Nomenclature hasmerely beenupdated |
| Coil length | 1cm – 50cm | 1cm – 65cm | None. Anincrease in lengthrange has no effecton the intendedperformance of thedevice. |
| Stretchresistance/attachmentthread | .0022” PolyolefinEngage thread.0009” PET thread | .0022” Polyolefin Engagethread | None. Minorchange toaccommodatethermaldetachmentmechanism |
| Coupler | N/A | 90%/10% Pt/IrMarkerband | None. Minorchange toaccommodatethermaldetachmentmechanism |
| Detachment Zone | .020" (nominal) | 0.050" (nominal) | None. Minorchange toaccommodatethermaldetachmentmechanism |
| Delivery System | |||
| Construction/Design | SSTL core wire | Body coil laser welded tohypotube | None. Minorchange toaccommodatethermaldetachmentmechanism.Change has noeffect on theintendedperformance of thedevice. |
| Body coil | RO Coil (92/8 Pt/W) | 4-part coilA. Heater coil (92/8 Pt/W)B. Distal Coil (SSTL)C. Radio-opaque (RO) Coil (92/8 Pt/W) | None. Minorchange toaccommodatethermaldetachment |
| D. Proximal Coil (SSTL) | mechanism.Change has noeffect on theintendedperformance of thedevice. | ||
| Hypotube | N/A | SSTL hypotube | None. Minorchange toaccommodatethermaldetachmentmechanism.Change has noeffect on theintendedperformance of thedevice. |
| Connector | N/A | Gold plated, SSTLhypotube | None. Minorchange toaccommodatethermaldetachmentmechanism.Change has noeffect on theintendedperformance of thedevice. |
| Adhesive | Dymax 1128A-M | Dymax 1128A-M-VT | None. Minorchange in adhesiveviscosity does notaffect the intendedperformance of thedevice. |
| Jacket | PET | Same | None. Identical |
| Flouro safe markers | Pad Printed PETShrink tube | Same | None. Identical |
| Epoxy | N/A | Epoxy 353 ND | None. Minorchange toaccommodatethermaldetachmentmechanism.Change has noeffect on theintendedperformance of thedevice. |
| Lead wires | N/A | Polyimide coated silverlead wires | None. Minor |
| accommodatethermaldetachmentmechanism.Change has noeffect on theintendedperformance of thedevice. | |||
| Heater coil coating | N/A | Polyimide coating | None. Minorchange toaccommodatethermaldetachmentmechanism.Change has noeffect on theintendedperformance of thedevice. |
| Detachment Controller | |||
| Coil detachment | Electrolytic viadetachment controller | Thermal via detachmentcontrolled | None. Change indetachmentmethod does notalter the intendedperformance of thedevice. |
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The implant segment detaches via a thermal detachment mechanism upon activation of the XCEL Detachment Controller. The predicate device, Barricade Coil System implant segment detaches via an electrolytic detachment mechanism upon activation of the detachment controller. The device is designed to be deployed and detached in the neuro and peripheral vasculature to permanently obstruct blood flow. The difference in detachment mechanism does not alter the intended performance of the device; therefore, the change in detachment mechanism does not affect the safety, effectiveness, and benefit/risk profile of the Optima Coil System.
PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance benching testing and animal testing indicate that Optima Coil System meets established performance requirements, and is substantially equivalent for its intended use.
| Performance Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Corrosion Resistance | The deployed coil was placed in asodium phosphate buffered salinesolution and the resting potential(Er) is recorded for one (1) hour in | All test samples passed testing. |
| an open circuit configuration and allowed to plateau. | ||
| Advancement andRetraction Force | The test represents the maximum force required to advance and retract the coil through the microcatheter | All test samples passed testing. |
| MRI Compatibility | SAR patterns and temperature rises were evaluated under MRI conditions using RF coils at 64-MHz and 128 MHz and to determine the magnetic field interactions, heating, and artifacts. for the Optima Coil System. The SEMCAD software package was used to evaluate surface heating patterns for the Optima Coil when placed inside the gel of the ASTM phamtom under 1.5T and 3-T MRI systems. | All test samples passed testing. MR Conditional. |
| MRI Artifact | The MRI artifact was evaluated under predetermined magnetic resonance angiography (MRA) imaging parameters. | All test samples passed testing. |
| DetachmentTemperatureCharacterization | The temperature characterization of the Optima Coil System's delivery pusher during the detachment cycle was evaluated by comparing the temperature of the delivery pusher to commercially available thermal detachment coils. | All test samples passed testing. |
| Simulated Use testing | Simulated use testing is to demonstrate that the device will meet the requirements of the product specifications and to demonstrate that the device will meet the product specifications requirements when tested in worst case tortuosity vessel. | All test samples passed testing. |
| Usability - XCELDetachment Controller | The clinical results of the usability of XCEL Detachment Controller were evaluated in accordance to IEC 60601-1-6:2010 + AMD1:2013 and IEC 62366-1:2015. | All test samples passed testing. |
| ParticulateCharacterization | Particulate matter in injections of the device were quantified after advancement/retraction procedures. | All test samples passed testing. |
| Design Verification and | This test is to evaluate the device | All test samples passed testing. |
| Packaging Validation | design and packaging design andto demonstrate that the device willmeet the product specificationrequirements at t=0-year time-point after exposing to 1x Gammasterilization. Bubble immersion,seal peel strength, simulated use,detachment, SR tensile test and DZtensile strength testing wereperformed. | |
| Performance Animal Testing | ||
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo performance of the OptimaCoil System and XCELDetachment Controller in an acuteporcine model. Performancemetrics such as Introduction,Tracking, Deployment, Reposition,and Detachment within an | All test samples passed testing. |
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Biocompatibility:
| Biocompatibility Test | Results | Conclusion |
|---|---|---|
| Optima Coil Implant | ||
| Cytotoxicity - MEM Elution(GLP) - 72 hour extractISO 10993-5 | The test article scored '0' at 24,48 and 72±4 hours | Non-cytotoxic |
| Sensitization - ISO Guinea PigMaximization Sensitization Test(GLP-2 extract)ISO 10993-10 | None of the extracts of the testarticle exhibited a sensitizationresponse greater than '0'. | Did not elicit sensitizationresponse |
| Irritation or Intracutaneousirritation reactivity - ISOIntracutaneous Irritation Test(GLP-2 Extracts)ISO 10993-10 | The difference in the mean testand control scores of the extractdermal observations were lessthan 1.0. | Non-irritant |
| Acute systemic toxicity - ISOAcute Systemic Injection Test(GLP-2 Extracts)ISO 10993-11 | None of the test article treatedanimals were observed withclinical signs consistent withtoxicity at any of theobservation periods. | No signs of toxicity |
| Acute systemic toxicity - ISOMaterial Mediated Rabbitpyrogen (GLP) | None of the test article extractshad a temperature rise > 0.5 °Cat the required observation timepoints. | Non-pyrogenic |
| ISO 10993-11 | ||
| Hemocompatibility - ASTMHemolysis Assay – DirectContact and Extract Method(GLP) | Based on the validity of theassay, the test article isconsidered non-hemolytic underthe test conditions employed. | Non-hemolytic |
| ISO 10993-4 | ||
| Hemocompatibility -Prothrombin Time (PT) -GLP | No statistically significantdifference was observedbetween the plasma exposed tothe test article, predicate andcontrol. | No adverse effect onprothrombin coagulation |
| ISO 10993-4 | ||
| Hemocompatibility -Complement Activation SC5b-9Assay with Sponsor-SuppliedComparison Article (GLP) | When compared to the referencecontrol data the test article andcomparison article results for theSC5b9 assay showed nostatistically significantdifference between the results(p<0.05). | Exhibited activation notsignificant/Passed |
| ISO 10993-4 | ||
| Genotoxicity - ISO In VitroMouse Lymphoma withExtended Treatment (GLP) | No test article mutant frequencywas found to be significantlydifferent than concurrentnegative controls according tostatistical analysis. No testarticle result exceeded the GEFin any treatment. The test articleis considered to be non-mutagenic and non-clastogenicin the test system. | Non-mutagenic and non-clastogenic |
| ISO 10993-3 | ||
| Genotoxicity ISO BacterialMutagenicity Test – Ames assay(GLP-4 Salmonella Strains and1 E. Coli Strain - 2 Extracts) | The test article did not inducesubstantial increases inreversion rates of the type thatare associated with mutagenesis.Furthermore, no substantialtest article toxicity was noted thatmay have interfered with theability of the test system to detectmutagens. | Non-mutagenic |
| ISO 10993-3 | ||
| Genotoxicity - ISO In VivoMouse Micronucleus Assay(GLP-2 Extracts) | There were no apparent grossmanifestations of toxicity norbiologically significanterythropoietic disturbancesresulting in delayedmutagenesis. Furthermore, therewere no biologically significantincreases in mPCE production inthe test article treated groups ascompared to the concurrentnegative controls | Non-mutagenic |
| ISO 10993-3 | ||
| Implantation - ISOIntramuscular Implantation Testwith Histopathology – 4 Week –3 Rabbits (GLP)ISO 10993-6 | The average irritation score ofthe test article is 6.7 whereas theaverage irritation score of thecontrol article is 6.3. | When comparing the irritationscore of the test article to thecontrol article, the irritationscores are found to becomparable.Pass |
| Implantation - ISOIntramuscular Implantation withHistopathology– 13 Week – 4 RabbitsISO 10993-6 | The average irritation score ofthe test article is 8.8 whereas theaverage irritation score of thecontrol article is 9.3. | When comparing the score ofthe test article to the controlarticle, the irritation scores arefound to be comparable.Pass |
| CarcinogenicityISO 10993-18ISO 10993-17 | Toxicological Risk Assessment | Non-carcinogenic |
| Subacute/Subchronic TooxicityISO 10993-11 | Toxicological Risk Assessment | Pass |
| ChronicToxicityISO 10993-11 | Toxicological Risk Assessment | Pass |
