i-ED COIL System

K210638 · Kaneka Medical America, LLC · HCG · Mar 26, 2021 · Neurology

Device Facts

• Record ID: K210638
• Device Name: i-ED COIL System
• Applicant: Kaneka Medical America, LLC
• Product Code: HCG · Neurology
• Decision Date: Mar 26, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The i-ED COIL System is a neurovascular embolization device used in hospital interventional neuroradiology settings by physicians. It consists of the i-ED COIL (implantable platinum-tungsten alloy coil, pusher wire, PVA rod) and the ELECTRO DETACH GENERATOR v4 (EDG v4). The EDG v4 is a battery-powered electrical unit that uses thermal fusing of the PVA rod to detach the coil from the delivery wire. The system is used to permanently obstruct blood flow to aneurysms or vascular malformations. The device is MR conditional. The current submission covers packaging changes (blister pack) and shelf-life extension for the EDG v4 unit.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included package integrity, shipping/detachment functionality, and accelerated aging to validate the new packaging and extended shelf-life for the EDG v4 unit.

Technological Characteristics

System comprises platinum-tungsten alloy coils with polypropylene internal lines and stainless steel pushers. Detachment via thermal fusing of PVA rod using a mono-polar electrical circuit powered by three AA batteries. EDG v4 dimensions: 125x55x25 mm. Sterilization via EtO. Packaging: Blister pack (PETG/Tyvek). Connectivity: None (standalone).

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels to permanently obstruct blood flow; and venous embolizations in the peripheral vasculature.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Predicate Devices

• i-ED COIL System (K192068)

Reference Devices

• InZone Detachment System (K160096)

Submission Summary (Full Text)

