KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular pattern around a symbol. The symbol is a stylized representation of three human profiles facing right, with a wing-like shape above them. JUL - 6 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Paul W. Evans Director, Regulatory Affairs The Kendall Company A Division of Tyco Healthcare Group LP 15 Hampshire Street Mansfield, Massachusetts 02048 Re: K042461 Trade/Device Name: Kendall/Argyle 1.9 Fr. Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 9,2004 Received: September 15,2004 Dear Mr. Evans: This letter corrects our substantially equivalent letter of December 10,2004 regarding the product code and classification (regulation number and name). 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 (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. {1}------------------------------------------------ Page 2 - Mr. Evans 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely Yours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 14042461 510(k) Number: Device Name: Kendall / Argyle 1.9 Fr Neonatal / Pediatric Peripherally Inserted Central Catheter (PICC) ### Indications for Use: The catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cutdown as well. The catheter may be used to administer fluids for hydration and parenteral nutrition, as well other commonly used intravenous medications. ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Prescription Use OR Over-The Counter Use_ (Per 21 CFR §801.109) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) i. Kunk v. Kunk (Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control. Dental Devices 510(k) Number: Kay 2 רקי 06 {3}------------------------------------------------ K042461 DEC 1 0 2004 #### H. SMDA Information Summary of Safety and Effectiveness | Submitted by: | The Kendall Company<br>15 Hampshire Street<br>Mansfield, MA 02048 | |----------------------|---------------------------------------------------------------------------------------------------| | Contact Person: | Paul W. Evans<br>(508) 261-8203 | | Date Prepared: | September 9, 2004 | | Proprietary Name: | Kendall Argyle® 1.9 Fr Dual Lumen<br>Neonatal/Pediatric Peripherally Inserted<br>Central Catheter | | Common Name: | Peripherally Inserted Central Catheter (PICC) | | Classification Name: | Long-term catheters (30 days or more) | | Predicate Devices: | L-Cath Peel Away System (K920755) | | | VYGON Premi-Cath – Long Term Catheter<br>(K954302) | | | Neo-PICC (K970434) | | | Kendall Argyle 2.0 Fr. Single Lumen PICC<br>(K974015) | ## Description of the Device: The Argyle 1.9 Fr Neonatal/Pediatric Peripherally Inserted Central Catheter PICC) is a dual lumen polyurethane tube that bifurcates into two 5.0 Fr polyurethane tubes (pigtails), the proximal ends of the tubes ending in insert molded hubs. One pigtail is longer than the other. The primary longer lumen will be clear. The shorter secondary lumen will be tinted a lavender color to distinguish it from the primary lumen. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains a sequence of handwritten characters. The sequence appears to be "K442461". The characters are written in a simple, somewhat cursive style, with varying stroke thicknesses. The image is in black and white. ## Intended Use of the Device: The proposed PICC catheter is designed for cases in which venous catheterization or long term I.V. administration is necessary in the neonate or pediatric patient. Placement is routinely achieved from a peripheral venous site. The catheter may be used to administer fluids simultaneously for hydration and parenteral nutrition, as well as other commonly used intravenous medications. ## Technological Characteristics: The Argyle Neonatal / Pediatric PICC is equivalent to the referenced predicate devices in that they are fabricated from similar materials, have the same function, equivalent indications for use, and similar overall design. ## Nonclinical testing: Biocompatibility testing was performed on the Argyle PICC catheter, following ISO-10993 Biological Evaluation of Medical Devices. The testing found that the materials used in the Kendall Argyle PICC catheter are biocompatible.