(51 days)
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.
Not Found
I apologize, but the provided text from the FDA 510(k) summary for the Engage™/Engage TR™ Introducer does not contain information about acceptance criteria or a study that proves the device meets those criteria.
This document is a marketing clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices. It does not include performance data, clinical study details, or specific acceptance criteria for the device itself.
Therefore, I cannot extract the requested information from the provided 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 (800) 638-2041 or (240) 276-3150 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)
second
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).