The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Device Description

The FX Detachable Coil System consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a handheld mechanical FX detachment actuator which facilities the release of the coil from the delivery pusher tip. The Nexus version of the FX Detachable coil is enlaced with absorbable polymer microfilaments. The FX Detachment Actuator is sold separately.

AI/ML Overview

The provided text describes a 510(k) submission for the FX Detachable Coil System, focusing on its substantial equivalence to predicate devices rather than a study demonstrating performance against specific acceptance criteria for standalone device performance. The study described is primarily a set of bench tests designed to show that the new device performs similarly to or meets the same engineering specifications as the predicate devices.

Therefore, many of the requested categories, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, and details on training sets for AI algorithms, are not applicable or cannot be extracted from this document, as it does not describe a clinical trial or an AI/ML-based device performance study.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various bench tests and states that the device "Met established criteria" for each. The specific numerical acceptance criteria themselves are not provided in this summary.

Acceptance Criteria (Bench Testing)	Reported Device Performance
Dimensional & Visual Analysis	Met established criteria
Force Transfer	Met established criteria
Ease of Delivery/Coil Frictional Characteristics	Met established criteria
Reliability After Fatigue & Premature Detachment	Met established criteria
Tensile Strength of Delivery Pusher	Met established criteria
Tensile Strength at Detachment Zone	Met established criteria
Particulate Generation - Adjusted Particles / 1 mL	Met established criteria
Delivery Pusher Distal Tip Buckling	Met established criteria
Delivery Pusher Distal Stiffness Profile	Met established criteria
Packaging Integrity	Met established criteria
Detachment Actuator Life Cycle and Reliability	Met established criteria
Time and Reliability of Detachment	Met established criteria
Radiopacity	Met established criteria

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document details bench tests, which often involve a specific number of units tested per criterion, but these numbers are not disclosed.
Data Provenance: Not applicable in the context of a clinical test set. The data originates from internal engineering bench testing performed by the submitting company (Micro Therapeutics, Inc. / ev3 Neurovascular). It is not retrospective or prospective clinical data, nor does it refer to country of origin in that sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for bench tests is typically established by engineering specifications, validated test methods, and industry standards, not by clinical experts.

4. Adjudication method for the test set

Not applicable. Bench tests are typically pass/fail against predefined criteria, not subject to expert adjudication in the same way clinical image reviews would be.

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. This is not an AI/ML device, and no MRMC study was performed or described. This submission is for a physical medical device (neurovascular embolization coil).

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

Not applicable. This is not an AI/ML device. "Standalone performance" here refers to the physical device's performance as measured by the bench tests.

7. The type of ground truth used

The "ground truth" for the bench tests is based on established engineering specifications, validated test methodologies, and material standards, presumably benchmarked against the predicate devices or industry requirements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no "training set" in that context is used. The development of the device would involve engineering design and verification, not machine learning training.

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

Not applicable. No training set for an AI/ML algorithm is involved.

Summary

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Trade Name:	FX Detachable Coil System
Generic Name:	Neurovascular Embolization Device	APR 24 2007
Classification:	Class II, 21 CFR 882.5950
Submitted By:	Micro Therapeutics, Inc.DBA ev3 Neurovascular2 GoodyearIrvine, California 92618
Contact:	Florin Truuvert

Predicate Device:

Number	Description	Predicate For	Clearance Date
K041649	Sapphire NXT DetachableCoil System	FX Detachable Coil System	July 16, 2004
K050543 K051425 K051560	Nexus Detachable CoilSystem	FX Detachable Coil System	April 27, 2005June 22, 2005June 28, 2005

Device Description

Indication For Use

The FX Detachable Coils are intended for embolization of those intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neurovascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

510(k) Summarv

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K060747

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Verification and Test Summary Table

Bench Testing	Result
Dimensional & Visual Analysis	Met established criteria
Force Transfer	Met established criteria
Ease of Delivery/Coil Frictional Characteristics	Met established criteria
Reliability After Fatigue & Premature Detachment	Met established criteria
Tensile Strength of Delivery Pusher	Met established criteria
Tensile Strength at Detachment Zone	Met established criteria
Particulate Generation - Adjusted Particles / 1 mL	Met established criteria
Delivery Pusher Distal Tip Buckling	Met established criteria
Delivery Pusher Distal Stiffness Profile	Met established criteria
Packaging Integrity	Met established criteria
Detachment Actuator Life Cycle and Reliability	Met established criteria
Time and Reliability of Detachment	Met established criteria
Radiopacity	Met established criteria

Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the FX detachable coil system compared with the predicate device NXT and Nexus detachable coil system.

The devices,

Have the same intended use, .
Use the same operating principle, .
Incorporate the same basic design, .
Use similar construction and material, .
Are packaged and sterilized using same processes. .

In summary, the FX Detachable Coil System described in this submission is, in our opinion, substantially equivalent to the predicate device.

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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 eagle with its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Micro Therapeutics, Inc., DBA ev3 Neurovascular % Mr. Tom Daughters Director, Regulatory Affairs 9775 Toledo Way Irvine, California 92618

APR 2 4 2007

Rc: K060747

Trade/Device Name: FX Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: March 30, 2007 Received: April 2, 2007

Dear Mr. Daughters:

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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Tom Daughters

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Mark N. Melkerson
Director
Division of General, Restorative

DEP DIR
4/24/07

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: FX Detachable Coil System

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

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510(k) Number 16060747

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).