FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER

K093026 · Footprint Medical · DYB · Feb 24, 2010 · Cardiovascular

Device Facts

• Record ID: K093026
• Device Name: FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
• Applicant: Footprint Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

This device is intended to facilitate placing a catheter through the skin into a vein or artery.

Device Story

The Footprint Medical 1.9 Fr PICC Introducer is a catheter introducer used to facilitate the percutaneous placement of catheters into the vascular system. It functions as a conduit for catheter insertion. The device is intended for use by healthcare professionals in clinical settings. It provides a pathway for venous or arterial access, aiding in the successful placement of indwelling catheters for patient treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

1.9 Fr catheter introducer; percutaneous access device; Class II; Product Code DYB; 21 CFR 870.1340.

Indications for Use

Indicated for facilitating the percutaneous placement of a catheter into a vein or artery.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB 2 4 2010

FEB 24 2010

Footprint Medical, Inc. c/o Mr. Clyde Baker 1203 Camden Street San Antonio, TX 78215

Re: K093026

·Trade/Device Name: Footprint Medical 1.9 Fr PICC Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 20, 2010 Received: January 27, 2010

Dear Mr. Baker:

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.

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 – Mr. Baker

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,

Dune R. Visher

Bram Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

______________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): K-093026

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use: This device is intended to facilitate placing a catheter through the skin into a vein or artery.

Prescription Use ___xx________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Alleries B. Valmer (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_ko 930ZG