AMPLATZER SIZING BALLOON

K993248 · Aga Medical Corp. · MJN · Jul 12, 2000 · Cardiovascular

Device Facts

• Record ID: K993248
• Device Name: AMPLATZER SIZING BALLOON
• Applicant: Aga Medical Corp.
• Product Code: MJN · Cardiovascular
• Decision Date: Jul 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended Use

The AMPLATZER® Sizing Balloon 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

The AMPLATZER® Sizing Balloon is a 7F double-lumen catheter featuring a compliant, stretchable plastic membrane balloon. The balloon-carrying segment is angled at 45° to the shaft to facilitate a right-angled position relative to the atrial septum. The device is used by physicians in a clinical setting to measure cardiovascular defects. By inflating the balloon within the defect, the clinician obtains an accurate measurement, which informs the selection of an appropriately sized occluder device. This process assists in ensuring proper fit and function of the occluder, potentially improving patient outcomes for cardiovascular defect repair.

Clinical Evidence

Bench testing only. In vitro functional testing included inflation/deflation time, leakage, burst testing, and pull tests on bifurcation and shaft. Biocompatibility testing included hemocompatibility, cytotoxicity, dermal sensitization, intracutaneous injection, systemic toxicity, and pyrogenicity. Animal testing was also performed.

Technological Characteristics

7F double-lumen catheter; radiopaque nylon construction; compliant stretchable plastic membrane balloon; 45° angled balloon-carrying segment. Device is a mechanical catheter for measurement; no software or electronic components.

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

• Cordis Corporation STABILIZER Marker Wire (K962765)
• Cordis Corporation WIZDOM Marker Wire (K962765)

Submission Summary (Full Text)

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K93248

# JUL 1 2 2000

#### Summary of Safety and Effectiveness 2.

Sponsor:

AGA Medical Corporation 682 Mendelssohn Avenue Golden Valley, MN 55427

Contact person:

Jodi L. Locher Regulatory Affairs Manager

October 1, 1999 Submission Date:

Balloon Dilatation Catheter Common/Usual Name:

AMPLATZER® Sizing Balloon Trade/Proprietary name:

Classification Name:

AGA Medical Corporation believes the proposed device can be described by the following device classification names:

Catheter, Percutaneous ( 870.1250) .

Catheter, Balloon Type (878.4200) .

AGA Medical believes the proposed device is Device Classification: classified as a Class II device under:

- 74 DQY .
- 79 GBA .

Device Description: The AMPLATZER® Sizing Balloon is a 7F double lumen balloon catheter made from radiopaque nylon. The balloon is compliant and made from a very thin stretchable plastic membrane. The balloon-carrying segment is angled to 45° to the shaft providing a more or less right-angled position in relation to the atrial septum.

Intended Use: The AMPLATZER® Sizing Balloon 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.

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#### Substantial Equivalence: The AMPLATZER® Sizing Balloon is equivalent design to currently marketed balloon in catheters used for temporary vessel occlusion.

The intended use is equivalent to the Cordis Corporation STABILIZER Marker Wire and the WIZDOM Marker Wire (K962765).

Safety and Performance: The following in vitro functional tests were performed on the AMPLATZER Sizing Balloon:

- Calculation of Inflation/Deflation Time, cc, . Leakage and Burst Testing
- Pull Test Bifurcation and Port Tubing ●
- Pull Test Bifurcation and Shaft .
- Animal Testing .

In addition the following Biocompatibility Testing was performed:

- Hemocompatibility ●
- Cytotoxicity .
- Dermal Sensitization ●
- Intracutaneous Injection .
- Systemic Toxicity .
- Pyrogenicity .

Statement of Equivalence: The

AMPLATZER® Sizing Balloon is substantially equivalent in product design and packaging to currently marketed balloon catheters used for temporary vessel occlusion. The proposed device is substantially equivalent in intended use (as a measurement tool with of marker bands) to incorporation the Marker Wires STABLIZER and WIZDOM currently marketed by Cordis Corporation.

AMPLATZER® Sizing Balloon

2-2

Premarket Notification

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 2 2000

Ms. Jodi Raus Regulatory Affairs Manager AGA Medical Corporation 682 Mendelssohn Avenue Golden Valley, MN 55427

K993248 Re : Amplatzer® Sizing Balloon Regulatory Class: II (Two) Product Code: MJN June 12, 2000 Dated: Received: June 14, 2000

Dear Ms. Raus:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your section of (i.). He determined the device is the device referenced above and no have to use stated in the substantially equivated (102 cordicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate commerce prior to they connect that have been reclassified
Medical Device Amendments, or to devices that Food, Drug, and Medical Device Amendments, of on on the Federal Food, Drug, and in accordance with the provisions or cal market the device, subject to Cosmeric Act (Act). Tod maj), coof the Act. The general controls the general Controls provisions of the montal registration, and provisions of the nee increase acquiring practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device is crassified (bes aboro), it may be subject to such Controls) of Class III (Fremailes of regulations affecting your device additional Controls: "Existing any and Regulations, Title 21, Parts 800
can be found in the Code of Federal Regulations, Title 21, Parts 800 can be round in the Code of reactal nogermination assumes compliance co 655. It babbeansed in the current of the requirements, as set with the Current Cood namall Regulation (QS) for Medical Devices: rorth in the Quarrey byboam negalation and that, through periodic QSS General Tegulation (Er Original Administration (FDA) will werify such Inspections, the rood and bray with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. regaratory acur device in the Federal Register. Please note: this concerning your device in the ification submission does not affect any response to your premarked inders sections 531 through 542 of the Act obligation you might have ander booses Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Jodi Raus

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Brim E. Aum
James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) NUMBER (IF KNOWN): K993748

DEVICE NAME: AMPLATZER®Sizing Balloon

INDICATIONS FOR USE:

The AMPLATZER® Sizing Balloon 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

Brian E. Davagni

OR Over - The - Counter - Use (Optional Format 1-2-96) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ._