The Axium™ 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™ Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.

Device Description

The Axium™ 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 the size offerings of the Axium™ Detachable Coil (subject device) by adding thirty-five (35) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers are a line extension of the currently sold predicate device and range in size from 1mm diameter x 1cm length to 3.5mm diameter x 10cm length. All thirtv-five (35) new SKUs have a smaller primary wire diameter than the predicate device. This line extension includes six (6) coils having a 1mm diameter which is outside of the currently cleared Axium size range of 1.5mm diameter x 1cm length to 25mm diameter x 50cm length.

The second modification features a change to the Implant Delivery Pusher by replacing the PET material of the Positive Load Indicator (PLI) and Hypotube Break Indicator (BI) with a laser mark.

These modifications to the currently cleared predicate device were made solely to accommodate the new smaller implant coil size of the subject line extension. All other aspects of the subject device (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.

AI/ML Overview

This document describes a 510(k) submission for a medical device called the Axium™ Detachable Coil System. The submission is for a line extension of an already cleared device, introducing new coil sizes and a minor change to the implant delivery pusher.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the bench tests performed. The acceptance criteria for each test are implicitly that "All devices met acceptance criteria." The device performance is reported as meeting these criteria.

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Visual and Dimensional Inspection (Coil, Sheath, Implant Delivery Pusher)	Dimensions (ID, OD, length) were measured, and key characteristics were inspected of the implant coil, sheath, and coupler tube, within specified tolerances.	All devices met acceptance criteria.
Softness and Conformability (Coil Deformation)	The first loop of the coil is advanced until it exits the sheath and is compressed to a deformation distance that is a percentage of the coil's loop OD. The peak force is recorded within an acceptable range for proper coil softness and conformability.	All devices met acceptance criteria.
Ease of Deliverability (Force Transfer, Friction Testing, Fatigue and Knotting)	Force Transfer: Peak delivery force measured through a representative tortuous anatomical model must be within acceptable limits. Friction Testing: The proximal end of the device is advanced until the distal force exceeds a specified value, and the force transfer must be calculated within acceptable limits. Fatigue and Knotting: The device is placed inside the microcatheter and advanced until the coil is deployed completely inside the aneurysm model, then retracted and the cycle repeated for a required number of cycles without evidence of fatigue or knotting upon inspection.	All devices met acceptance criteria.
Detachment (Coil Tensile – Polypropylene, Coil Tensile – Implant/Weld)	Coil Tensile – Polypropylene: The coil is stretched until the stretch resistant member breaks, and the peak force result is recorded and must be within an acceptable range. Coil Tensile – Implant/Weld: The primary wire of the coil is stretched until the coil-coil shell weld breaks, and the peak force result is recorded and must be within an acceptable range to ensure proper detachment and integrity.	All devices met acceptance criteria.
Labeling Verification	Text and format of drawings were visually compared to labeling and packaging product specifications and must match.	All devices met acceptance criteria.
Physician Usability Testing	The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm to assess coil softness, conformability, ease of delivery, and biomechanical stability according to pre-defined criteria.	All test results met the acceptance criteria.
Adopted Tests (from predicate device):
Torque Response	The device's response to applied torque must be within acceptable limits to ensure steerability and control.	Passed (implied by adoption from cleared predicate)
Coil Tensile - Assembly	The tensile strength of the coil assembly (excluding specific weld/fiber breaks, which have individual tests) must meet predefined strength requirements.	Passed (implied by adoption from cleared predicate)
Pusher Dimensions	Dimensions of the implant delivery pusher must conform to specifications.	Passed (implied by adoption from cleared predicate)
Marker Radiopacity	The radiopacity of the marker on the device must be sufficient for clear visualization under fluoroscopy.	Passed (implied by adoption from cleared predicate)
Tip Buckling	The device tip must not buckle under specified forces or conditions.	Passed (implied by adoption from cleared predicate)
Detachment Zone Stiffness	The stiffness of the detachment zone must be within an acceptable range to ensure reliable detachment while maintaining appropriate flexibility.	Passed (implied by adoption from cleared predicate)
Kink Resistance	The device must resist kinking when navigated through tortuous paths or under simulated use conditions.	Passed (implied by adoption from cleared predicate)
Hypotube and Weld Tensile Strength	The tensile strength of the hypotube and its welds must meet specified requirements to prevent breakage during use.	Passed (implied by adoption from cleared predicate)
Pusher Elongation	The implant delivery pusher must not elongate beyond specified limits under typical forces encountered during use.	Passed (implied by adoption from cleared predicate)
MRI Compatibility	The device must be demonstrated to be safe for use in an MRI environment according to relevant standards.	Passed (implied by adoption from cleared predicate)
Sterilization, Biocompatibility, and Aging data (for the new SKUs)	Must demonstrate sterility, biocompatibility, and shelf-life equivalent to the predicate device due to no changes in manufacturing process, packaging, or materials of construction for the implant coil, and reduced mass. For the laser marks, physicochemical and cytotoxicity testing confirmed no impact on safety.	Passed (implied by adoption from cleared predicate, and specific testing for laser marks)

