INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044

{0}------------------------------------------------ K 052738 VeinRx, Inc. #### 2005 DEC. 6 #### 510(k) Summary | General Information<br>Classification | Class II | |---------------------------------------|-------------------------------------------------------------------------------------| | Trade Name | InfusionCath™ Peripheral Infusion Catheter | | Submitter | VeinRx Inc<br>8200 N.W. 27th Street<br>Suite 102<br>Miami, FL 33122<br>305-716-7005 | | Contact | Gregory J. Mathison<br>Vice President - Regulatory Affairs | # Intended Use The VeinRx Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature. ### Predicate Devices InfusionCath Peripheral Infusion Catheter Manufactured by VeinRx, Inc. K041517 # Device Description The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch. #### Materials All materials used in the manufacture of the InfusionCath Peripheral Infusion Catheter are suitable for this use and have been used in numerous previously cleared products. #### Testing Summary The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests. {1}------------------------------------------------ # Summary of Substantial Equivalence The modified InfusionCath Peripheral Infusion Catheter is equivalent to the predicate product, the original InfusionCath Peripheral Infusion Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. VeinRx, Inc. believes the modified InfusionCath Peripheral Infusion Catheter is substantially equivalent to existing legally marketed devices {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains an image of an eagle with three lines representing its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is written around the top of the circle. The text is written in a bold, sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 2005 DEC 6 Mr. Gregory Mathison Vice President Vein RX, Inc. 8299 NW 27 St. Suite 102 Miami, FL, 33122 Re: K052738 Trade Name: Infusion Catl(TM Regulation Number: 21 CI R 870.3470 Regulation Name: Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 08, 2005 Received: November 11, 2005 Dear Mr. Mathison: 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, 1971, 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 provisions of the Pederal Food, Drug, You may, therefore, market the desire approval of a premarket approval applicat You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing prictice, labeling, and prohibitions against misting and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional cool and class in opecial Confort of Class II (PMA), and (PMA), and Claim be found in the Code of Foderal Revel, time Title of M. Bleving yo be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FiDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Ms. Gregory Mathison Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA S ISSuance of a succession of the requirements of the Act that FDA has made a determination that your device and accracies. You must that FDA has made a decemination administered by other Federal agencies. You must a or any Federal statures and regulations administered of registration and listing (2) comply with all the Act's requirements, including, but not limited to: est comply with an the Act 31equirements, moraans, were and and the requirements as set CrK Part 807), labeling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 510(k) I his letter will anow you to ocgin mankeang your and equivalence of your device to a legally premarket nother in the PDA miding of backers on the sice and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acon (240) 276-0120. Also, please note the regulation entitled, colliact the Office of Comphanes an (21CFR Part 807.97). You may obtain Milsolanding by televelee to premainters in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet and Coliss http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Dura R. Vochner A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use InfusionCath Peripheral Infusion Catheter K052738 510(k) Number (if known): Device Name: Indications For Use: The InfusionCath Peripheral Infusion Catheter is intended for The infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ouma R. Vochmer (Division Sign-Off) (Division Sign-On) Division of Cardiovascular Devices 510(k) Number K0652738 Page 1 of 1