Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical and electrical system for embolization, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes.

Explanation: The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities to permanently obstruct blood flow, which is a therapeutic intervention.

Diagnostic

No

Explanation: The device is described as an embolization device intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of two component devices, a detachable coil (hardware) and a detachment generator (hardware), and mentions hardware components like platinum coils, a pusher, a PVA rod, a sheath adapter, a power source, and connection cables. While software verification and validation testing was performed, the device itself is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the endovascular embolization and vascular occlusion of blood vessels within the neurovascular and peripheral vasculature. This is a therapeutic procedure performed in vivo (within the body) to treat conditions like aneurysms and malformations.
Device Description: The device is a system of coils and a generator used to physically block blood flow. This is a mechanical/electrical intervention, not a test performed on biological samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

HCG, KRD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intracranial, neurovascular, peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital, interventional neuroradiology sites

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following in vitro tests were performed:

Appearance test on i-ED COIL: 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 and passed the acceptance criteria.
Dimensional verification on i-ED COIL: 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: 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: A test sample was inserted into the microcatheter in a simulated ICA circuit. All samples met the acceptance criteria about maximum load based on the result of the control device.
Detachment performance test on i-ED COIL System: After the PVA rod of the detach coil was swelled, the detach coil was advanced through the sheath adapter. The detachment part of the sample was soaked in heparinized saline at 35°C in the beaker. The tester pressed the detach button of the EDG v4, and confirmed that the platinum coil could be successfully detached from the pusher within pre-specified time. All test samples could be detached within the pre-specified time and met the acceptance criteria.
Detachment durability test on EDG v4: Measured whether sufficient power for the detachment of i-ED COIL was output from the EDG v4 samples during 30 times detachment operations using the digital power meter and non-inductive variable resistor. Since the outputs from all EDG v4 samples during 30 times detachment procedures were stable, the acceptance criteria was met.
Corrosion resistance test on i-ED COIL: In reference to ISO 11070: 2014, test procedures were carried out. The tester confirmed whether there was sign of corrosion in metal section of sample using a digital microscope. In all test samples, there was no sign of corrosion. Therefore, the result met the acceptance criterion.
Particulate evaluation on i-ED COIL: The simulated use test model incorporated with the tortuous part was used for the evaluation. After 20 cycles of retraction and advancement of a test sample were repeated in the model, the platinum coil was detached with the EDG v4. The test sample solution and the baseline sample solution were analysed using the light obscuration tester. The particulates generated from i-ED COIL were equivalent or less than the control device. Therefore, the result met the acceptance criterion.
Simulated use evaluation on i-ED COIL System: The vessel model with aneurysms, the biplane imaging system and simulated worst neurovascular system, guiding catheter, microcatheters, etc. were used in this test. Physicians semi-quantitatively evaluated trackability and delivery performance in microcatheter, coil positioning performance, repositioning performance (repeat delivery), framing, filling and finishing performance, and detachment performance of i-ED COIL System. Considering the test results, the i-ED COIL System was judged to be able to use without problems even in the very tortuous vasculature considered to be the worst case.
Usability evaluation on i-ED COIL System: Physicians were briefed on the device operation, testing procedures, and were provided i-ED COIL and EDG v4 IFUs. The physicians semi-quantitatively scored each stage (from the preparation of i-ED COIL and EDG v4 to the detachment of the platinum coil). In all of stages, all of physicians scored the usability as equal to or greater than the acceptance criterion. Therefore, it was concluded the i-ED COIL System had adequate usability.
MRI Compatibility tests on i-ED COIL: In reference to related FDA Guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment' and related ASTM F2052-15, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07, effects of displacement force, torque, heating by RF fields, image artifact of MR imaging on implanted i-ED COIL were evaluated to establish safety and compatibility of i-ED COIL in the MR environment. It was concluded that i-ED COIL was MR conditional as same as the predicate devices. The MR compatibility information was reflected appropriately in the labeling.
MRA Artifact on i-ED COIL: According to ASTM F2119-07, image artifact of i-ED COIL in MR Angiography was measured. The worst-case image artifact by i-ED COIL was considered as minimal as with the predicate device.
Shelf Life testing on i-ED COIL: Aging test was conducted on samples that underwent simulated transportation (according to ISO 4180) and accelerated-aged storage equivalent to three years real time storage. Package integrity tests were carried out on the samples in reference to ASTM standards including F88/F88M and F2096. All results of the aging tests met the acceptance criteria were the same as those of the performance testing. Therefore, three-years shelf-life of i-ED COIL was established.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161429 / K160096, K162999, K151760

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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.

