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.

Axium™ Prime Detachable Coil:

(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)

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.

Axium™ Prime Detachable Coil:

(Models: FC-X-Y-3D)

The Axium™ Prime Detachable Col 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 consist 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 I.D. is sold separately.

AI/ML Overview

The document provided focuses on the substantial equivalence of the "Axium™ Detachable Coil" and "Axium™ Prime Detachable Coil" with the addition of fluorosafe markers. The primary purpose of the submission is to demonstrate that these changes do not raise new questions of safety and effectiveness compared to the predicate devices. Therefore, the "device" in question is not an AI/ML powered diagnostic device, but rather a neurovascular embolization device with a minor design change.

As such, many of the typical acceptance criteria and study details relevant to AI/ML powered devices, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or provided in this document. The provided text describes bench testing and biocompatibility testing for the physical device itself.

However, I can extract the relevant "acceptance criteria" and "reported device performance" as presented for the specific tests conducted for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from "Results" column)	Reported Device Performance
Biocompatibility
Cytotoxicity	Not induce cytotoxicity	Did not induce cytotoxicity.
Sensitization	Not be considered a sensitizer	Were not considered a sensitizer.
Irritation	Be considered non-irritant	Are considered non-irritant.
Acute Systemic Toxicity	Show no mortality or evidence of acute systemic toxicity	Showed no mortality or evidence of acute systemic toxicity.
Indirect (extract) Hemolysis	Be considered non-hemolytic	Are considered non-hemolytic.
Material-Mediated Pyrogenicity	Meet USP 151 requirements and be non-pyrogenic	Met the requirements and were found to be non-pyrogenic.
Bench Testing
Visual Inspection	Darkness of fluorosafe etch mark and 360° etch mark around delivery pusher meet specifications	Met the acceptance criteria for visual inspection.
Marker Dimensional (Marker Position and Total Marker Length) Inspection	Total length of fluorosafe markers and their position on the delivery pusher meet specifications	Met the acceptance criteria for marker dimensional inspection.
Corrosion Resistance	No corrosion on the delivery pusher after soaking in saline and immersion in boiling water per ISO 10555-1, Annex A	Met the acceptance criteria for corrosion resistance.
Fluorosafe Marker Visibility	Meet user needs for visibility under simulated use conditions	Met the user needs for which it was designed and tested.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each test, but standard for device verification and validation. For biocompatibility, animal models were used (guinea pig, rabbit, mice). For bench tests, "devices" (plural) were evaluated, implying a sample size greater than one but not specified numerically.
Data Provenance: Not applicable in the context of AI/ML data sets. These are laboratory tests on physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The "ground truth" for this device modification is established through physical and objective measures against predefined specifications and recognized international standards (e.g., ISO 10993, USP 151) and user needs (for marker visibility). The "clinical users" who evaluated fluorosafe marker visibility are mentioned, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). These tests involve objective measurements and evaluations against specified criteria and standards.

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

Not applicable. This submission is for a physical medical device (embolization coil) with a minor design change (adding fluorosafe markers), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is based on objective measurements against established engineering specifications, chemical/biological compatibility standards (ISO 10993, USP 151), and documented user needs. For example, meeting the criteria for "non-cytotoxic" or demonstrating "no corrosion."

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary

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November 7, 2023

Image /page/0/Picture/1 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.

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

Re: K233420

Trade/Device Name: Axium Detachable Coil; Axium Prime Detachable Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: October 9, 2023 Received: October 10, 2023

Dear Lekshmi Pillai:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S

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

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Indications for Use

510(k) Number (if known) K233420

Device Name Axium™ Detachable Coil; Axium™ Prime Detachable Coil

Indications for Use (Describe)

Axium™ Detachable Coil:

Axium™ Prime Detachable Coil:

(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)

Axium™ Prime Detachable Coil:

(Models: 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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K233420 510(k) Summary

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618, USAEstablishment Registration: 2029214
Contact Person:	Lekshmi PillaiSenior Regulatory Affairs SpecialistTelephone: (917) 291-3810Email : lekshmiajaykumar.pillai@medtronic.com

Date SummaryPrepared:	06 November 2023
Trade Name of Device:	Axium™ Detachable CoilAxium™ Prime Detachable Coil
Common Name ofDevice:	Neurovascular Embolization Device, Vascular Embolization Device
Review Panel:	Neurology, Cardiovascular
Product Code:	HCG, KRD
Regulation Number:	21 CFR 882.5950; 21 CFR 870.3300
Regulation Name:	Neurovascular Embolization Device, Vascular Embolization Device
Device Classification	Class II
Predicate Device:	K203432Axium™ Detachable CoilAxium™ Prime Detachable Coil

Device Description:

Indications for Use Statement:

Axium™ Detachable Coil and Axium Prime Detachable Coil Indications for Use
Model Numbers	Trade Name	Indications for Use
QC-X-Y-HELIX
QC-X-Y-3D	Axium™DetachableCoil	Axium™ Detachable Coils are intended for the endovascular embolizationof intracranial aneurysms. Axium™ Detachable Coils are also intended forthe embolization of other neuro vascular abnormalities such asarteriovenous malformations and arteriovenous fistulae.
NC-X-Y-HELIX
PC-X-Y-HELIX
PC-X-Y-3D

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Axium™ Detachable Coil and Axium Prime Detachable Coil Indications for Use
Model Numbers	Trade Name	Indications for Use
APB-X-Y-3D-ES	Axium™PrimeDetachableCoil	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
APB-X-Y-HX-ES
APB-X-Y-HX-SS
FC-X-Y-3D	Axium™PrimeDetachableCoil	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.

