i-ED COIL System

• K Number: K210638
• Device Name: i-ED COIL System
• Manufacturer: Kaneka Medical America LLC
• Date Cleared: 2021-03-26 ( 23 days)
• Product Code: HCG KRD
• Regulation Number: 882.5950

Intended 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.

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 of vascular diseases 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.

Predicate Devices

K192068

Reference Devices

K160096

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and electrical aspects of a coil embolization system and do not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention aimed at treating medical conditions.

Diagnostic

No

Explanation: The device is described as an "embolization device" intended for "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and "vascular occlusion of blood vessels." Its purpose is to treat these conditions by obstructing blood flow, not to diagnose them.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including coils, wires, a generator, and cables, indicating it is a hardware-based medical device system.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Function: The i-ED COIL System is an interventional device used within the body to physically embolize (block) blood vessels. It involves the placement of a coil and a detachment system to achieve this.
• Intended Use: The intended use clearly describes a procedure performed in vivo (within a living organism) to treat neurovascular abnormalities and occlude blood vessels.

The device's function and intended use are entirely focused on a therapeutic intervention performed directly on the patient's vascular system, not on analyzing samples taken from the patient.

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 of vascular diseases 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial, neurovascular system, 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)

• Package integrity test on EDG v4: In order to verify integrity of the new sterilization packages of EDG v4, including maintenance of sterility, a package integrity test was carried out on samples that underwent simulated transportation in accordance with ASTM D4169-16. The used standards for the test included ASTM F1886/F1886M-16, F88/F88M-09, F1929-15 and F2096-11.
  • Results: All samples passed the acceptance criteria.
• Shipping and detachment test on EDG v4: In order to verify that the new package could protect the EDG v4 during transportation and the functionality was not impaired, testing including output measurements and operation check, and a detachment test using i-ED COILS were carried out on EDG v4 samples that had undergone simulated transportation challenge in accordance with ASTM D4169-16.
  • Results: All samples passed the acceptance criteria.
• Shelf-life testing on EDG v4: In order to expand the shelf-life of EDG v4, aging test was conducted on the samples that underwent simulated transportation (ASTM D4169-16) and accelerated-aging storage equivalent to two-years real-time aging (ASTM F1980-16). The test items were same as above-mentioned package integrity test and shipping and detachment test.
  • Results: All samples passed the acceptance criteria.

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.

K192068

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.

K160096

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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 26, 2021

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

Re: K210638

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: February 26, 2021 Received: March 3, 2021

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant 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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Indications for Use

510(k) Number (if known) K210638

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)

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510(K) SUMMARY, K210638

i-ED COIL System

510(k) Submitter

Kaneka Medical America LLC 623 Fifth Avenue, New York NY, 10022, The United States Contact Person: Audra Bogucki Telephone: [phone] Email: [e-mail]

Official Correspondent

Takeaki Miyata Manager, Regulatory Affairs & Quality Assurance Team KANEKA CORPORATION 1-12-32 , Akasaka, Minato-ku, Tokyo 107-6028, Japan Phone: [phone] Email: [e-mail]

Date Prepared: March 25, 2021

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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:

• Predicate (original) device: i-ED COIL System [K192068 (Kaneka Corporation)]
• . Reference device: InZone Detachment System [K160096 (Stryker Neurovascular)]

The predicate device and reference device 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 of vascular diseases 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.

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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 Device

The i-ED COIL System has the same intended use (vascular and neurovascular embolization and permanent occlusion of blood flow) as the predicate device and InZone Detachment System. The indications for use of the i-ED COIL System is identical to that of the predicate device, and similar to that of the InZone Detachment System.

Comparison of Technological Characteristics to Predicate Device and Reference Device

Comparison table of the technological characteristics to the predicate, original i-ED COIL System, and reference device is provided in Table 1 below:

Characteristics	Predicate Device	Reference Device	Subject Device	Identicalness, similarity, or difference
General Information
Intended use	i-ED COIL System
[K192068]
(Kaneka
Corporation)	InZone Detachment
System [K160096]
(Stryker
Neurovascular)	i-ED COIL System
(Kaneka
Corporation)	Identical
Configuration
of an
embolization
coil device	The i-ED COIL consists
of an embolization coil
implant comprised of
platinum-tungsten alloy,
affixed to a pusher
(delivery wire) with a
sheath adapter to
facilitate insertion into
the hub of a
microcatheter.	Not applicable	The i-ED COIL consists
of an embolization coil
implant comprised of
platinum-tungsten alloy,
affixed to a pusher
(delivery wire) with a
sheath adapter to
facilitate insertion into
the hub of a
microcatheter.	Identical to the
predicate device
	Predicate Device	Reference Device	Subject Device
Characteristics	i-ED COIL System
[K192068]
(Kaneka
Corporation)	InZone Detachment
System [K160096]
(Stryker
Neurovascular)	i-ED COIL System
(Kaneka
Corporation)	Identicalness,
similarity, or
difference
Use
environments	Hospital, interventional
neuroradiology sites	Hospital,
interventional
neuroradiology sites	Hospital, interventional
neuroradiology sites	Identical
		Dimension/Shape of Coil
Primary coil
outer diameter
(mm)	• Helical: 0.25 to 0.43
• Complex: 0.25 to
0.35	Not applicable	• Helical: 0.25 to 0.43
• Complex: 0.25 to
0.35	Identical to the
predicate device
Secondary coil
outer diameter
(mm)	• Helical: 1.5 to 24.0
• Complex: 1.0 to
16.0	Not applicable	• Helical: 1.5 to 24.0
• Complex: 1.0 to
16.0	Identical to the
predicate device
Primary coil
length (mm)	10 to 500	Not applicable	10 to 500	Identical to the
predicate device
Deployed coil
shape	Helical, Complex	Not applicable	Helical, Complex	Identical to the
predicate device
Pusher length
(mm)	1870	Not applicable	1870	Identical to the
predicate device
Pusher outer
diameter (grip
part; mm)	0.335	Not applicable	0.335	Identical to the
predicate device
		Dimension of Detachment device
Dimension
(mm)	125 × 55 × 25	140 × 58 × 28	125 × 55 × 25	Identical to the
predicate device
		Material of Detachable Coil
Coil	Platinum-tungsten
alloy	Not applicable	Platinum-tungsten
alloy	Identical to the
predicate device
Inner line
(stretch
resistance)	Polypropylene internal
line (two lines)	Not applicable	Polypropylene internal
line (two lines)	Identical to the
predicate device
Pusher (main
or core wire
component)	Stainless steel	Not applicable	Stainless steel	Identical to the
predicate device
Sheath	Polypropylene	Not applicable	Polypropylene	Identical to the
predicate device
Specification of Detachment Device
Coil
detachment
principle	Thermal fusing of
PVA rod	Electrolytic
dissolution of stainless
steel	Thermal fusing of
PVA rod	Identical to the
predicate device
Circuit system	Mono-polar type	Bi-polar type or
Mono-polar-type	Mono-polar type	Identical to the
predicate device
Power source	Three AA (1.5V)
alkaline batteries	Two AAAA (1.5 V)
batteries	Three AA (1.5V)
alkaline batteries	Identical to the
predicate device
	Predicate Device	Reference Device	Subject Device
Characteristics	i-ED COIL System
[K192068]
(Kaneka
Corporation)	InZone Detachment
System [K160096]
(Stryker
Neurovascular)	i-ED COIL System
(Kaneka
Corporation)	Identicalness /
similarity, or
difference
Output	Alternate current (AC)
up to 61.0 mA/
Voltage up to 22.5 V	2.4 mA maximum
direct (DC)/ 28 VDC
maximum output	Alternate current (AC)
up to 61.0 mA/ Voltage
up to 22.5 V	Identical to the
predicate device
Detachments
per unit	30 (based on the
verification test result)	20	30 (based on the
verification test result)	Identical to the
predicate device
Sterilization Packaging Materials
Detachable
coil	Sterilization bag (film
and Tyvek)	Not applicable	Sterilization bag (film
and Tyvek)	Identical to the
predicate device
Detachment
device	Sterilization bag (film
and Tyvek)	Blister packaging
(PETG tray and Tyvek
lid)	Blister packaging
(PETG and Tyvek)	Similar to the
reference device
Other Characteristics
Radiopaque
marker of
pusher	Yes (Platinum coil
part of pusher)	Not applicable	Yes (Platinum coil
part of pusher)	Identical to the
predicate device
Concomitantly
used devices	Microcatheter, guiding
catheter, rotating
hemostatic valve
(RHV)	Stryker Neurovascular
detachable coils
(Target, GDC, and
Matrix)	Microcatheter, guiding
catheter, rotating
hemostatic valve
(RHV)	Identical to the
predicate device
Compatible
microcatheter
of coil (inner
diameter: mm)	0.33 to 0.53
(depending on
dimensional
specification of a
platinum coil)	Not applicable	0.33 to 0.53
(depending on
dimensional
specification of a
platinum coil)	Identical to the
predicate device
MRI
compatibility
of coil (stated
in the
IFU/DFU)	MR conditional	Not applicable	MR conditional	Identical to the
predicate device
Sterilization
method	EtO	EtO	EtO	Identical
Shelf-Life	Detachable coil (i-ED
COIL) : Three years
Detachment device
(EDG v4): Six months	Not applicable
Two years	Detachable coil (i-ED
COIL): Three years
Detachment device
(EDG v4): Two years	Identical to the
predicate device
The shelf-life of
the EDG v4 is
extended from
six months to
two years

