AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

K090867 · Ep Dynamics, Inc. · DYB · Jul 30, 2009 · Cardiovascular

Device Facts

• Record ID: K090867
• Device Name: AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
• Applicant: Ep Dynamics, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

AirBloc™ Transseptal Introducer is a catheter introducer system designed to facilitate access to the left side of the heart. The device is inserted through the interatrial septum to allow for the placement of various cardiovascular catheters. It is intended for use by trained physicians in a clinical or hospital setting. The device functions as a conduit for diagnostic or therapeutic catheters, enabling access to cardiac structures for procedures. It does not contain active electronic components or software.

Clinical Evidence

Bench testing only.

Technological Characteristics

Catheter introducer system. Mechanical device; no electronic or software components. Materials and design are consistent with standard cardiovascular introducer catheters.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EP Dynamics. Inc. c/o Albert Rego, Ph.D. 27001 La Paz #314 Mission Viejo, CA 92691

JUL 8 0 2009

Re: K090867

> Trade/Device Name: AirBloc™ Transseptal Introducer Common Name: Catheter Introducer Regulation Number: 21 CFR 870.1340 Regulatory Class: II Product Code: DYB Dated: July 17, 2009 Received: July 23, 2009

Dear Dr. Rego:

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.

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.

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· Page 2 - Albert Rego, Ph.D.

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/CDRH0ffices/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 your

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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510(k) Number (if known): K090867

Device Name:

AirBloc™ Transseptal Introducer

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter-Use

(Part 12 CFR 801 Subpart D)

(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)

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