| Delivery Pusher | ||
| Cytotoxicity - ISO MEMElution Using L-929 MouseFibroblast Cells (GLP)ISO 10993-5 | The test article scored '0' at 24,48, and 72 + 4 hours | Non-cytotoxic |
| Sensitization - ISO Guinea PigMaximization Sensitization Test(GLP-2 extract)ISO 10993-10 | None of the animals challengedwith the test article extractswere observed with asensitization response greaterthan '0'. | Did not elicit sensitizationresponse |
| Irritation or Intracutaneousirritation reactivity - ISOIntracutaneous Irritation Test(GLP-2 Extracts)ISO 10993-10 | The differences in the mean testand control scores of the extractdermal observations were lessthan 1.0 | Non-irritant |
| Acute systemic toxicity - ISOAcute Systemic Injection Test(GLP-2 Extracts)ISO 10993-11 | None of the test article treatedanimals were observed withclinical signs consistent withtoxicity at any of theobservation periods. | No signs of toxicity |
| Acute systemic toxicity - ISOMaterials Mediated Rabbit | None of the e test article extractshad a temperature rise > 0.5 0C | Non-pyrogenic |
| ISO 10993-11 | ||
| HemocompatibilityHemolysis Assay - DirectContact and Extract Method(GLP) | Based on the validity of theassay, the test article isconsidered non-hemolytic underthe test conditions employed. | Non-hemolytic |
| ISO 10993-4 | ||
| HemocompatibilityComplement Activation - SC5b-9 Assay with Sponsor-SuppliedComparison Article (GLP) | The SC5b-9 assay results for thereference control and the resultsof test article were notstatistically significant ( $p>0.05$ )and is considered satisfactoryunder the test conditionsemployed. The SC5b-9 assayresults for the comparison articlewere statistically significantly( $p<0.05$ ) lower than thereference control data. | Exhibited activation notsignificant |
| ISO 10993-4 | ||
| Hemocompatibility -Prothrombin Time (PT) – GLP | No statistically significantdifference was observedbetween the plasma exposed tothe test article, predicate andcontrol. | No adverse effect onprothrombin coagulation |
| ISO 10993-4 | ||
| Hemocompatibility -Thromboresistance Evaluation(GLP -4 Hour – 2 Dog) | Implantation of the test andcontrol devices in the jugularveins of two canines resulted inno adverse effects or clinicalsigns. | Thrombus formation notsignificant/Passed |
| ISO 10993-4 | ||
| Hemocompatibility - ISO inVitro Mouse Lymphoma withExtended Treatment (GLP) | No test article mutant frequencyexceeded the GEF or wassignificantly different fromconcurrent negative controlresults at a 95% confidenceinterval. | Non-mutagenic and non-clastogenic |
| ISO 10993-3 | ||
| Genotoxicity - ISO BacterialMutagenicity Test – Ames assay(GLP-4 Salmonella Strains and1 E. Coli Strain - 2 Extracts) | The test article did not inducesubstantial increases inreversion rates of the type thatare associated with mutagenesis. | Non-mutagenic |
| ISO 10993-3 |
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Sterilization:
| Test | Test Method Summary | Results |
|---|---|---|
| Sterilization –Optima Coil System | To establish the sterilization dose and a routine sterilization process and to validate the sterilization process to achieve an SAL of 10-6 for the Optima | All test samples passed testing. |
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| Coil System. | ||
|---|---|---|
| Bioburden, dose verification,Sterility, and B&F testing wereperformed. | ||
| Sterilization –XCEL Detachment Controller | To establish the sterilizationcycle and a routine sterilizationprocess and to validate thesterilization process to achievean SAL of 10-6 for the XCELDetachment Controller.Bioburden, EO and ECHresidual, and sterility testingwere performed. | All test samples passed testing. |
| Bacterial Endotoxin (LAL) | Fully packaged devices wereassembled and packaged usingapproved materials defined forthe finished product andsterilized per the documentedsterilization process. Sampleswere tested forInhibition/Enhancement Assayand Kinetic chromogenic LALBacterial Endotoxin testing | All test samples passed testing. |
Shelf Life and Packaging:
| Test | Test Method Summary | Results |
|---|---|---|
| Shelf Life- Optima Coil System | Test samples were subjected toone (1) time Gammasterilization cycle at themaximum dose range,accelerated aged for theequivalent of 2 years,environmentally conditioned perASTM F1980-16 and subjectedto transportation simulation perASTM 4169-16. | All test samples passed testing. |
| Shelf Life-XCEL DetachmentController | Test samples were subjected toEO sterilization,environmentally conditionedand subjected to transportationsimulation per ASTM 4169.Subsequent to the transportsimulation, packaging tests wereperformed to evaluate theintegrity and seal strength of thesterile barrier system | All test samples passed testing. |
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CONCLUSIONS
The Optima Coil System met all specified criteria and did not raise new safety or performance questions. Based on the 510(k) summary and information provided herein, we conclude the subject device, Optima Coil System, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate device, Barricade Coil System (K151760).
§ 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).