RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM

K042908 · Guidant Corp. · NTE · Nov 12, 2004 · Cardiovascular

Device Facts

• Record ID: K042908
• Device Name: RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
• Applicant: Guidant Corp.
• Product Code: NTE · Cardiovascular
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RX ACCUNET™ 2 Embolic Protection System 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 portery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

Device Story

RX ACCUNET™ 2 is a filtration-based embolic protection system used during carotid artery angioplasty and stenting. The system comprises a delivery sheath with a flexible tip coil and a second-generation recovery catheter. The device is delivered to the target site; the filter basket is expanded in the arterial lumen by peeling the delivery sheath from the guidewire. The filter captures embolic debris during the procedure. Upon completion, the filter basket is collapsed into the recovery catheter, and the entire system is removed as a single unit. Used in clinical settings by physicians; radiopaque markers on the filter and delivery sheath facilitate navigation through tortuous anatomy. The device benefits patients by reducing the risk of distal embolization during carotid interventions.

Clinical Evidence

Bench testing and in vivo studies were conducted to evaluate the safety and effectiveness of the device. No clinical trial data provided. Testing confirmed that performance properties, biocompatibility, and mechanical integrity are equivalent to the predicate device.

Technological Characteristics

Filtration-based embolic protection system; nitinol filter basket; polyurethane filter membrane; rapid exchange design; compatible with 0.014" guidewires and 6F guide catheters; available in 190 cm and 300 cm lengths; radiopaque markers on filter and delivery sheath tips for visualization.

Indications for Use

Indicated for patients undergoing angioplasty and stenting in carotid arteries with vessel diameters between 3.25 mm and 7.0 mm, requiring containment and removal of embolic material.

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 (K024418)

Submission Summary (Full Text)

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KO42908 p/2

NOV 1 2 2004

RX ACCUNET™ 2 Embolic Protection System Special 510(k)

# GUIDANT

## 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: | 408-845-2233<br>408-845-2304 |
| Contact Person: | Virginia Singer |
| Date Prepared: | October 20, 2004 |
| Device Trade Name: | RX ACCUNET™ 2 Embolic Protection System |
| Device Common Name: | Embolic Protection System |
| Device Classification Name: | Embolic Protection System |
| Device Classification: | Class II |

#### Summary of Substantial Equivalence:

The RX ACCUNET™ 2 Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection System.

#### Device Description:

The RX ACCUNET™ 2 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 and a second-generation RX ACCUNET™ 2 Recovery Catheter. The RX ACCUNET™ 2 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 the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy

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### Guidant Corporation

#### RX ACCUNET™ 2 Embolic Protection System Special 510(k)

#### Intended Use:

The RX ACCUNET™ 2 Embolic Protection System 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 portery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

#### Technological Characteristics:

The design modifications incorporated into the RX ACCUNET™ 2 Embolic Protection System include minor material, dimensional and design configuration changes made to the Oyclommeraus Minor mucery System. No changes were made to the RX ACCUNET™ Delivery System.

The RX ACCUNET™ 2 Embolic Protection System is substantially equivalent to the RX ACCUNET™ Embolic Protection Systems (K024418) with regard to device design, principals of operation, materials, and indications for use. The following design attributes are the same or similar for both subject devices and the predicate device:

- Rapid exchange systems .
- Filter based technology .
- Polyurethane 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 .

Any new issues of safety or efficacy were addressed through pre-clinical evaluation including functional, in vivo and in vitro testing.

Comparisons of the new 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 in vitro bench tests and in vivo studies demonstrated the safety and effectiveness of the RX ACCUNET™ 2 Embolic Protection System.

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Public Health Service

Image /page/2/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 that resembles an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 2004

Ms. Virginia Singer Manager Regulatory Affairs Guidant Corporation Mailstop S216 3200 Lakeside Drive Santa Clara, CA 95054

Re: K042908

RX ACCUNET™ 2 Embolic Protection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NFA Dated: October 20, 2004 Received: October 21, 2004

Dear Ms. Singer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wind 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 encreativent of the enactment date of the Medical Device Amendments, or to ecommerce prior to Has) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, devices that hat to been 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 r ou mayy aron's 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 may or our 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 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 (301) 594-_. 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,

Diana P. Buchner

- ( / 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 Statement

510(k) Number:

Device Name:

The RX ACCUNET™ Embolic Protection System is Indications For Use: 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 3.25 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)

Diana R. Vachner

(Division Sign-Off) (Division Olgh of Cardiovascular Devices

510(k) Number_k 042968