AMPLATZER NOODLEWIRE GUIDEWIRE

K053187 · Aga Medical Corp. · DQX · Apr 27, 2006 · Cardiovascular

Device Facts

• Record ID: K053187
• Device Name: AMPLATZER NOODLEWIRE GUIDEWIRE
• Applicant: Aga Medical Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.

Device Story

AMPLATZER Noodlewire Guidewire consists of stainless steel cable and coil; outer layer features flat wire component coated with PTFE. Device facilitates percutaneous vessel entry, typically using Seldinger technique, to enable subsequent introduction of intravascular devices. Used in clinical settings by physicians for vascular access. Device provides mechanical guidance for catheter placement; benefits patient by enabling minimally invasive vascular procedures.

Clinical Evidence

Clinical evidence includes data from a feasibility clinical trial conducted in the United States. Bench testing performed per ISO 11070 and FDA Coronary and Cerebrovascular Guidewire Guidance included kink, torqueability, torque strength, corrosion, fracture, flexure, tip flexibility, lubricity, and pull testing. Simulated life testing and biocompatibility testing per ISO 10993-1 were also completed.

Technological Characteristics

Materials: stainless steel cable and coil, PTFE coating. Principle: mechanical guidewire for vascular access. Dimensions/form factor: cable-in-coil construction. Sterilization: not specified, but stated as same as predicate. Connectivity: none (mechanical device).

Indications for Use

Indicated for percutaneous vessel entry, typically via Seldinger technique, to facilitate subsequent introduction of an intravascular device in patients requiring vascular access.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Lake Region Manufacturing Guidewire

Submission Summary (Full Text)

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# 510(k) Summary

APR 2 7 2006

| Application Date: | November 14, 2005 |
|------------------------------------------|-------------------------------------------------------------------------------------|
| Submission Type: | Traditional 510(k) |
| Applicant<br>Manufacturing<br>Address: | AGA Medical Corporation<br>682 Mendelssohn Avenue<br>Golden Valley, Minnesota 55427 |
| Contact Person: | Patricia A. LaForte<br>Regulatory Affairs Associate |
| Establishment<br>Registration<br>Number: | 2135147 |
| Device<br>Classification Name: | Wire, Guide, Catheter |
| Device<br>Common/Usual Name: | Guidewire |
| Device<br>Proprietary Name: | AMPLATZER® Noodlewire Guidewire |
| Device<br>Classification: | Class II, Reviewed by Cardiovascular |
| Device<br>Product Code: | DQX |
| Reason for 510(k): | New Device Submission |
| Equivalence<br>Device Comparison: | Lake Region Manufacturing Guidewire |
| Performance<br>Standards: | Performance standards have not been promulgated to<br>date for these devices |

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### Device Description

The AMPLATZER Noodlewire Guidewire is a guidewire comprised of a stainless steel cable and coil. The cable wire component forms the inner body of the guidewire. The outer layer of the guidewire consists of a flat wire component coated with PTFE. The cable is placed within the coil. All components are secured together forming a single quidewire.

### Intended Use

The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.

### Technological Characteristics as Compared to Predicate Device

The AMPLATZER Noodlewire Guidewire is constructed from the same biocompatible materials, coated with polytetrafluoroethylene (PTFE), packaged / sterilized utilizing the same materials / methods, and have the same principle of use as the predicate device.

### Summary of Studies:

#### A. Functional Testing

In-vitro testing was conducted in accordance with ISO 11070, Sterile single-use intravascular catheter introducers and FDA Coronary and Cerebrovascular Guidewire Guidance, January, 1995. The AMPLATZER Noodlewire samples were subjected to kink, torqueability, torque strength, corrosion, fracture, flexure, tip flexibility, lubricity, and pull testing.

In-vitro Simulated Life Testing to document performance of the AMPLATZER Noodlewire Guidewire under simulated, but accelerated, in-use conditions was performed.

Biocompatibility testing was completed per ISO 10993-1.

#### B. Clinical Studies

The AMPLATZER Noodlewire Guidewire was used as a part of a feasibility clinical trial conducted in the United States. Specific data to the Noodlewire Guidewire was collected as part of the clinical trial.

#### C. Conclusions Drawn from the Studies

The results of the testing indicated that the AMPLATZER Noodlewire Guidewire functions according to specifications and the materials used in the Noodlewire Guidewire are biocompatible. Therefore, the Noodlewire Guidewire is considered acceptable for human use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

127 7 7 2006

AGA Medical Corporation c/o Ms. Patricia A. LaForte Regulatory Affairs Associate 682 Mendelssohn Avenue Golden Valley, MN 55427

K053187 Re:

> AMPLATZER® Noodlewire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: II Product Code: DQX Dated: March 24, 2006 Received: March 27, 2006

Dear Ms. LaForte:

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 – Ms. Patricia A. LaForte

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 on ); pro "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,

Duna R. Vichner

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: AMPLATZER® Noodlewire Guidewire

Indications for Use: The AMPLATZER Noodlewire Guidewire is intended for percutaneous vessel entry typically using the Seldinger technique to facilitate subsequent introduction of an intravascular device.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Duna R. Lochnes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Kos

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