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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 ([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<br>Embolization Device |
| Classification name | Neurovascular Embolization Device [21 CFR 882.5950;<br>product code HCG] and Vascular Embolization Device [21<br>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<br>[K192068]<br>(Kaneka<br>Corporation) | InZone Detachment<br>System [K160096]<br>(Stryker<br>Neurovascular) | i-ED COIL System<br>(Kaneka<br>Corporation) | Identical |
| Configuration<br>of an<br>embolization<br>coil device | The i-ED COIL consists<br>of an embolization coil<br>implant comprised of<br>platinum-tungsten alloy,<br>affixed to a pusher<br>(delivery wire) with a<br>sheath adapter to<br>facilitate insertion into<br>the hub of a<br>microcatheter. | Not applicable | The i-ED COIL consists<br>of an embolization coil<br>implant comprised of<br>platinum-tungsten alloy,<br>affixed to a pusher<br>(delivery wire) with a<br>sheath adapter to<br>facilitate insertion into<br>the hub of a<br>microcatheter. | Identical to the<br>predicate device |
| | Predicate Device | Reference Device | Subject Device | |
| Characteristics | i-ED COIL System<br>[K192068]<br>(Kaneka<br>Corporation) | InZone Detachment<br>System [K160096]<br>(Stryker<br>Neurovascular) | i-ED COIL System<br>(Kaneka<br>Corporation) | Identicalness,<br>similarity, or<br>difference |
| Use<br>environments | Hospital, interventional<br>neuroradiology sites | Hospital,<br>interventional<br>neuroradiology sites | Hospital, interventional<br>neuroradiology sites | Identical |
| | | Dimension/Shape of Coil | | |
| Primary coil<br>outer diameter<br>(mm) | • Helical: 0.25 to 0.43<br>• Complex: 0.25 to<br>0.35 | Not applicable | • Helical: 0.25 to 0.43<br>• Complex: 0.25 to<br>0.35 | Identical to the<br>predicate device |
| Secondary coil<br>outer diameter<br>(mm) | • Helical: 1.5 to 24.0<br>• Complex: 1.0 to<br>16.0 | Not applicable | • Helical: 1.5 to 24.0<br>• Complex: 1.0 to<br>16.0 | Identical to the<br>predicate device |
| Primary coil<br>length (mm) | 10 to 500 | Not applicable | 10 to 500 | Identical to the<br>predicate device |
| Deployed coil<br>shape | Helical, Complex | Not applicable | Helical, Complex | Identical to the<br>predicate device |
| Pusher length<br>(mm) | 1870 | Not applicable | 1870 | Identical to the<br>predicate device |
| Pusher outer<br>diameter (grip<br>part; mm) | 0.335 | Not applicable | 0.335 | Identical to the<br>predicate device |
| | | Dimension of Detachment device | | |
| Dimension<br>(mm) | 125 × 55 × 25 | 140 × 58 × 28 | 125 × 55 × 25 | Identical to the<br>predicate device |
| | | Material of Detachable Coil | | |
| Coil | Platinum-tungsten<br>alloy | Not applicable | Platinum-tungsten<br>alloy | Identical to the<br>predicate device |
| Inner line<br>(stretch<br>resistance) | Polypropylene internal<br>line (two lines) | Not applicable | Polypropylene internal<br>line (two lines) | Identical to the<br>predicate device |
| Pusher (main<br>or core wire<br>component) | Stainless steel | Not applicable | Stainless steel | Identical to the<br>predicate device |
| Sheath | Polypropylene | Not applicable | Polypropylene | Identical to the<br>predicate device |
| Specification of Detachment Device | | | | |
| Coil<br>detachment<br>principle | Thermal fusing of<br>PVA rod | Electrolytic<br>dissolution of stainless<br>steel | Thermal fusing of<br>PVA rod | Identical to the<br>predicate device |
| Circuit system | Mono-polar type | Bi-polar type or<br>Mono-polar-type | Mono-polar type | Identical to the<br>predicate device |
| Power source | Three AA (1.5V)<br>alkaline batteries | Two AAAA (1.5 V)<br>batteries | Three AA (1.5V)<br>alkaline batteries | Identical to the<br>predicate device |
| | Predicate Device | Reference Device | Subject Device | |
| Characteristics | i-ED COIL System<br>[K192068]<br>(Kaneka<br>Corporation) | InZone Detachment<br>System [K160096]<br>(Stryker<br>Neurovascular) | i-ED COIL System<br>(Kaneka<br>Corporation) | Identicalness /<br>similarity, or<br>difference |
| Output | Alternate current (AC)<br>up to 61.0 mA/<br>Voltage up to 22.5 V | 2.4 mA maximum<br>direct (DC)/ 28 VDC<br>maximum output | Alternate current (AC)<br>up to 61.0 mA/ Voltage<br>up to 22.5 V | Identical to the<br>predicate device |
| Detachments<br>per unit | 30 (based on the<br>verification test result) | 20 | 30 (based on the<br>verification test result) | Identical to the<br>predicate device |
| Sterilization Packaging Materials | | | | |
| Detachable<br>coil | Sterilization bag (film<br>and Tyvek) | Not applicable | Sterilization bag (film<br>and Tyvek) | Identical to the<br>predicate device |
| Detachment<br>device | Sterilization bag (film<br>and Tyvek) | Blister packaging<br>(PETG tray and Tyvek<br>lid) | Blister packaging<br>(PETG and Tyvek) | Similar to the<br>reference device |
| Other Characteristics | | | | |
| Radiopaque<br>marker of<br>pusher | Yes (Platinum coil<br>part of pusher) | Not applicable | Yes (Platinum coil<br>part of pusher) | Identical to the<br>predicate device |
| Concomitantly<br>used devices | Microcatheter, guiding<br>catheter, rotating<br>hemostatic valve<br>(RHV) | Stryker Neurovascular<br>detachable coils<br>(Target, GDC, and<br>Matrix) | Microcatheter, guiding<br>catheter, rotating<br>hemostatic valve<br>(RHV) | Identical to the<br>predicate device |
| Compatible<br>microcatheter<br>of coil (inner<br>diameter: mm) | 0.33 to 0.53<br>(depending on<br>dimensional<br>specification of a<br>platinum coil) | Not applicable | 0.33 to 0.53<br>(depending on<br>dimensional<br>specification of a<br>platinum coil) | Identical to the<br>predicate device |
| MRI<br>compatibility<br>of coil (stated<br>in the<br>IFU/DFU) | MR conditional | Not applicable | MR conditional | Identical to the<br>predicate device |
| Sterilization<br>method | EtO | EtO | EtO | Identical |
| Shelf-Life | Detachable coil (i-ED<br>COIL) : Three years<br>Detachment device<br>(EDG v4): Six months | Not applicable<br>Two years | Detachable coil (i-ED<br>COIL): Three years<br>Detachment device<br>(EDG v4): Two years | Identical to the<br>predicate device<br>The shelf-life of<br>the EDG v4 is<br>extended from<br>six months to<br>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<br>on EDG v4 | In order to verify integrity of the new sterilization packages<br>of EDG v4, including maintenance of sterility, a package<br>integrity test was carried out on samples that underwent<br>simulated transportation in accordance with ASTM D4169-<br>16.<br>The used standards for the test included ASTM | All samples passed<br>the acceptance<br>criteria. |
| | F1886/F1886M-16, F88/F88M-09, F1929-15 and F2096-11. | |
| Shipping and<br>detachment test on<br>EDG v4 | In order to verify that the new package could protect<br>the EDG v4 during transportation and the<br>functionality was not impaired, testing including<br>output measurements and operation check, and a<br>detachment test using i-ED COILS were carried out<br>on EDG v4 samples that had undergone simulated<br>transportation challenge in accordance with ASTM<br>D4169-16. | All samples passed<br>the acceptance<br>criteria. |
| Shelf-life testing on<br>EDG v4 | In order to expand the shelf-life of EDG v4, aging test<br>was conducted on the samples that underwent simulated<br>transportation (ASTM D4169-16) and accelerated-aging<br>storage equivalent to two-years real-time aging (ASTM<br>F1980-16). The test items were same as above-mentioned<br>package integrity test and shipping and detachment test. | All samples passed<br>the acceptance<br>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.