Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial anewrysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The Axium™ Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Device Description

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as "Axium™ device family"), consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The Instant Detacher (I.D.) is sold separately.

AI/ML Overview

This document does not describe an AI/ML device and therefore does not contain the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance.

The document is a 510(k) premarket notification summary for the Axium™ Detachable Coil and Axium™ Prime Detachable Coil, which are neurovascular embolization devices. It describes a proposed change to the labeling concerning the accessory sheath (from femoral to arterial, allowing radial access) and the removal of certain peripheral vasculature indications for specific models.

The performance data presented are for bench testing of the physical device (e.g., ease of delivery, detachment reliability, retractability, retrieval) and explicitly states:

"The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction." (Regarding animal and clinical data).

Therefore, I cannot provide details on:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample sizes for test sets or data provenance for AI/ML model evaluation.
Number and qualifications of experts for AI/ML ground truth.
Adjudication methods for AI/ML test sets.
MRMC studies or human reader improvement with AI assistance.
Standalone performance of an algorithm.
Type of ground truth used for AI/ML.
Sample size for AI/ML training set.
How ground truth for an AI/ML training set was established.

Summary

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July 7, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized eagle with the words "DEPARTMENT OF HEALTH" written vertically along the left side of the symbol. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Bhavika Patel Senior Specialist, Regulatory Affairs 5290 California Avenue Irvine, California 92617

Re: K203432

Trade/Device Name: Axium Detachable Coil and Axium Prime Detachable Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: June 3, 2021 Received: June 4, 2021

Dear Bhavika Patel:

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 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

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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,

Xiaolin Zheng, Ph.D. 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) K203432

Device Name Axium™ Detachable Coil Axium™ Prime Detachable Coil

Indications for Use (Describe)

Axium™ Detachable Coil:

Axium™ Prime Detachable Coil (Model Numbers APB-X-Y-3D/HX-ES/SS):

Axium™ Prime Detachable Coil (Model Numbers FC-X-Y-3D):

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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K203432 510(k) Summary

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration: 2029214
Contact Person:	Bhavika PatelSenior Regulatory Affairs SpecialistTelephone: (949) 434-5030Email: bhavika.patel@medtronic.com

Date Summary Prepared:	06 July 2021
Trade Name of Device:	Axium™ Detachable CoilAxium™ Prime Detachable Coil
Common Name of Device:	Neurovascular Embolization Device
Review Panel:	Neurology
Product Code:	HCG , KRD
Regulation Number:	21 CFR 882.5950
Regulation Name:	Neurovascular Embolization Device
Device Classification	Class II
Predicate Device:	K133310 Axium™ Detachable Coil SystemK151447 Axium™ Detachable Coil SystemK162704 Axium™ Prime Detachable Coil System

Device Description:

Indication for Use Statement:

The Axium™ device family product model numbers and associated indications for use are outlined in the table below. The model numbers are formatted to summarize sizes available, where X is the coil loop outer diameter in mm and Y is the implant length in cm.

Axium™ Device Family Indications for Use
Model Numbers	Trade Name	Indications for Use
QC-X-Y-HELIX	Axium™	Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
QC-X-Y-3D	Detachable
NC-X-Y-HELIX	Coil
PC-X-Y-HELIX
PC-X-Y-3D
APB-X-Y-3D-ES	Axium™	The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
APB-X-Y-3D-SS	Prime
APB-X-Y-HX-ES	Detachable
APB-X-Y-HX-SS	Coil

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Axium™ Device Family Indications for Use
Model Numbers	Trade Name	Indications for Use
FC-X-Y-3D	Axium™PrimeDetachableCoil	The Axium™ Prime Detachable Coil is intended for the endovascularembolization of intracranial aneurysms and other neurovascular abnormalities,such as arteriovenous malformations and arteriovenous fistulae. The Axium™Prime Detachable Coils are also intended for arterial and venous embolizationsin the peripheral vasculature.

Proposed Change:

Medtronic requests clearance of Axium™ Detachable Coil and Axium™ Prime Detachable Coil (referred to collectively as the "Axium™ device family") for revised labeling that includes changes to the directions for use to modify the accessory sheath required to perform a procedure, from femoral sheath to arterial sheath. The proposed change will allow the physician to use radial artery route during access as an alternative to femoral artery for the introduction of the device during a procedure if deemed appropriate. Axium™ Detachable Coil and Axium™ Prime Detachable Coil revised labeling also includes removal of the indication "The Axium™ [Prime] Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature" for Axium™ Detachable Coil and Axium™ Prime Detachable Coil (excludes Model Numbers FC-X-Y-3D).

Device Comparison:

Design Feature	Predicate:Axium™ Detachable Coil System(K133310, K151447)Axium™ Prime Detachable Coil System(K162704)	Subject:Axium™ Detachable CoilAxium™ Prime Detachable Coil
Indications for Usefor Axium™Detachable Coil	The Axium™ Detachable Coil System isindicated for the endovascular embolizationof intracranial aneurysms and otherneurovascular abnormalities, such asarteriovenous malformations andarteriovenous fistulae. The Axium™Detachable Coils are also indicated forarterial and venous embolizations in theperipheral vasculature.	Axium™ Detachable Coils are intendedfor the endovascular embolization ofintracranial aneurysms. Axium™Detachable Coils are also intended for theembolization of other neuro vascularabnormalities such as arteriovenousmalformations and arteriovenous fistulae.
Indications for Usefor Axium™ PrimeDetachable Coil(Model NumbersAPB-X-Y-3D/HX-ES/SS)	The Axium™ Detachable Coil System isindicated for the endovascular embolizationof intracranial aneurysms and otherneurovascular abnormalities, such asarteriovenous malformations andarteriovenous fistulae. The Axium™Detachable Coils are also indicated forarterial and venous embolizations in theperipheral vasculature.	The Axium™ Prime Detachable Coils areintended for the endovascularembolization of intracranial aneurysms.The Axium™ Prime Detachable Coils arealso intended for the embolization ofother neuro vascular abnormalities such asarteriovenous malformations andarteriovenous fistulae.
Indications for Usefor Axium™ PrimeDetachable Coil(Model NumbersFC-X-Y-3D)	The Axium™ Prime Detachable CoilSystem is indicated for the endovascularembolization of intracranial aneurysms andother neurovascular abnormalities, such asarteriovenous malformations andarteriovenous fistulae. The Axium™ PrimeDetachable Coils are also indicated forarterial and venous embolizations in theperipheral vasculature.	The Axium™ Prime Detachable Coil isintended for the endovascularembolization of intracranial aneurysmsand other neurovascular abnormalities,such as arteriovenous malformations andarteriovenous fistulae. The Axium™Prime Detachable Coils are also intended
Design Feature	Predicate:	Subject:
	Axium™ Detachable Coil System(K133310, K151447)	Axium™ Detachable Coil
	Axium™ Prime Detachable Coil System(K162704)	Axium™ Prime Detachable Coil
		for arterial and venous embolizations in
		the peripheral vasculature.
Dimensions
Device Size Range	Axium™ Bare Helix:1.5-20 mm – Loop OD1-50 cm - LengthAxium™ Bare 3D:2-25 mm - Loop OD2-50 cm - LengthAxium™ Nylon 3D:2-4 mm – Loop OD1-10 cm - LengthAxium™ PGLA Helix:2-10 mm – Loop OD1-30 cm - LengthAxium™ PGLA 3D:2-18 mm – Loop OD2-40 cm - LengthAxium™ Prime 3D1-6 mm – Loop OD2-20 cm – LengthAxium™ Prime Helix1-6 mm – Loop OD1-20 cm - LengthAxium™ Prime 3D3-25 mm - Loop OD6-50 cm - Length	Same
Coil Shape	Helical and 3D	Same
Compatible Accessories
CatheterCompatibility	Axium™ detachable coils (Bare) should bedelivered through microcatheters withminimum ID of 0.0165".Axium™ detachable coils (Nylon andPGLA) should be delivered throughmicrocatheters with minimum ID of 0.0165"- 0.020".Axium™ Prime detachable coils shouldonly be delivered through a microcatheterwith a minimum inside diameter of0.0165"-0.017" with two marker bands	Same
Design Feature	Predicate:	Subject:
	AxiumTM Detachable Coil System(K133310, K151447)	AxiumTM Detachable Coil
	AxiumTM Prime Detachable Coil System(K162704)	AxiumTM Prime Detachable Coil


Guide CatheterCompatibility	6-8F	Same
Method of CoilDetachment	Instant Detacher – standalone hand-heldmechanical unit that, when connected to theproximal end of the pusher, pulls the releaseelement inside of the pusher, resulting inrelease of the implant from the distal end ofthe delivery pusher	Same
Sterilization

Method of Supply	Sterile and single use	Same
Sterilization Method	Ethylene Oxide (EO)	Same
Stability

Shelf Life	3 years	Same
Magnetic Resonance Imaging
MRI Compatibility	MR Conditional	Same

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Biocompatibility:

There is no change to the biocompatibility of the products associated with the proposed changes.

Performance Data – Bench:

Non-clinical bench testing was conducted to evaluate the performance of Axium™ Detachable Coil and Axium™ Prime Detachable Coil in a clinically representative access model.

The following non-clinical bench tests were conducted:

Design Verification
Test	Test Method Summary	Results
Ease of Delivery – Friction	Device navigated through tortuousbench top model in order to assessfriction	All test results met acceptancecriteria

Design Validation
Test	Test Method Summary	Results
Ease of Delivery	Device navigated through tortuousbench top model in order to assessdeliverability	All test results met acceptancecriteria
Detachment Reliability andRetractability	Cycle the coil (manipulate withinthe embolic target) withoutpremature detachment	All test results met acceptancecriteria
Detachment Reliability andRetractability	Detach the coil successfully in 3 orfewer attempts	All test results met acceptancecriteria
Retrieval	Retrieve the pusher through themicrocatheter after detachment	All test results met acceptancecriteria

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Performance Data - Animal:

The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction.

Performance Data - Clinical:

The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction.

Conclusion:

Axium™ Detachable Coil and Axium™ Prime Detachable Coil revised labeling includes changes to the directions for use to modify the accessory sheath required to perform a procedure, from femoral sheath. Axium™ Detachable Coil and Axium™ Prime Detachable Coil revised labeling also includes removal of the indication "The Axium™ [Prime] Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature" for Axium™ Detachable Coil and Axium™ Prime Detachable Coil (excludes Model Numbers FC-X-Y-3D). The proposed changes do not alter the intended use, design, materials, or fundamental scientific technology. The successful results of the performance evaluation verify that the proposed changes do not raise new questions of safety and efficacy. Therefore, Axium™ Detachable Coil and Axium™ Prime Detachable Coil are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).