ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE by CORDIS CORP.

The ANGIOGUARD™ XP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

The ANGIOGUARD™ RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Device Description

Both subject and predicate ANGIOGUARD XP and RX devices consist of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

AI/ML Overview

The Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires are embolic protection guidewires used during carotid artery angioplasty and stenting procedures. The device's primary function is to contain and remove embolic material (thrombus/debris). This 510(k) notification is for a special 510(k) due to a change in the adhesive material used to adhere radiopaque markers to the filter basket struts.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Design Outputs meet Device Inputs	"Results demonstrated that design outputs continue to meet device inputs."
Biocompatibility	Met per ISO 10993-1.
Sterility Assurance Level (SAL)	Unchanged from predicate device.
Material Composition (except adhesive)	Unchanged from predicate device.
Intended Use	Unchanged from predicate device.
Indication for Use	Unchanged from predicate device.
Design & Dimensions	Unchanged from predicate device.
Size Range	Unchanged from predicate device.
Fundamental Technology and Operating Principle	Unchanged from predicate device.
Manufacturing Site and Methods	Unchanged from predicate device.
Sterilization Site, Method, Parameters	Unchanged from predicate device.
Packaging	Unchanged from predicate device.
Labeling / Instructions for use	Unchanged from predicate device.
Shelf Life	Unchanged from predicate device.

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

The document describes "Design verification activities" rather than a clinical human trial needing a test set with specific sample sizes. The testing involved:

Deployment and Capture Testing: This would likely involve in vitro or bench testing. No specific sample size is provided.
Visual Inspections: No specific sample size is provided.
Bioburden Testing: No specific sample size is provided.
Endotoxin Testing: No specific sample size is provided.
EtO Residual Testing: No specific sample size is provided.
Biocompatibility Testing: Conducted per ISO 10993-1. This is a series of tests, and the "sample size" would relate to the number of test articles and controls used in each specific biological evaluation (e.g., cytotoxicity, sensitization, irritation). No specific detailed numbers are given in this summary.

The data provenance is not explicitly stated as retrospective or prospective in the context of human data. Given the "Special 510(k)" for a material change, the focus is on bench testing and laboratory evaluations to confirm the new adhesive does not alter the device's fundamental performance or safety.

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

Not applicable. This submission is for a material change to an already cleared device, relying on design verification activities (bench testing, lab tests) rather than a clinical test set requiring expert ground truth establishment for a diagnostic or imaging device.

4. Adjudication Method for the Test Set:

Not applicable. Since the evaluation consists of design verification activities (bench and lab testing), there is no "adjudication method" in the sense of expert review for clinical data.

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 device is an embolic protection guidewire, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.

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 or AI software.

7. The Type of Ground Truth Used:

For the design verification activities:

Technical Specifications/Device Inputs: The "ground truth" for the tests described (Deployment and Capture Testing, Visual Inspections, Bioburden, Endotoxin, EtO residual testing, biocompatibility testing) is adherence to predefined engineering specifications, performance standards, and regulatory standards (e.g., ISO 10993-1). The summary states "Results demonstrated that design outputs continue to meet device inputs."

8. The Sample Size for the Training Set:

Not applicable. This is a change to a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

Summary

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KU1651

Special 510(k) Notification

Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires

510(k) Summary

Applicant	Cordis Corporation, a Johnson & Johnson Company430 Rt. 22 EastBridgewater, New Jersey 08807Telephone: 908-541-4888Fax: 908-541-4559		JUL - 9 2010
ContactPerson	Joan MartinManagerRegulatory Affairs
Date	June 10, 2009
Device Name	Trade Name: ANGIOGUARD™ XP Emboli Capture GuidewireANGIOGUARD™ RX Emboli Capture Guidewire Common or UsualName: Common Name: Embolic Protection GuidewireCardiovascular Percutaneous Catheter per 21 CFR870.1250 and Catheter Guidewire per 21 CFR870.1330 Classification: Class II Classification Panel Cardiovascular
PredicateDevices	The device is substantially equivalent to Cordis' current, legally-marketedANGIOGUARD™ XP Emboli Capture Guidewire and ANGIOGUARD™

RX Emboli Capture Guidewire which were found to be substantially equivalent to Boston Scientific's FilterWire EX Embolic Protection System (K023691) and PercuSurge, Inc.'s Percusurge Guardwire Temporary Occlusion and Aspiration System (K013913) via 510(k) K062531 on September 22, 2006.

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Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires Special 510(k) Notification

Both subject and predicate ANGIOGUARD XP and RX devices consist of a Device guidewire with integrated emboli filter basket at the distal end. The devices Description function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The subject and predicate ANGIOGUARD XP and ANGIOGUARD RX Intended Use Emboli Capture Guidewire devicves are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Summary of Substantial Equivalence

With the exception of a change to the adhesive material used to adhere radiopaque markers to the filter basket struts, the subject and predicate devices share the same:

Intended use .
Indication for use
Design & Dimensions .
Size Range .
Materials (with exception of adhesive material change described herein) .
Fundamental technology and operating principle .
Manufacturing site and methods .
Sterilization site, method, parameters, and sterility assurance level .
Packaging .
Labeling / Instructions for use .
. Shelf Life

subject ANGIOGUARD XP Emboli Capture Guidewire and The ANGIOGUARD RX Emboli Capture Guidewire devices are substantially equivalent to the predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices.

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Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires Special 510(k) Notification

Design verification activities (Deployment and Capture Testing, Visual Summary of Inspections, Bioburden, Endotoxin, EtO residual testing and biocompatibility & Conclusions testing per ISO 10993-1) were conducted to confirm that the modified devices Drawn from meet the same requirements as the current, legally marketed predicate Design devices. Verification Activities

Results demonstrated that design outputs continue to meet device inputs. Hence, the subject ANGIOGUARD XP and RX Emboli Capture Guidewire devices are substantially equivalent to the current, legally marketed ANGIOGUARD XP and RX Emboli Capture Guidewire predicate devices.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird, possibly an eagle, with its wings spread. The bird is stylized with thick, curved lines, giving it a modern and symbolic appearance.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JUL - 9 2010

Cordis Corporation c/o Joan Martin Manager, Regulatory Affairs 430 Route 22 East Bridgewater, NJ 08807

Re: K101651

Trade/Device Name: Angioguard XP and RX Emboli Capture Guidewires Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: NTE Dated: June 10, 2010 Received: June 11, 2010

Dear Ms. Martin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Joan Martin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

R. Vilmer

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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Special 510(k) Notification

Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires

Indication for Use

K10165 510(k) Number: ___

Device Name: ANGIOGUARD™ XP Emboli Capture Guidewire System

Indications For Use: The ANGIOGUARD™ XP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Prescription Use: X (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)

Duna D. Valuer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K101651

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Special 510(k) Notification

Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires

Indication for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: ANGIOGUARD™ RX Emboli Capture Guidewire System

Indications For Use: The ANGIOGUARD™ RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Prescription Use: X (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)

brmea D. McAlusen

Division Sian-Off) Division of Čardiovascular Devices

510(k) Number

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).