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™ coil configurations include bare platinum, PGLA laced platinum and Nylon laced platinum coils. The AXIUM™ DETACHABLE COIL SYSTEM consists of three components: 1- Implantable Coil, 2- Implant Delivery Pusher, 3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.

AI/ML Overview

The provided text describes a medical device, the AXIUM™ DETACHABLE COIL SYSTEM, and its regulatory clearance process, focusing on an expanded indication for use. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically required for AI/algorithm performance.

The document is a 510(k) summary for a medical device (a coil system for embolization), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative metrics through a clinical trial or algorithm validation study.

Therefore, many of the requested bullet points regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it pertains to a physical medical device, not an AI or algorithmic medical device.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not applicable / Cannot be extracted from this document. This document is for a physical medical device's 510(k) clearance, not an AI or algorithmic device. It does not provide quantitative acceptance criteria or performance metrics in the context of an algorithm's output (e.g., sensitivity, specificity, accuracy). The "Performance Data" section refers to bench and animal testing for the physical device, not for an algorithm.

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

Not applicable / Cannot be extracted from this document. This document does not discuss a "test set" in the context of validating an algorithm. The performance data mentioned (bench and animal testing) relates to the physical device. The information about sample sizes or data provenance for such studies is not detailed here.

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)

Not applicable / Cannot be extracted from this document. This document does not describe the establishment of ground truth for an algorithmic test set.

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

Not applicable / Cannot be extracted from this document. This document does not involve an algorithmic test set or adjudication.

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

Not applicable / Cannot be extracted from this document. This device is a physical embolization coil system, not an AI-assisted diagnostic or treatment planning system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

Not applicable / Cannot be extracted from this document. This device is a physical medical implant, not a standalone algorithm.

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

Not applicable / Cannot be extracted from this document. As there's no algorithm involved, there's no "ground truth" to establish for an algorithm's performance. The "performance data" refers to the physical characteristics and safety of the implant itself, likely validated through engineering tests, animal studies, and comparison to predicate devices, rather than a diagnostic ground truth.

8. The sample size for the training set

Not applicable / Cannot be extracted from this document. There is no "training set" as this is not an AI/ML device.

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

Not applicable / Cannot be extracted from this document. There is no "training set" or corresponding ground truth for an algorithm.

Summary

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Ev3® Inc. 23 May, 2008

5 510(K) SUMMARY

Applicant:	ev3® Inc.9775 Toledo WayIrvine, CA 92618USAPhone: +1-949-837-3700Fax: +1-949-837-2044	AUG 19 2008
Date:	May 22, 2008
Contact Person:	Neelu MedhekarDirector, Global Regulatory Affairs
Proprietary Device Name:	AXIUMTM DETACHABLE COIL SYSTEM
Common Device Name:	Neurovascular Embolization Device(21CFR 882.5950, Product Code HCG)
Classification:	Class II
Predicate Devices:	Micro Therapeutics, Inc. FX Detachable Coil System(K060747) cleared 04/24/07 – marketed as the ev3® AXIUMTMDETACHABLE COIL SYSTEMMicrus® Microcoil Delivery System (K073442) 02/26/2008Boston Scientific/Target Therapeutics, Guglielmi DetachableCoil (K962503) cleared 09/20/1996
Manufacturer:	ev3® Neurovascular a division of ev3® Inc.9775 Toledo WayIrvine, CA 92618USA

Note: Micro Theraputics Inc., does business as ev3ª Neurovascular, which is a division of ev38 Inc. To simplify the product identification for the purposes of this submission, references will only be made to ev3 Inc.

5.1 Substantially Equivalent To:

The AXIUM™ DETACHABLE COIL SYSTEM is substantially equivalent to the Micro Therapeutics, Inc. FX Detachable Coil System (K060747) -- marketed as the ev3 AXIUM™ DETACHABLE COL SYSTEM, Microcoil Delivery System (K073442), and the Boston Scientific/Target

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Ev30 Inc. 23 May, 2008

Traditional 510(k) – Axium™ Detachable Coil System of 154 CONFIDENTIAL

Therapeutics, Guglielmi Detachable Coil (K962503) in terms of intended use, design, specifications, and materials. These systems are all indicated for use in the embolization of aneurysms. The predicate devices, Microcoil Delivery System (K073442), and the Boston Scientific/Target Therapeutics, Guglielmi Detachable Coil (K962503) are indicated for neurovascular embolizations as well as embolizations in the peripheral vasculature.

The AXIUM™ DETACHABLE COL SYSTEM uses the same design, methods and materials in construction, packaging and sterilization as its predicates. The modification to the indications use statement has not altered the fundamental scientific technology of the AXIUM™ devices.

5.2 Description of the Device Subject to Premarket Notification:

The AXIUM™ DETACHABLE COIL SYSTEM consists of three components:

l Implantable Coil,
2- Implant Delivery Pusher,

3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.

This submission expands the indications for use statement to include arterial and venous embolizations in the peripheral vasculature. This indication is discussed further in Section 10.

Indications for Use: 5.3

Performance Data: 5.4

Bench data were generated to support the original FX Detachable Coil System (K060747), and are valid as the subject of this submission is an expanded indication and there is no change to the fundamental scientific technology of the device. Subsequent to the submission of K060747, additional bench and animal testing was performed for the AXIUM™ DETACHABLE COUL SYSTEM. A summary of the bench data are presented in Section 18 and the animal data are presented in Section 19 of this submission.

The risk assessment documentation for the AXIUM™ DETACHABLE COL SYSTEM was reviewed to assess any new or unique risks posed by the peripheral vascular indication. No new risks were identified.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a winding snake around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2008

EV3® Inc. c/o Ms. Neelu Medhekar Director, Global Regulatory Affairs 9775 Toledo Way Irvine, CA 92618

Re: K081465 Axium™ Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: May 23, 2008 Reccived: May 27, 2008

Dear Ms. Medhckar:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Neelu Medhekar

CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ev30 Inc. 23 May, 2008

INDICATIONS FOR USE STATEMENT র্ব

510(k) No (if known): K081465

Device Name: AXIUM™ DETACHABLE COIL SYSTEM

Indications for Use:

Prescription Use V (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 CDRH, Office of Device Evaluation (ODE)

echmel

Page 1 of 1

of Cardiovascular Devices

510(k) Number_ KOBILES

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).