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.

AI/ML Overview

The i-ED COIL System is a neurovascular embolization device. The provided text describes the 510(k) summary for a modification to this system, specifically focusing on changes to the sterilization packaging materials and an extension of the shelf-life for the EDG v4 component.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All samples passed the acceptance criteria" for each test. However, it does not explicitly list the quantitative acceptance criteria for each test. It generally refers to "acceptance criteria" without providing the specific thresholds or metrics.

Test	Acceptance Criteria (Not explicitly stated in detail, assumed to be successful performance)	Reported Device Performance
Package Integrity Test on EDG v4	(Implied: Maintain integrity, sterility)	All samples passed the acceptance criteria.
Shipping and Detachment Test on EDG v4	(Implied: Device protected during transport, functionality maintained including output measurements, operation check, and detachment using i-ED COILS)	All samples passed the acceptance criteria.
Shelf-Life Testing on EDG v4	(Implied: Maintain performance and integrity for 2-year shelf life after simulated transport and accelerated aging)	All samples passed the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (number of units or tests performed) for any of the performance tests. It refers to "samples" being tested.
Data Provenance: The study is described as performance testing conducted to "mitigate risks identified in our risk analysis of the modifications" and "demonstrate substantial equivalence." This is internal testing performed by Kaneka Medical America LLC as part of their 510(k) submission. The country of origin for the data is not explicitly stated beyond the submitter's location (New York, USA) and the official correspondent being in Japan, implying internal company testing. It is a prospective study in the sense that new tests were conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the tests conducted (package integrity, shipping, shelf-life) are engineering/performance verification tests for a medical device's physical and functional properties, not clinical studies requiring expert ground truth for interpretation of medical data (e.g., image analysis, disease diagnosis).

4. Adjudication Method for the Test Set

This section is not applicable for the type of engineering verification tests described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving multiple human readers interpreting medical data.

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

This section is not applicable. The device is an embolization coil system and detachment generator, which is a physical implant/instrument. It is not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

This section is not applicable as the device is not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance testing mentioned:

Package integrity: The ground truth for package integrity would be established by predefined physical and sterility requirements (e.g., no leaks, no microbial ingress, seal strength within specifications).
Shipping and detachment test: The ground truth would be the device's ability to function as intended (correct output measurements, successful coil detachment) after simulated transport.
Shelf-life testing: The ground truth would be the device's ability to maintain its specified performance and integrity for the extended shelf life (2 years) after accelerated aging and simulated transport.
These are all based on engineering specifications and established test methods (like ASTM standards).

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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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: 917-628-9870 Email: Audra.boguchi@kaneka.com

Official Correspondent

Takeaki Miyata Manager, Regulatory Affairs & Quality Assurance Team KANEKA CORPORATION 1-12-32 , Akasaka, Minato-ku, Tokyo 107-6028, Japan Phone: +81-3-5574-8023 Email: Takeaki.Miyata@kaneka.co.jp

