Axium Detachable Coil; Axium Prime Detachable Coil

K233420 · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · HCG · Nov 7, 2023 · Neurology

Device Facts

• Record ID: K233420
• Device Name: Axium Detachable Coil; Axium Prime Detachable Coil
• Applicant: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
• Product Code: HCG · Neurology
• Decision Date: Nov 7, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 aneurysms. 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 Story

Neurovascular embolization system; consists of platinum/tungsten alloy coil attached to composite stainless steel hypotube delivery pusher; includes radiopaque positioning marker and fluorosafe markers on proximal pusher end. Used in endovascular procedures; operated by interventional neuroradiologists/physicians. Coil delivered via microcatheter to target site; detached mechanically using hand-held Instant Detacher (I.D.) unit. Provides permanent occlusion of aneurysms/vascular abnormalities; benefits patient by preventing rupture or reducing blood flow to malformations. Fluorosafe markers improve visualization during procedure.

Clinical Evidence

No clinical or animal data provided. Substantial equivalence supported by non-clinical bench testing, including visual inspection, marker dimensional inspection, corrosion resistance (ISO 10555-1), and simulated-use clinical evaluation of marker visibility.

Technological Characteristics

Platinum/tungsten alloy coil; polypropylene tension-safe filament; stainless steel hypotube pusher with PTFE jacket/liner. Fluorosafe markers added to proximal pusher. MR Conditional. Sterilized via Ethylene Oxide (EO). Single-use.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae. Axium™ Prime models also indicated for arterial and venous embolizations in 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

• Axium™ Detachable Coil; Axium™ Prime Detachable Coil (K203432)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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™ 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.

Type of Use (Select one or both, as applicable)

| | <span> <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|---------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### K233420 510(k) Summary

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618, USA<br>Establishment Registration: 2029214 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lekshmi Pillai<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email : [e-mail] |

| Date Summary<br>Prepared: | 06 November 2023 |
|---------------------------|-------------------------------------------------------------------|
| Trade Name of Device: | Axium™ Detachable Coil<br>Axium™ Prime Detachable Coil |
| Common Name of<br>Device: | 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: | K203432<br>Axium™ Detachable Coil<br>Axium™ Prime Detachable Coil |

