The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED 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 venous embolizations in the peripheral vasculature.

Device Description

i-ED COIL System is a neurovascular and vascular embolization device, which consists of two component devices, i-ED COIL Detachable Coil (hereafter i-ED COIL) and ELECTRO DETACH GENERATOR v4 Detachment System (hereafter EDG v4).

The i-ED COIL is composed of a detach coil and a sheath adapter. Furthermore, the detach coil consists of a platinum coil (embolization material), to be placed at the site of vascular diseases, a pusher (delivery wire) to guide the platinum coil to the site and a PVA (polyvinyl alcohol) rod that connects the platinum coil and the pusher. The sheath adapter consists of a PP (polypropylene) sheath and an adapter. The i-ED COIL is designed for use with the EDG v4.

The EDG v4 consists of a power source and connection cables attached with clips. EDG v4 is a medical electrical equipment to be used to detach the implantable platinum coil from the delivery wire of the i-ED COIL. It is intended for use in multiple coil detachments performed during a single procedure.

The i-ED COIL and EDG v4 are provided sterile (EtO), and separately packaged and distributed in the U.S.

AI/ML Overview

The provided document describes the performance testing, biocompatibility testing, electrical safety, electromagnetic compatibility, and software verification and validation testing for the i-ED COIL System. However, it does not explicitly define "acceptance criteria" as a single, consolidated table with specific numerical thresholds for each test, nor does it present a "study" in the traditional sense (e.g., a multi-reader multi-case clinical study for an AI algorithm).

The document details various performance tests to demonstrate that the device meets pre-specified acceptance criteria. These acceptance criteria are generally qualitative or described in terms of meeting manufacturing specifications, equivalence to a control device, or compliance with standards.

Here's an attempt to extract the requested information based on the provided text, with not applicable (N/A) for information that is not present for this type of device (e.g., AI-specific metrics, ground truth for AI):

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (as implied or stated)	Reported Device Performance
Appearance	Visual appearance meets pre-specified acceptance criteria and is clinically usable. No visual abnormalities.	All samples had no visual abnormalities and passed the acceptance criteria.
Dimensional Verification	Dimensional values meet pre-specified acceptance criteria and are designed as intended.	All samples were confirmed to meet all acceptance criteria based on the dimensional specification.
Strength	Physical strength meets pre-specified acceptance criteria; can withstand forces in clinical usage.	All samples without deviation passed each acceptance criterion. Demonstrated necessary strength for clinical usage.
Delivery Performance	Delivery performance is at least equivalent to the control device.	All samples met the acceptance criteria about maximum load based on the result of the control device.
Detachment Performance	i-ED COIL detachable with EDG v4 within pre-specified time; reliable detachment mechanism for clinical usage.	All test samples could be detached within the pre-specified time and met the acceptance criteria.
Detachment Durability (EDG v4)	Sufficient power output from EDG v4 for i-ED COIL detachment during 30 operations; stable outputs.	Outputs from all EDG v4 samples during 30 detachment procedures were stable; acceptance criteria met.
Corrosion Resistance	No signs of corrosion in the intended clinical use.	In all test samples, there was no sign of corrosion. Result met acceptance criterion.
Particulate Evaluation	Quantity and size of particulates generated are equivalent to or less than particulates from control device.	Particulates generated from i-ED COIL were equivalent to or less than the control device. Result met acceptance criterion.
Simulated Use Evaluation	Judged to be usable without problems even in very tortuous vasculature (worst case).	Judged to be able to use without problems even in the very tortuous vasculature considered to be the worst case.
Usability Evaluation	Physicians score usability as equal to or greater than the acceptance criterion. Adequate usability.	In all stages, all physicians scored the usability as equal to or greater than the acceptance criterion. Adequate usability.
MRI Compatibility	MR conditional, similar to predicate devices.	Concluded that i-ED COIL was MR conditional as same as the predicate devices.
MRA Artifact	Worst-case image artifact is minimal, similar to predicate device.	The worst-case image artifact by i-ED COIL was considered as minimal as with the predicate device.
Shelf Life Testing	All aging tests meet acceptance criteria (same as performance testing). Sterility maintained.	All results of the aging tests met the acceptance criteria were the same as those of the performance testing. Three-years shelf-life of i-ED COIL established.
Biocompatibility	Meets biological safety requirements; non-toxic, non-sensitizing, non-pyrogenic, non-mutagenic, non-carcinogenic.	Analysis showed no definite toxic substances. Not cytotoxic. No-skin sensitizing. Acceptable intracutaneous reactivity. No acute systemic toxicity. Non-pyrogenicity. Non-mutagenic. No properties injurious to paravertebral muscle of rabbits. Non-hemolytic. Thrombogenesis risk equivalent or lower than legally-marketed devices. Complement activation within acceptable range. No chronic systemic toxicities. Non-carcinogenic.
Electrical Safety (EDG v4)	Complies with IEC 60601-1 standard.	Device complies with the IEC 60601-1 standard.
Electromagnetic Compatibility (EDG v4)	Complies with IEC 60601-1-2 standard.	Device complies with the IEC 60601-1-2 standard.
Software Verification and Validation	Meets recommended guidance for software in medical devices.	Documentation provided as recommended by FDA guidance.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Specific numerical sample sizes are generally not provided for each test, other than phrases like "All samples" or "all EDG v4 samples," implying multiple units were tested. For particulate evaluation, an unspecified "test sample solution" was analyzed. For shelf life, "samples" that underwent simulated transportation and accelerated aging were tested.
Data Provenance: The studies are described as "in vitro tests," "bench testing," and "simulated use tests." Given the nature of a neurovascular embolization device, these are laboratory and simulated environment tests. There is no mention of country of origin for the data or whether it's retrospective or prospective, as these are not clinical studies primarily.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: For the "Simulated use evaluation on i-ED COIL System," "Physicians who participated in this study, semi-quantitatively evaluated trackability and delivery performance..." The exact number of physicians is not specified, but it implies more than one. For "Usability evaluation on i-ED COIL System," it states "physician trained for neuro-interventional procedures" and "all of physicians scored the usability," again implying multiple.
Qualifications of Experts: For simulated use and usability evaluation, the experts are identified as "Physicians who participated in this study" and "physician trained for neuro-interventional procedures," suggesting relevant medical expertise in the field where the device would be used. Specific years of experience are not provided.

4. Adjudication method for the test set

Adjudication Method: Not explicitly stated. For the evaluations involving physicians (Simulated Use, Usability), it's implied that their assessments directly formed the "results" for those tests. There's no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for these types of bench or simulated use tests.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a neurovascular embolization coil system, not an AI or imaging diagnostic algorithm that involves human readers interpreting images. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. The device is a physical medical device, not an AI algorithm. There is no "algorithm only" performance to assess in this context. While software verification and validation were performed for the EDG v4, this refers to the control software of the detachment generator, not a diagnostic or prescriptive AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the performance tests, the "ground truth" is typically defined by pre-specified manufacturing specifications, established engineering standards (e.g., ISO, ASTM), and the performance of legally marketed control devices. For aspects like simulated use and usability, the "ground truth" comes from the qualitative or semi-quantitative assessments of qualified physicians using the device in a simulated environment. There is no biological "ground truth" like pathology or outcomes data directly for these bench and simulated tests, though the biocompatibility section relates to biological responses.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI model, so there is no training set. The device is a physical medical device.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no AI training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 25, 2020

Kaneka Pharma America LLC % Takeaki Miyata Manager, Regulatory Affairs & Quality Assurance Team Kaneka Corporation 1-12-32 Akasaka Minato-ku, Tokyo 107-6028 Japan

Re: K192068

Trade/Device Name: i-ED COIL System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 25, 2020 Received: March 26, 2020

Dear Takeaki Miyata:

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. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192068

Device Name i-ED COIL System

Indications for Use (Describe)

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

i-ED COIL System

510(k) Submitter

Kaneka Pharma America LLC 546 Fifth Avenue, 21st Floor, New York NY, The United States Contact Person: Kazuhiko Inoue Telephone: 212-705-4343 Email: Kazuhiko.inoue@kaneka.com

Official Correspondent

Takeaki Miyata Manager, Regulatory Affairs & Quality Assurance Team Medical Devices Solutions Vehicle Kaneka Corporation 1-12-32, Akasaka, Minato-ku Tokyo, Japan Phone: +81-3-5574-8023 Email: Takeaki.Miyata@kaneka.co.jp

Date Prepared: April 25, 2020

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Subject Device Name:

Trade Name	i-ED COIL System
Common or usual name	Neurovascular Embolization Device andVascular Embolization Device
Classification name	Neurovascular Embolization Device [21 CFR882.5950; product code HCG] and VascularEmbolization Device [21 CFR 870.3300;product code KRD]
Class	II
Classification Panel	Neurology (84) and Cardiovascular (74)

Predicate Devices:

. Primary predicate device: Target Detachable Coils / InZone Detachment System (or Target Coils and InZone System) [K161429 / K160096 (Stryker Neurovascular)]
. MicroPlex Coil System [K162999 (MicroVention, Inc.)]
Barricade Embolization Coil System (or Barricade Coil System) [K151760 (Blockade Medical)]

These predicate devices have not been subject to a design-related recall.

Device Description:

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The i-ED COIL and EDG v4 are provided sterile (EtO), and separately packaged and distributed in the U.S.

Indications for Use

The i-ED 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 Indications for Use to Predicate Devices

The i-ED COIL System has the same intended use (vascular and neurovascular embolization and permanent occlusion of blood flow) as the Target Coils and InZone System, MicroPlex Coil System and Barricade Coil System. The indications for use of the i-ED COIL System is identical to those of the MicroPlex Coil System and the Barricade Coil System, and similar to that of the Target Coils and InZone System.

Comparison of Technological Characteristics to Predicate Device

Catheter-based vascular and neurovascular intervention is the technological principle for both i-ED COIL System and the predicate devices. The vascular and neurovascular embolization coil devices including the i-ED COIL System and the predicate devices consist of a coil (embolization material) and a delivery wire and an instrument for detachment of a coil (detachment system device).

Comparison table of the technological characteristics to the primary predicate device is provided in Table 1 below:

Characteristics	Primary Predicate Device	Subject Device	Identicalness/ similarity,or difference
	Target Coils and InZoneSystem) [K161429 / K160096(Stryker Neurovascular)]	i-ED COIL System (KanekaCorporation)
General Information
Intended use	Vascular and neurovascularembolization and permanentocclusion of blood flow.	Vascular and neurovascularembolization and permanentocclusion of blood flow.	Identical
Configuration of anembolization coildevice	The Target Coils consists of anembolization coil implantcomprised of platinum-tungstenalloy, affixed to a delivery wirewith an introducer sheath to	The i-ED COIL consists of anembolization coil implantcomprised of platinum-tungstenalloy, affixed to a pusher(delivery wire) with a sheath	Similar
	Primary Predicate Device	Subject Device	Identicalness/ similarity, or difference
Characteristics	Target Coils and InZone System) [K161429 / K160096(Stryker Neurovascular)]facilitate insertion into the hubof a microcatheter.	i-ED COIL System (Kaneka Corporation)adapter to facilitate insertioninto the hub of a microcatheter.	Identical
Usage environments	Hospital, interventionalneuroradiology sites	Hospital, interventionalneuroradiology sites	Identical
	Dimension/Shepe of Coil
Primary coil outerdiameter (mm)	0.25 to 0.43	• Helical: 0.25 to 0.43• Complex: 0.25 to 0.35	Similar
Secondary coil outerdiameter (mm)	1.0 to 24.0	• Helical: 1.5 to 24.0• Complex: 1.0 to 16.0	Similar
Primary coil length(mm)	• Helical: 10 to 500• Complex: 11 to 500	10 to 500	Similar
Deployed coil shape	Helical, Complex (360 shape,3D)	Helical, Complex	Similar
Pusher length (mm)	1850	1870	Similar
Pusher outer diameter(grip part; mm)	0.34	0.335	Similar
	Dimension of Detachment device
Dimension (mm)	140 × 58 × 28	125 × 55 × 25	Similar
	Material of Coil
Coil	Platinum-tungsten alloy	Platinum-tungsten alloy	Identical
Inner line (stretchresistance)	Polypropylene suture (twolines)	Polypropylene internal line(two lines)	Identical
Pusher (main or corewire component)	Stainless steel	Stainless steel	Identical
Sheath	High density polyethylene withpigment	Polypropylene	Similar asthermoplasticresin
	Specification of Detachment Device
Coil detachmentprinciple	Electrolytic dissolution ofstainless steel	Thermal fusing of PVA rod	Different
Circuit system	• Bi-polar type (for Target)• Mono-polar type (for GDCand Matrix)	Mono-polar type	Similar to fordetachment forGDC andMatrix
Power source	Two AAAA (1.5 V) batteries	Three AA(1.5V) alkalinebatteries	Similar
Outputcurrent/voltage	Direct current (DC) up to 2.4mA/ Volage up to 28 VDC	Alternate current (AC) up to 61.0mA/ Voltage up to 22.5 V	Different
Detachments per unit	20	30 (based on the verificationtest result)	Similar
Other Characteristics
Radiopaque marker ofpusher	Yes	Yes (Platinum coil part ofpusher)	Similar
Characteristics	Primary Predicate Device	Subject Device	Identicalness / similarity, or difference
Concomitantly used devices	Microcatheter, guiding catheter, rotating hemostatic valve (RHV)	Microcatheter, guiding catheter, rotating hemostatic valve (RHV)	Identical
Compatible microcatheter of coil (inner diameter: mm)	0.41 to 0.48	0.33 to 0.53 (depending on dimensional specification of a platinum coil)	i-ED COIL has broader compatibility with microcatheter
MRI compatibility of coil (stated in the IFU/DFU)	MR conditional	MR conditional	Similar (detailed conditions are different)
Sterilization method	EtO	EtO	Identical

Table 1 Comparison table about technological characteristics

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Performance Testing

To demonstrate substantial equivalence of i-ED COIL System to the predicate devices, the technological characteristics and performance criteria were evaluated in reference to the bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices" (dated December 29, 2004). In vitro tests in Table 2 below were performed on the subject device:

Test	Test Method Summary	Results
Appearance test on i-ED COIL	The purpose was to demonstrate that visual appearance of i-ED COIL meets pre-specified acceptance criteria and could be considered to be clinically usable.Visual inspection using a microscope was conducted on the detach coil and the sheath adaptor. In addition, the position markers was visually checked.	All samples had no visual abnormalities at all and passed the acceptance criteria.
Dimensional verification on i-ED COIL	The purpose was to demonstrate that dimensional values of i-ED COIL samples meet pre-specified acceptance criteria and the i-ED COIL samples are dimensionally designed as intended.Dimensions of the samples were measured with instruments (gauge, caliper, and scale).	All samples were confirmed to meet all acceptance criteria based on the dimensional specification.
Strength test on i-ED COIL	The purpose was to demonstrate that physical strength of i-ED COIL meet pre-specified acceptance criteria, and could withstand forces that the i-ED COIL may encounter in clinical usage.After swelling the PVA rod, inner line strength, product strengths, coil strength and pusher strength were measured by a tensile tester.	All samples without deviation passed each acceptance criterion. It was demonstrated that i-ED COIL has necessary strength for clinical usage.
Delivery performance test on i-ED COIL	The purpose was to demonstrate that delivery performance of i-ED COIL is at least equivalent to the control device that is legally distributed in the U.S.A test sample was inserted into the microcatheter in a simulated ICA circuit Consequently the test sample was	All samples met the acceptance criteria about maximum load based on the result of the control device
Test	Test Method Summary	Results
Detachmentperformance teston i-ED COILSystem	The purpose was to demonstrate that i-ED COIL could bedetachable with the EDG v4 within pre-specified time, andthe combination of i-ED COIL and the EDG v4 is a reliabledetachment mechanism for the clinical usage.According to the IFU, after the PVA rod of the detach coilwas swelled, the detach coil was advanced through thesheath adapter. The detachment part of the sample wassoaked in heparinized saline at 35°C in the beaker. The testerpressed the detach button of the EDG v4, and confirmed thatthe platinum coil could be successfully detached from thepusher within pre-specified time.	All test samples could bedetached within the pre-specified time and metthe acceptance criteria.
Detachmentdurability test onEDG v4	In order to demonstrate the detachment reliability of i-EDCOIL System and durability of the EDG v4, it was measuredwhether sufficient power for the detachment of i-ED COILwas output from the EDG v4 samples during 30 timesdetachment operations using the digital power meter andnon-inductive variable resistor.	Since the outputs fromall EDG v4 samplesduring 30 timesdetachment procedureswere stable, theacceptance criteriawas met.
Corrosionresistance test oni-ED COIL	The purpose was to demonstrate that the i-ED COIL does notshow sign of corrosions in the intended clinical use.In reference to ISO 11070: 2014, test procedures werecarried out. The tester confirmed whether there was sign ofcorrosion in metal section of sample using a digitalmicroscope.	In all test samples, therewas no sign of corrosion.Therefore, the result metthe acceptance criterion.
Particulateevaluation on i-ED COIL	The purpose was to demonstrate that the quantity and size ofparticulates generated during operation of i-ED COILSystem are equivalent or less than particulates generatedfrom the control device that is distributed in the U.S.The simulated use test model incorporated with the tortuouspart was used for the evaluation. After 20 cycles of retractionand advancement of a test sample were repeated in themodel, the platinum coil was detached with the EDG v4. Thetest sample solution and the baseline sample solution wereanalysed using the light obscuration tester.	The particulatesgenerated from i-EDCOIL were equivalent orless than the controldevice. Therefore, theresult met the acceptancecriterion.
Simulated useevaluation on i-ED COILSystem	In order to simulate actual clinical environment, the vesselmodel with aneurysms, the biplane imaging system andsimulated worst neurovascular system, guiding catheter,microcatheters, etc. were used in this test. Physicians whoparticipated in this study, semi-quantitatively evaluatedtrackability and delivery performance in microcatheter, coilpositioning performance, repositioning performance (repeatdelivery), framing, filling and finishing performance, anddetachment performance of i-ED COIL System.	Considering the testresults, the i-ED COILSystem was judged to beable to use withoutproblems even in thevery tortuousvasculature consideredto be the worst case.
Usabilityevaluation on i-ED COILSystem	The purpose was to evaluate the usability of i-ED COILSystem by physician trained for neuro-interventionalprocedures.Prior to the testing, the physicians were briefed on the deviceoperation, testing procedures, and were provided i-ED COILand EDG v4 IFUs. The physicians semi-quantitatively	In all of stages, all ofphysicians scored theusability as equal to orgreater than theacceptance criterion.Therefore, it was
Test	Test Method Summary	Results
MRICompatibilitytests on i-EDCOIL	scored each stage (from the preparation of i-ED COIL andEDG v4 to the detachment of the platinum coil).In reference to related FDA Guidance 'Establishing Safetyand Compatibility of Passive Implants in the MagneticResonance (MR) Environment' and related ASTM F2052-15, ASTM F2213-06, ASTM F2182-11a, and ASTMF2119-07, effects of dispalacement force, torque, heating byRF fields, image artifact of MR imaging on implanted i-EDCOIL were evaluated to establish safety and compatibility ofi-ED COIL in the MR environment.	COIL System hadadequate usability.It was concluded that i-ED COIL was MRconditional as same asthe predicate devices.The MR compatibilityinformation wasreflected appropriatelyin the labeling.
MRA Artifact oni-ED COIL	According to ASTM F2119-07, image artifact of i-ED COILin MR Angiography was measured.	The worst-case imageartifact by i-ED COILwas considered asminimal as with thepredicate device.
Shelf Life testingon i-ED COIL	In order to establish shelf life of i-ED COIL, aging test wasconducted on samples that underwent simulatedtransportation (according to ISO 4180) and accelerated-aged storage equivalent to three years real time storage. Thetest items were same as above-mentioned performancetesting except for the MRI compatibility and MRA artifacttestings. Furthermore, to verify maintenance of sterility forsterilization packages of i-ED COIL within the proposedshelf life, package integrity tests were carried out on thesamples in reference to ASTM standards includingF88/F88M and F2096.	All results of the agingtests met the acceptancecriteria were the same asthose of the performancetesting.Therefore, three-yearsshelf-life of i-ED COILwas established.

Table 2 Summary of performance testing

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The results from these tests demonstrate that the technological characteristics and performance criteria of the i-ED COIL System are adequate for the intended use of the device, and that the device can perform in a manner equivalent to devices currently distributed on the market with the same intended use.

Biocompatibility:

To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the i-ED COIL to the predicate devices, the biocompatibility testing listed in Table 3 below was performed in accordance with "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff" (dated June 16, 2016):

Test item / Testedcomponent	Test Method Summary	Results
ChemicalCharacterization byanalysis of extractedsubstances / Platinumcoil	In reference to USP<661> and ISO 10993-18, thetest articles were extracted by one or more thanone vehicle(s). The extracted substances wereanalyzed by multiple analysis including GC-MS,LC-MS and IC.	Analysis results showed thatthe platinum coil did notleach definite toxicsubstances.
Test item / Testedcomponent	Test Method Summary	Results
Cytotoxicity /Platinum coil, Pusherand Sheath adapter	In reference to ISO 10993-5, cytotoxicity on V79cells was examined by a colony formation assayusing medium extract.	Not cytotoxic (the mediumextract from test article didnot inhibit colony formationof V79 cells)
Sensitization / Platinumcoil, Pusher and Sheathadapter	In reference to ISO 10993-10, a skin sensitizationtest in guinea pigs was conducted using extractsof the platinum coil, Pusher or Sheath Adapter byphysiological saline and olive oil.In reference to ISO 10993-10, a skin sensitizationtest in guinea pigs was conducted using extractsof the platinum coil by methanol.	No-skin sensitizing potency
IntracutaneousReactivity / Platinumcoil, Pusher and Sheathadapter	In reference to ISO 10993-10, the test and controlsolutions were intracutaneously injected intorabbits. The injection sites were macroscopicallyobserved immediately after injection, and at 24,48 and 72 hours after injection.	Acceptable intracutaneousreactivity
Acute Systemic Toxicity/ Platinum coil, Pusherand Sheath adapter	In reference to ISO 10993-11, the test and controlsolutions prepared by extractions with vehicleswere injected into mice. Observation of generalconditions, measurement of body weight andnecropsy were performed on the mice.	No acute systemic toxicity(test solution did not containany substance having acutesystemic toxicity)
Pyrogenicity (materialmediated) / Platinumcoil, Pusher and Sheathadapter	Material mediated rabbit pyrogen test wasconducted according to ISO 10993-11 and USP<151>. The body temperature of the animals weremeasured before and after injection(multiple timepoints) of extract.	Non-pyrogenicity (none ofthe animals showed a bodytemperature rise of 0.5°C ormore)
Genotoxicity / Platinumcoil	In reference to ISO 10993-3 and OECDGuideline No. 471, bacterial reverse mutation testwas conducted by the preincubation method withand without metabolic activation system (S9 mix)using tester strains.In reference to ISO 10993-3 and OECDGuideline No. 473, an in vitro chromosomalaberration test in CHL/IU cells.	Non-mutagenic (nomutagenic activity(negative))Non-mutagenic (noinduction ofchromosomal aberrations)
IntramuscularImplantation / Platinumcoil	In reference to ISO ISO 10993-6, platinum coilswere implanted into paravertebral muscles ofrabbits for 4 weeks and 13 weeks. Theimplantation sites were examinedmacroscopically and histologically.	No properties injurious tothe paravertebral muscle ofrabbits
Heamocompatibility /Platinum coil, Pusherand Sheath adapter	In reference to ASTM F756 and ISO 10993-4, ahemolysis test using human blood was conductedon both, the extract of the component obtainedwith PBS (-) (indirect contact condition; forPlatinum coil, Pusher and Sheath adapter) and thecomponent itself (direct contact condition; forPlatinum coil and Pusher).In reference to ISO 10993-4, thrombogenicity(coagulation system: TAT and platelet: β-TG) ofthe Pusher was evaluated.Changes in complement factors (SC5b-9) afterexposure of human serum or plasma to the	Non-hemolytic propertyIt was judged thethrombogenesis risk wasequivalent or lower to thatof legally-marketed devices.The complement activationby the platinum coil and thepusher was within the
Test item / Testedcomponent	Test Method Summary	Results
	platinum coil or the pusher, in vitro , wereexamined.	acceptable range as amedical device.
Chronic SystemicToxicity / Platinum coil	In reference to ISO 10993-11, the platinum coilswere implanted subcutaneously in the back of ratsfor 26 weeks, and chronic systemic toxicity wasevaluated.	The platinum coil did notcause any chronic systemictoxicities.
Carcinogenicity /Platinum coil	In reference to ISO 10993-17, toxicological RiskAssessment on extracted substances wasconducted.	Non-carcinogenic

Table 3 Summary of biocompatibility testing

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The results from these tests demonstrate that the i-ED COIL System is biocompatible for its intended use similar to the predicate devices.

Electrical safety and electromagnetic compatibility (EMC):

Electrical safety and EMC testing were conducted on the EDG v4, consisting of the power source and connection cables attached clips. The detachment system device complies with the IEC 60601-1 standard for the electrical safety and the IEC 60601-1-2 standard for the EMC.

Software Verification and Validation Testing:

Software verification and validation testing were conducted, and documentation was provided in this 510(k) submission as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (dated May 11, 2005).

Conclusions:

The i-ED COIL System met all of the predetermined acceptance criteria for the design verification and validation as specified by applicable standards, guidances, test protocols and/or customer inputs. The i-ED COIL System is substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 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).