Who is the manufacturer of Spartan eCoil System?

Spartan Micro, Inc. filed the 510(k) submission for Spartan eCoil System (K180653).

What is the FDA product code for Spartan eCoil System?

HCG. It is classified under 21 CFR 882.5950 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Spartan eCoil System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Spartan eCoil System?

Micro Therapeutics Inc. Axium Prime Detachable Coil System (K162704).

Who can help prepare an FDA 510(k) submission like Spartan eCoil System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Spartan eCoil System

K180653 · Spartan Micro, Inc. · HCG · Dec 4, 2018 · Neurology

Device Facts

Record ID	K180653
Device Name	Spartan eCoil System
Applicant	Spartan Micro, Inc.
Product Code	HCG · Neurology
Decision Date	Dec 4, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5950
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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.

Device Story

Spartan eCoil System is a mechanically detachable embolic coil system for neurovascular and peripheral embolization. Device consists of an embolic coil attached to a delivery wire with a fluoroscopic marker band, housed in an introducer sheath. Used by physicians in clinical settings to occlude blood flow in vascular abnormalities. Physician navigates the device through a microcatheter (min ID 0.017") to the target site under fluoroscopic guidance. Mechanical detachment is achieved by exposing an internal release wire to free a spherical component captured by a mechanical interference feature. Provides scaffolding and packaging to induce embolic reaction. Benefits include stabilization of aneurysms and treatment of vascular abnormalities. No additional equipment required.

Clinical Evidence

Bench testing only. No clinical or animal testing performed. Bench studies included visual/dimensional inspection, simulated use flow model testing, magnetically induced displacement/torque, RF heating, MR artifact evaluation, corrosion resistance (ASTM F2129-17, F3044-14), fatigue/torsional resistance, friction testing, and biocompatibility (ISO 10993). Physician use testing in tortuous benchtop models confirmed stability, neck coverage, conformability, and delivery smoothness. All tests met acceptance criteria.

Technological Characteristics

Mechanically detachable embolic coil system. Implant materials: 92% Platinum/8% Tungsten alloy, Polypropylene monofilament. Delivery system: SS 304, PET, PTFE. Dimensions: 0.0110"-0.0145" primary diameter, 3mm-25mm secondary diameter. Compatible with microcatheters (min 0.017" ID). Sterilization: Ethylene Oxide. Standards: ASTM F2129-17, F3044-14, F2119-07, F2182-11a, F2213-06, F2052-15, ASTM 2503/IEC 62570, ASTM F1929-15, F2096, D4332, F1960.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and arterial/venous embolizations in peripheral vasculature in patients with vascular abnormalities and hemorrhagic vascular trauma.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Micro Therapeutics Inc. Axium Prime Detachable Coil System (K162704)