1

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)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

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 and
Vascular Embolization Device
Classification name	Neurovascular Embolization Device [21 CFR
882.5950; product code HCG] and Vascular
Embolization 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:

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.

5

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 (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 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 InZone
System) [K161429 / K160096
(Stryker Neurovascular)] | i-ED COIL System (Kaneka
Corporation) | |
| General Information | | | |
| Intended use | Vascular and neurovascular
embolization and permanent
occlusion of blood flow. | Vascular and neurovascular
embolization and permanent
occlusion of blood flow. | Identical |
| Configuration of an
embolization coil
device | The Target Coils consists of an
embolization coil implant
comprised of platinum-tungsten
alloy, affixed to a delivery wire
with an introducer sheath to | The i-ED COIL consists of an
embolization coil implant
comprised of platinum-tungsten
alloy, 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 hub
of a microcatheter. | i-ED COIL System (Kaneka Corporation)
adapter to facilitate insertion
into the hub of a microcatheter. | Identical |
| Usage environments | Hospital, interventional
neuroradiology sites | Hospital, interventional
neuroradiology sites | Identical |
| | Dimension/Shepe of Coil | | |
| Primary coil outer
diameter (mm) | 0.25 to 0.43 | • Helical: 0.25 to 0.43
• Complex: 0.25 to 0.35 | Similar |
| Secondary coil outer
diameter (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 (stretch
resistance) | Polypropylene suture (two
lines) | Polypropylene internal line
(two lines) | Identical |
| Pusher (main or core
wire component) | Stainless steel | Stainless steel | Identical |
| Sheath | High density polyethylene with
pigment | Polypropylene | Similar as
thermoplastic
resin |
| | Specification of Detachment Device | | |
| Coil detachment
principle | Electrolytic dissolution of
stainless steel | Thermal fusing of PVA rod | Different |
| Circuit system | • Bi-polar type (for Target)
• Mono-polar type (for GDC
and Matrix) | Mono-polar type | Similar to for
detachment for
GDC and
Matrix |
| Power source | Two AAAA (1.5 V) batteries | Three AA(1.5V) alkaline
batteries | Similar |
| Output
current/voltage | Direct current (DC) up to 2.4
mA/ Volage up to 28 VDC | Alternate current (AC) up to 61.0
mA/ Voltage up to 22.5 V | Different |
| Detachments per unit | 20 | 30 (based on the verification
test result) | Similar |
| Other Characteristics | | | |
| Radiopaque marker of
pusher | Yes | Yes (Platinum coil part of
pusher) | 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
Detachment
performance test
on i-ED COIL
System	The purpose was to demonstrate that i-ED COIL could be
detachable with the EDG v4 within pre-specified time, and
the combination of i-ED COIL and the EDG v4 is a reliable
detachment mechanism for the clinical usage.
According to the IFU, after the PVA rod of the detach coil
was swelled, the detach coil was advanced through the
sheath adapter. The detachment part of the sample was
soaked in heparinized saline at 35°C in the beaker. The tester
pressed the detach button of the EDG v4, and confirmed that
the platinum coil could be successfully detached from the
pusher within pre-specified time.	All test samples could be
detached within the pre-
specified time and met
the acceptance criteria.
Detachment
durability test on
EDG v4	In order to demonstrate the detachment reliability of i-ED
COIL System and durability of the EDG v4, it was measured
whether sufficient power for the detachment of i-ED COIL
was output from the EDG v4 samples during 30 times
detachment operations using the digital power meter and
non-inductive variable resistor.	Since the outputs from
all EDG v4 samples
during 30 times
detachment procedures
were stable, the
acceptance criteria
was met.
Corrosion
resistance test on
i-ED COIL	The purpose was to demonstrate that the i-ED COIL does not
show sign of corrosions in the intended clinical use.
In reference to ISO 11070: 2014, test procedures were
carried out. The tester confirmed whether there was sign of
corrosion in metal section of sample using a digital
microscope.	In all test samples, there
was no sign of corrosion.
Therefore, the result met
the acceptance criterion.
Particulate
evaluation on i-
ED COIL	The purpose was to demonstrate that the quantity and size of
particulates generated during operation of i-ED COIL
System are equivalent or less than particulates generated
from the control device that is distributed in the U.S.
The simulated use test model incorporated with the tortuous
part was used for the evaluation. After 20 cycles of retraction
and advancement of a test sample were repeated in the
model, the platinum coil was detached with the EDG v4. The
test sample solution and the baseline sample solution were
analysed using the light obscuration tester.	The particulates
generated from i-ED
COIL were equivalent or
less than the control
device. Therefore, the
result met the acceptance
criterion.
Simulated use
evaluation on i-
ED COIL
System	In order to simulate actual clinical environment, the vessel
model with aneurysms, the biplane imaging system and
simulated worst neurovascular system, guiding catheter,
microcatheters, etc. were used in this test. Physicians who
participated in this study, semi-quantitatively evaluated
trackability and delivery performance in microcatheter, coil
positioning performance, repositioning performance (repeat
delivery), framing, filling and finishing performance, and
detachment performance of i-ED COIL System.	Considering the test
results, the i-ED COIL
System was judged to be
able to use without
problems even in the
very tortuous
vasculature considered
to be the worst case.
Usability
evaluation on i-
ED COIL
System	The purpose was to evaluate the usability of i-ED COIL
System by physician trained for neuro-interventional
procedures.
Prior to the testing, the physicians were briefed on the device
operation, testing procedures, and were provided i-ED COIL
and EDG v4 IFUs. The physicians semi-quantitatively	In all of stages, all of
physicians scored the
usability as equal to or
greater than the
acceptance criterion.
Therefore, it was
Test	Test Method Summary	Results
MRI
Compatibility
tests on i-ED
COIL	scored each stage (from the preparation of i-ED COIL and
EDG v4 to the detachment of the platinum coil).

In reference to related FDA Guidance 'Establishing Safety
and Compatibility of Passive Implants in the Magnetic
Resonance (MR) Environment' and related ASTM F2052-
15, ASTM F2213-06, ASTM F2182-11a, and ASTM
F2119-07, effects of dispalacement force, torque, heating by
RF fields, image artifact of MR imaging on implanted i-ED
COIL were evaluated to establish safety and compatibility of
i-ED COIL in the MR environment. | COIL System had
adequate usability.

It was concluded that i-ED COIL was MR
conditional as same as
the predicate devices.
The MR compatibility
information was
reflected appropriately
in the labeling. |
| MRA Artifact on
i-ED COIL | According to ASTM F2119-07, image artifact of i-ED COIL
in MR Angiography was measured. | The worst-case image
artifact by i-ED COIL
was considered as
minimal as with the
predicate device. |
| Shelf Life testing
on i-ED COIL | In order to establish shelf life of i-ED COIL, aging test was
conducted on samples that underwent simulated
transportation (according to ISO 4180) and accelerated-
aged storage equivalent to three years real time storage. The
test items were same as above-mentioned performance
testing except for the MRI compatibility and MRA artifact
testings. Furthermore, to verify maintenance of sterility for
sterilization packages of i-ED COIL within the proposed
shelf life, package integrity tests were carried out on the
samples in reference to ASTM standards including
F88/F88M and F2096. | All results of the aging
tests met the acceptance
criteria were the same as
those of the performance
testing.
Therefore, three-years
shelf-life of i-ED COIL
was 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 / Tested

