The ANGIOGUARD™ XP Emboli Capture Guidewire and the ANGIOGUARD™ RX Emboli Capture Guidewire 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.

Device Description

ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with an integrated emboli filter at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of the stents and interventional devices during carotid procedures. The devices are delivered via a deployment sheath and captured via a capture sheath. The ANGIOGUARD devices have a filter 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 device is available with filter basket diameters of 4, 5, 6, 7 and 8mm. The ANGIOGUARD devices are intended to capture emboli during carotid stenting procedures.

AI/ML Overview

The provided text describes the ANGIOGUARD™ XP Emboli Capture Guidewire System and the ANGIOGUARD™ RX Emboli Capture Guidewire System. However, it does not include a table of acceptance criteria or a direct study proving the device meets specific numerical criteria. Instead, it demonstrates substantial equivalence to predicate devices and presents clinical trial outcomes for safety and effectiveness.

Here’s the information based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for the device's performance in preventing emboli capture or reducing adverse events. Instead, it highlights the device's performance through a non-inferiority study against a surgical alternative.

Performance Metric	Acceptance Criteria (Implicit from Non-inferiority)	Reported Device Performance (ANGIOGUARD Stent Group)
Incidence of death, stroke, or MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in randomized arm	Non-inferiority to surgical group (Carotid Endarterectomy - CEA) within a 3% delta.	12.0% (20/167)
Non-inferiority difference (Stent vs. CEA)	The difference needed to be within a 3% delta to show non-inferiority of the stent arm.	-7.2% ({14.9%, 0.6)}, indicating the upper bound of the 95% CI for the difference was below the 3% non-inferiority margin, thus establishing non-inferiority.
Incidence of death, stroke and MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in the Registry Study Arm	Not explicitly defined against a numerical acceptance criterion in the text, but tested against an "OPC" (Optimal Performance Criterion), with varying p-values.	15.8% (64/406)

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

Test Set (Clinical Study):
- Randomized Arm: 334 subjects (167 in the stent group and 167 in the CEA group).
- Non-randomized Stent Arm: 406 subjects.
- Non-randomized Surgical Arm: 7 subjects.
- Overall Total: 747 patients.
Data Provenance: The clinical evaluation was a multi-center, randomized study (SAPPHIRE) conducted at 29 investigative sites in the United States. This indicates a prospective, multi-center US study.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical endpoints (death, stroke, MI). Clinical endpoints like death and MI are typically determined by clinical event committees or adjudicated by qualified medical professionals, but specifics are missing here.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) for the clinical endpoints. However, in major clinical trials like SAPPHIRE, it is standard practice to have an independent Clinical Events Committee (CEC) adjudicate events to ensure consistency and minimize bias.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a physical medical device (guidewire with an embolic filter) and not an imaging or diagnostic AI-powered tool that would typically involve human readers interpreting cases. The study compared the device (in conjunction with stenting) against surgical intervention (Carotid Endarterectomy).

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense, a "standalone" performance was assessed for the device itself through:

In-vitro testing: dimensional, tensile/torque testing, and functional testing.
Biocompatibility, sterilization qualification, residual analysis, packaging testing, product shelf-life testing.
Functional testing in animal models (porcine models): used to evaluate device performance and demonstrate satisfactory characteristics.
Emboli capture and vessel damage studies utilizing an earlier version of the ANGIOGUARD device, showing satisfactory results with no significant luminal disruption or hemolysis.

These tests evaluate the device's physical and functional properties independent of human decision-making in real-time, focusing on its design and material integrity in performing its intended function.

7. Type of Ground Truth Used

The ground truth used in the clinical study was based on clinical outcomes data (death, stroke, MI) and ipsilateral stroke at specific time points, as adjudicated by medical professionals based on established definitions.

8. Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or AI model, as this is a physical medical device. The "training data" for the device's design and preclinical evaluation would implicitly be the various in-vitro tests and animal models used during its development. If we interpret "training set" as the data that informed the device's development or initial design, then the preclinical data (in-vitro, animal studies) served this purpose. No specific "sample size" is applicable in the AI/ML sense.

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

Given that this is a physical medical device and not an AI/ML algorithm, the concept of "ground truth for the training set" as it relates to expert annotation or consensus is not directly applicable.

The "truth" for the in-vitro tests was based on engineering specifications and physical measurements.
For animal models, the "truth" was established through direct observation, physiological measurements, and histological analysis (e.g., for luminal disruption or hemolysis) in the porcine arteries after device deployment and retrieval. Pathological assessment would likely be the ground truth method in such cases. The document states these demonstrated "satisfactory device performance characteristics."

Summary

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APPENDIX A

SEP 2 2 2006

510(K) SUMMARY OF SAFETY AND EFFECTIVINESS

Submitter:	Joan MartinManager, Regulatory AffairsCordis Corporation7 Powderhorn DriveWarren, NJ 07059
Telephone:	908-412-7250
Fax	908-412-3008
e-mail address	jmartin@crdus.jnj.com

Date Prepared: August 23, 2006

GeneralProvisions:	Trade Name	ANGIOGUARD™ XP Emboli Capture Guidewire SystemANGIOGUARD™ RX Emboli Capture Guidewire System
	Common Name	Embolic Protection Guidewire
	Classification Name	Cardiovascular Percutaneous Catheter (per 21 CFR 870.1250) & Catheter Guidewire (per 21 CFR 870.1330)
	Device-classification	Class II
PredicateDevices:		The subject Cordis ANGIOGUARD™ RX Emboli Capture Guidewire System andANGIOGUARD™ XP Emboli Capture Guidewire System are substantiallyequivalent to:• FilterWire ™ EX Embolic Protection System, Boston Scientific Corp.• PercuSurge GuardWire Temporary Occlusion and Aspiration System,PercuSurge, Inc.
DeviceDescription	ANGIOGUARD XP and ANGIOGUARD RX devices consist of a guidewire with anintegrated emboli filter at the distal end. The devices function as an interventionalguidewire and distal protection device during delivery and placement of the stentsand interventional devices during carotid procedures. The devices are delivered via adeployment sheath and captured via a capture sheath. The ANGIOGUARD deviceshave a filter 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 passivehemo-filtration with subsequent emboli capture. At the end of the procedure, thefilter is collapsed and retrieved. The device is available with filter basket diametersof 4, 5, 6, 7 and 8mm.The ANGIOGUARD devices are intended to capture emboli during carotid stenting

procedures.

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Indications for ANGIOGUARD XP " Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire Use

The ANGIOGUARD XP Emboli Capture Guidewire and the ANGIOGUARD RX Emboli Capture Guidewire 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.

Performance In-vitro testing consisted of dimensional, tensile/torque testing and functional Data: testing. Biocompatibility, sterilization qualification and residual analysis, packaging testing, product shelf-life testing and functional testing in animal models have also been successfully conducted.

Cordis conducted emboli capture and vessel damage studies utilizing an earlier version ANGIOGUARD device; which demonstrated satisfactory results with no significant luminal disruption or hemolysis. Results are applicable to ANGIOGUARD XP and ANGIOGUARD RX, as the basket components of the devices are identical.

Acute studies were conducted on the ANGIOGUARD XP and RX devices to evaluate device performance. Porcine models were used to simulate the anatomy of tortuous human arteries because of the similarity in arterial diameter to human vessels. Results demonstrated satisfactory device performance characteristics.

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Clinical A clinical evaluation in a multi-center, randomized study (SAPPHIRE) was Summary conducted at 29 investigative sites in the United States. The study assessed carotid artery stenting with distal protection, utilizing the Cordis PRECISE® Nitinol Stent System and the ANGIOGUARD XP Emboli Capture Guidewire, as compared to carotid endarterectomy in patients at high-risk for surgery. A separate stent arm was included for patients meeting the entry criteria, but who were determined by the vascular surgeon to be at too high a risk for surgery. Also included was a surgical arm for patients meeting the entry criteria, who the interventionalist determined to be unacceptable candidates for stenting. A total of 334 subjects were entered into the randomized arm of the study (167 stent and 167 CEA patients). A total of 406 subjects were entered into the non-randomized stent arm and 7 subjects were entered into the non-randomized surgical arm. Hence, an overall total of 747 patients were entered into Cordis' pivotal SAPPHIRE study.

Clinical evaluation of ANGIOGUARD XP, together with the preclinical data supporting both ANGIOGUARD XP and RX, was used to provide reasonable assurance of the safety and effectiveness of both devices for the intended clinical indication.

Multicenter clinical data reached the following conclusions:

Randomized Study Arm: The incidence of death, stroke, or MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) in the carotid stent group was 12.0% (20/167) compared with 19.2% (32/167) in the surgical group. In comparing treatment arms for MAE at 360 days, the stent arm was noninferior to the CEA arm within the designated 3% delta (-7.2% {14.9%, 0.6)}). The difference represented a trend for superiority of the stent arm (p=0.067).

Registry Study Arm: The incidence of death, stroke and MI at 30 days plus death or ipsilateral stroke at 360 days (MAE) was 15.8% (64/406). In a test of the primary endpoint against the OPC, despite the fact that the rate was numerically less than the OPC plus the delta, the p-value was found to be 0.2899. In a test of the MAE rate when post 30-day non-neurological deaths are not included, the p-value was <0.0001. The causes of these nonneurological deaths are well documented and consist of cardiac deaths, cancer deaths, renal failure, and respiratory failure.

The results of the pre-clinical studies and the clinical investigation provide valid scientific evidence and reasonable assurance that the ANGIOGUARD XP and ANGIOGUARD RX devices are safe and effective for their intended use.

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Summary of Substantial Equivalence

Cordis Corporation considers ANGIOGUARD XP and RX Emboli Capture Guidewire Systems substantially equivalent to the FilterWire EX Embolic Protection System and Percusurge Guardwire Temporary Occlusion and Aspiration System. All the devices facilitate placement of stents and interventional devices and capture emboli. ANGIOGUARD XP and RX devices and predicate devices are based on 0.014-inch diameter guidewire platforms. ANGIOGUARD XP and RX devices and Boston Scientific's Filterwire EX involve filter-based technology.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Cordis Corporation c/o Ms. Joan Martin Manager, Regulatory Affairs 7 Powder Horn Drive Warren, NJ 07059

Re: K062531

ANGIOGUARD™ RX and ANGIOGUARD™ XP Emboli Capture Guidewire Systems Regulation Number: 21 CFR 870.1250 Regulation Name: Embolic Protection Guidewire Regulatory Class: Class II (Two) Product Code: NTE Dated: August 28, 2006 Received: August 29, 2006

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.

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 - 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); 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,

R. balmer

Image /page/5/Picture/6 description: The image contains a handwritten symbol that resembles a combination of the letters 'b' and 'n'. The symbol is drawn with thick, dark lines, and it appears to be slightly tilted to the left. The background is plain white, which makes the symbol stand out clearly. The symbol is simple and abstract.

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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Cordis ANGIOGUARD XP & RX Emboli Capture Guidewire

p. ⊥ of ⊥

Cordis Corporation

Indication for Use

510(k) Number:	KO62531
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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 R. h. dures

(Division Sign-Off) Division of Cigh-Oll)
Division of Cardiovascular Devices

510(k) Number_K062531

ANGIOGUARD Original 510(k).doc

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).