The SpideRX™ 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 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

The provided text is a 510(k) summary for the SpideRX™ Embolic Protection Device. It describes the device, its intended use, and the FDA's substantial equivalence determination. However, the document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics typically found in clinical trials or validation studies.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SpideRX Embolic Protection Device K053195) based on the device description and intended use, particularly the modification to reflect compatibility with drug-eluting stents.

Therefore, I cannot provide the requested table and study details as they are not present in the input text.

To directly answer your numbered points based on the provided text's limitations:

A table of acceptance criteria and the reported device performance: Not provided in the text.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
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 provided in the text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
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 relevant to this device, as it is a physical medical device (embolic protection system), not an AI-assisted diagnostic tool. No such study information is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm or AI device. No such study information is provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the text. The 510(k) process for this type of device typically relies on bench testing, animal studies, and clinical data showing safety and effectiveness comparable to a predicate, but specifics are not in this summary.
The sample size for the training set: Not applicable/not provided. This is a physical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable/not provided. This is a physical device, not a machine learning model.

Summary

{0}------------------------------------------------

510(k) Summary SpideRXTM Embolic Protection Device

510(k) Number: K06220 |

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

General Provisions:
Submitter's Name	ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442
Official Contact:	Brenda JohnsonSr. Regulatory Affairs Specialistev3 Inc.9600 54th Avenue NorthPlymouth, MN 55442Tel: (763) 398-7238Fax: (763) 398-7200brenda.johnson@ev3.net
Trade Name:	SpideRXT™ Embolic Protection Device
Common Name/Usual Name:	Embolic Protection Device
Classification Name:	Catheter, Percutaneous
Class:	Class II, 21 CFR 870.1250

Predicate Devices:

SpideRX Embolic Protection Device (K053195)

Device Description:

{1}------------------------------------------------

Intended Use:

Summary of Labeling Change:

The labeling has been modified to reflect use compatibility of the SpideRX Device with currently marketed drug-eluting stents.

{2}------------------------------------------------

Food and Drug Administrat. 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

Ms. Brenda Johnson Senior Regulatory Affairs Specialist ev3 Inc. 4600 Nathan Lane North Plymouth, MN 55442-2920

Re: K062201

Trade/Device Name: ev3 Inc. SpideRX Embolic Protection Device Regulation Number: 21 CFR 870.1250 Regulation Name: Distal Embolic Protection Guidewire Regulatory Class: Class II Product Code: NFA Dated: July 27, 2006 Received: August 1, 2006

Dear Ms. Johnson

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.

{3}------------------------------------------------

Page 2 -- Ms. Brenda Johnson

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. product lauxiness on on 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 prorketed 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,

Bram D. Zuckerman, M.D.

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

Enclosure

{4}------------------------------------------------

Indications For Use

510(k) Number (if known): _ KO6220)

Device Name: SpideRX™ Embolic Protection Device

Indications for Use:

The SpideRX 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 arotection system has not been established in the cerebral or peripheral vasculature.

Over-The-Counter Use Prescription Use X 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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number. K062201

Page 1 of 1

iii

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).