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (Bench Testing): The document does not explicitly state the sample sizes for each specific bench test (e.g., "n=X coils"). It states "All devices met acceptance criteria," suggesting that multiple units of each new SKU were tested. The total number of new SKUs is 35.
Data Provenance: The data is based on bench testing performed by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular). It is prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate substantial equivalence of the new offerings. There is no mention of geographical origin for the bench testing data; it's assumed to be from the manufacturer's testing facilities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This submission relies primarily on engineering and performance bench testing, not clinical data or expert visual assessment in the traditional sense of diagnostic imaging.
For the "Physician Usability Testing," the document states, "The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess coil softness, conformability, ease of delivery and biomechanical stability." It doesn't specify the number or qualifications of physicians who performed or assessed this usability testing. Given it's a benchtop test, it likely involved internal engineering or R&D personnel with relevant medical device experience, possibly overseen or advised by clinicians. It is not mentioned as a formal clinical study with expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of diagnostic performance or clinical outcomes. The bench tests have defined parameters and measurements, with results either meeting or not meeting the acceptance criteria. The "Physician Usability Testing" outcome is reported as "All test results met the acceptance criteria," indicating a singular decision based on the assessment criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "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."

6. Standalone (Algorithm Only) Performance Study:

No, this is a physical medical device (embolization coils), not an AI or software algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

Engineering Specifications and Performance Standards: For the bench testing, the "ground truth" is defined by established engineering specifications, performance requirements, and industry standards for medical devices of this type. These standards relate to dimensions, mechanical properties (e.g., force, tensile strength, resistance to deformation), and functional performance (e.g., detachment, deliverability).
Predicate Device Data: A significant portion of the "ground truth" or basis for comparison comes from the predicate Axium™ Detachable Coil System. The new devices are deemed substantially equivalent by demonstrating similar performance to the already cleared predicate device, and in many cases, adopting the predicate's testing data for aspects where no change occurred or where the change (e.g., smaller size, laser mark) was proven not to negatively impact performance.

8. Sample Size for the Training Set:

Not applicable. This device does not use machine learning or AI algorithms that would require a 'training set.'

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 28, 2015

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Patricia Casing Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K151447

Trade/Device Name: Axium™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG and KRD Dated: June 30, 2015 Received: Julv 1, 2015

Dear Ms. Casing:

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

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Carlos L. Pena நி/Δ

Carlos L. Peña, PhD, MS 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) K151447

Device Name Axium Detachable Coil System

Indications for Use (Describe)

The Axium 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 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

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No. 2029214
Contact Person:	Patricia CasingRegulatory Affairs SpecialistTelephone: (949) 680 - 1307E-mail: patricia.casing@covidien.com
Date SummaryPrepared:	June 30, 2015
Trade Name ofDevice:	Axium™ 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: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 sizes to the Axium coil line and to establish substantialequivalence to predicate Axium™ Detachable Coil System :
	Dimensions - Coil, Sheath, Implant Delivery Pusher●Visual Inspections - Coil, Sheath, Implant Delivery●PusherFriction●Force Transfer●Coil Deformation●Fatigue and Knotting●Coil Tensile – Polypropylene●Coil Tensile - Implant/Weld (Implant Coil to Coil●Shell Weld)Labeling verification●The following testing was adopted from existing test data for currentlycleared Axium™ coil sizes:
	Torque Response●Coil Tensile - Assembly●

Pusher Dimensions
Marker Radiopacity ●
Tip Buckling
. Detachment Zone Stiffness

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Kink Resistance ●
Hypotube and Weld Tensile Strength ●
Pusher Elongation ●
MRI Compatibility

Sterilization, biocompatibility and aging data were also adopted from the predicate device as there is no change to the manufacturing process or packaging for the addition of these new SKUs.

In addition, 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 more extensive testing.

Conclusion: The thirty-five (35) new Axium™ Detachable Coil System size offerings are substantially equivalent to the currently cleared Axium™ 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.

Device Description:

The second modification features a change to the Implant Delivery Pusher by replacing the PET material of the Positive Load Indicator (PLI) and Hypotube Break Indicator (BI) with a laser mark.

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Indications for Use:

Device Comparison:

The table below provides a comparison of the technological characteristics of the subject Axium device line extension and the currently cleared predicate Axium device line.

