SELECTRA CS LEAD INTRODUCER SYSTEM

K110461 · Biotronik, Inc. · DQY · Apr 20, 2011 · Cardiovascular

Device Facts

• Record ID: K110461
• Device Name: SELECTRA CS LEAD INTRODUCER SYSTEM
• Applicant: Biotronik, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Device Story

Selectra CS lead introducer system facilitates coronary sinus lead placement; assists lead introduction into left heart via coronary sinus; provides access to coronary sinus venous system; enables coronary sinus probing. System includes guiding catheter, dilator, and technical manual. Used by clinicians in clinical settings. Device functions as mechanical guide for lead delivery; output is physical access path for lead implantation. Benefits patient by enabling minimally invasive placement of cardiac leads.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Percutaneous guiding catheter system. Includes catheter and dilator. Sterile, single-use. Mechanical device; no energy source or software. Materials and design are substantially equivalent to predicate ScoutPro ACS.

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 ACS Catheters (K101776)

Submission Summary (Full Text)

{0}------------------------------------------------

# Selectra Lead Introducer System

APR 2 0 2011

# Additional Information for Special 510(k) #K110461

#### 510(K) SUMMARY 1.

Name and Address of Applicant:

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

1028232

Establishment Registration Number:

Device Name:

.

.

.

.

.

Proprietary Name: Classification:

Product Code:

Classification Name:

Selectra Class II (21 CFR 870.1250; 870.1310; 870.1330) Wire, Guide, Catheters, Percutaneous DQY, DRE, DQX

#### General Description:

The Selectra CS lead introducer system is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with introducing leads into 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 following Selectra guiding catheters are the subject of this Special 510(k):

- . Selectra Amplatz 6.0-45
- ♥ Selectra Amplatz 6.0-55

Selectra Straight-55

Selectra BIO2-45

Selectra BIO2-55

- Selectra Straight-45
- . Selectra Extended Hook-45
- . Selectra Extended Hook-રક
- . Selectra Hook-45
- . Selectra Hook-55
- Selectra MPEP-45 .
- Selectra MPEP-55 .
- . Selectra MPH-45
- Selectra MPH-55
- Selectra Right-45 .
- Selectra Right-55

The Selectra Guiding Catheter is packaged with the following components:

- 1 Selectra CS guiding catheter (sterile) .
- . 1 dilator for the guiding catheter (sterile)
- . 1 technical manual or web-card (non-sterile)

#### Device Modification:

The changes made to the Selectra compared to the previously cleared ScoutPro ACS are mainly minor changes in design.

The usage of the Selectra remains unchanged and the product characteristics such as indications for use, contraindications, and functions are identical to the previously cleared ScoutPro ACS quiding catheters in submission K101776, cleared on July 23, 2010. Therefore, this previously cleared version will serve as the predicate device for the modified product family included in this Special 510(k). Predicate Device:

BIOTRONIK's ScoutPro ACS Catheters (K101776, 23-Jul-2010)

- ScoutPro ACS Amplatz 6.0 (45cm) .
- . ScoutPro ACS Amplatz 6.0 L (50cm)

ScoutPro ACS Straight L (50cm)

- ScoutPro ACS BIO2 (45cm) . . ScoutPro ACS BIO2 L (50cm)
- . ScoutPro ACS Straight (45cm)
- . ScoutPro ACS Extended Hook (45cm)
- ScoutPro ACS Extended Hook L (50cm) .

{1}------------------------------------------------

#### BIOTRONIK, Inc., Selectra, Additional Information for Special 510(k) #K110461.

- ScoutPro ACS Hook (45cm) .
- . ScoutPro ACS Hook L (50cm)
- ScoutPro ACS MPEP (45cm) .
- . ScoutPro ACS MPEP L (50cm)
- ScoutPro ACS MPH (45cm) .

#### Indication for Use:

The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

#### Name and Address of Manufacturing Site:

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

#### Name and Address of Manufacturing Site:

BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach, Switzerland 011-41-44-864-5169

#### Name and Address of Contract Sterilizer:

Sterigenics Germany GmbH (reg. no. 3002807090) Kasteler Straße 45 (Rheingaustrasse 190 - 196) D-65203 Wiesbaden, Germany

#### 510(k) Contact Person and Phone Number:

Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 Phone [phone] Fax [phone] [e-mail]

- . ScoutPro ACS MPH L (50cm)
- . ScoutPro ACS Right (45cm)
- ScoutPro ACS Right L (50cm) .

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

APR 2 0 2011

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

Re: K110461

Trade/Device Name: Selectra Lead Introducer System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: February 17, 2011 Received: April 13, 2011

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. 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.

{3}------------------------------------------------

Page 2 -- Mr. Jon Brumbaugh

Please be advised that ITDA '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 of medical device-related adverse events) (21 CFR 803); 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.

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/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 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

{4}------------------------------------------------

K110461

. . . .

# Indications for Use

. . .

### 510(k) Number (if known): TBD

Device Name: Selectra CS Lead Introducer System Indications for Use:

The Selectra CS lead introducer system is used to facilitate lead implantation in the left side of the heart via the coronary sinus.

Prescription Use V (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) | |
|--------------------------------------------------------|-------------|
| | Page 1 of 1 |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices<br>510(k) Number | K110461 |