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.

Proposed Change:

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular requests clearance for the Axium™ Detachable Coil and Axium™ Prime Detachable Coil with addition of fluorosafe markers on the proximal end of the coil delivery pusher.

Device Comparison:

Design Feature	Predicate Devices (K203432):Axium™ Detachable Coil;Axium™ Prime Detachable Coil	Subject Devices:Axium™ DetachableCoil;Axium™ PrimeDetachable Coil
Indications for Use	Axium™ Detachable Coil:Axium™ Detachable Coils are intended for the endovascularembolization of intracranial aneurysms. Axium™ Detachable Coilsare also intended for the embolization of other neuro vascularabnormalities such as arteriovenous malformations andarteriovenous fistulae.Axium™ Prime Detachable Coil (APB-X-Y-3D-ES, APB-X-Y-3D-SS,APB-X-Y-HX-ES, APB-X-Y-HX-SS):The Axium™ Prime Detachable Coils are intended for theendovascular embolization of intracranial aneurysms. The Axium™Prime Detachable Coils are also intended for the embolization ofother neuro vascular abnormalities such as arteriovenousmalformations and arteriovenous fistulae.Axium™ Prime Detachable Coil (FC-X-Y-3D):The Axium™ Prime Detachable Coil is intended for the endovascularembolization of intracranial aneurysms and other neurovascularabnormalities, such as arteriovenous malformations andarteriovenous fistulae. The Axium™ Prime Detachable Coils are also	Same
Design Feature	Predicate Devices (K203432):Axium™ Detachable Coil;Axium™ Prime Detachable Coil	Subject Devices:Axium™ DetachableCoil;Axium™ PrimeDetachable Coil
	intended for arterial and venous embolizations in the peripheralvasculature.
Visual Markers	None	Fluorosafemarkers
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 3D:1-6 mm – Loop OD2-20 cm – LengthAxium™ Prime Helix:1-6 mm – Loop OD1-20 cm – LengthAxium™ Prime 3D:3-25 mm – Loop OD6-50 cm – Length	Same
Coil Shape	Helical and 3D	Same
	Compatible Accessories
CatheterCompatibility	Axium™ Detachable Coils (Bare) should be delivered throughmicrocatheters with minimum ID of 0.0165".Axium™ Detachable Coils (Nylon and PGLA) should be deliveredthrough microcatheters with minimum ID of 0.0165"-0.020".	SameSame
	Axium™ Prime Detachable Coils should be delivered throughmicrocatheters with minimum ID of 0.0165"-0.017".	Axium™ PrimeDetachable Coilsshould be deliveredthrough
Design Feature	Predicate Devices (K203432):Axium™ Detachable Coil;Axium™ Prime Detachable Coil	Subject Devices:Axium™ Detachable Coil;Axium™ PrimeDetachable Coilmicrocatheters withminimum ID of0.0165".
Guide CatheterCompatibility	6-8F	Same
Method of CoilDetachment	Instant Detacher - standalone hand-held mechanical unit that, when connected to the proximal end of the pusher, pulls the release element inside of the pusher, resulting in release of the implant from the distal end of the delivery pusher.	Same
Material of Construction
Main Coil	Platinum/Tungsten alloy	Same
Tension Safe/Stretch ResistantFilament	Polypropylene	Same
Delivery System	Pusher: Composite hypotube stainless steel with PTFE outer jacket and liner and PET & Pt/w alignment marker	Same
Introducer Sheath	Polypropylene and HDPE	Same
Sterilization
Method of Supply	Sterile and single use	Same
SterilizationMethod	Ethylene Oxide (EO)	Same
Packaging
Pouch Material	For PC-X-Y-HELIX and PC-X-Y-3D:PLK235/Uncoated 2FS TyvekFor all other models:PET/Tyvek	SameFor all other models:Nylon/Tyvek
Pouch Dimensions	For PC-X-Y-HELIX and PC-X-Y-3D:17" X 9.8" (pre-sterilization)For all other models:10 1/8" X 10.838"	SameFor all other models:11.98" X 10.94"
Carton	Cardboard, Solid Bleach Sulfate	Same
MRI Card	None	3 1/2" x 4" (+/-1/8"), 1/1 Black -Black and white,2 sided
Stability
Shelf Life	36 months	Same
MRI Compatibility	Magnetic Resonance ImagingMR Conditional	Same

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Biocompatibility:

The fluorosafe marker (subject to this submission) added onto the proximal end of the delivery pusher is considered external communicating device having indirect blood contact via the fluid path, as it is only in contact with the delivery catheter and does not have direct exposure to circulating blood. The distal end of the delivery pusher is categorized as external communicating device with limited exposure duration (د 24 hrs.) with circulating blood. The embolization coil is considered an implant with long-term (> 30 days) direct contact with circulating blood. There are no material or contact duration changes to the components of the device that directly contact circulating blood in the current submission. Therefore, prior hemocompatibility (complement activation, direct hemolysis, and thrombogenicity) tests demonstrate the biocompatibility of the unmodified regions and components of the subject device that contact blood directly.

