AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET

{0}------------------------------------------------ K120272 Page 1 of 5 #### Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions FEB 1 7 2012 SECTION 5 510(k) SUMMARY - Date of Submission: September 26, 2011 - Official Contact: Keith Rooks RA/QA Manager Kentec Medical, Inc. #### Address of Manufacturing - Facility: Kentec Medical Technology Co. 90 Gao Xin Road, ZhouZhuang Kunshan 215325, China T: 86 512 5720 0500 - Proprietary Name: Kentec Medical Ameritus® Enteral Feeding Extension Set (EFES) - Common/ Usual Name: Gastrointestinal tubes and accessories Classification Reference: 21 CFR 876.5980 KNT Product Code: Predicate Devices: NeoMed Enteral Only Extension Set (K100288) CORFLO Anti-I.V. Enteral Feeding Extension Set (K083786) CORFLO Anti-I.V. Enteral Feeding Extension Set 20-1060AIV-S (K083791, K083786) #### Indication for Use: The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric/ oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system. #### Patient Population/ Environment of Use: The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements. The Enteral Feeding Extension Set is a sterile disposable for single patient use only. {1}------------------------------------------------ K120272 Page 245 #### Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Ouestions ### Substantial Equivalence The EFES is substantially equivalent to many commercially available enteral feeding extension sets. The EFES' indications for use and FDA Product Code/ Classification Codes are identical to the NeoMed Enteral Only Extension Set (K100288) and are substantial equivalent to both the CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension Set (K083786) and the CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set Model # 21-1060AIV-S (K083791). The Kentec Medical EFES components' biocompatible materials are either identical to, or substantially equivalent to: - The NeoMed Enteral Only Extension Set (K100288), . - . The CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension Set (K083786) and/ or - The CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set . Model # 21-1060AIV-S (K083791). The EFES' Technical Characteristics, Packaging and Ethylene Oxide Sterilization Characteristics, as well as Labeling Characteristics, are substantially equivalent to: - The NeoMed Enteral Only Extension Set (K100288), . - The CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension . Set (K083786) and/or - The CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set . Model # 21-1060AIV-S (K083791). The EFES and its components successfully completed in-vitro testing which demonstrated that the device functions according to its specifications (including the inability to connect to a Luer connection) and is thus substantially equivalent in function to - The NeoMed Enteral Only Extension Set (K100288), . - The CORPAK MedSystem's CORFLO Anti-I.V. Enteral Feeding Extension . Set (K083786) and/ or - The CORPAK MedSystem's Anti I.V. Enteral Feeding Extension Set . Model # 21-1060AIV-S (K083791). Design verification tests were performed on the EFES as a result of the risk analysis and product requirements. The following tests and analysis were conducted demonstrating the EFES met the acceptance criteria. {2}------------------------------------------------ K120272 Page 3 of 5 #### Kentec Medicał, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions | Specific Test | Test Model | Justification | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Extension Set<br>Connector Tensile Test | Kentec Medical EFES,<br>NeoMed Enteral Only<br>Extension Set (K100288) and<br>CORFLO EFES (K083791,<br>K083786) tested | Actual proposed device,<br>predicate (K100288) and<br>predicate (K083791) tested | | Extension Set<br>Liquid Leakage Test | EFES, NeoMed Enteral Only<br>Extension Set (K100288) and<br>CORFLO EFES (K083791,<br>K083786) tested | Actual proposed device,<br>predicate (K100288) and<br>predicate (K083791) tested | | Luer Connection Testing<br>(anti-IV test connection) | EFES | Actual proposed device tested | | Flow Characteristics | EFES | Actual proposed device tested | | ISO 80369-1 requirements | EFES | Actual proposed device tested | | Size and Material Inspection | EFES | Actual proposed device tested | | Biocompatibility Test (EFES<br>materials) | EFES | Actual proposed device tested | | Biocompatibility Test (orange<br>colorant) | EFES | Actual proposed device tested | | Sterilization Related Test | EFES | Actual proposed device and<br>packaging integrity tested | | Storage and Shelf Life Test<br>(accelerated-time aging) | EFES | Actual proposed device and<br>packaging integrity tested | | Package Related Test | EFES | Actual proposed device<br>packaging integrity tested | #### Device Description The Kentec Medical Enteral Feeding Extension Set (EFES) is a sterile disposable device for single patient use only. The device is designed to connect existing feeding tubes (nasogastric, oralgastric, gastric, etc) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The device consist of flexible PVC tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors. The basic set (OC-ENT-60) consists of tubing with a step connector (catheter tip) and an oral syringe connector not compatible with intravencus (I.V.) tubing or stopcocks. Other variations include: - The basic set with shorter tubing (OC-ENT-36) t - The basic set with step connector changed into oral syringe connector . (20C-ENT-60) {3}------------------------------------------------ K120272 Page 4 of 5 #### Kentec Medical, Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions - The basic set with the addition of a "Y" site with an oral syringe connector . to allow the clinician to attach other equipment. #### Connectors The Enteral Feeding Extension Set (EFES) incorporates safety oral syringe connectors which eliminate the risk of I.V. administration through the feeding tube, i.e., the safety connectors do not mate with Luer Lock or Luer slip fittings. Analytical comparison and lab testing of the EFES' connector's dimensions to others devices listed in ISO 80369-1 allow the conclusions that: - The EFES' connectors are substantial equivalent to the NeoMed (K100288) and the CORPAK (K083786, K083791) devices. - · The EFES' oral syringe female connector is not compliant with the ISO 594 standard's (Luer) connector requirements (i.e., does not connect). - The EFES' oral syringe female connector is not compliant with other small-bore connectors listed in the ISO 80369-1, except for enteral feeding tips. The EFES connector analytical engineering evaluation demonstrated that the width (inner diameter, ID) of the EFES female connector is much larger than the ISO 594 Male Luer Connector standard I.V. connector outside diameter (OD) dimension [Φ3.925mm-Φ4.027 mm].Thus, the EFES female connector cannot physically fit into an ISO 594 rigid male Luer connector or naturally disengaged without any force, and does not conform to the ISO 594 standard's requirements. While Kentec Medical has searched for an applicable standard for the dimensions of oral enteral feeding syringes' rigid male connectors, none were found. However, in order for hospital to purchase feeding syringes from a variety of manufactures and be assured that these different devices will all be compatible with the hospitals' existing equipment, the industry utilizes the same male connector OD dimensions, e.g., a "common use" industry standard. To ensure these "common use" dimensions were tested, the EFES was evaluated against two (2) commercially available oral enteral feeding syringes in relation to their connectors. These analyses demonstrated that the Kentec Medical Enteral Feeding Extension Set dimensions fit well within the male connector of commercially available feeding syringes, e.g., the Philips Children's Medical Venture Oral/Enteral Syringe (K100099)), the Kentec Medical Oral/Enteral Syringe (K110853). {4}------------------------------------------------ K120272 Page 575 #### Kentec Medical; Inc. Ameritus® Medical Enteral Feeding Extension Set Response to December 7, 2011 Questions #### Materials The Enteral Feeding Extension Sets are manufactured from polyvinyl chloride (PVC) tubing. The connectors, caps, and slide clamps are manufactured of several plastics: PVC, Polypropylene (PP), and Polyethylene (PE). All materials have been evaluated in accordance with ISO 10993-1 Biological Evaluation of Medical Device – Part 1: Evaluate and Testing. Based on comparisons to these materials used in other devices, no additional biocompatibility testing was necessary; however, Kentec Medical conducted three confirmatory tests (cytotoxicity, sensitization, and irritation) which confirmed the acceptable biocompatible status of these materials. The EFES' component materials are substantial equivalent to the materials utilized in the NeoMed (K100288) and the CORPAK (K083786, K083791) devices. #### Conclusion The conclusions drawn from the actual conducted (as well as the referenced) analytical engineering evaluations, the nonclinical tests and the commercial use of similar and predicate devices, demonstrates that the Kentec Medical Enteral Feeding Extension Set (EFES) is as safe and effective as the legally marketed (predicate) devices. {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned above three wavy lines, which may represent the nation's waters. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Kentec Medical, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 FEB 1 7 2012 Re: K120272 Trade/Device Name: Ameritus® Medical Enteral Feeding Extension Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 27, 2012 Received: January 30, 2012 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device w onave and have 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 for abe said in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered processified 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 r ou may, arerelove, 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 adulteration. Thease noter of 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 your device is exassimou 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 that I Dr. Has made a cond regulations administered by other Federal agencies. You must of any I coordi statutes and regulements, including, but not limited to: registration and listing Comply with an the roll blog (21 CFR Part 801); medical device reporting (reporting of medical {6}------------------------------------------------ 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerély vours, Sincerely yours, Benjamin K. Evanko 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 {7}------------------------------------------------ Kentec Medical Enteral Feeding Extension Set PreMarket Notification [510(k)] Application #### SECTION 4 INDICATION FOR USE STATEMENT Page 1 of 1 # 510(k) Number (if known): _ K12 0272 # Device Name: Ameritus® Medical Enteral Feeding Extension Set #### Indication for Use: The Ameritus® Enteral Feeding Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety naoogaatires which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system. #### Patient Population/ Environment of Use: The Enteral Feeding Extension Set is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements. The Enteral Feeding Extension Set is a sterile disposable for single patient use only. Prescription Use X (Part 21 CFR 801 Subpart D) AND/ OR Over-The-Counter Use (Part 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) Tom McWhirter Division Sign-Off) ivision of Reproductive, Gastro-Renal, and Irological Devices K12027) 510(k) Number