AMPLATZER TORQ VUE LP DELIVERY SYSTEM

K131063 · St Jude Medical · DQY · Aug 15, 2013 · Cardiovascular

Device Facts

• Record ID: K131063
• Device Name: AMPLATZER TORQ VUE LP DELIVERY SYSTEM
• Applicant: St Jude Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The AMPLATZER TorqVue Low Profile Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

Device Story

Sterile, single-use handheld catheter system; facilitates introduction of therapeutic devices into heart chambers, coronary vasculature, and peripheral vasculature. System components: single-lumen delivery catheter (4F or 5F), loader, optional delivery wire, plastic vise, and hemostasis valve. Operated by physicians in clinical settings. Catheter provides pathway for implantable device advancement, placement, and potential recapture. Hemostasis valve minimizes bleeding and facilitates air flushing. Device enables minimally invasive delivery of implants; improves procedural access to target vasculature.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed functional equivalence to predicates, including catheter integrity, kink resistance, leak resistance, hub strength, and ability to deliver various implantable devices.

Technological Characteristics

Single-lumen catheter system; 4F and 5F outer diameter compatibility; 60 cm and 80 cm lengths. Includes loader, delivery wire, plastic vise, and hemostasis valve. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring introduction of therapeutic devices into the chambers and coronary vasculature of the heart or peripheral vasculature.

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

• AMPLATZER® TorqVue® Delivery System (K072313)
• AMPLATZER® TorqVue® Low Profile Delivery System (K080757)

Submission Summary (Full Text)

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## 4 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## 4.1 Applicant Information

| | Date Prepared: | March XX, 2013 | |
|--------------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Submitter: | AGA Medical Corporation | |
| | Address: | 5050 Nathan Lane North | |
| | | Plymouth, MN 55442 | AUG 1 5 2013 |
| | Establishment<br>Registration No: | 2135147 | |
| | Contact Person: | Heather M Taylor | |
| | | Sr. Regulatory Affairs Specialist | |
| | Telephone Number: | [phone] | |
| | Fax Number: | [phone] | |
| 4.2 | Device Information | | |
| | Trade Name: | AMPLATZER® TorqVue® Low Profile Delivery System | |
| | Common Name: | Delivery System | |
| | Classification Name: | Catheter, Percutaneous | |
| Classification: | | Class II, 21 CFR 870.1250 | |
| | Product Code: | DQY | |
| Predicate Devices: | | AMPLATZER® TorqVue® Delivery System<br>510(k) K072313, Reg. No. 870.1250; Product Code: DQY | |
| | | Predicate Device Intended Use: The AMPLATZER® TorqVue®<br>Delivery System is intended to provide a pathway through<br>which devices are introduced within the chambers and<br>coronary vasculature of the heart or in the peripheral<br>vasculature. | |

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AMPLATZER® TorqVue® Low Profile Delivery System

510(k) K080757, Reg. No. 870.1250; Product Code: DQY

Predicate Device Intended Use: The AMPLATZER TorqVue LP delivery system is intended to provide a pathway through which devices are introduced into the peripheral vasculature.

Device Description: The AMPLATZER TorqVue Low Profile Delivery System is a sterile, single-use device designed to facilitate the introduction of devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.

> The catheter has a single lumen for passage of devices with maximum outer diameters of 4 and 5 French. The catheters will be provided in 60 cm and 80 cm usable lengths. The system includes the following components:

- . Delivery Catheter - used to deliver devices
- . Loader – used to help introduce the selected implantable device into the delivery catheter
- . Delivery Wire (optional) - 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.]
- . Plastic Vise (included with delivery wire) – 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® TorgVue Low Profile Delivery System is Intended Use: intended to provide a pathway through which devices are

AMPLATZER® TorqVue® Low Profile Delivery System 510(k) Premarket Notification

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introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

## Comparison to

The AMPLATZER TorqVue Low Profile Delivery System is Predicate Devices: substantially equivalent to the predicate devices cleared by K072313 and K080757. This submission seeks to add a cardiac indication to the already cleared K080757. All systems are handheld catheter systems designed to facilitate access and placement of specified implantable devices within the chambers and coronary vasculature of the heart. All three delivery catheters are single lumen design with a hemostasis valve. The device included in this submission is identical in design to the already cleared K080757, and is using the already cleared K072313 to support the cardiac indication for use. Test Data: Verification and validation testing confirms that the functional characteristics of the AMPLATZER® TorqVue® Low Profile Delivery Systems are substantially equivalent

to the predicate devices cited. This included catheter integrity, catheter kink resistance, leak resistance, hub strength and the ability to deliver various implantable devices.

Summary: Based on the technical information, intended use, laboratory verification tests and in vitro performance information provided, the AMPLATZER® TorqVue® Low Profile Delivery System is substantially equivalent to the currently marketed predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal with text and a stylized symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Inside the circle is a symbol that resembles a stylized caduceus, with three wavy lines representing snakes intertwined around a staff.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 15, 2013

St. Jude Medical C/O Heather Taylor 5050 Nathan Lane North Plymouth, MN 55442 US

Re: K131063

> Trade/Device Name: AMPLATZER TorqVue Low Profile Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: July 25, 2013 Received: July 26, 2013

Dear Ms. Taylor:

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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.S. Hillman

for

for
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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## 3 STATEMENT OF INDICATIONS FOR USE

K131063 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: AMPLATZER TorqVue Low Profile Delivery System

Indications for use:

The AMPLATZER TorqVue Low Profile Delivery System is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Hilleman

(Division Sign-Off) AMPLATZER® TorqVue® Low Profile Delivery System Division Sign-Off)
510(k) Premarket Notification 510(k) Premarket Notification K131063 510(k) Number: