PASSEO-35 PTA CATHETER

K082933 · Biotronik, Inc. · DQY · Nov 3, 2008 · Cardiovascular

Device Facts

• Record ID: K082933
• Device Name: PASSEO-35 PTA CATHETER
• Applicant: Biotronik, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Passeo-35 is a peripheral transluminal angioplasty (PTA) balloon catheter used by physicians to dilate stenotic vessels. The device features a dual-lumen shaft: one lumen for balloon inflation/deflation via an external inflation device, and one for 0.035" guide wire passage. Radiopaque markers at balloon ends facilitate fluoroscopic positioning. A tapered soft tip aids advancement through lesions. The balloon is silicone-coated to enhance trackability and pushability. Used in clinical settings, the device allows physicians to restore vessel patency, potentially improving blood flow and treating obstructive lesions in dialysis fistulae.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-lumen catheter design; silicone-coated shaft; radiopaque markers for fluoroscopic visualization; compatible with 0.035" guide wires; inflation/deflation via Luer port; non-implantable; sterile.

Indications for Use

Indicated for patients requiring dilatation of stenotic segments in renal, iliac, femoral, popliteal, and infrapopliteal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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

• Pheron PTA Catheter (K033217, K052757)
• Passeo-18 PTA Catheter (K072765)

Submission Summary (Full Text)

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K6r2933

BIOTRONIK, Passeo-35, Special 510(k)

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November 3, 2008

# Passeo-35 PTA Catheter Special 510(k) Premarket Notification

## 1. 510(K) SUMMARY

Name and Address of Sponsor:

Establishment Registration Number:

Applicant Name and Address:

BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035

1028232

BIOTRONIK AG Ackerstraße 6 8180 Bülach Switzerland

Passeo-35

Device Name:

Proprietary Name: Common Name: Classification: Classification Name: Product Code:

Date Prepared:

DQY

Class II (21 CFR 870.1250)

Percutaneous Transluminal Angioplasty (PTA) Catheter

Catheter, angioplasty, peripheral, transluminal

November 3, 2008

#### General Description:

The Passeo-35 peripheral transluminal angioplasty (PTA) balloon catheter is indicated for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.

The balloon catheter shaft has two Luer ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer sheath (introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating to improve the trackability and pushability characteristics.

#### Predicate Devices:

BIOTRONIK proposes the following PTA catheters cleared through 510(k) notifications as the predicate devices for the Passeo-35 PTA Catheter:

- . BIOTRONIK's Pheron PTA Catheter (K033217, cleared October 31, 2003 and K052757, cleared October 28, 2005)
- BIOTRONIK's Passeo-18 PTA Catheter (K072765, cleared December 12, 2007) .

#### Indication for Use:

The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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| Name and Address of Manufacturer: | BIOTRONIK AG (reg. no. 8043892)<br>Ackerstrasse 6<br>8180 Bülach, Switzerland |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer's Registration Number: | 8043892 |
| Manufacturing Site Contact Person and Phone Number: | Marcel Schaefer<br>BIOTRONIK AG<br>Ackerstraße 6<br>8180 Bülach, Switzerland<br>011-41-44-864-51-78<br>[e-mail] |
| 510(k) Contact Person and Phone Number: | Jon Brumbaugh<br>Vice President, Regulatory Affairs and Compliance<br>BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2008

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Biotronik, Inc. c/o Mr. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, OR 97035

Re: K082933

Trade/Device Name: Passeo-35 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: September 30, 2008 Received: October 1, 2008

Dear Mr. Brumbaugh:

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.

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

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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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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,

R. Vahner

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

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510(k) Number (if known):

1082933

Device Name:

Passeo-35 PTA Catheter

Indications For Use:

The Passeo-35 peripheral dilatation catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Dana R. Vicines

(Division Sinn-Off) (Division of Cardiovascular Devices

510(K) Number K082933