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 coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Axium™ Detachable Coil System consists of three (3) components: 1 -- Implantable Coil, 2 - Implant Delivery Pusher, 3 - Instant Detacher. The Instant Detacher is packaged and sold separately. Axium™ coil configurations include bare platinum, PGLA enlaced platinum and Nylon enlaced platinum coils. Bare configuration coils are non-fiber-enlaced, whereas PGLA and Nylon are enlaced with PGLA and Nylon fibers respectively. This submission expands the size offerings of the Axium™ Detachable Coil System by adding one (1) new model number to the Axium bare product portfolio with a new diameter and coil length combination (SKU QC-1.5-1-Helix). Currently cleared sizes for Axium™ bare under K081465 already include a coil diameter of 1.5mm and a coil length of 1cm; however, not in combination.

AI/ML Overview

This document describes a 510(k) submission for the Axium™ Detachable Coil System, which is a neurovascular embolization device. The submission is for expanding the size offerings of an already cleared device.

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

1. A table of acceptance criteria and the reported device performance

The provided document describes the performance data in textual form, stating that "The following test(s) was performed to support the addition of the new size offering" and then lists several categories of bench testing. It does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it states that these tests were "adopted from existing test data for currently cleared Axium™ coil sizes" and that the conclusion is based on "successful completion of non-clinical testing; a thorough assessment of existing test data; as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use."

Therefore, the acceptance criteria are implicitly that the new size offering (SKU QC-1.5-1-Helix) performs comparably to the previously cleared Axium™ coils in the listed bench tests. The reported device performance is that it did successfully meet these implied criteria.

Implied Acceptance Criteria and Reported Performance:

Acceptance Criteria Category	Reported Device Performance
Dimensions - 1st Loop Outer Diameter	Successfully met (implied by "successful completion of non-clinical testing")
Dimensions - Length	Successfully met (implied by "successful completion of non-clinical testing")
Coil Deformation	Successfully met (implied by "successful completion of non-clinical testing")
Friction	Successfully met (implied by "successful completion of non-clinical testing")
Fatigue After Knotting and Reliability Detachment	Successfully met (implied by "successful completion of non-clinical testing")
Torque Response	Successfully met (implied by "successful completion of non-clinical testing")
Force Transfer - Implant	Successfully met (implied by "successful completion of non-clinical testing")
Coil Tensile - Polypropylene	Successfully met (implied by "successful completion of non-clinical testing")
Coil Tensile - Implant/Weld (Implant Coil to Coil Shell Weld)	Successfully met (implied by "successful completion of non-clinical testing")
Coil Tensile - Assembly	Successfully met (implied by "successful completion of non-clinical testing")
Particulate	Successfully met (implied by "successful completion of non-clinical testing")
Pusher Dimensions	Successfully met (implied by "successful completion of non-clinical testing")
Marker Radiopacity	Successfully met (implied by "successful completion of non-clinical testing")
Tip Buckling	Successfully met (implied by "successful completion of non-clinical testing")
Detachment Zone Stiffness	Successfully met (implied by "successful completion of non-clinical testing")
Kink Resistance	Successfully met (implied by "successful completion of non-clinical testing")
Hypotube and Weld Tensile Strength	Successfully met (implied by "successful completion of non-clinical testing")
Force Transfer - Pusher	Successfully met (implied by "successful completion of non-clinical testing")
Pusher Elongation	Successfully met (implied by "successful completion of non-clinical testing")
MRI Compatibility	Successfully met (implied by "successful completion of non-clinical testing")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to "bench testing" and "existing test data" for currently cleared devices. It does not specify the sample size for the new SKU (QC-1.5-1-Helix) or the provenance (country of origin, retrospective/prospective) of the data. Given it's a 510(k) for an additional size, it's highly likely this is internal R&D data from the company, likely prospective for the new SKU but leveraging retrospective data for comparison to the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This submission does not involve clinical studies with human expert evaluation for establishing ground truth in the traditional sense of a diagnostic or AI device. The testing is bench-based and focuses on physical and mechanical properties. Therefore, these questions are not applicable to this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is bench testing, not a clinical study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This submission is for a physical medical device (detachable coil system) and does not involve AI or a multi-reader, multi-case study. This question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This submission is for a physical medical device and does not involve an algorithm or standalone performance testing in this context. This question is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing, the "ground truth" would be the established engineering and materials specifications and performance characteristics derived from recognized standards and internal quality control protocols for the predicate devices. These are quantitative and measurable physical properties.

