AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120

K093476 · Aga Medical Corp. · DQY · Feb 5, 2010 · Cardiovascular

Device Facts

• Record ID: K093476
• Device Name: AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120
• Applicant: Aga Medical Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

AMPLATZER TorqVue 2 Delivery Sheath is a sterile, single-use, percutaneous delivery catheter; 120 cm length; 5 Fr, 6 Fr, or 7 Fr inner diameters. Used in peripheral vasculature to provide a pathway for device delivery. Includes a dilator for tissue penetration. Operated by clinicians under fluoroscopic guidance. Radiopaque body for visualization. Construction: two-segment Pebax polyether block amide; stainless-steel braid support for maneuverability and kink resistance; 55-durometer Pebax soft tip to minimize vessel trauma. Facilitates safe device advancement and vessel engagement.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual and dimensional inspection, resistance to kinking, leakage testing (air/liquid), tensile strength, device interaction testing, and distribution simulation.

Technological Characteristics

Single-lumen percutaneous delivery sheath; 120 cm length; 5/6/7 Fr diameters. Materials: Pebax (polyether block amide) segments, 55-durometer Pebax soft tip, stainless-steel braid support. Radiopaque for fluoroscopy. Sterile, single-use. No electronic components 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)

Submission Summary (Full Text)

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L093476

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

### FEB - 5 2010

- 1. Applicant Information Date Prepared:
November 6, 2009

2135147

Submitter:

AGA Medical Corporation 5050 Nathan Lane North Plymouth, MN 55442 USA

Establishment Registration Number:

Contact person:

Diane Carroll Regulatory Affairs Associate Telephone Number: 763.531.3161 Fax Number: 763.647.5932

- 2. General Device Information Trade Name:
AMPLATZER® TorqVue® 2 Delivery Sheath

Common Name:

Classification Name: Classification: Product Code:

Catheter, Percutaneous Class II, 21 CFR 870.1250 DQY

Catheter, Delivery Sheath

Predicate Device:

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

#### 3. Device Description

The AMPLATZER® TorqVue® 2 Delivery Sheath is a sterile, single-use, general-purpose sheath that is an extension of the TorqVue 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® 2 Delivery Sheath has a usable length of 120 cm and is available with a 5 Fr, 6 Fr, or 7 Fr inner diameter. A dilator, which eases penetration of tissue, is packaged with each sheath. The distal

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

end of both the sheath and dilator are straight. The body of each sheath is radiopaque for visibility under fluoroscopy.

The single-lumen sheath is constructed of two segments of different polyether block amide (Pebax®) materials to provide support for device advancement and tip flexibility for vessel engagement. The Pebax® encapsulates a stainless-steel braid 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® 2 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

### 5. Comparison to Predicate

The AMPLATZER® TorqVue® 2 Delivery Sheath has the following similarities when compared to the predicate device:

- · Indications for Use for the TorqVue 2 Delivery Sheath are 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

#### 6. Test Data

The functional characteristics of the AMPLATZER® TorqVue® 2 Delivery Sheath are substantially equivalent to the predicate devices cited. Bench testing of the AMPLATZER® TorqVue® 2 Delivery Sheath included visual and dimensional inspection, resistance to kinking due to bending, freedom from leakage of air and liquid, tensile strength, device interaction testing, and distribution simulation.

#### 7. Summary

Based on the technical information, intended use, and laboratory verification test information provided, the AMPLATZER® TorgVue® 2 Deliverv Sheath 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

FEB - 5 2010

Re: K093476

AMPLATZER® TorqVue® 2 Delivery Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 06, 2009 Received: November 09, 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. 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.

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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/Reporta.Problem/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,

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: | K093476 |
|----------------|-------------------------------------|
| Device Name: | AMPLATZER TorqVue 2 Delivery Sheath |

Indications for Use: The AMPLATZER ToroVue Delivery Sheath is intend

The AMPLATZER TorqVue 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) ് Nivision Sign-Off)

Division of Cardiovascular Devices

510(k) Number K093476

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