ENGAGE/ENGAGE TR INTRODUCERS

K111092 · St Jude Medical · DYB · Jun 9, 2011 · Cardiovascular

Device Facts

• Record ID: K111092
• Device Name: ENGAGE/ENGAGE TR INTRODUCERS
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 9, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Engage™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential. The Engage TR™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a radial vessel where minimizing blood loss is essential.

Device Story

Engage/Engage TR Introducer is a catheter introducer system designed for percutaneous vascular access. Device facilitates insertion of diagnostic/interventional catheters and electrodes into blood vessels while maintaining hemostasis to minimize blood loss. Used by clinicians in clinical settings (e.g., cath lab) for vascular procedures. Operates as a mechanical conduit; provides access path for secondary devices. Benefits include reduced blood loss during catheterization procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Percutaneous catheter introducer; mechanical design for vascular access and hemostasis; intended for femoral, radial, and brachial artery use.

Indications for Use

Indicated for introduction of angiographic, closed end, balloon catheters, and electrodes into blood vessels (femoral, radial, brachial) where minimizing blood loss is required.

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

St. Jude Medical Cardiovascular Division c/o Mr. Venkata Damaraju Regulatory Affairs Specialist 177 East Country Road B St. Paul, MN 55117

JUN - 9 2011

Re: K111092

Trade/Device Name: Engage™/Engage TRTM Introducer Regulation Number: 21 CFR 870.1250 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: May 20, 2011 Received: May 23, 2011

Dear Mr. Damaraju:

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. Venkata Damaraju

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/CDRHQffices/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.

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

Enclosure

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## Indication for Use Statement

510(k) Number: K||092

Device Name: Engage™/Engage TR™ Introducer

## Indication for Use:

The Engage™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

The Engage TR™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a radial vessel where minimizing blood loss is essential.

Prescription Use: X (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)

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