AMPLATZER RELIANT CATHETER DELIVERY SYSTEM

K070238 · Aga Medical Corp. · DQY · Feb 28, 2007 · Cardiovascular

Device Facts

• Record ID: K070238
• Device Name: AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
• Applicant: Aga Medical Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.

Device Story

Sterile, single-use catheter delivery system; facilitates introduction of transvenous devices (6-12 French diameter) into heart chambers and coronary vasculature. System components: delivery catheter (single lumen), dilator (vessel dilation/placement guidance), loader (implant introduction), delivery wire (advancement/placement/recapture), vise (handle), and hemostasis valve (bleeding control/flushing). Used by physicians in clinical settings to navigate vasculature and deliver implantable devices. Output is physical access pathway; enables precise placement of therapeutic devices. Benefits patient by providing controlled, minimally invasive delivery route for cardiac interventions.

Clinical Evidence

Bench testing only. Verification and validation testing included catheter integrity, kink resistance, leak resistance, hub strength, and ability to deliver various implantable devices. No clinical data provided.

Technological Characteristics

Single-lumen catheter system; 60 cm and 80 cm usable lengths; accommodates 6-12 French (2.0-4.0 mm) devices. Includes dilator, loader, delivery wire, vise, and hemostasis valve. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use as a pathway for introducing diagnostic and therapeutic transvenous devices into the chambers and coronary vasculature of the heart.

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

• Medtronic® SelectSite® Deflectable Catheter Delivery System (K033989)

Submission Summary (Full Text)

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K070238

FEB 2 8 2007

# 510(k) SUMMARY of Safety and Effectiveness

#### Applicant Information: l.

| Date Prepared:<br>Submitter: | January 19, 2007<br>AGA Medical Corporation |
|-----------------------------------|----------------------------------------------------------|
| Address: | 5050 Nathan Lane North<br>Plymouth, MN 55442 |
| Establishment<br>Registration No. | 2135147 |
| Contact Person: | David D. Cox, Ph.D.<br>Senior Regulatory Affairs Manager |
| Telephone Number:<br>Fax Number: | [phone]<br>[phone] |

### II. Device Information:

| Trade Name: | AMPLATZER® Reliant™ Catheter Delivery System |
|--------------|----------------------------------------------|
| Common Name: | Catheter Delivery System |

| Classification Name: | Catheter, Percutaneous |
|----------------------|---------------------------|
| Classification: | Class II, 21 CFR 870.1250 |
| Product Code: | DQY |

- Medtronic® SelectSite® Deflectable Catheter Delivery System Predicate Device: 510(k) No. K033989, Reg. No. 870.1250; Product Code: DQY
Predicate Device Intended Use: The deflectable catheter system is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

- The AMPLATZER® Reliant™ Catheter Delivery System is a sterile. Device Description: single-use device designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart.
The catheter has a single lumen for passage of transvenous devices with maximum outer diameters of 6-12 French (2.0-4.0 mm). The catheters currently come in 60 cm and 80 cm usable lengths. The system includes the following components:

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- Delivery Catheter used to deliver transvenous devices � Dilator - used within the Delivery Catheter to dilate the vessel . and to help direct the Delivery Catheter during placement Loader- used to help introduce the selected implantable . device into the delivery catheter Delivery Wire - attaches to the implantable device and . facilitates advancement through the catheter, placement and, if desired, recapture of the specified implantable device. [If this surgical accessory (Product Code = DWS) is included, the labeling will specify compatibility with the appropriate implantable devices.] Vise – a handle that is attached to the Delivery Wire by means . of a set screw Hemostasis Valve- used on the proximal end of the Loader to . minimize bleeding from the Delivery Catheter and for flushing air from the system The AMPLATZER® Reliant™ Catheter Delivery System is intended Intended Use: to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart. Comparison to The AMPLATZER® Reliant™ Catheter Delivery System is Predicate Device: substantially equivalent to the predicate device cleared by K033989. The two systems are both handheld catheter systems designed to facilitate access and placement of specified implantable devices within the chambers and coronary vasculature of the heart. Both delivery catheters are single lumen design with a hemostasis valve and an included dilator and introducer. Verification and validation testing confirms that the functional Test Data: characteristics of the AMPLATZER® Reliant" Catheter Delivery System are substantially equivalent to the predicate device cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.
- Based on the technical information, intended use, laboratory Summary: verification tests and in vitro performance information provided. the AMPLATZER® Reliant™ Catheter Delivery System is substantially equivalent to the currently marketed predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AGA Medical Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

FEB 2 8 2007

Re: K070238

Amplatzer Reliant Catheter Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: February 6, 2006 Received: February 7, 2006

Dear Mr. Job:

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 - Mr. Mark Job

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 [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/industry/support/index.html.

Sincerely yours,

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

Enclosure

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## Statement of Indications for Use

16070238 510(k) Number:

Device Name: AMPLATZER® Reliant® Catheter Delivery System

Indications for use:

The AMPLATZER® Reliant™ Catheter Delivery System is intended to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart.

Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDE! D

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Syn-om

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DIVISION

ko 70238

AMPLATZER® Reliant™ Catheter Delivery System 510(k) Premarket Notification

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