MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM

K052166 · Guidant Corporation · NTE · Aug 18, 2005 · Cardiovascular

Device Facts

• Record ID: K052166
• Device Name: MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM
• Applicant: Guidant Corporation
• Product Code: NTE · Cardiovascular
• Decision Date: Aug 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire 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 3.25 mm and 7.0 mm.

Device Story

RX ACCUNET™ Embolic Protection System is a filtration-based device used during carotid artery angioplasty and stenting. It functions as a guidewire and embolic filter; delivered via a sheath with a flexible tip to navigate tortuous anatomy. Once positioned distal to the lesion, the filter basket is deployed by peeling the delivery sheath. The filter captures thrombus/debris during the procedure. Post-intervention, the basket is collapsed into a recovery catheter (selected based on physician preference/anatomy) and the entire system is removed. Used in clinical settings by physicians; radiopaque markers and tips assist in visualization and navigation. Benefits include reduction of embolic events during carotid interventions.

Clinical Evidence

Bench testing only. Packaging integrity studies were performed to validate the safety and effectiveness of the new 3-in-1 packaging configuration. No clinical data was required or provided.

Technological Characteristics

Rapid exchange filtration system. Components: Nitinol filter/basket, polyurethane filter membrane, radiopaque tips/markers. Compatible with .014" guidewires and 6F guide catheters. Lengths: 190 cm and 300 cm. Sterilization and materials are identical to predicate devices (K042218, K042908).

Indications for Use

Indicated for patients undergoing carotid artery angioplasty and stenting requiring embolic protection. Applicable for vessel diameters between 3.25 mm and 7.0 mm.

Regulatory Classification

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.

Predicate Devices

• RX ACCUNET™ Embolic Protection System (K042218)
• RX ACCUNET™ 2 Recovery Catheter (K042908)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2005

Guidant Endovascular Solutions c/o Ms. Julia Anastas Advisor, Regulatory Affairs 3200 Lakeside Drive Santa Clara, CA 95054

Re: K052166

RX ACCUNET™ Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: August 8, 2005 Received: August 9, 2005

Dear Ms. Anastas:

This letter corrects our substantially equivalent letter of August 18, 2005.

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 (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 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. Julia Anastas

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 (OS) 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 continue 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 [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dmnel R. Vichner

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): K052166

Device Name:

RX ACCUNET™ Embolic Protection System

Indications For Use:

The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire 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 3.25 mm and 7.0 mm.

Prescription Use × (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)

Auley B. Bvan
(Division Sign-Off)

Division of Cigit Off
Division of Cardiovascular Devices

Page 1 of _1

510(k) Number_KO5266

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K052166 p. 1 of 2

RX ACCUNET™ Embolic Protection System "3 in 1 Packaging Configuration" Special 510(k)

# GUIDANT

AUG 1 8 2005

## 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

| Submitter's Name: | Guidant Corporation |
|-----------------------------|----------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95052 |
| Telephone:<br>Fax: | 408-845-2201<br>408-845-2304 |
| Contact Person: | Julia Anastas |
| Date Prepared: | August 8, 2005 |
| Device Trade Name: | RX ACCUNET™ Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification Name: | Embolic Protection System |
| Device Classification: | Class II |

## Summary of Substantial Equivalence:

The proposed RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration" is substantially equivalent to the currently marketed RX ACCUNET™ Embolic Protection System and RX ACCUNET™ 2 Recovery Catheter.

## Device Description:

The RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET™ 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET™ Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.

Confidential

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### Intended Use:

The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire and The KX AOOONE T - Embolio Protoction and remove embolic material (thrombus / debris) while embolic protection oyoton to contain or carotid arteries. The diameter of the performing anglopidsty and cloning promote should be between 3.25 mm and 7.0 mm.

### Technological Characteristics:

No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System.

The RX ACCUNET™ Embolic Protection System is substantially equivalent to the RX The RX ACCONET - Embolic Protection Systems (K042218) and the RX ACCUNET™ 2 Recovery Catheter (K042908) with regard to device design, principles of operation, materials, and Oather (189200) with rogard to asign attributes are the same or similar for both the subiect device and the predicate device:

- Rapid exchange systems .
- Filter based technology .
- Polvurethane filter membrane .
- Nitinol filter/basket component .
- Compatibility with .014" guidewires ●
- Compatibility with 6F guide catheters .
- Available in 190 and/or 300 cm lengths .
- Accommodates same vessel sizes .
- Radiopaque guidewire tips and/or delivery sheath tips .
- Radiopaque markers on filter ●
- Delivery System /Recovery Catheter compatability

Comparisons of the subject and predicate devices show that technological characteristics Such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices.

#### Performance Data:

The results of the packaging integrity studies have demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration."