Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters

K143193 · Boston Scientific · LIT · Jul 24, 2015 · Cardiovascular

Device Facts

• Record ID: K143193
• Device Name: Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
• Applicant: Boston Scientific
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 24, 2015
• 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 indicated for Percutaneous Transluminal Angioplasty of narrowed or obstructed iliac, femoral, or renal vessels in the peripheral vasculature.

Device Story

Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters are percutaneous catheters used by physicians for angioplasty in peripheral vessels. The device consists of a balloon catheter designed to dilate narrowed or obstructed iliac, femoral, or renal arteries. It is operated by a physician in a clinical setting. The device is inserted into the vasculature to mechanically expand the vessel lumen, improving blood flow. The primary change from the predicate is the use of a new Pebax resin in the shaft due to vendor discontinuation of the previous material. The device is provided sterile.

Clinical Evidence

Bench testing and biocompatibility testing only. No clinical data provided.

Technological Characteristics

Percutaneous balloon dilatation catheter. Materials include Pebax resin in the shaft. Sterilization via established methods. Device is a mechanical catheter; no electronic components, software, or connectivity.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty for narrowed or obstructed iliac, femoral, or renal peripheral vessels.

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 (K060959)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2015

Boston Scientific Ms. Anna Deraney Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311

Re: K143193

Trade/Device Name: Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 5, 2015 Received: June 8, 2015

Dear Ms. Deraney:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 801and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

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807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kenneth J. Cavanaugh -S

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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## 510k Summary

## Per 21 CFR §807.92

| Common or Usual<br>Name | Balloon Dilatation Catheter | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Trade Name(s) | Boston Scientific Symmetry™ and Symmetry Stiff Shaft Balloon<br>Dilatation Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal | |
| Classification of<br>Device | Symmetry Balloon Dilatation catheters and accessories have been<br>classified as Class II devices according to 21 CFR 870.1250 -<br>Percutaneous Catheter. | |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311-1566 | |
| Contact Name and<br>Information | Anna Deraney<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Section 514 of the<br>Act Performance<br>Standards | Currently no FDA mandated or voluntary performance standards exist<br>for this device. | |
| Establishment<br>Registration<br>Numbers | Owner /Operator: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752 |
| | Manufacturing<br>Facility: | Boston Scientific Ireland Ltd. (BSIL) |
| | Ballybrit Business Park<br>Galway, Ireland | |
| | ERN: 9681260 | |
| | Sterilization<br>Facilities: | Synergy Health Ireland Limited<br>IDA Business & Technology Park<br>Tullamore, County Offaly, Ireland |
| Predicate Devices | Symmetry Balloon Dilatation Catheter K060959 cleared April 12,<br>2006. | |
| Intended Use/<br>Indications for Use | Symmetry™ and Symmetry Stiff Shaft Balloon Dilatation Catheters<br>are indicated for Percutaneous Transluminal Angioplasty of narrowed<br>or obstructed iliac, femoral, or renal vessels in the peripheral<br>vasculature. | |
| Comparison of<br>Required<br>Technological<br>Characteristics | The proposed Symmetry Balloon Dilatation Catheter is substantially<br>equivalent to the existing Symmetry Balloon Dilatation Catheter<br>cleared by FDA under premarket notification K060959 (April 12,<br>2006). Symmetry has the same intended use, scientific technology,<br>design, materials (with the exception of the Pebax resin used in the<br>shaft), sterilization method, and packaging materials as the applicable<br>predicate device.<br><br>The vendor is discontinuing the supply of the current Pebax resin,<br>which is used in the shaft of the device; therefore a new resin is being<br>supplied. | |
| Summary of Non-<br>Clinical Test<br>Summary | Bench testing and biocompatibility testing were performed to support a<br>determination of substantial equivalence. The results of these tests<br>provide reasonable assurance that the proposed device has been<br>designed and tested to assure conformance to the requirements for its<br>intended use. No new safety or performance issues were raised<br>during the device testing. | |
| Conclusion | Based on the indications for use, technological characteristics, and<br>safety and performance testing, the proposed Symmetry Balloon<br>Dilatation Catheter has been shown to be appropriate for its intended<br>use and is considered to be substantially equivalent to the Symmetry<br>Balloon Dilatation Catheter (K060959). | |

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