Axium Prime Detachable Coil System
Device Facts
| Record ID | K162704 |
|---|---|
| Device Name | Axium Prime Detachable Coil System |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product Code | HCG · Neurology |
| Decision Date | Jan 3, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Axium Prime Detachable Coil System is indicated 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 indicated for arterial and venous embolizations in the peripheral vasculature.
Device Story
Axium Prime Detachable Coil System consists of platinum/tungsten embolization coil attached to composite implant delivery pusher; includes radiopaque positioning marker. Used with hand-held Axium I.D. (Instant Detacher) for coil release. Device navigated through vasculature to target site (intracranial aneurysm or peripheral vessel) by physician; coil deployed to induce embolization. System provides mechanical occlusion of vascular abnormalities. Line extension adds 44 new 3D-configuration models (6-loop design) to existing portfolio. Used in clinical settings by neurovascular specialists/interventionalists. Benefits include improved stability and conformability for aneurysm treatment.
Clinical Evidence
No clinical or animal testing performed. Substantial equivalence supported by non-clinical bench testing (visual/dimensional inspection, deformation force, friction/deliverability, tensile strength, fatigue/knotting, and physician usability testing in tortuous benchtop models) and adoption of existing biocompatibility, sterilization, and shelf-life data from the predicate device.
Technological Characteristics
Implant coil: Pt (92%)/W (8%) alloy; stretch-resistant member: polypropylene. Delivery pusher: SS 304 unibody, PTFE jacket, Pt/W marker coil. 3D loop configuration (6-loop). Dimensions: 3mm-25mm diameter, 6cm-50cm length. Sterilization: Ethylene Oxide. Connectivity: None (mechanical).
Indications for Use
Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae, as well as arterial and venous embolizations in the peripheral vasculature.
Regulatory Classification
Identification
A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2016
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Joyce Zhong, PhD, RAC Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K162704
Trade/Device Name: Axium™ Prime Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 18, 2016 Received: November 21, 2016
Dear Dr. Zhong:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J.
Heetderks -A
Digitally signed by William J. Heetderks
-A
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People,
0.9.2342.19200300.100.1.1=0010149848
, cn=William J. Heetderks -A
Date: 2017.01.03 16:31:53 -05'00'
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K162704
Device Name Axium Prime Detachable Coil System
#### Indications for Use (Describe)
The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial anewrysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary for K162704
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No. 2029214 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joyce Zhong<br>Regulatory Affairs Specialist<br>Telephone: (949) 680-1307<br>E-mail: joyce.zhong@medtronic.com |
| Date Summary<br>Prepared: | December 19, 2016 |
| Trade Name of<br>Device: | Axium™ Prime Detachable Coil System |
| Common Name of<br>Device: | Neurovascular Embolization Device |
| Classification of<br>Device: | 21 CFR 882.5950 – Class II |
| Product Code | HCG and KRD |
| Predicate Device: | Axium™ Detachable Coil System:<br>K151447, cleared July 28, 2015 K133310, cleared January 10, 2014 K081465, cleared August 19, 2008 K060747, cleared April 24, 2007 |
| Performance Data: | The following bench tests were performed to support the addition of<br>new models to the Axium coil portfolio and to establish substantial<br>equivalence to predicate Axium™ Detachable Coil System :<br>Visual and Dimensional Inspection First loop OD post-sterilization Dimensional Inspection Deformation Force Friction in Sheath Friction in Catheter Force Transfer Stretch Resistant Polypropylene Tensile Test Coil Shell Tensile Test Fatigue and Knotting Labeling verification Physician use testing<br>The following testing was adopted from existing test data for currently<br>cleared Axium™ coil sizes: |
- Porque Responsions .
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- Shield Coil Weld ●
- Coil Tensile - Assembly
- Marker Radiopacity ●
- Tip Buckling
- . Detachment Zone Stiffness
- Detachment Reliability
- Kink Resistance
- Hypotube and Weld Tensile Strength ●
- Pusher Elongation
- Pusher Tensile
- Positive Load Indicator Dimension
- Break Indicator Dimension
- Sheath wave-lock .
- Thrombogenicity ●
- MRI Compatibility ●
Sterilization, biocompatibility, packaging and aging data were also adopted from the predicate device as there is no change to the materials or packaging for the addition of these new models.
No clinical or animal testing was performed, as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device. In addition, there is no change in the indications for use or the fundamental scientific technology of the device that would require any additional testing.
Conclusion: The forty-four (44) new Axium™ Prime Detachable Coil System models are substantially equivalent to the currently cleared AxiumTM Detachable Coil System based on the successful completion of nonclinical testing; a thorough assessment of existing test data; as well as identical materials of coil implant construction, principles of operation, packaging and indications for use. The subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device.
