AbbVie J

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 14, 2015 AbbVie, Inc. Katherine Wortley, Ph.D. Director Regulatory Affairs 1 N. Waukegan Road North Chicago, I1 60064 Re: K142816 Trade/Device Name: AbbVie J Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: January 9, 2015 Received: January 12, 2015 Dear Katherine Wortley, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Benjamin R. Fisher -A Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K142816 Device Name AbbVie J Indications for Use (Describe) The AbbVie J is intended to provide long-term enteral access for administration to the small intestine. The AbbVie J is indicated for the administration of the medication DUOPA (carbidopa enteral suspension). | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | <div> <span> <b> X </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # SUBMITTER AbbVie Inc. 1 N. Waukegan Road North Chicago, IL 60064 Phone: (847) 938-7707 Fax: (847) 775-4997 Contact Person: Katherine Wortley, Ph.D., Director Regulatory Affairs Email: Katherine.wortley@abbvie.com Date Prepared: September 25, 2014 # DEVICE | Name of Device: | AbbVie J | |--------------------------|----------------------------------------------------------------------------------------| | Common or Usual<br>Name: | Intestinal Tube | | Classification Name: | Tubes, Gastrointestinal and Accessories<br>21 CFR 876.5980, Product Code KNT, Class II | # PREDICATE DEVICE AbbVie J, K133096 No reference devices were used in this submission. {4}------------------------------------------------ # DEVICE DESCRIPTION The AbbVie J (List Number 62918) is a 9 FR intestinal (J) tube, 120 cm in length. The kit includes: AbbVie J intestinal tube (polyurethane), Guide Wire (Teflon™-coated stainless steel), Y-Connector, Click Adaptor. The kit is supplied sterile (ethylene oxide). The AbbVie J is inserted through the AbbVie PEG with the aid of the guide wire. The guide wire is used to aid insertion and is removed once the tube is in place. The intestinal tube's tip is placed in the small intestine for the administration of medication in a home and/or healthcare facility environment. A Y-Connector and Click Adaptor are included in the AbbVie J kit to connect the AbbVie PEG and intestinal tubes. # INDICATIONS FOR USE The AbbVie J is intended to provide long-term enteral access for administration of medication to the small intestine. The AbbVie J is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension). ### COMPARISON OF TECHNILOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The proposed device is substantially equivalent to the cleared device (AbbVie J, K133096) as it is identical with the exception of the proposed indication for use with DUOPA. ### PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility Testing The biocompatibility evaluation for the AbbVie J was conducted in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,' published May 1, 1995, FDA Draft Guidance for Industry and Food and Drug Administration Staff: {5}------------------------------------------------ Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" published April 23, 2013 and International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. An intestinal tube is considered an external communicating device through tissue contact, with contact duration greater than 30 days. The battery of testing included the following: - Cytotoxicity Sensitization Irritation (intracutaneous reactivity) Systemic toxicity (acute) Subchronic Toxicity (subacute toxicity) Pyrogen Testing Genotoxicity and Implantation. ### Non-Clinical Performance Data The AbbVie J was assessed for conformance to standard EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors – Design and testing. An assessment of the AbbVie J has been completed and shown to be acceptable per ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications-Part 1: General requirements. Food contact testing was conducted on the AbbVie J and demonstrated that the materials that constitute the AbbVie J are acceptable for food contact use. The study was conducted as described in 21 CFR 177.2600 Indirect Food Additives: Polymers, Rubber articles intended for repeated use per the extractable limits. Performance of the guide wire included in the AbbVie J kit was evaluated per ISO 11070 Sterile single-use intravascular catheter introducers. MR compatibility was assessed in accordance with Guidance for Industry and FDA Staff: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. AbbVie J has passed compatibility testing with the medication DUOPA. {6}------------------------------------------------ # Clinical Performance Data No clinical evaluations were performed or relied upon for the determination of substantial equivalence. # CONCLUSIONS The proposed device, AbbVie J, is substantially equivalent to the predicate device as it is identical to the previously cleared predicate device (AbbVie J, K133096). The indication for use with DUOPA does not alter the intended use (enteral delivery of fluids) or introduce a difference that impacts safety or effectiveness of the device.