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

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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 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](KanekaCorporation)	InZone DetachmentSystem [K160096](StrykerNeurovascular)	i-ED COIL System(KanekaCorporation)	Identical
Configurationof anembolizationcoil device	The i-ED COIL consistsof an embolization coilimplant comprised ofplatinum-tungsten alloy,affixed to a pusher(delivery wire) with asheath adapter tofacilitate insertion intothe hub of amicrocatheter.	Not applicable	The i-ED COIL consistsof an embolization coilimplant comprised ofplatinum-tungsten alloy,affixed to a pusher(delivery wire) with asheath adapter tofacilitate insertion intothe hub of amicrocatheter.	Identical to thepredicate device
	Predicate Device	Reference Device	Subject Device
Characteristics	i-ED COIL System[K192068](KanekaCorporation)	InZone DetachmentSystem [K160096](StrykerNeurovascular)	i-ED COIL System(KanekaCorporation)	Identicalness,similarity, ordifference
Useenvironments	Hospital, interventionalneuroradiology sites	Hospital,interventionalneuroradiology sites	Hospital, interventionalneuroradiology sites	Identical
		Dimension/Shape of Coil
Primary coilouter diameter(mm)	• Helical: 0.25 to 0.43• Complex: 0.25 to0.35	Not applicable	• Helical: 0.25 to 0.43• Complex: 0.25 to0.35	Identical to thepredicate device
Secondary coilouter diameter(mm)	• Helical: 1.5 to 24.0• Complex: 1.0 to16.0	Not applicable	• Helical: 1.5 to 24.0• Complex: 1.0 to16.0	Identical to thepredicate device
Primary coillength (mm)	10 to 500	Not applicable	10 to 500	Identical to thepredicate device
Deployed coilshape	Helical, Complex	Not applicable	Helical, Complex	Identical to thepredicate device
Pusher length(mm)	1870	Not applicable	1870	Identical to thepredicate device
Pusher outerdiameter (grippart; mm)	0.335	Not applicable	0.335	Identical to thepredicate device
		Dimension of Detachment device
Dimension(mm)	125 × 55 × 25	140 × 58 × 28	125 × 55 × 25	Identical to thepredicate device
		Material of Detachable Coil
Coil	Platinum-tungstenalloy	Not applicable	Platinum-tungstenalloy	Identical to thepredicate device
Inner line(stretchresistance)	Polypropylene internalline (two lines)	Not applicable	Polypropylene internalline (two lines)	Identical to thepredicate device
Pusher (mainor core wirecomponent)	Stainless steel	Not applicable	Stainless steel	Identical to thepredicate device
Sheath	Polypropylene	Not applicable	Polypropylene	Identical to thepredicate device
Specification of Detachment Device
Coildetachmentprinciple	Thermal fusing ofPVA rod	Electrolyticdissolution of stainlesssteel	Thermal fusing ofPVA rod	Identical to thepredicate device
Circuit system	Mono-polar type	Bi-polar type orMono-polar-type	Mono-polar type	Identical to thepredicate device
Power source	Three AA (1.5V)alkaline batteries	Two AAAA (1.5 V)batteries	Three AA (1.5V)alkaline batteries	Identical to thepredicate device
	Predicate Device	Reference Device	Subject Device
Characteristics	i-ED COIL System[K192068](KanekaCorporation)	InZone DetachmentSystem [K160096](StrykerNeurovascular)	i-ED COIL System(KanekaCorporation)	Identicalness /similarity, ordifference
Output	Alternate current (AC)up to 61.0 mA/Voltage up to 22.5 V	2.4 mA maximumdirect (DC)/ 28 VDCmaximum output	Alternate current (AC)up to 61.0 mA/ Voltageup to 22.5 V	Identical to thepredicate device
Detachmentsper unit	30 (based on theverification test result)	20	30 (based on theverification test result)	Identical to thepredicate device
Sterilization Packaging Materials
Detachablecoil	Sterilization bag (filmand Tyvek)	Not applicable	Sterilization bag (filmand Tyvek)	Identical to thepredicate device
Detachmentdevice	Sterilization bag (filmand Tyvek)	Blister packaging(PETG tray and Tyveklid)	Blister packaging(PETG and Tyvek)	Similar to thereference device
Other Characteristics
Radiopaquemarker ofpusher	Yes (Platinum coilpart of pusher)	Not applicable	Yes (Platinum coilpart of pusher)	Identical to thepredicate device
Concomitantlyused devices	Microcatheter, guidingcatheter, rotatinghemostatic valve(RHV)	Stryker Neurovasculardetachable coils(Target, GDC, andMatrix)	Microcatheter, guidingcatheter, rotatinghemostatic valve(RHV)	Identical to thepredicate device
Compatiblemicrocatheterof coil (innerdiameter: mm)	0.33 to 0.53(depending ondimensionalspecification of aplatinum coil)	Not applicable	0.33 to 0.53(depending ondimensionalspecification of aplatinum coil)	Identical to thepredicate device
MRIcompatibilityof coil (statedin theIFU/DFU)	MR conditional	Not applicable	MR conditional	Identical to thepredicate device
Sterilizationmethod	EtO	EtO	EtO	Identical
Shelf-Life	Detachable coil (i-EDCOIL) : Three yearsDetachment device(EDG v4): Six months	Not applicableTwo years	Detachable coil (i-EDCOIL): Three yearsDetachment device(EDG v4): Two years	Identical to thepredicate deviceThe shelf-life ofthe EDG v4 isextended fromsix months totwo 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 teston EDG v4	In order to verify integrity of the new sterilization packagesof EDG v4, including maintenance of sterility, a packageintegrity test was carried out on samples that underwentsimulated transportation in accordance with ASTM D4169-16.The used standards for the test included ASTM	All samples passedthe acceptancecriteria.
	F1886/F1886M-16, F88/F88M-09, F1929-15 and F2096-11.
Shipping anddetachment test onEDG v4	In order to verify that the new package could protectthe EDG v4 during transportation and thefunctionality was not impaired, testing includingoutput measurements and operation check, and adetachment test using i-ED COILS were carried outon EDG v4 samples that had undergone simulatedtransportation challenge in accordance with ASTMD4169-16.	All samples passedthe acceptancecriteria.
Shelf-life testing onEDG v4	In order to expand the shelf-life of EDG v4, aging testwas conducted on the samples that underwent simulatedtransportation (ASTM D4169-16) and accelerated-agingstorage equivalent to two-years real-time aging (ASTMF1980-16). The test items were same as above-mentionedpackage integrity test and shipping and detachment test.	All samples passedthe acceptancecriteria.

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.

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).