6F ENGAGE/ENGAGE TR INTRODUCER

K101883 · St Jude Medical · DYB · Sep 7, 2010 · Cardiovascular

Device Facts

• Record ID: K101883
• Device Name: 6F ENGAGE/ENGAGE TR INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into the vasculature (femoral, radial, and brachial access) where minimizing blood loss is essential.

Device Story

Engage/Engage TR Introducer is a vascular access device designed to facilitate the insertion of various catheters and electrodes into the femoral, radial, or brachial arteries. The device functions as a conduit for interventional tools while incorporating features to minimize blood loss during the procedure. It is intended for use by clinicians in a hospital or clinical setting. By providing a stable access point and hemostasis, the device assists physicians in performing diagnostic or interventional cardiovascular procedures, ultimately benefiting the patient by reducing procedural blood loss and facilitating efficient catheter navigation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vascular introducer sheath system. Designed for femoral, radial, and brachial access. Features include hemostasis mechanisms to minimize blood loss during catheter introduction. Non-implantable, single-use device.

Indications for Use

Indicated for patients requiring vascular access (femoral, radial, or brachial) for the introduction of angiographic, closed end, or balloon catheters and electrodes, specifically in procedures 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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#### Public Health Service

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

SEP 0 7 2010

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

Re: K101883

> Trade/Device Name: Engage™/Engage™ TR Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: August 5, 2010 Received: August 6, 2010

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. 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.

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## Page 2 - Mr. Venkata Damaraju

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 In addition

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 libsting (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 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,

Bra
Di

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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K101883
SEP. 07 2010

## Indication for Use Statement

- 510(k) Number: K101882

Device Name: Engage™/Engage™ TR Introducer

Indication for Use:

The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into The introduction of the catheero, emoral, radial, and brachial access) 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)

W.A.C.

510(k) Number K100682