AMPLATZER TORQVUE EXCHANGE SYSTEM

K080994 · Aga Medical Corp. · DQY · May 16, 2008 · Cardiovascular

Device Facts

• Record ID: K080994
• Device Name: AMPLATZER TORQVUE EXCHANGE SYSTEM
• Applicant: Aga Medical Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: May 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

Device Story

The AMPLATZER TorqVue Exchange System is a sterile, single-use percutaneous catheter delivery system. It consists of a delivery sheath, dilator, loader, hemostasis valve, delivery cable, and vise. The device is used by clinicians in a clinical setting to facilitate the exchange of delivery sheaths during interventional procedures. The dilator features an enlarged inner lumen to allow passage over a delivery cable. The system is available in 180° and 45° distal end curvatures. It functions as a mechanical tool to maintain access while swapping sheaths, thereby supporting the delivery of other medical devices.

Clinical Evidence

Bench testing only. Verification testing included visual, performance, and compatibility assessments. Biocompatibility testing was conducted in accordance with ISO 10993-1.

Technological Characteristics

Sterile, single-use percutaneous catheter system. Components: delivery sheath, dilator, loader, hemostasis valve, delivery cable, vise. Available in 180° and 45° distal curvatures. Sterilization: ETO. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for patients requiring the removal and exchange of an AMPLATZER Delivery Sheath for one of equal or larger diameter.

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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K080994

# 510(k) Summary

MAY 1 6 2008

| Date Prepared | April 4, 2008 |
|-----------------------|-------------------------------------------------------------------|
| Submitter | AGA Medical Corporation<br>5050 Nathan Lane<br>Plymouth, MN 55442 |
| Contact | Michelle Nivala<br>Sr. Regulatory Affairs Specialist |
| Telephone | 763.531.3061 |
| Fax | 763.647.5932 |
| E-mail | [e-mail] |
| Trade Name | AMPLATZER TorqVue Exchange<br>System |
| Common Name | Catheter Delivery System |
| Device Classification | Class II, 21 CFR 870.1250<br>Catheter, Percutaneous |
| Product Code | DQY |

#### Summary of Substantial Equivalence

The design, materials and performance of the AMPLATZER TorqVue Exchange System are substantially equivalent to the following predicate device:

- AMPLATZER TorqVue Delivery System K072313 cleared November 2, 2007. -
### Device Description

The AMPLATZER TorqVue Exchange System is a sterile, single use device comprised of a delivery sheath, dilator, loader, hemostasis valve, delivery cable and vise. The system components are identical to the AMPLATZER TorqVue Delivery System, with the exception of the dilator, which incorporates an enlarged inner lumen for passage over a delivery cable. The Exchange System is available in two distal end curvatures: 180° and 45°.

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### Indications for Use

The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

#### Technological Characteristics

The design, materials, performance and packaging materials are substantially equivalent or identical to the predicate device referenced.

#### Summary of Testing

Device verification testing is presented to demonstrate the AMPLATZER TorqVue Exchange System meets established performance criteria and to support equivalency to the predicate device. Visual, performance and compatibility testing was completed. All design and compatibility requirements were met.

Biocompatibility testing consistent with ISO 10993-1: "Biological Evaluation of Medical devices -- Part 1: Evaluation and Testing" is also presented.

The AMPLATZER TorqVue Exchange System will continue to be sterilized using a validated ETO sterilization process.

#### Conclusion

AGA Medical Corporation considers the AMPLATZER TorqVue Exchange System to be substantially equivalent to legally marketed predicate devices through the data and information presented.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol composed of three curved lines that resemble a human figure or a stylized representation of a person.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2008

AGA Medical Corporation c/o Ms. Michelle Nivala Senior Regulatory Affairs Specialist 5050 Nathan Lane North Plymouth, MN 55442-3209

Re: K080994

Trade Name: Amplatzer Torqvue Exchange System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY, Dated: April 8, 2008 Received: April 7, 2008

Dear Ms. Nivala:

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. Michelle Nivala

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

\$\qquad\$

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: | K080994 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AMPLATZER TorqVue Exchange System |
| Indications for Use: | The AMPLATZER TorqVue Exchange System is intended for<br>removal of an AMPLATZER Delivery Sheath and subsequent<br>exchange for an AMPLATZER Delivery Sheath of equal or larger<br>diameter. |

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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K080994

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