Axium Detachable Coil; Axium Prime Detachable Coil
Device Facts
| Record ID | K203432 |
|---|---|
| Device Name | Axium Detachable Coil; Axium Prime Detachable Coil |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product Code | HCG · Neurology |
| Decision Date | Jul 7, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for 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
Axium device family consists of platinum embolization coils attached to composite implant delivery pushers; includes radiopaque positioning marker. Operated via hand-held Instant Detacher (I.D.) unit; mechanical activation pulls release element within pusher to detach coil at target site. Used in neurovascular procedures; physician-operated in clinical settings. Revised labeling allows radial artery access as alternative to femoral artery. Device provides mechanical occlusion of aneurysms/vascular abnormalities; benefits include reduced blood flow to malformations/aneurysms, potentially preventing rupture or hemorrhage.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included ease of delivery (friction/tortuous path), detachment reliability, retractability, and retrieval success. All tests met acceptance criteria.
Technological Characteristics
Platinum embolization coils; composite implant delivery pusher; radiopaque marker. Mechanical detachment via hand-held I.D. unit. MR Conditional. Sterilized via Ethylene Oxide (EO). Single-use. Compatible with microcatheters (min ID 0.0165"-0.020") and 6-8F guide catheters.
Indications for Use
Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae. Specific models (FC-X-Y-3D) 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 System (K133310)
- Axium™ Detachable Coil System (K151447)
- Axium™ Prime Detachable Coil System (K162704)
Submission Summary (Full Text)
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July 7, 2021
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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™ 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 (Model Numbers APB-X-Y-3D/HX-ES/SS):
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.
Axium™ Prime Detachable Coil (Model Numbers FC-X-Y-3D):
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.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-variant: normal;"> <span style="font-weight: normal;"> <span> </span> </span> </span> </span> </span> </span> | |
| 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 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration: 2029214 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bhavika Patel<br>Senior Regulatory Affairs Specialist<br>Telephone: (949) 434-5030<br>Email: bhavika.patel@medtronic.com |
| Date Summary Prepared: | 06 July 2021 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of Device: | Axium™ Detachable Coil<br>Axium™ 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 System<br>K151447 Axium™ Detachable Coil System<br>K162704 Axium™ Prime Detachable Coil System |
## 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.
#### 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™<br>Prime<br>Detachable<br>Coil | The Axium™ Prime Detachable Coil is intended for the endovascular<br>embolization of intracranial aneurysms and other neurovascular abnormalities,<br>such as arteriovenous malformations and arteriovenous fistulae. The Axium™<br>Prime Detachable Coils are also intended for arterial and venous embolizations<br>in 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:<br>Axium™ Detachable Coil System<br>(K133310, K151447)<br>Axium™ Prime Detachable Coil System<br>(K162704) | Subject:<br>Axium™ Detachable Coil<br>Axium™ Prime Detachable Coil |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>for Axium™<br>Detachable Coil | The Axium™ Detachable Coil System is<br>indicated for the endovascular embolization<br>of intracranial aneurysms and other<br>neurovascular abnormalities, such as<br>arteriovenous malformations and<br>arteriovenous fistulae. The Axium™<br>Detachable Coils are also indicated for<br>arterial and venous embolizations in the<br>peripheral vasculature. | Axium™ Detachable Coils are intended<br>for the endovascular embolization of<br>intracranial aneurysms. Axium™<br>Detachable Coils are also intended for the<br>embolization of other neuro vascular<br>abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae. |
| Indications for Use<br>for Axium™ Prime<br>Detachable Coil<br>(Model Numbers<br>APB-X-Y-3D/HX-<br>ES/SS) | The Axium™ Detachable Coil System is<br>indicated for the endovascular embolization<br>of intracranial aneurysms and other<br>neurovascular abnormalities, such as<br>arteriovenous malformations and<br>arteriovenous fistulae. The Axium™<br>Detachable Coils are also indicated for<br>arterial and venous embolizations in the<br>peripheral vasculature. | The Axium™ Prime Detachable Coils are<br>intended for the endovascular<br>embolization of intracranial aneurysms.<br>The Axium™ Prime Detachable Coils are<br>also intended for the embolization of<br>other neuro vascular abnormalities such as<br>arteriovenous malformations and<br>arteriovenous fistulae. |
| Indications for Use<br>for Axium™ Prime<br>Detachable Coil<br>(Model Numbers<br>FC-X-Y-3D) | The Axium™ Prime Detachable Coil<br>System is indicated for the endovascular<br>embolization of intracranial aneurysms and<br>other neurovascular abnormalities, such as<br>arteriovenous malformations and<br>arteriovenous fistulae. The Axium™ Prime<br>Detachable Coils are also indicated for<br>arterial and venous embolizations in the<br>peripheral vasculature. | The Axium™ Prime Detachable Coil is<br>intended for the endovascular<br>embolization of intracranial aneurysms<br>and other neurovascular abnormalities,<br>such as arteriovenous malformations and<br>arteriovenous fistulae. The Axium™<br>Prime Detachable Coils are also intended |
| Design Feature | Predicate: | Subject: |
| | Axium™ Detachable Coil System<br>(K133310, K151447) | Axium™ Detachable Coil |
| | Axium™ Prime Detachable Coil System<br>(K162704) | Axium™ Prime Detachable Coil |
| | | for arterial and venous embolizations in |
| | | the peripheral vasculature. |
| 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<br>delivered through microcatheters with<br>minimum ID of 0.0165".<br><br>Axium™ detachable coils (Nylon and<br>PGLA) should be delivered through<br>microcatheters with minimum ID of 0.0165"<br>- 0.020".<br><br>Axium™ Prime detachable coils should<br>only be delivered through a microcatheter<br>with a minimum inside diameter of<br>0.0165"-0.017" with two marker bands | Same |
| Design Feature | Predicate: | Subject: |
| | AxiumTM Detachable Coil System<br>(K133310, K151447) | AxiumTM Detachable Coil |
| | AxiumTM Prime Detachable Coil System<br>(K162704) | AxiumTM Prime Detachable Coil |
| | | |
| | | |
| Guide Catheter<br>Compatibility | 6-8F | Same |
| Method of Coil<br>Detachment | Instant Detacher – standalone hand-held<br>mechanical unit that, when connected to the<br>proximal end of the pusher, pulls the release<br>element inside of the pusher, resulting in<br>release of the implant from the distal end of<br>the 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 tortuous<br>bench top model in order to assess<br>friction | All test results met acceptance<br>criteria |
| Design Validation | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------|
| Test | Test Method Summary | Results |
| Ease of Delivery | Device navigated through tortuous<br>bench top model in order to assess<br>deliverability | All test results met acceptance<br>criteria |
| Detachment Reliability and<br>Retractability | Cycle the coil (manipulate within<br>the embolic target) without<br>premature detachment | All test results met acceptance<br>criteria |
| Detachment Reliability and<br>Retractability | Detach the coil successfully in 3 or<br>fewer attempts | All test results met acceptance<br>criteria |
| Retrieval | Retrieve the pusher through the<br>microcatheter after detachment | All test results met acceptance<br>criteria |
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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.
