The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

Device Description

The SpiderFX™ 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 320/190 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.

AI/ML Overview

Acceptance Criteria and Device Performance for SpiderFXTM Embolic Protection Device

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantatitive acceptance criteria for the SpiderFX™ device. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" can be inferred as achieving equivalence to the predicate device's performance in various tests.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Summary of Testing)
Equivalent in vitro bench performance	Test results verified that the SpiderFX Device is equivalent to the predicate device.
Equivalent package integrity	Test results verified that the SpiderFX Device is equivalent to the predicate device.
Equivalent in vivo animal study performance	Test results verified that the SpiderFX Device is equivalent to the predicate device.
Adequacy for intended use	Test results verified that the SpiderFX Device is adequate for its intended use.
Substantially equivalent to predicate device in intended use, materials, technological characteristics, and performance.	The SpiderFX™ Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K062201) in intended use, materials, technological characteristics and performance.

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify exact sample sizes for the "in vitro bench testing," "package integrity testing," or "in vivo animal studies." It only generally states that these tests were conducted.
Data Provenance: The studies were non-clinical, involving in vitro bench testing and in vivo animal studies. The country of origin for the data is not specified, but the manufacturer is based in Plymouth, MN, USA. The data is implicitly prospective as it was generated to support the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: This information is not provided in the text.
Qualifications of Experts: This information is not provided in the text.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Since the studies were non-clinical bench and animal tests, the concept of expert adjudication as used in clinical imaging studies would not typically apply.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The device is a physical medical device (embolic protection device), not an AI algorithm for diagnostic imaging that typically involves MRMC studies to assess human reader improvement.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable as the SpiderFX™ Embolic Protection Device is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

For the non-clinical studies:

In vitro bench testing: The ground truth would be based on physical and engineering measurements against predefined specifications or comparative performance with the predicate device.
In vivo animal studies: The ground truth would be established through direct observation, animal physiological measurements, and potentially necropsy results to evaluate the device's ability to contain and remove embolic material, as well as its safety.

8. Sample Size for the Training Set

This question is not applicable. The SpiderFX™ Embolic Protection Device is a physical medical device. It does not employ machine learning or AI that would require a "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, not data-driven training of an algorithm.

9. How Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons stated in point 8.

Summary

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SpiderFXTM Embolic Protection Device

510(k) Number:

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

General Provisions:

Submitter's Name	ev39600 54th Avenue NorthPlymouth, MN 55442	JAN 1 9 2007
Official Contact:	David Worrell, MS, RACManager, Regulatory Affairsev39600 54th Avenue NorthPlymouth, MN 55442Tel: (763) 398-7000Fax: (763) 398-7200dworrell@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 Device:

SpideRXTM Embolic Protection Device (K062201)

Device Description:

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Intended Use:

Summary of Technological Characteristics:

The SpiderFXTM Embolic Protection Device is a rapid exchange distal embolic protection device that is compatible with 0.014" primary guidewires and utilizes a nitinol mesh filter to capture debris. The SpiderFX Device is substantially equivalent to the SpideRX™ Embolic Protection Device (K062201) 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 the predicate device and is adequate for its intended use.

Statement of Equivalence:

The SpiderFXTM Embolic Protection Device is substantially equivalent to the currently marketed SpideRX™ Embolic Protection Device (K062201) in intended use, materials, technological characteristics and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ev3, Inc. c/o Mr. David Worrell Manager, Regulatory Affairs 9600 54th Avenue North Plymouth, MN 55442-2111

JAN 1 9 2007

Re: K063785

SpiderFXTM Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: NFA Dated: December 19, 2006 Received: December 21, 2006

Dear Mr. Worrell:

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.

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Page 2 - Mr. David Worrell

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,

una R. h. hmes

Image /page/3/Picture/5 description: The image contains a handwritten signature or symbol on the left, followed by the words "Br" and "Di" stacked vertically on the right. The signature appears to be a stylized, looping design. The text is simple and straightforward, suggesting it might be part of a name or title.

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):

Device Name: SpiderFXTM 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)

Duna R. Vachner
(Division Sign-Off)

ാസിടിഠന ഗ്രീപ്പ് വിട്ടിം വിരുന്ന

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n Number_K063785

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).