8. The sample size for the training set

This is not an AI/machine learning device; therefore, there is no training set in the conventional sense. The "training data" equivalent in this context would be the extensive manufacturing specifications, material properties, and performance data accumulated from the predicate devices' development and testing.

9. How the ground truth for the training set was established

As there is no training set for an AI algorithm, this question is not applicable. The "ground truth" for the overall device's performance is established through rigorous engineering design, material science characterization, and comprehensive bench testing against established industry standards and internal acceptance criteria for medical devices.

Summary

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0133310 JAN 1 0 2014

・

510(k) Summary

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618
	Establishment Registration No. 2029214
Contact Person:	Angela LampreyRegulatory Affairs SpecialistTelephone: (949) 297-9611E-mail: angela.lamprey@covidien.com
Date SummaryPrepared:	09 December 2013
Trade Name ofDevice:	Axium™ Detachable Coil System
Common Name ofDevice:	Neurovascular Embolization Device
Classification ofDevice:	21 CFR 882.5950-Class II
Predicate Device:	Axium™ Detachable Coil System (K081465)Cleared 08/19/2008
Device Description:	The Axium™ Detachable Coil System consists of a platinum coil securedto a composite delivery wire and is compatible with a 2-marker bandmicro catheter and a mechanical detachment system. TheAxium™ Detachable Coil System consists of three (3) components:
	1 -- Implantable Coil2 - Implant Delivery Pusher3 - Instant Detacher. The Instant Detacher is packaged and soldseparately.
	Axium™ coil configurations include bare platinum, PGLA enlacedplatinum and Nylon enlaced platinum coils. Bare configuration coilsare non-fiber-enlaced, whereas PGLA and Nylon are enlaced withPGLA and Nylon fibers respectively.
	This submission expands the size offerings of the Axium™ DetachableCoil System by adding one (1) new model number to the Axium bareproduct portfolio with a new diameter and coil length combination (SKUQC-1.5-1-Helix). Currently cleared sizes for Axium™ bare underK081465 already include a coil diameter of 1.5mm and a coil length of1cm; however, not in combination.

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Intended Use:	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.
Performance Data:	The following test(s) was performed to support the addition of the new size offering:
	Non-Clinical
	Bench Testing:
	There were no material, design, sterilization, packaging or manufacturing process changes that resulted from the introduction of the new SKU (QC-1.5-1-Helix). The following testing was adopted from existing test data for currently cleared Axium™ coil sizes:
	Dimensions - 1st Loop Outer DiameterDimensions - LengthCoil DeformationFrictionFatigue After Knotting and Reliability DetachmentTorque ResponseForce Transfer - ImplantCoil Tensile - PolypropyleneCoil Tensile - Implant/Weld (Implant Coil to Coil Shell Weld)Coil Tensile - AssemblyParticulatePusher DimensionsMarker RadiopacityTip BucklingDetachment Zone StiffnessKink ResistanceHypotube and Weld Tensile StrengthForce Transfer - PusherPusher ElongationMRI Compatibility
	In addition, no clinical or animal testing was performed as there is no change in the indications for use or the fundamental scientific technology of the device.
Conclusion:	The new Axium™ Detachable Coil System size offering (QC-1.5-1-Helix) is substantially equivalent to the currently cleared Axium™ Detachable Coil System based on the successful completion of non-clinical testing; a thorough assessment of existing test data; as well as identical principles of operation, materials of construction, dimensions, packaging, and indications for use.

· . ·

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

Public Health Service

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

January 10, 2014

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular c/o Ms. Angela Lamprey Regulatory Affairs Special 9775 Toledo Way Irvine, CA 92618

Re: K133310

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: December 9, 2013 Received: December 11, 2013

Dear Ms. Lamprey:

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 or any I 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Angela Lamprey

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

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): K133310

Device Name: Axium™ Detachable Coil System

Indications For Use:

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.

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of 1

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).