SCOUTPRO 7F LONG CATHETERS

K093303 · Biotronik, Inc. · DQY · Nov 20, 2009 · Cardiovascular

Device Facts

• Record ID: K093303
• Device Name: SCOUTPRO 7F LONG CATHETERS
• Applicant: Biotronik, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Device Story

ScoutPro 7F Long Catheters are delivery systems for coronary sinus leads; used to assist lead introduction into left-sided heart vessels via coronary sinus; facilitates coronary sinus access and probing. System includes guiding catheters with seven distal arc shapes and associated dilators. Modification from predicate involves 5 cm increase in length and modified X-ray marker; patient-contacting materials remain identical. Used in clinical settings by physicians to facilitate lead implantation; output is physical access to coronary sinus for lead placement; benefits include improved reach for lead delivery.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Percutaneous guiding catheter system; 7F diameter; seven distal arc shapes; modified X-ray marker; includes dilator. Materials identical to predicate. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring lead implantation in the left side of the heart via the coronary sinus.

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

• ScoutPro 7F (K060807)
• ScoutPro 7F (K072329)

Submission Summary (Full Text)

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5093303

BIOTRONIK, ScoutPro 7F Long Catheters, Special 510(k)

October 20, 2009

## ScoutPro 7F Long Guiding Catheters Special 510(k) Premarket Notification

1028232

NOV 2 0 2009

## 1. 510(k) SUMMARY

Name and Address of Sponsor:

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

Establishment Registration Number:

Device Name:

Proprietary Name:

ScoutPro 7F Sheath Multipurpose Hook L

ScoutPro 7F Sheath Amplatz 6.0 L

... ScoutPro 7F Sheath BIO2 L

ScoutPro 7F Sheath MPEP L

ScoutPro 7F Sheath Hook L

ScoutPro 7F Sheath Extended Hook L

ScoutPro 7F Sheath Extended Hook Right L

Class II (21 CFR 870.1250; 870.1310; 870.1330) Classification: Guide, Catheters, Percutaneous Classification Name: DQY, DRE Product Code:

### General Description:

ScoutPro 7F is a delivery system for coronary sinus leads. It is designed to assist with introducing leads into the vessels of the left side of the heart via the coronary sinus. The system also facilitates access to the coronary sinus venous system as well as probing the coronary sinus. The system contains guiding catheters with seven distal arc shapes and accessories to facilitate the lead implantation. This Special 510(k) introduces additional catheters as shown below, which have the same distal arc shapes but are 5 cm longer in length: :

ScoutPro 7F Sheath Hook L

ScoutPro 7F Sheath Multipurpose Hook L

ScoutPro 7F Sheath Amplatz 6.0 L

ScoutPro 7F Sheath BIO2 L

ScoutPro 7F Sheath MPEP L

ScoutPro 7F Sheath Extended Hook L

ScoutPro 7F Sheath Extended Hook Right L

Each of these catheters is separately available from the ScoutPro 7F kit and contains the following components:

- · 1 quiding catheter
• 1 (long) dilator for the guiding catheter

36

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#### Device Modification: .

The main difference between the predicate device ScoutPro 7F catheters and the ScoutPro 7F long catheters described in this documentation is the long catheters also utilize a modified X-ray marker which is described in this document; however the patient contacting materials remain identical to the predicate. Additionally, a new dilator which is identical to the predicate but differs in length is also described.

## Predicate Device:

BIOTRONK's ScoutPro 7F (#K060807, 24-Apr-2006)

- ScoutPro 7F Sheath Amplatz 6.0 .
- ScoutPro 7F Sheath Hook .
- ScoutPro 7F Sheath Multipurpose Hook .

BIOTRONIK's ScoutPro 7F (#K072329, 25-Mar-2008)

- ScoutPro 7F Sheath BIO2 .
- . ScoutPro 7F Sheath Extended Hook
- ScoutPro 7F Sheath Extended Hook Right .
- ScoutPro 7F Sheath MPEP | i .

#### Indication for Use:

The ScoutPro 7F long catheters are used in coniunction with the ScoutPro 7F CS Lead Introducer System to facilitate lead implantation in the left side of the heart via the coronary sinus.

Name and Address of Manufacturer:

BIOTRONIK SE & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-1210

Name and Address of Contract Manufacturer: BIOTRONIK AG (reg. no. 8043892)

Contact Person(s) and Phone Number:

Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169

Jon Brumbaugh VP, Regulatory Affairs and Compliance Phone [phone] Fax [phone] jon [e-mail]

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

NOV 2 0 2009

Re: K093303

Trade/Device Name: ScoutPro 7F Long Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY, DRE Dated: October 20, 2009 Received: October 21, 2009

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 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 - Mr. Jon Brumbaugh

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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):

K093303

Device Name:

ScoutPro 7F Long Catheters

Indications For Use:

The ScoutPro CS lead introducer system and its separately available accessories are used to facilitate lead implantation in the left side of the heart via the coronary sinus.

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 e of Device Evaluation (ODE)

W.M.

on Sian-Off Division of Cardiovascular Devices

510(k) Number K093303

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