To assess the addition of fluorosafe markers on the proximal end of the delivery pusher, the following biocompatibility tests were performed on the final, finished delivery pusher subassemblies incorporating the fluorosafe marker.

Test Description	Study Method	Results
Cytotoxicity	Axium™ Detachable Coil and Axium™ PrimeDetachable Coil were evaluated per ISO 10993-5: 2009, using the MEM elution method.	The Axium™ Detachable Coil andAxium™ Prime Detachable Coil didnot induce cytotoxicity.
Sensitization	Axium™ Detachable Coil and Axium™ PrimeDetachable Coil were evaluated per ISO 10993-10:2021, using a guinea pig maximization test.	The Axium™ Detachable Coil andAxium™ Prime Detachable Coilwere not considered a sensitizer.
Irritation	Axium™ Detachable Coil and Axium™ PrimeDetachable Coil were evaluated per ISO 10993-23:2021, using a rabbit intracutaneous reactivitytest.	The Axium™ Detachable Coil andAxium™ Prime Detachable Coil areconsidered non-irritant.
AcuteSystemicToxicity	Axium™ Detachable Coil and Axium™ PrimeDetachable Coil were evaluated per ISO 10993-11:2017, using an acute systemic injection testin mice.	The Axium™ Detachable Coil andAxium™ Prime Detachable Coilshowed no mortality or evidence ofacute systemic toxicity.
Indirect(extract)Hemolysis	Axium™ Detachable Coil and Axium™ PrimeDetachable Coil were evaluated per ISO 10993-4:2017, using ASTM hemolysis study.	The Axium™ Detachable Coil andAxium™ Prime Detachable Coil areconsidered non-hemolytic.
Material-MediatedPyrogenicity	Axium™ Detachable Coil and Axium™ PrimeDetachable Coil were evaluated per USP 151(2020), using USP rabbit pyrogen test -material-mediated.	The Axium™ Detachable Coil andAxium™ Prime Detachable Coil metthe requirements and were foundto be non-pyrogenic.

The Axium™ Detachable Coil and Axium™ Prime Detachable Coil have been evaluated to meet requirements specified in FDA guidance, "Use of International Standard ISO 10993-1, "Biocompatibility Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", " issued

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on September 8, 2023.

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 neurovascular access model. The successful results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate devices.

The following non-clinical bench tests were conducted:

Design Verification
Test	Test Method Summary	Results
Visual Inspection	Visual inspection verified for thedarkness of the etch mark offluorosafe markers and the 360°etch mark around the deliverypusher.	Axium™ Detachable Coil andAxium™ Prime Detachable Coilmet the acceptance criteria forvisual inspection.
Marker Dimensional (MarkerPosition and Total MarkerLength) Inspection	Marker dimensional inspectionverified the total length of thefluorosafe markers and theirposition on the delivery pusher.	Axium™ Detachable Coil andAxium™ Prime Detachable Coilmet the acceptance criteria formarker dimensional inspection.
Corrosion Resistance	The test verified the corrosionresistance on the delivery pusherusing the method of soaking thedevices in saline followedbyimmersion in boiling water per themethod specified in Annex A of ISO10555-1.	Axium™ Detachable Coil andAxium™ Prime Detachable Coilmet the acceptance criteria forcorrosion resistance.

Design Validation
Test	Test Method Summary	Results
Fluorosafe Marker Visibility	The clinical users evaluated thedevicesunder simulateduseconditions and rated fluorosafemarker visibility.	The devices met the user needsfor which it was designed andtested.

Performance Data – Animal and Clinical:

The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the indications for use statement, fundamental scientific technology, principles of operation or materials of construction except for the addition of fluorosafe markers. No clinical data or animal study were deemed necessary to support the subject device submission.

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Conclusion:

There is no change to the indications for use statement, fundamental scientific technology or principle of operation of the Axium™ Detachable Coils and Axium™ Prime Detachable Coils in comparison to the predicate devices. The addition of fluorosafe markers on the proximal end of the embolization coil delivery pusher does not raise new questions of safety and effectiveness and is supported by non-clinical bench testing using well-established acceptable scientific methods. The information provided in this submission supports a determination of substantial equivalence for Axium™ Detachable Coils and Axium™ Prime Detachable Coils 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).