#### Device Description:
The Axium™ Prime Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately.
This submission expands Axium™ Detachable Coil (subject device) family by adding forty-four (44) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers come in the 3D configuration only and are a line extension of the currently sold predicate device, ranging in size from 3mm diameter x 6cm length to 25mm diameter x 50cm length. All forty-four (44) new SKUs fall within the currently cleared Axium size range of 1mm diameter x 1cm length to 25mm diameter x 50cm length.
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The subject device was modified to change the 3D loop configuration from a 4-loop configuration to a 6-loop configuration and to slightly increase the primary wire diameter size for the 7 - 10mm and the 12 - 25mm size coils.
All other aspects of the subject device design (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.
### Indications for Use:
The Axium Prime Detachable Coil System is indicated 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 indicated for arterial and venous embolizations in the peripheral vasculature.
### Device Comparison:
The table below provides a comparison of the technological characteristics of the subject device and the currently cleared predicate Axium device line.
| | Predicate Device | Subject Device | Rationale for<br>Difference (if<br>applicable) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Characteristics | Axium™ Detachable Coil<br>System (K133310, K081465,<br>K060747, K151447) | Axium™ Prime Detachable<br>Coil System (K162704) | |
| Indication for<br>Use | The Axium Detachable Coil<br>System is indicated for the<br>endovascular embolization of<br>intracranial aneurysms and other<br>neurovascular abnormalities, such<br>as arteriovenous malformations<br>and arteriovenous fistulae. The<br>Axium Detachable Coils are also<br>indicated for arterial and venous<br>embolizations in the peripheral<br>vasculature. | Same* | N/A |
| Method of<br>Supply | Stored within dispenser coil,<br>Tyvek pouch, & shipping carton | Same | N/A |
| Sterilization<br>Method | Ethylene Oxide | Same | N/A |
| Device Size<br>Range<br>(Coil Diameter x<br>Coil Length) | 1mm x 1cm - 25mm x 50cm | 3mm x 6cm - 25mm x 50cm | Subject device size<br>range falls within<br>the currently<br>cleared predicate<br>device size range |
| 3D Loop<br>Configuration | 4 loops | 6 loops | Additional loops<br>provide improved<br>stability |
| Primary wire<br>diameter | 0.0015" for 3-3.5 mm size coils<br>0.0020" for 4-6 mm size coils<br>0.00225" for 7-10mm size coils | same<br>same<br>0.0025" for 7-10mm size coils | Larger wire<br>diameter provide<br>improved stability |
| | 0.00275" for 12-25mm size coils | 0.0030" for 12-25mm size coils | |
| Materials<br>(Implant Coil) | | | |
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| | Axium™ Detachable Coil System<br>(K133310, K081465, K060747,<br>K151447) | Axium™ Prime<br>Detachable Coil<br>System (K162704) | |
| Implant Coil<br>Wire | Pt (92%)/ W (8%) | Same | N/A |
| Stretch<br>Resistant<br>Member | Polypropylene | Same | N/A |
| Coil Shell | Pt (92%)/ W (8%) | Same | N/A |
| Detach<br>Subassembly | SS 316LVM | Same | N/A |
| Materials<br>(Implant Delivery Pusher) | | | |
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| | Axium™ Detachable Coil System<br>(K133310, K081465, K060747,<br>K151447) | Axium™ Prime<br>Detachable Coil<br>System (K162704) | |
| Unibody | SS 304 | Same | N/A |
| Outer Jacket | PTFE | Same | N/A |
| Marker Coil | Pt (92%)/ W (8%) | Same | N/A |
| Lumen Stop | SS 304 | Same | N/A |
| Inner Liner | PTFE | Same | N/A |
| Coupler Tube | SS 304 | Same | N/A |
| Actuator<br>Interface | SS 304 | Same | N/A |
| Release Wire | SS 304 | Same | N/A |
| Retainer Ring | SS 304 | Same | N/A |
| Break Indicator | PET shrink tubing or Laser mark | PET shrink tubing | N/A |
| Positive Load<br>Indicator | PET shrink tubing or Laser mark | PET shrink tubing | N/A |
| Materials<br>(Introducer sheath) | | | |
| Introducer<br>sheath | Polypropylene/HDPE | Same | N/A |
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*product name has been rebranded to Axium™ Prime, otherwise identical.
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### Sterilization and Shelf Life
The subject device was adopted into the EO sterilization cycle originally cleared under K060747 for the predicate device. The materials of construction of the subject device, packaging and overall manufacturing process are the same to the predicate device. EO residual, bioburden and pyrogen testing were adopted as well for these reasons.