## 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.

## 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™<br>Detachable<br>Coil | Axium™ Detachable Coils are intended for the endovascular embolization<br>of intracranial aneurysms. Axium™ Detachable Coils are also intended for<br>the embolization of other neuro vascular abnormalities such as<br>arteriovenous 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™<br>Prime<br>Detachable<br>Coil | 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™<br>Prime<br>Detachable<br>Coil | 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):<br>Axium™ Detachable Coil;<br>Axium™ Prime Detachable Coil | Subject Devices:<br>Axium™ Detachable<br>Coil;<br>Axium™ Prime<br>Detachable Coil |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Axium™ Detachable Coil:<br>Axium™ Detachable Coils are intended for the endovascular<br>embolization of intracranial aneurysms. Axium™ Detachable Coils<br>are also intended for the embolization of other neuro vascular<br>abnormalities such as arteriovenous malformations and<br>arteriovenous fistulae.<br><br>Axium™ Prime Detachable Coil (APB-X-Y-3D-ES, APB-X-Y-3D-SS,<br>APB-X-Y-HX-ES, APB-X-Y-HX-SS):<br>The Axium™ Prime Detachable Coils are intended for the<br>endovascular embolization of intracranial aneurysms. The Axium™<br>Prime Detachable Coils are also intended for the embolization of<br>other neuro vascular abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae.<br><br>Axium™ Prime Detachable Coil (FC-X-Y-3D):<br>The Axium™ Prime Detachable Coil is intended for the endovascular<br>embolization of intracranial aneurysms and other neurovascular<br>abnormalities, such as arteriovenous malformations and<br>arteriovenous fistulae. The Axium™ Prime Detachable Coils are also | Same |
| Design Feature | Predicate Devices (K203432):<br>Axium™ Detachable Coil;<br>Axium™ Prime Detachable Coil | Subject Devices:<br>Axium™ Detachable<br>Coil;<br>Axium™ Prime<br>Detachable Coil |
| | intended for arterial and venous embolizations in the peripheral<br>vasculature. | |
| Visual Markers | None | Fluorosafe<br>markers |
| Dimensions | | |
| Device Size Range | Axium™ Bare Helix:<br>1.5-20 mm - Loop OD<br>1-50 cm - Length<br>Axium™ Bare 3D:<br>2-25 mm - Loop OD<br>2-50 cm - Length<br>Axium™ Nylon 3D:<br>2-4 mm – Loop OD<br>1-10 cm – Length<br>Axium™ PGLA Helix:<br>2-10 mm – Loop OD<br>1-30 cm – Length<br>Axium™ PGLA 3D:<br>2-18 mm – Loop OD<br>2-40 cm – Length<br>Axium™ Prime 3D:<br>1-6 mm – Loop OD<br>2-20 cm – Length<br>Axium™ Prime Helix:<br>1-6 mm – Loop OD<br>1-20 cm – Length<br>Axium™ Prime 3D:<br>3-25 mm – Loop OD<br>6-50 cm – Length | Same |
| Coil Shape | Helical and 3D | Same |
| | Compatible Accessories | |
| Catheter<br>Compatibility | Axium™ Detachable Coils (Bare) should be delivered through<br>microcatheters with minimum ID of 0.0165".<br>Axium™ Detachable Coils (Nylon and PGLA) should be delivered<br>through microcatheters with minimum ID of 0.0165"-0.020". | Same<br>Same |
| | Axium™ Prime Detachable Coils should be delivered through<br>microcatheters with minimum ID of 0.0165"-0.017". | Axium™ Prime<br>Detachable Coils<br>should be delivered<br>through |
| Design Feature | Predicate Devices (K203432):<br>Axium™ Detachable Coil;<br>Axium™ Prime Detachable Coil | Subject Devices:<br>Axium™ Detachable Coil;<br>Axium™ Prime<br>Detachable Coil<br>microcatheters with<br>minimum ID of<br>0.0165". |
| Guide Catheter<br>Compatibility | 6-8F | Same |
| Method of Coil<br>Detachment | 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/<br>Stretch Resistant<br>Filament | 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 |
| Sterilization<br>Method | Ethylene Oxide (EO) | Same |
| Packaging | | |
| Pouch Material | For PC-X-Y-HELIX and PC-X-Y-3D:<br>PLK235/Uncoated 2FS Tyvek<br><br>For all other models:<br>PET/Tyvek | Same<br><br>For all other models:<br>Nylon/Tyvek |
| Pouch Dimensions | For PC-X-Y-HELIX and PC-X-Y-3D:<br>17" X 9.8" (pre-sterilization)<br><br>For all other models:<br>10 1/8" X 10.838" | Same<br><br>For all other models:<br>11.98" X 10.94" |
| Carton | Cardboard, Solid Bleach Sulfate | Same |
| MRI Card | None | 3 1/2" x 4" (+/-<br>1/8"), 1/1 Black -<br>Black and white,<br>2 sided |
| Stability | | |
| Shelf Life | 36 months | Same |
| MRI Compatibility | Magnetic Resonance Imaging<br>MR 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™ Prime<br>Detachable Coil were evaluated per ISO 10993-<br>5: 2009, using the MEM elution method. | The Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil did<br>not induce cytotoxicity. |
| Sensitization | Axium™ Detachable Coil and Axium™ Prime<br>Detachable Coil were evaluated per ISO 10993-<br>10:2021, using a guinea pig maximization test. | The Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil<br>were not considered a sensitizer. |
| Irritation | Axium™ Detachable Coil and Axium™ Prime<br>Detachable Coil were evaluated per ISO 10993-<br>23:2021, using a rabbit intracutaneous reactivity<br>test. | The Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil are<br>considered non-irritant. |
| Acute<br>Systemic<br>Toxicity | Axium™ Detachable Coil and Axium™ Prime<br>Detachable Coil were evaluated per ISO 10993-<br>11:2017, using an acute systemic injection test<br>in mice. | The Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil<br>showed no mortality or evidence of<br>acute systemic toxicity. |
| Indirect<br>(extract)<br>Hemolysis | Axium™ Detachable Coil and Axium™ Prime<br>Detachable Coil were evaluated per ISO 10993-<br>4:2017, using ASTM hemolysis study. | The Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil are<br>considered non-hemolytic. |
| Material-Mediated<br>Pyrogenicity | Axium™ Detachable Coil and Axium™ Prime<br>Detachable Coil were evaluated per USP 151<br>(2020), using USP rabbit pyrogen test -<br>material-mediated. | The Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil met<br>the requirements and were found<br>to 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 the<br>darkness of the etch mark of<br>fluorosafe markers and the 360°<br>etch mark around the delivery<br>pusher. | Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil<br>met the acceptance criteria for<br>visual inspection. |
| Marker Dimensional (Marker<br>Position and Total Marker<br>Length) Inspection | Marker dimensional inspection<br>verified the total length of the<br>fluorosafe markers and their<br>position on the delivery pusher. | Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil<br>met the acceptance criteria for<br>marker dimensional inspection. |
| Corrosion Resistance | The test verified the corrosion<br>resistance on the delivery pusher<br>using the method of soaking the<br>devices in saline followed<br>by<br>immersion in boiling water per the<br>method specified in Annex A of ISO<br>10555-1. | Axium™ Detachable Coil and<br>Axium™ Prime Detachable Coil<br>met the acceptance criteria for<br>corrosion resistance. |

| Design Validation | | | | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--|--|--|
| Test | Test Method Summary | Results | | | |
| Fluorosafe Marker Visibility | The clinical users evaluated the<br>devices<br>under simulated<br>use<br>conditions and rated fluorosafe<br>marker visibility. | The devices met the user needs<br>for which it was designed and<br>tested. | | | |

## 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.