AMPLATZER SIZING BALLOON II

K053440 · Aga Medical Corp. · MJN · Dec 30, 2005 · Cardiovascular

Device Facts

• Record ID: K053440
• Device Name: AMPLATZER SIZING BALLOON II
• Applicant: Aga Medical Corp.
• Product Code: MJN · Cardiovascular
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended Use

The AMPLATZER® Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Device Story

Triple lumen balloon catheter; features three radiopaque marker bands inside balloon for radiographic measurement; center contains pair of marker bands 0.4mm apart; one marker band 15mm proximal. Used by clinicians to measure cardiovascular defects; enables selection of appropriately sized occluder device. Device provides physical sizing reference via fluoroscopic visualization of markers.

Clinical Evidence

Bench testing only. Tests included inflation time, deflation time, burst volume, bifurcation separation, tip separation, sidearm stopcock to tube separation, sidearm luer to tube separation, marker band placement, and biological testing.

Technological Characteristics

Triple lumen balloon catheter; radiopaque marker bands for radiographic measurement; materials unspecified. No energy source. Standalone device. Sterilization method not specified.

Indications for Use

Indicated for patients with cardiovascular defects requiring accurate measurement of the defect to select an appropriately sized occluder device.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• AMPLATZER Sizing Balloon (K993248)
• Numed PTA-OS Sizing Balloon (K003320)

Submission Summary (Full Text)

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K05340

:

OEC 3 0 2005

## APPENDIX D 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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## 510(K) SUMMARY AS DESCRIBED IN 21 CFR 807.92

| Manufacturer: | AGA Medical Corporation<br>682 Mendelssohn Avenue<br>Golden Valley, MN 55427 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | 2135147 |
| Contact: | Amanda Johnson, Regulatory Affairs Manager<br>[phone] phone, [phone] fax<br>[e-mail] (e-mail) |
| Date: | December 8, 2005 |
| Product Trade Name: | AMPLATZER® Sizing Balloon II |
| Common/Usual Name: | Temporary Occluding Catheter |
| Classification Name: | Catheter, Intravascular Occluding, Temporary<br>21 CFR 870.4450 (Product Code MJN) |
| Predicate Devices: | The AMPLATZER® Sizing Balloon II is equivalent<br>in design to currently marketed balloon catheters<br>for temporary vessel occlusion:<br>• AMPLATZER Sizing Balloon (K993248)<br>• Numed PTA-OS Sizing Balloon (K003320) |
| Performance Standards: | No performance standards have been developed<br>under section 514 for this device. |
| Device Description: | The AMPLATZER® Sizing Balloon II is a triple<br>lumen balloon catheter with three (3) radiopaque<br>marker bands located inside the balloon to allow for<br>radiographic measurement. The center of the<br>balloon contains a pair of marker bands 0.4mm<br>apart (inside to inside), and one (1) marker band 15<br>mm proximal of that pair. |
| Intended Use: | The AMPLATZER® Sizing Balloon II is intended for<br>use in those patients with cardiovascular defects<br>wherein accurate measurement of the defect is<br>important to select the appropriately sized occluder<br>device. |

Summary of Non-Clinical Testing: The following non-clinial tests were performed on the AMPLATZER® Sizing Balloon II:

- Inflation time .
- Deflation time .
- Burst volume .
- Bifurcation separation .

.

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- . Tip separation
- Sidearm stopcock to tube separation .
- Sidearm luer to tube separation .
- Marker band placement .
- . Biological testing

## Conclusions:

The currently marketed AMPLATZER Sizing Balloon (K993248) has been modified to include design modifications, a new supplier and an additional catheter size (18mm). This modified product has been given the trade name AMPLATZER Sizing Balloon II. The modifications made did not alter the intended use or fundamental scientific technology of the predicate product.

The AMPLATZER® Sizinq Balloon II is substantially equivalent to currently marketed balloon catheters used for temporary vessel occlusion, which include the AMPLATZER Sizing Balloon and Numed PTA-OS Sizing Balloon.

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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 and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

DEC 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AGA Medical Corporation c/o Ms. Amanda Johnson Regulatory Affairs Manager 682 Mendelssohn Avenue Golden Valley, Minnesota 55427

Re: K053440

Trade Name: Amplatzer® Sizing Balloon II Regulation Number: 21CFR 870.4450 Regulation Name: Sizing Balloon Regulatory Class: II (two) Product Code: MJN Dated: December 8, 2005 Received: April 15, 2005

Dear Ms. Johnson:

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. Maureen Montbriand

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 entitled, "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,

Blummenau 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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## Indications for Use

510(k) Number (if known):

Device Name: AMPLATZER® Sizing Balloon II

Indications for Use:

AMPLATZER® Sizing Balloon II is indicated for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR Over-The-Counter Use_
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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An finte for Bram D. Zuckerman-
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K053440