AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54

K091793 · Aga Medical Corp. · DQY · Jul 9, 2009 · Cardiovascular

Device Facts

• Record ID: K091793
• Device Name: AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
• Applicant: Aga Medical Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

Device Story

Sterile, single-use delivery sheath; provides pathway for device introduction into peripheral vasculature. Features 104 cm or 54 cm usable length; 8 Fr inner diameter; includes dilator for tissue penetration. Construction: Pebax® body with stainless-steel coil support for maneuverability/kink resistance; soft 55-durometer Pebax® distal tip to minimize vessel trauma. Radiopaque for fluoroscopic visibility. Used by clinicians in clinical settings to facilitate peripheral vascular procedures. Output is physical access to vasculature; enables delivery of therapeutic devices.

Clinical Evidence

Bench testing only. Testing included visual and dimensional inspection, resistance to kinking (torque/bending), leakage testing (air/liquid), tensile strength, device interaction, and distribution simulation at baseline and after 3-year accelerated aging.

Technological Characteristics

Materials: Polyether block amide (Pebax®), stainless-steel coil. Dimensions: 104 cm or 54 cm length, 8 Fr inner diameter. Radiopaque. Sterile, single-use. Mechanical delivery system; no energy source or software.

Indications for Use

Indicated for use as a pathway for the introduction of devices into the 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® LP Delivery System (K080757)

Submission Summary (Full Text)

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JUL - 9 2009

1091793

## 510(K) Summary (per 21 CFR 807.92)

- 1. Applicant Information
Date Prepared:

June 15, 2009

Submitter:

5050 Nathan Lane North Plymouth, MN 55442 USA

2135147

AGA Medical Corporation

Registration Number:

Contact person:

Establishment

Diane Carroll Regulatory Affairs Associate

Telephone Number: Fax Number:

763.531.3161 763.647.5932

#### 2. General Device Information

Trade Name: Common Name:

Classification Name: Classification: Product Code:

Predicate Device:

AMPLATZER® TorqVue® 3 Delivery Sheath Catheter, Delivery Sheath

Catheter, Percutaneous Class II, 21 CFR 870.1250 DQY

AMPLATZER® TorqVue® Delivery System, K072313, cleared November 2, 2007 Reg. No. 870.1250

AMPLATZER® TorqVue® LP Delivery System, K080757, cleared April 18, 2008 Reg. No. 870.1250

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## 510(K) Summary (per 21 CFR 807.92) (continued)

#### 3. Device Description

The AMPLATZER® TorqVue® 3 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorgVue Delivery System product line. It is designed to provide a pathway through which a device may be delivered to the peripheral vasculature.

The AMPLATZER® TorqVue® 3 Delivery Sheath has a usable length of 104 cm or 54 cm and is available with an 8 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal end of both the sheath and dilator are straight.

The body of each sheath is radiopaque for visibility under fluoroscopy. The sheath is constructed of polyether block amide (Pebax®) which encapsulates a stainless-steel coil support structure that provides maneuverability while minimizing kinking. The distal end of the sheath has a soft tip composed of 55-durometer Pebax® to minimize vessel trauma.

#### 4. Intended Use

The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

#### 5. Comparison to Predicate

The AMPLATZER® TorqVue® 3 Delivery Sheath has the following similarities when compared to the predicate device:

- Indications for Use for the TorqVue 3 Delivery Sheath are identical . to the TorqVue LP Delivery System and a subset of the TorqVue Delivery System
- . Operating principal is the same
- Manufacturing materials and processes are similar .
- Sterilization method is the same ●
- Sterile package materials are the same

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#### 6. Test Data

The functional characteristics of the AMPLATZER® TorqVue® 3 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 3 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to torque and bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation at baseline (Time=0) and after 3-year accelerated aging.

#### 7. Summary

Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER® TorqVue® 3 Delivery Sheath is substantially equivalent to the currently marketed predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 9 2009

AGA Medical Corporation c/o Ms. Diane Carroll Regulatory Affairs Associate 5050 Nathan Lane Plymouth, MN 55442

Re: K091793

Trade/Device Name: AMPLATZER TorqVue 3 Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: June 15, 2009 Received: June 17, 2009

### Dear Ms. Carroll:

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 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. Diane Carroll

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Duna D. Vorhmer

h

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:

# K_091793

Device Name:

### AMPLATZER® TorqVue® 3 Delivery Sheath

Indications for Use:

The AMPLATZER® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/ 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)

Dura R. LaLonde

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

14091793 510(k) Number

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