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

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for device performance based on the clinical study. Instead, the study's conclusion is that the "differences observed between the primary endpoint event rates were not statistically significant," which "demonstrates the safety and performance of the SpideRX Device for its intended use." This implies that the acceptance criterion was likely non-inferiority to predicate devices or a pre-defined acceptable complication rate, which was met.

Acceptance Criteria (Implied)	Reported Device Performance
Non-inferiority in safety and performance compared to predicate devices, or acceptable event rates.	"The differences observed between the primary endpoint event rates were not statistically significant," demonstrating safety and performance for intended use.

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

Test Set Sample Size: Not explicitly stated. The study is described as a "non-randomized multi-center registry study."
Data Provenance: Not explicitly stated, but "multi-center registry study" suggests data from multiple clinical sites, likely within the country where the trial was conducted (presumably the US, given the FDA submission). It is a prospective clinical study, as it was performed to assess the safety and performance of the device when used with another system.

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

This information is not provided in the document. The clinical study assessed "safety and performance," which would involve clinical outcomes and event rates, but the method for establishing "ground truth" (e.g., assessing the nature of embolic material, or specific clinical outcomes via independent review) is not detailed.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a "non-randomized multi-center registry study" focused on the safety and performance of the SpideRX device, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is not applicable as the SpideRX Embolic Protection Device is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used:

The ground truth for the clinical study was based on clinical outcomes/events related to safety and performance (e.g., embolic events, complications, successful deployment/retrieval). The document doesn't specify how these events were formally adjudicated or categorized as "ground truth," but it would typically involve clinical assessments and potentially imaging. It does not mention pathology or outcomes data in the sense of long-term follow-up beyond the immediate procedural context being assessed.

8. Sample Size for the Training Set:

This is not applicable. The SpideRX Embolic Protection Device is a physical medical device; thus, there is no "training set" in the context of machine learning or AI. The term "training set" is generally used for algorithms that learn from data.

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

This is not applicable, as there is no "training set" for a physical medical device.

Summary

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510(k) Summary SpideRX™ Embolic Protection Device

510(k) Number: K052659

This 510(k) summary is being submitted in accordance with the requirements of 2 i CFR 8807.92.

Submitter/Contact Person:

Submitter's Name:	ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7000Fax: (763) 398-7200
Official Contact:	Glen SmytheSr. Regulatory Affairs Specialistev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442Tel: (763) 398-7391Fax: (763) 398-7200gsmythe@ev3.net

Summary Preparation Date:

September 22, 2005

Device Name and Classification:

Trade Name:	SpideRX TM Embolic Protection Device
Common Name/Usual Name:	Embolic Protection Device
Classification Name:	Catheter, Percutaneous
Class:	Class II, 21 CFR 870.1250

Predicate Devices:

RX ACCUNET™ Embolic Protection System (K042218) FilterWire EZTM Embolic Protection System (K032884)

Device Description:

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Intended Use:

The SpideRX 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 (inrotious areries. 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 SpideRX Embolic Protection Device is a rapid exchange distal embolic r no Spideret Line on is compatible with 0.014"/0.018" primary guidewires and utilizes a nitinol mesh filter to capture debris.

The delivery end of the SpideRX dual-ended Catheter is placed distal to the lesion by tracking over the primary guidewire. The primary guidewire is then removed and the SpideRX Capture Wire is advanced through the delivery end of the SpideRX Catheter. Filter deployment is accomplished by holding the SpideRX Capture Wire steady while pulling back and removing the SpideRX Catheter. When deployed, the nitinol mesh filter opens, apposes the vessel wall, and then acts as a strainer by capturing debris while allowing uninterrupted blood flow distally. The Capture Wire then functions as the guidewire while percutaneous transluminal angioplasty or stenting procedures are performed. Upon completion of the intervention, the recovery end of the SpideRX Catheter is advanced over the Capture Wire and the filter is recovered into the SpideRX Catheter, closing the filter and trapping the embolic debris inside the filter. The system is then removed.

The SpideRX Embolic Protection Device is substantially equivalent to the Guidant® RX ACCUNET™ Embolic Protection System (K042218) and the Boston Scientific FilterWire EZ Embolic Protection System (K032884) in regards to device design, principals of operation and materials. The SpideRX Embolic Protection Device is also substantially equivalent to the RX ACCUNET in intended use. The following features are the same or similar between the SpideRX Device and the predicate devices:

Distal filter embolic protection .
Ranid-exchange devices .
Filter/basket component .
Compatible with 0.014" interventional devices .
Capture Wire accommodates both rapid exchange and over-the-wire PTA . devices (FilterWire EZ and RX ACCUNET are available in both 190 and 300cm lengths, while SpideRX Device wire is 320cm in length, and snaps to 190cm to accommodate rapid exchange devices)
Intended for use in similar vessel sizes .
Radionaque guidewire tips and filter markers .
Radiopaque markers on sheath/catheter tips .

052659

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Comparisons of the SpideRX Device to the predicate devices show that technological characteristics such as materials, biocompatibility, performance technological onaracteries ackaging are substantially equivalent to the currently marketed RX ACCUNET and FilterWire EZ devices.

Summary of Testing:

Non-Clinical: In vitro testing of the SpideRX Embolic Protection Device consisted of biocompatibility, sterilization, packaging, product shelf life and consisted of crossing Functional performance testing was also completed in portormalies testings verified that the SpideRX Device is adequate for its intended use. Additionally, the test results demonstrated that the SpideRX Device is equivalent to its predicate devices.

Clinical: The SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution (CREATE) Trial was a non-randomized multi-center registry study that was performed to assess the safety and performance of the SpideRX Device when used with the commercially available ACCULINK™ Carotid Stent System. The differences observed between the primary endpoint event rates were not statistically significant, which demonstrate the safety and performance of the SpideRX Device for its intended use.

Statement of Equivalence:

The SpideRX Embolic Protection Device is substantially equivalent to the currently marketed RX ACCUNET™ Embolic Protection System (K042218) in intended use, materials, technological characteristics and performance. The SpideRX Embolic Protection Device is substantially equivalent to the FilterWire EZTM Embolic Protection System (K032884) in materials, technological characteristics and performance.

K052659

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

ev3 Endovascular Inc. c/o Mr. Glen D. Smythe Senior Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442-2920

Re: K052659

SpideRXTM Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: February 10, 2006 Received: February 13, 2006

Dear Mr. Smythe:

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 encreated ) 76, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 2017, 11:12 accordance with the provisions of the Federal Food, Drug, de necs mat have been recar 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a susplies with other requirements of the Act that TDA has made a determination and Joint Federal agencies. You must of any Federal Statures and regulations administers of the registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), ademig (21 OFR Part 820); and If applicable, the electronic forth in the quality systems (QD) regulanen (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declosis over device as described in your Section 510(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket nothcation. The PDA maing of basification 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 If you ucare specific advice 101-300-2401 276-0120. Also, please note the regulation entitled, contact the Office of Complance as (21 notification" (21CFR Part 807.97). You may obtain Milsolanding of Icrerchee to premantonibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consultip://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar for

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: SpideRX™ Embolic Protection Device

Indications for Use:

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima
Non Sign On

antion of Cardlove scular Devices . Jik) Number

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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).