component	Test Method Summary	Results
Chemical
Characterization by
analysis of extracted
substances / Platinum
coil	In reference to USP and ISO 10993-18, the
test articles were extracted by one or more than
one vehicle(s). The extracted substances were
analyzed by multiple analysis including GC-MS,
LC-MS and IC.	Analysis results showed that
the platinum coil did not
leach definite toxic
substances.
Test item / Tested
component	Test Method Summary	Results
Cytotoxicity /
Platinum coil, Pusher
and Sheath adapter	In reference to ISO 10993-5, cytotoxicity on V79
cells was examined by a colony formation assay
using medium extract.	Not cytotoxic (the medium
extract from test article did
not inhibit colony formation
of V79 cells)
Sensitization / Platinum
coil, Pusher and Sheath
adapter	In reference to ISO 10993-10, a skin sensitization
test in guinea pigs was conducted using extracts
of the platinum coil, Pusher or Sheath Adapter by
physiological saline and olive oil.
In reference to ISO 10993-10, a skin sensitization
test in guinea pigs was conducted using extracts
of the platinum coil by methanol.	No-skin sensitizing potency
Intracutaneous
Reactivity / Platinum
coil, Pusher and Sheath
adapter	In reference to ISO 10993-10, the test and control
solutions were intracutaneously injected into
rabbits. The injection sites were macroscopically
observed immediately after injection, and at 24,
48 and 72 hours after injection.	Acceptable intracutaneous
reactivity
Acute Systemic Toxicity
/ Platinum coil, Pusher
and Sheath adapter	In reference to ISO 10993-11, the test and control
solutions prepared by extractions with vehicles
were injected into mice. Observation of general
conditions, measurement of body weight and
necropsy were performed on the mice.	No acute systemic toxicity
(test solution did not contain
any substance having acute
systemic toxicity)
Pyrogenicity (material
mediated) / Platinum
coil, Pusher and Sheath
adapter	Material mediated rabbit pyrogen test was
conducted according to ISO 10993-11 and USP
. The body temperature of the animals were
measured before and after injection
(multiple timepoints) of extract.	Non-pyrogenicity (none of
the animals showed a body
temperature rise of 0.5°C or
more)
Genotoxicity / Platinum
coil	In reference to ISO 10993-3 and OECD
Guideline No. 471, bacterial reverse mutation test
was conducted by the preincubation method with
and without metabolic activation system (S9 mix)
using tester strains.
In reference to ISO 10993-3 and OECD
Guideline No. 473, an in vitro chromosomal
aberration test in CHL/IU cells.	Non-mutagenic (no
mutagenic activity
(negative))
Non-mutagenic (no
induction of
chromosomal aberrations)
Intramuscular
Implantation / Platinum
coil	In reference to ISO ISO 10993-6, platinum coils
were implanted into paravertebral muscles of
rabbits for 4 weeks and 13 weeks. The
implantation sites were examined
macroscopically and histologically.	No properties injurious to
the paravertebral muscle of
rabbits
Heamocompatibility /
Platinum coil, Pusher
and Sheath adapter	In reference to ASTM F756 and ISO 10993-4, a
hemolysis test using human blood was conducted
on both, the extract of the component obtained
with PBS (-) (indirect contact condition; for
Platinum coil, Pusher and Sheath adapter) and the
component itself (direct contact condition; for
Platinum coil and Pusher).
In reference to ISO 10993-4, thrombogenicity
(coagulation system: TAT and platelet: β-TG) of
the Pusher was evaluated.
Changes in complement factors (SC5b-9) after
exposure of human serum or plasma to the	Non-hemolytic property
It was judged the
thrombogenesis risk was
equivalent or lower to that
of legally-marketed devices.
The complement activation
by the platinum coil and the
pusher was within the
Test item / Tested
component	Test Method Summary	Results
	platinum coil or the pusher, in vitro , were
examined.	acceptable range as a
medical device.
Chronic Systemic
Toxicity / Platinum coil	In reference to ISO 10993-11, the platinum coils
were implanted subcutaneously in the back of rats
for 26 weeks, and chronic systemic toxicity was
evaluated.	The platinum coil did not
cause any chronic systemic
toxicities.
Carcinogenicity /
Platinum coil	In reference to ISO 10993-17, toxicological Risk
Assessment on extracted substances was
conducted.	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.