Aging and packaging studies for the predicate device have established the product and packaging remain functional and maintain sterility for 3 years. Aging studies for packaging integrity (per ASTM F2096-11) and conditioning (ASTM-4169, ISTA-2A) and device functionality were adopted from the predicate device and met all acceptance criteria. The materials of implant coil construction, manufacturing process, and packaging of the new line extension models of the subject device are identical to the predicate device.
### Biocompatibility
Biocompatibility data for the subject device has been adopted from the predicate device. A summary of adopted biocompatibility tests is provided in the table below.
| Test | Test method | Results | Conclusion |
|----------------------------|---------------------------------------------------------|---------|----------------------------------------------------------|
| Cytotoxicity | MEM Elution Using L-929 Mouse<br>Fibroblast Cells | Pass | Non-cytotoxic |
| Sensitization | Guinea Pig Maximization<br>Sensitization | Pass | A Grade I sensitization<br>rate is not significant |
| Irritation | Intracutaneous Irritation Test | Pass | Negligible irritant |
| Acute Systemic<br>Toxicity | Acute Systemic Injection Test | Pass | No significant<br>difference comparing<br>to the control |
| Genotoxicity | Materials Mediated Rabbit Pyrogen | Pass | Non-pyrogenic |
| | Bacterial Mutagenicity Test (Ames<br>Assay) | Pass | Not mutagenic |
| | In Vitro Mouse Lymphoma Assay | Pass | Not mutagenic |
| | Chromosomal Aberration Assay | Pass | Non-clastogenic |
| Hemo-<br>compatibility | Thrombosis (In Vivo) - Dog (4hr) | Pass | Insignificant<br>thrombosis |
| | Lee & White Clotting<br>Time/Coagulation | Pass | Not significant<br>different comparing to<br>controls |
| | Unactivated Partial Thromboplastin<br>Time (UPTT) | Pass | No significant<br>difference comparing<br>to controls |
| | In Vitro Hemocompatibility<br>(includes Platelet count) | Pass | No adverse effects |
| | Hemolysis (Direct Contact) | Pass | Non-hemolytic |
| | Hemolysis (Extract) | Pass | Non-hemolytic |
| | Complement Activation C3a and | Pass | No difference from |
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| | SC5b-9 Assay | | controls |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------|----------------------------------------------------------|
| In Vivo Animal<br>Study (systemic<br>effects – SubAcute<br>/SubChronic) | SubChronic (14-day) Intravenous<br>Toxicity Study in Rats or Mice,<br>with Histopathology | Pass | Non-toxic |
| In Vivo Animal<br>Study (localized<br>effects)<br>Implantation | Intramuscular Implantation Test<br>(Rabbits) with Histopathology - 1<br>wk | Pass | No significant<br>difference comparing<br>to the control |
| | Intramuscular Implantation Test<br>(Rabbits) with Histopathology -<br>4wk | Pass | No significant<br>difference comparing<br>to the control |
| | Intramuscular Implantation Test<br>(Rabbits) with Histopathology -<br>13wk | Pass | No significant<br>difference comparing<br>to the control |
# Performance Data – Bench
A summary of the non-clinical bench testing performed for the subject device is presented in the table below:
| Test | Test Method | Conclusion |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Visual and Dimensional<br>Inspection of Coil:<br>• Length<br>• First Loop OD | Dimensions were measured and key<br>characteristics of the implant coil were<br>inspected. | All devices met acceptance<br>criteria. |
| Coil Deformation Force | The first loop is compressed to a<br>deformation distance of 20% of the<br>coil's loop OD. The peak force is<br>recorded. | All devices met acceptance<br>criteria. |
| Ease of Deliverability<br>• Friction Testing<br>• Force Transfer<br>• Fatigue and<br>Knotting | • Peak delivery force was measured<br>through a representative tortuous<br>anatomical model.<br>• The proximal end of the device is<br>advanced until the distal force<br>exceeds a specified value. The force<br>transfer is calculated.<br>• The device is placed inside the<br>microcatheter and advanced until<br>the coil is deployed completely<br>inside the aneurysm model. The<br>device is retracted and the cycle is<br>repeated. After the required<br>number of cycles the device is<br>inspected. | All devices met acceptance<br>criteria. |
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| Test | Test Method | Conclusion |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Detachment<br>Stretch Resistant Polypropylene Tensile test Coil-Coil Shell Tensile Test | The coil is stretched until the stretch resistant member breaks. The peak force result was recorded The primary wire of the coil is stretched until the coil-coil shell weld breaks. The peak force result was recorded | All devices met acceptance criteria. |
| Labeling Verification | Text and format of drawings were visually compared to labeling and packaging product specifications. | All devices met acceptance criteria. |
| Physician Usability Testing | The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess stability, neck coverage, conformability, softness and smoothness of delivery. | All test results met the acceptance criteria. |
### Performance Data – Animal
No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.
#### Performance Testing - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.