Related Devices

K173614 — Penumbra Coil 400, Ruby Coil System, POD System · Penumbra, Inc. · Apr 17, 2018
K050954 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) · MicroVention, Inc. · Jun 28, 2005
K081465 — AXIUM DETACHABLE COIL SYSTEM · Micro Therapeutics, Inc. · Aug 19, 2008
K151760 — Barricade Embolization Coil System · Blockade Medical · Jul 27, 2015
K120686 — ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM · Codman & Shurtleff, Inc. · Apr 4, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 Skyway Court Fremont, CA 94539 Phone: (512) 270-8501 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------| | Contact Person | Ms. Vikki M. O'Connor Regulatory Affairs Consultant Phone: 1-207-214-8535 Email: vikki0730@yahoo.com | | Date Prepared | November 2, 2018 | | Trade Name | Spartan eCoil™ System | | Proposed Class | Class II | | Classification Name and Number | 882.5950 - Neurovascular Embolization Device 870.3300 - Vascular Embolization Device | | Common Name | Neurovascular Embolization Device | | Product Code / Panel | HCG, Neurology KRD, Cardiovascular | | Predicate Device | Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704 | | Special Controls | Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices | {4}------------------------------------------------ | Performance Data | The following performance testing was performed to establish 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 and accelerated aging data were also collected. No clinical or animal testing was performed, as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device. In addition, there is no change in the indications for use or the fundamental scientific technology of the device that requires additional testing. | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Spartan eCoil™ System is also indicated for arterial and venous embolizations in the peripheral vasculature. | | Summary of Technological Characteristics | The Spartan eCoil™ System is designed to deliver, deploy and detach embolic coils of various sizes, shapes and profiles and to embolize or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. As such, the system is constructed of implant grade materials. The system comes in 57 different configurations, two (2) shape configurations and a range of primary and secondary diameters and coil lengths. The Spartan eCoil™ System is designed to work with market available microcatheters with minimum working inner diameters of at least 0.017". The Delivery Wire includes a radiopaque marker used as a positioning reference. | | Conclusion | Based on the indications for use, technological characteristics, materials, required performance testing, principles of operation, anatomical site, safety characteristics and comparison to the predicate device, Spartan's eCoil™ System has been shown to be substantially equivalent to the legally marketed predicate device. | {5}------------------------------------------------ {6}------------------------------------------------ ### Device Comparison The table below provides a comparison of the subject device and the currently cleared predicate Axium device line. | Characteristics | Subject Device Spartan eCoil System K180653 | Predicate Device Axium Prime K162704 | Rationale for Differences / Comments | |--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Classification | Class II | Class II | Same | | FDA Product Code | HCG, KRD | HCG, KRD | Same | | FDA Regulation | 882.5950, 870.3300 | 882.5950, 870.3300 | Same | | Special Guidance | Guidance for Industry and Staff - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices | Guidance for Industry and Staff - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices | Same | | Characteristics | Subject Device Spartan eCoil System K180653 | Predicate Device Axium Prime K162704 | Rationale for Differences / Comments | | Indications for Use | 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 with vascular abnormalities and hemorrhagic vascular trauma | Patients with vascular abnormalities and hemorrhagic vascular trauma | Same | | Technical Method | Provides scaffolding, packaging, and an embolic reaction in vascular anatomy | Provides scaffolding, packaging, and an embolic reaction in vascular anatomy | Same | | Target Area | Neurovascular and peripheral vascular anatomy | Neurovascular and peripheral vascular anatomy | Same | | Method of Supply | Inserted in a rigid HDPE Hoop, in a Tyvek Pouch, placed in a shelf card, in a shipping carton | Stored within Dispenser Coil, in Tyvek pouch, in a shipping carton | Similar Spartan utilizes a shelf card (i.e., Cardboard carton) to hold each Tyvek Pouch | | Implant Design | Alloy coil with atraumatic tip and various shapes and sizes to accommodate different arterial spaces. | Alloy coil with atraumatic tip and various shapes and sizes to accommodate different arterial spaces. | Same | | Detachment Mechanism | Mechanical release induced by exposing internal release wire, to free a spherical component previously captured by a mechanical interference feature. | Mechanical release induced by exposing internal release wire, to free a spherical component previously captured by a mechanical interference feature. | Same | | Number of Models | 57 | 140 | Subject device falls within the range of model offerings as the currently cleared predicate device models. | | Sterilization (EO Residuals and Bioburden) | Ethylene Oxide - Pass | Ethylene Oxide - Pass | Same | | Implant Shape | Helix and 360 | Helix and 3D | Subject device shape is similar to the predicate | | Device Size / Range Primary Diameter | 0.0110" - 0.0145" | 0.0108" – 0.0145" | Subject device size range falls within the currently cleared | | | | | predicate device size range | | Device Size / Range Secondary Diameter | 3mm – 25mm | 1mm – 25mm | Subject device size range falls within the currently cleared predicate device size range | | Size Range Length (in sheath) | 5.5cm - 50cm | 1cm - 50cm | Subject device size range falls within the currently cleared predicate device size range | | Characteristics | Subject Device Spartan eCoil System K180653 | Predicate Device Axium Prime K162704 | Rationale for Differences / Comments | | Visual Positioning Aides | Radiopaque Marker and Flouro- Saver Marker | Radiopaque Marker | The subject device contains an additional Flouro-Saver Marker for device visibility. | | Stretch Resistant Member | Yes | Yes | Same | | Catheter Compatibility | Micro catheters with a minimum I.D. of .017" | Micro catheters with a minimum I.D. of .017" | Same | | Materials (Implant Coil) | | | | | Primary Coil | 92% Platinum 8% Tungsten Alloy | 92% Platinum 8% Tungsten Alloy | Same | | Stretch Resistant Monofilament | Polypropylene | Polypropylene | Same | | Coil Shell | 92% Platinum 8% Tungsten Alloy | 92% Platinum 8% Tungsten Alloy | Same | | Detach Subassembly | Cobalt Chromium – MP35N Alloy Cobalt Chromium – 35N LT Alloy Pt (92%) / W (8%) | SS 316LVM | Subject device utilizes Cobalt Chromium, which performed adequately in terms of corrosion resistance, MRI compatibility, and material strength when compared to the predicate device. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ | Materials (Delivery System) | | | | |-----------------------------|-----------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------| | Unibody | SS 304 | SS 304 | Same | | Outer Jacket | PET | PTFE | Subject device utilizes PET to laminate the delivery wire. | | Marker Coil | 92% Platinum 8% Tungsten Alloy | 92% Platinum 8% Tungsten Alloy | Same | | Lumen Stop | N/A | SS 304 | Subject device does not use this component in the implant. | | Inner Liner | PTFE | PTFE | Same | | Coupler Tube | N/A | SS 304 | Subject device does not use this component in the implant. | | Actuator Interface | | | | | Actuator Interface | N/A | SS 304 | Subject device does not use this component in the implant. | | Release Wire | SS 304 | SS 304 | Same | | Retainer Ring | N/A | SS 304 | Subject device does not use this component in the implant. | | Break Indicator | PET Shrink Tubing | PET Shrink Tubing | Same | | Positive Load Indicator | N/A | PET Shrink Tubing | Subject device does not use this component in the implant. | | Introducer Sheath | Nylon 12 | Polypropylene / HDPE | Subject devices utilizes Nylon 12 for retention of the Spartan eCoil System when packaged. | {14}------------------------------------------------ {15}------------------------------------------------ | Test | Test Method | Test Results | Comments | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------------|----------------------------------|-------------------| | Bench Testing | | | | | | | | | Coil Tensile Study | Compare the accepted values to the minimum acceptable specification limit. All tensile strengths must be equal or greater than the minimum spec. Further, a minimum confidence and reliability level of 95% and 95% respectively must be demonstrated. | Pass | N/A | | | | | | eCoil Anchor Bond | | Test the Coil to anchor component bond joint and determine the tolerance limit of the tensile strength of the bond joint from the anchor | Pass | N/A | | | | | | | | | | | | | | | | | component to the eCoil joint. A confidence and reliability interval of 95%/95% is required. | | | | | | Coil Deformation | | | Test to attain a coil deformation force and observe 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. | Pass | Equivalent | | | | Tab Compression and Rebound Study | | | Test to provide evidence from direct observation that the lock tab returns to its unfolded position when the lock component 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 Weld and Tension Strength | | 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 micro catheter and compare it to the predicate. | | | | | | | Friction in Sheath | | Test the friction load in the introducer sheath (must not buckle during advancement) as compared to the predicate. | Pass | Equivalent | | | | | Release Wire Tensile | 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. | Pass | N/A | | | | | | Marker Radiopacity | Test the delivery wire radiopaque marker and compare the radiopacity of the radiopaque marker to the predicate device. | Pass | Equivalent | | | | | | Physician Use Testing | The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess stability, neck coverage, conformability, softness and smoothness of delivery. | Pass | N/A | | | | | | Stretch Resistant Polypropylene Tensile Test | Pull monofilament (tension) to failure. | Pass | N/A | | | | | | Corrosion / Corrosion Resistance | Tested as per ASTM F2129-17, F3044-14 | Pass | N/A | | | | | | MRI Compatibility | ASTM testing to determine the safety and MR system scanning parameters for patients that will have this device. F2119-07, 2182- 11a, F2213-06, F2052-15, ASTM 2503/IEC 62570 | Pass | N/A | | | | | | Visual and Dimensional, First Loop OD Post Sterilization, Fatigue and Knotting, Label Verification, Pusher Dimensions, Detachment Reliability | Testing to prove outputs equal inputs. Dimensions were measured and key characteristics of the implant coil were inspected. | Pass | All devices met acceptance criteria. | | | | | | Biocompatibility | | | | | | | | | eCoil Implant (permanent implant with direct blood contact) and eCoil Delivery System (limited (≤ 24 hrs)) contact with blood | | | | | | | | | 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 | Hemocompatibility | Acute Systemic Injection Test | Thrombogenicity assessment, Direct and Indirect Hemolysis tests, and SC5b-9 Complement Activation test comparing subject device data with a comparator control | Pass | Pass | No acute systemic toxicity | Acceptable | | Material Mediated Pyrogenicity | eCoil Implant (permanent implant with direct blood contact) |…

Spartan eCoil System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

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Related Devices

Submission Summary (Full Text)

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