Characteristics	Predicate Device	Subject Device	Rationale forDifference (ifapplicable)
Indication for Use	Axium™ (K133310, (K081465,K060747)	Axium Line Extension	N/A
	The Axium Detachable CoilSystem is indicated for theendovascular embolization ofintracranial aneurysms and otherneurovascular abnormalities,such as arteriovenousmalformations and arteriovenousfistulae. The Axium DetachableCoils are also indicated forarterial and venousembolizations in the peripheralvasculature.	Same
Method of Supply	Stored within dispenser coil,Tyvek pouch, & shipping carton	Same	N/A
Sterilization Method	Ethylene Oxide	Same	N/A
Device Size Range(Coil Diameter x CoilLength)	1.5mm x 1cm – 25mm x 50cm	1mm x 1cm - 3.5mm x10cm	Difference in size isdue to the smallerdiameter primarywire. Bench testinghas demonstrated thatthe smallerdimensions do notaffect the safety andeffectiveness of thedevice.
Materials(Implant Coil)
Characteristics	Predicate Device	Subject Device	Rationale forDifference (ifapplicable)
Implant Coil Wire	Axium™ (K133310, (K081465,K060747)	Axium Line Extension	N/A
	Pt (92%)/W (8%)	Same
Characteristics	Predicate Device	Subject Device	Rationale for Difference (if applicable)
Stretch Resistant Member	Axium™ (K133310, (K081465, K060747)	Axium Line Extension	N/A
Coil Shell	Pt (92%)/ W (8%)	Same	N/A
Detach Subassembly	SS 316LVM	Same	N/A
Materials(Implant Delivery Pusher)
Characteristics	Predicate Device	Subject Device	Rationale for Difference (if applicable)
Unibody	Axium™ (K133310, K081465, K060747)	Axium Line Extension	N/A
Outer Jacket	SS 304	Same	N/A
Marker Coil	PTFE	Same	N/A
Lumen Stop	Pt (92%)/ W (8%)	Same	N/A
Inner Liner	SS 304	Same	N/A
Coupler Tube	PTFE	Same	N/A
Actuator Interface	SS 304	Same	N/A
Release Wire	SS 304	Same	N/A
Retainer Ring	SS 304	Same	N/A
Break Indicator	SS 304	Same	N/A
Positive Load Indicator	PET shrink tubing	Laser mark	Bench testing confirmed that the change in indicator design does not affect the safety and effectiveness of the device
	PET shrink tubing	Laser mark	Bench testing confirmed that the change in indicator design does not affect the safety and effectiveness of the device
Materials(Introducer sheath)
Introducer sheath	Polypropylene/HDPE	Same	N/A

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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 manufacturing process and packaging are identical to the predicate device. The smaller dimensions and the replacement of the PET shrink

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tubing with laser marking for the PLI and BI indicators on the Implant Delivery Pusher result in a reduction of mass/material.

EO residual testing for the subject device was adopted, as the materials of construction of the implant coil and the manufacturing process are identical to the currently cleared predicate device. In addition, the smaller dimensions and the replacement of the PET shrink tubing with laser marking for the PLI and BI indicators on the Implant Delivery Pusher result in a reduction of mass/material.

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 smaller sized 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. Physicochemical and cytotoxicity testing were performed on the laser marks of the Implant Delivery Pusher for reference only. Passing results provide confirmation that the laser marks do not impact the safety of the device and add justification for adopting previous biocompatibility studies conducted for the Axium coil predicate device.

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:• Coil• Sheath• Implant Delivery Pusher	Dimensions (ID, OD, length) weremeasured and key characteristicwere inspected of the implant coil,sheath and coupler tube	All devices metacceptance criteria.
Softness and Conformability• Coil Deformation	The first loop of the coil is advanceduntil it exits the sheath and iscompressed to a deformationdistance that is a percentage of thecoil's loop OD. The peak force isrecorded.	All devices metacceptance criteria.
Ease of Deliverability• Force Transfer• Friction Testing• Fatigue and Knotting	• Peak delivery force wasmeasured through arepresentative tortuousanatomical model.• The proximal end of the deviceis advanced until the distal force	All devices metacceptance criteria.

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Test	Test Method	Conclusion
	exceeds a specified value. Theforce transfer is calculated.• The device is placed inside themicrocatheter and advanceduntil the coil is deployedcompletely inside the aneurysmmodel. The device is retractedand the cycle is repeated. Afterthe required number of cyclesthe device is inspected.
Detachment• Coil Tensile –Polypropylene• Coil Tensile –Implant/Weld (ImplantCoil to Coil Shell Weld)	• The coil is stretched until thestretch resistant member breaks.The peak force result wasrecorded• The primary wire of the coil isstretched until the coil-coil shellweld breaks. The peak forceresult was recorded	All devices metacceptance criteria.
Labeling Verification	Text and format of drawings werevisually compared to labeling andpackaging product specifications.	All devices metacceptance criteria.
Physician Usability Testing	The device was navigated through atortuous benchtop model anddeployed into a simulated siliconeaneurysm in order to assess coilsoftness, conformability, ease ofdelivery and biomechanicalstability	All test results met theacceptance 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.

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).