SYMMETRY BALLOON DILATATION CATHETER

K060959 · Boston Scientific Corporation · LIT · Apr 12, 2006 · Cardiovascular

Device Facts

• Record ID: K060959
• Device Name: SYMMETRY BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.

Device Story

Symmetry Balloon Dilatation Catheter is an over-the-wire, three-lumen catheter designed for peripheral angioplasty. One lumen facilitates tracking over guidewires (0.018" or smaller); two separate lumens provide inflation/deflation for the balloon. Available in standard and stiff shaft configurations. Used by physicians in clinical settings to dilate narrowed or obstructed iliac, femoral, or renal vessels. Device is inserted percutaneously; inflation of the balloon restores vessel patency. Benefits include improved blood flow in peripheral vasculature.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and design to the predicate device.

Technological Characteristics

Over-the-wire, three-lumen catheter design. Available in standard and stiff shaft versions. Compatible with guidewires up to 0.018". Materials and design are identical to the predicate device.

Indications for Use

Indicated for percutaneous transluminal angioplasty of small, narrowed, or obstructed iliac, femoral, or renal vessels in 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

• Symmetry Balloon Dilatation Catheter (K953602)

Submission Summary (Full Text)

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K060959

APR 1 2 2006

## 510(k) Summary

per 21 CFR §807.92

| Submitter's Name<br>and Address | Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Angela Byland<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared | April 6, 2006 |
| Proprietary<br>Name(s) | Symmetry Balloon Dilatation Catheter |
| Common Name | Balloon Dilatation Catheter |
| Product Code | LIT |
| Classification of<br>Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Symmetry Balloon Dilatation Catheter K953602 October 18, 1995 |
| Device<br>Description | The Symmetry Balloon Dilatation Catheter is an over-the-<br>wire catheter offered in a three lumen catheter shaft design.<br>One lumen, marked "distal", is the central lumen of the<br>catheter which terminates at the distal tip. This lumen is<br>used to pass the catheter over a guidewire. The Symmetry<br>device is designed to be placed over guidewires which have<br>outer diameters of 0.018" or smaller. The lumen marked<br>"balloon" is comprised of two smaller, separate lumens<br>which both communicate with the balloon at one end and<br>terminate in a single balloon hub and lead tube at the<br>proximal end of the device.<br>The Symmetry device is offered in both standard and stiff<br>shaft versions. |
| Intended Use of<br>Device | Symmetry and Symmetry Stiff Shaft Balloon Dilatation<br>Catheters are recommended for Percutaneous Transluminal<br>Angioplasty of small, narrowed or obstructed iliac, femoral,<br>or renal vessels in the peripheral vasculature. |
| Comparison of<br>Technological<br>Characteristics | The materials and design of the Symmetry balloon dilatation<br>catheter are equivalent to the predicate Symmetry Balloon<br>dilatation catheter. |
| Support of<br>Substantial<br>Equivalence | Boston Scientific Corporation considers the proposed<br>Symmetry Balloon Dilatation Catheter to be substantially<br>equivalent to the existing Symmetry Balloon Dilatation<br>Catheter (K953602 cleared October 18, 1995). This<br>assessment is based upon identical device materials and<br>design characteristics and the only change being initiated is<br>to add a single warning to the Directions for Use. |
| Conclusion | Based on the indications for use and the technological<br>characteristics, the Symmetry Balloon Dilatation Catheter<br>has been shown to be equivalent in intended use and is<br>considered to be substantially equivalent to the Symmetry<br>Balloon Dilatation Catheter (K000798; cleared October 18,<br>1995). |

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APR 1 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation c/o Ms. Angela Byland Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566

Re: K060959

Symmetry Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II Product Code: LIT Dated: April 6, 2006 Received: April 7, 2006

Dear Ms. Byland:

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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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 (OS) 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,

R.Z. M.P.

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:

Symmetry Balloon Dilatation Catheter Device Name:

Indications for Use:

Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of small, narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.

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

Over-the-Counter Use (21 CFR 807 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) If Cardiovascular Devices Division o

510(k) Number K060957

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