The SpiderFXTM Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Device Description

The SpiderFXTM Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 190/320 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.

AI/ML Overview

The provided text describes the SpiderFXTM Embolic Protection Device and its 510(k) summary (K063204). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria with reported performance metrics, expert involvement, or statistical details.

The document states that:

"Non-clinical verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use."
The device is "substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K052659) in intended use, materials, technological characteristics and performance."

This indicates that the acceptance criteria and proof of performance were likely evaluated by demonstrating equivalence to the predicate device (SpideRX™ K052659) through these non-clinical tests. The K063204 document serves as the FDA's acceptance of this substantial equivalence, not as a detailed report of the underlying studies.

Therefore, for the specific questions asked, most of the information is not available in the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use," but it does not present specific quantitative acceptance criteria or corresponding device performance results (e.g., capture efficiency, deployment success rates, etc.).

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

Not available in the provided text. The document mentions "in vitro bench testing" and "in vivo animal studies" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective nature).

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

Not available in the provided text. The verification and validation involved non-clinical studies (bench and animal), not human expert-read test sets in the context of diagnostic or interpretive devices.

4. Adjudication Method for the Test Set

Not applicable/Not available in the provided text. This usually applies to studies involving human interpretation or performance on images/data, which is not described here for the non-clinical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an embolic protection device, not an AI-based diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its mechanical design and function. While bench and animal tests evaluate its standalone physical performance, it's not "algorithm only" in the sense of AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not explicitly stated in detail. For "in vitro bench testing," the ground truth would be established by the test parameters themselves (e.g., known particle sizes for filtration, known forces for mechanical integrity). For "in vivo animal studies," the ground truth would typically refer to outcomes observed in the animal model (e.g., prevention of emboli, vessel patency, tissue damage).

8. The Sample Size for the Training Set

Not applicable/Not available in the provided text. This device is not an AI algorithm that requires a training set.

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

Not applicable/Not available in the provided text. This device is not an AI algorithm that requires a training set.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device through non-clinical testing (bench and animal studies), rather than detailing specific clinical trial data with acceptance criteria and performance metrics in the format requested for a typical AI/diagnostic device study.

Summary

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SpiderFXTM Embolic Protection Device

510(k) Number: K063204

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.

General Provisions:

Submitter's Name	ev3 Inc.9600 54th Avenue NorthPlymouth, MN 55442
Official Contact:	Tamima Itani, Ph.D., RACVice PresidentClinical & Regulatory Affairsev3 Inc.9600 54th Avenue NorthPlymouth, MN 55442Tel: (763) 398-7050Fax: (763) 398-7200titani@ev3.net
Trade Name:	SpiderFXTM Embolic Protection Device
Common Name/Usual Name:	Embolic Protection Device
Classification Name:	Catheter, Percutaneous
Class:	Class II, 21 CFR 870.1250

Predicate Devices:

SpideRXTM Embolic Protection Device (K052659)

Device Description:

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Intended Use:

The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Summary of Technological Characteristics:

The SpiderFX™ Embolic Protection Device is a rapid exchange distal embolic protection device that is compatible with 0.014"/0.018" primary guidewires and utilizes a nitinol mesh filter to capture debris. The SpiderFX Device is substantially equivalent to the SpideRX™ Device (K052659) with several modifications, including the addition of a 23 gauge blunt tip needle and a rapid exchange length (190 cm) Capture Wire, and modifications to the radiopaque mouth marker, flexible connector, and marking of the primary wire exit port.

Summary of Testing:

Non-clinical verification and validation of the SpiderFX™ Embolic Protection Device consisted of in vitro bench testing, package integrity testing, and in vivo animal studies. Test results verified that the SpiderFX Device is equivalent to its predicate devices and is adequate for its intended use.

Statement of Equivalence:

The SpiderFX™ Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K052659) in intended use, materials, technological characteristics and performance.

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Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 4 2006

ev3, Inc. c/o Tamima Itami, Ph.D. Vice President, Clinical & Regulatory Affairs 9600 54th Avenue North Plymouth, MN 55442

Re: K063204 SpyderFX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: NTE Dated: October 20, 2006 Received: October 23, 2006

Dear Dr. Itami:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is segmy and cate of the Medical Device Amendments, or 10 connineres phor to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have occh rechasined in assire approval of a premarket approval application (PMA). and Cosmetic Hot (rec) that to device, subject to the general controls provisions of the Act. The I ou may, mercloro, manel the Act include requirements for annual registration, listing of general controls proficiouring 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 If your device is olassified (600 a00 0) and . Existing major regulations affecting your device can may be subject to back as a such as a most of the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 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) 276-0120. 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.

Dmia R. Holmes

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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Indications For Use

510(k) Number (if known): 166 3204

Device Name: SpiderFX™ Embolic Protection Device

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Nura R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

Page 1 of 1

510(k) Number_£063204

Confidential

ev3 Inc.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).