LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

K111603 · Ep Dynamics, Inc. · DYB · Aug 23, 2012 · Cardiovascular

Device Facts

• Record ID: K111603
• Device Name: LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
• Applicant: Ep Dynamics, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Story

LineBacker Transseptal Introducer is a catheter introducer system; facilitates access to left heart chambers via interatrial septum. Used by physicians in clinical/cardiac catheterization settings to guide cardiovascular catheters. Device provides a pathway for diagnostic or therapeutic instruments; enables transseptal puncture and catheter placement. Benefits include minimally invasive access to left-sided cardiac structures for electrophysiology or other cardiovascular procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Catheter introducer system; designed for transseptal access. Materials and dimensions consistent with standard cardiovascular introducer catheters. Non-active device; no software or electronic components.

Indications for Use

Indicated for use in patients requiring the introduction of cardiovascular catheters into the left side of the heart via the interatrial septum.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Submission Summary (Full Text)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

AUG 2 3 2012

EP Dynamics, Inc. c/o Albert Rego, PhD Regulatory Consultant 27001 La Paz Road, Suite 312 Mission Viejo, CA 92691

Re: K111603

Trade/Device Name: LineBacker Transseptal Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 3, 2012 Received: August 7, 2012

Dear Dr. Rego:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass bared in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1977, ins 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 r ou may, thereferey minuss 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 adulteration. " Teace noter, 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 IT your device is clussified (boo above). Existing major regulations affecting your device can be may of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in further announcements concerning your device in the Federal Register.

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

## Page 2 - Dr. Albert Rego

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleber

/ Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

000087

411603

510(k) Number (if known): Unknown

LineBacker™ Transseptal Introducer Device Name:

Indications for Use:

The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

Prescription Use × (Part 12 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (Part 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 __

~~Vandervoort~~ Mr. Wheeler

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number L111603