(97 days)
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.
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. 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.
The provided document is a 510(k) summary for the Axium™ Prime Detachable Coil System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual and Dimensional Inspection of Coil (Length, First Loop OD) | Key characteristics of the implant coil within specified dimensions. | All devices met acceptance criteria. |
| Coil Deformation Force | Peak force recorded when the first loop is compressed to 20% of its OD within specified limits. | All devices met acceptance criteria. |
| Ease of Deliverability: Friction Testing | Peak delivery force within specified limits when navigating a tortuous anatomical model. | All devices met acceptance criteria. |
| Ease of Deliverability: Force Transfer | Calculated force transfer when the device is advanced until distal force exceeds a specified value. | All devices met acceptance criteria. |
| Ease of Deliverability: Fatigue and Knotting | Device integrity maintained after deployment and retraction cycles; no damage observed upon inspection. | All devices met acceptance criteria. |
| Detachment Stretch Resistant Polypropylene Tensile test | Stretch resistant member breaks at a peak force above specified limit. | All devices met acceptance criteria. |
| Coil-Coil Shell Tensile Test | Coil-coil shell weld breaks at a peak force above specified limit. | All devices met acceptance criteria. |
| Labeling Verification | Text and format of drawings match labeling and packaging product specifications. | All devices met acceptance criteria. |
| Physician Usability Testing | Device demonstrates stability, neck coverage, conformability, softness, and smoothness of delivery. | All test results met the acceptance criteria. |
Note: Specific quantitative acceptance criteria values are not provided in the summary. The document generally states that "All devices met acceptance criteria" or "All test results met the acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing, meaning the tests were performed in a lab setting, not on patient data.
- Sample Size: The sample sizes for each specific bench test are not explicitly stated in the provided summary. The summary refers to "all devices" meeting criteria, implying that a sufficient number for each test was used and passed.
- Data Provenance: The data is from bench testing performed by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is retrospective, as it refers to testing conducted prior to this submission for substantial equivalence. The country of origin for the data is implied to be the USA where the company is located (Irvine, CA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the study described is a bench study for device performance, not a study evaluating diagnostic accuracy or a human-in-the-loop system requiring expert-established ground truth. Physician usability testing was performed by "physicians," but their number and specific qualifications (beyond being physicians) are not detailed, and this test assesses usability rather than ground truth for a diagnostic output.
4. Adjudication Method for the Test Set:
This information is not applicable as the described tests are objective bench tests (e.g., measuring forces, dimensions) or verification of physical characteristics, not involving subjective interpretations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. The submission relies on bench testing and comparison to a predicate device. The document explicitly states: "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."
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a neurovascular embolization coil system, a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. Type of Ground Truth Used:
The "ground truth" for the bench tests was established by engineering specifications and scientific principles that define acceptable ranges for physical properties and performance characteristics (e.g., specific force limits, dimensional tolerances, integrity after cycles). For biocompatibility, it was based on standardized test methods and passing criteria (e.g., "Non-cytotoxic," "Negligible irritant").
8. Sample Size for the Training Set:
Not applicable. This submission is for a physical medical device and does not involve an AI or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As stated above, there is no training set for this type of device submission.
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary for K162704
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214 |
|---|---|
| Contact Person: | Joyce ZhongRegulatory Affairs SpecialistTelephone: (949) 680-1307E-mail: joyce.zhong@medtronic.com |
| Date SummaryPrepared: | December 19, 2016 |
| Trade Name ofDevice: | Axium™ Prime Detachable Coil System |
| Common Name ofDevice: | Neurovascular Embolization Device |
| Classification ofDevice: | 21 CFR 882.5950 – Class II |
| Product Code | HCG and KRD |
| Predicate Device: | Axium™ Detachable Coil System: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 ofnew models to the Axium coil portfolio and to establish substantialequivalence to predicate Axium™ Detachable Coil System :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 testingThe following testing was adopted from existing test data for currentlycleared 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 forDifference (ifapplicable) | |
|---|---|---|---|
| Characteristics | Axium™ Detachable CoilSystem (K133310, K081465,K060747, K151447) | Axium™ Prime DetachableCoil System (K162704) | |
| Indication forUse | The Axium Detachable CoilSystem is indicated for theendovascular embolization ofintracranial aneurysms and otherneurovascular abnormalities, suchas arteriovenous malformationsand arteriovenous fistulae. TheAxium Detachable Coils are alsoindicated for arterial and venousembolizations in the peripheralvasculature. | Same* | N/A |
| Method ofSupply | Stored within dispenser coil,Tyvek pouch, & shipping carton | Same | N/A |
| SterilizationMethod | Ethylene Oxide | Same | N/A |
| Device SizeRange(Coil Diameter xCoil Length) | 1mm x 1cm - 25mm x 50cm | 3mm x 6cm - 25mm x 50cm | Subject device sizerange falls withinthe currentlycleared predicatedevice size range |
| 3D LoopConfiguration | 4 loops | 6 loops | Additional loopsprovide improvedstability |
| Primary wirediameter | 0.0015" for 3-3.5 mm size coils0.0020" for 4-6 mm size coils0.00225" for 7-10mm size coils | samesame0.0025" for 7-10mm size coils | Larger wirediameter provideimproved stability |
| 0.00275" for 12-25mm size coils | 0.0030" for 12-25mm size coils | ||
| Materials(Implant Coil) | |||
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| Axium™ Detachable Coil System(K133310, K081465, K060747,K151447) | Axium™ PrimeDetachable CoilSystem (K162704) | ||
| Implant CoilWire | Pt (92%)/ W (8%) | Same | N/A |
| StretchResistantMember | Polypropylene | Same | N/A |
| Coil Shell | Pt (92%)/ W (8%) | Same | N/A |
| DetachSubassembly | SS 316LVM | Same | N/A |
| Materials(Implant Delivery Pusher) | |||
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| Axium™ Detachable Coil System(K133310, K081465, K060747,K151447) | Axium™ PrimeDetachable CoilSystem (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 |
| ActuatorInterface | 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 LoadIndicator | PET shrink tubing or Laser mark | PET shrink tubing | N/A |
| Materials(Introducer sheath) | |||
| Introducersheath | 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 MouseFibroblast Cells | Pass | Non-cytotoxic |
| Sensitization | Guinea Pig MaximizationSensitization | Pass | A Grade I sensitizationrate is not significant |
| Irritation | Intracutaneous Irritation Test | Pass | Negligible irritant |
| Acute SystemicToxicity | Acute Systemic Injection Test | Pass | No significantdifference comparingto the control |
| Genotoxicity | Materials Mediated Rabbit Pyrogen | Pass | Non-pyrogenic |
| Bacterial Mutagenicity Test (AmesAssay) | Pass | Not mutagenic | |
| In Vitro Mouse Lymphoma Assay | Pass | Not mutagenic | |
| Chromosomal Aberration Assay | Pass | Non-clastogenic | |
| Hemo-compatibility | Thrombosis (In Vivo) - Dog (4hr) | Pass | Insignificantthrombosis |
| Lee & White ClottingTime/Coagulation | Pass | Not significantdifferent comparing tocontrols | |
| Unactivated Partial ThromboplastinTime (UPTT) | Pass | No significantdifference comparingto controls | |
| In Vitro Hemocompatibility(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 AnimalStudy (systemiceffects – SubAcute/SubChronic) | SubChronic (14-day) IntravenousToxicity Study in Rats or Mice,with Histopathology | Pass | Non-toxic |
| In Vivo AnimalStudy (localizedeffects)Implantation | Intramuscular Implantation Test(Rabbits) with Histopathology - 1wk | Pass | No significantdifference comparingto the control |
| Intramuscular Implantation Test(Rabbits) with Histopathology -4wk | Pass | No significantdifference comparingto the control | |
| Intramuscular Implantation Test(Rabbits) with Histopathology -13wk | Pass | No significantdifference comparingto 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 DimensionalInspection of Coil:• Length• First Loop OD | Dimensions were measured and keycharacteristics of the implant coil wereinspected. | All devices met acceptancecriteria. |
| Coil Deformation Force | The first loop is compressed to adeformation distance of 20% of thecoil's loop OD. The peak force isrecorded. | All devices met acceptancecriteria. |
| Ease of Deliverability• Friction Testing• Force Transfer• Fatigue andKnotting | • Peak delivery force was measuredthrough a representative tortuousanatomical model.• The proximal end of the device isadvanced until the distal forceexceeds a specified value. The forcetransfer is calculated.• The device is placed inside themicrocatheter and advanced untilthe coil is deployed completelyinside the aneurysm model. Thedevice is retracted and the cycle isrepeated. After the requirednumber of cycles the device isinspected. | All devices met acceptancecriteria. |
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| Test | Test Method | Conclusion |
|---|---|---|
| DetachmentStretch 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.
§ 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).