Table 1 Comparison table of technological characteristics

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Table 1 Comparison table of technological characteristics

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The subject device includes design changes to the sterilization packaging materials (change from a sterilization bag to a blister pack) and the shelf-life extension (from 6 months to 2 years) for the EDG v4. The change in the sterilization packaging materials is intended to improve the protection performance during the transportation, SAL (10t) and the sterilization method are not changed.

These modifications do not alter the intended use, indications for use, the fundamental scientific technology, or the performance specifications of the i-ED COIL System.

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Performance Testing

To mitigate risks identified in our risk analysis of the modifications subject to this submission and to demonstrate substantial equivalence of modified i-ED COIL System to the predicate device. following tests were conducted using well-established methods:

Test	Test Method Summary	Results
Package integrity test
on EDG v4	In order to verify integrity of the new sterilization packages
of EDG v4, including maintenance of sterility, a package
integrity test was carried out on samples that underwent
simulated transportation in accordance with ASTM D4169-

The used standards for the test included ASTM | All samples passed
the acceptance
criteria. |
| | F1886/F1886M-16, F88/F88M-09, F1929-15 and F2096-11. | |
| Shipping and
detachment test on
EDG v4 | In order to verify that the new package could protect
the EDG v4 during transportation and the
functionality was not impaired, testing including
output measurements and operation check, and a
detachment test using i-ED COILS were carried out
on EDG v4 samples that had undergone simulated
transportation challenge in accordance with ASTM
D4169-16. | All samples passed
the acceptance
criteria. |
| Shelf-life testing on
EDG v4 | In order to expand the shelf-life of EDG v4, aging test
was conducted on the samples that underwent simulated
transportation (ASTM D4169-16) and accelerated-aging
storage equivalent to two-years real-time aging (ASTM
F1980-16). The test items were same as above-mentioned
package integrity test and shipping and detachment test. | All samples passed
the acceptance
criteria. |

Table 2 Summary of performance testing

The results from these tests demonstrate that the technological characteristics and performance of the modified i-ED COIL System are substantially equivalent to the predicate device.

Biocompatibility:

The modifications do not affect the nature of body contact for the EDG v4 (non-contact). Therefore, in the design control activities for the modifications, the original testing on the predicate device applies to the modified i-ED COIL System.

Conclusions:

The modified i-ED COIL System met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and customer inputs. The i-ED COIL System is substantially equivalent to the predicate device.