MED-RX ORAL/ENTERAL SYRINGE

{0}------------------------------------------------ JUN 0 3 2014 Benlan™ MED-RX® Oral/Enteral Syringes ### SECTION 5 - 510(K) SUMMARY Date of Summary: April 25, 2013 # ()Benlan 2760 Brighton Road Oakville, ON L6H 5T4 Tel (905) 829-5004 Fax (905) 829-5006 Official Contact: Cheryl Brown – QA / RA Manager Proprietary Name: Common Name: Classification Name: Class: Product Code: Predicate Device: MED-RX® Oral/Enteral Syringe Feeding tubes Gastrointestinal tubes and accessories Class II KNT BD Oral/Enteral Syringe with BD UniVia Connection (K112434) ## Device Description The MED-RX® Oral/Enteral Syringe is available in two configurations, an enteral tip syringe and an overmolded enteral tip syringe. Both configurations of the MED-RX® Oral/Enteral Syringe are available in various volumes, from 1 to 60mL. All MED-RX® Oral/Enteral Syringe feature graduation markings along the barrel of the syringe, are provided with a tip cap, and are incompatible with standard luer devices. The MED-RX® Oral/Enteral Syringes are provided sterile, and are single use and disposable. ### Indications for Use The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only. ### Substantial Equivalence The information provided in the premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed MED-RX® Oral/Enteral Syringes are substantially equivalent to the predicate BD Oral/Enteral Sryinge with BD UniVia Connection (K112434). Both proposed and predicate devices have the same intended use to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. Both the proposed device and the predicate device are manufactured from equivalent materials and feature distinct enteral connectors that are not compatible with luer devices or other small bore non-luer devices. The MED-RX® Oral/Enteral Syringes and the BD Oral/Enteral Sryinge with BD UniVia Connection are single-use, sterile devices, packaged in peelable pouches and sterilized using gamma radiation. There are no significant differences between the {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for Benlan MED-RX Oral/Enteral Syringes. The logo features a stylized image of a drop to the left of the word "Benlan" in bold, black letters. Below the name is the text "MED-RX Oral/Enteral Syringes". proposed MED-RX® Oral/Enteral Syringes and the predicate device, BD Oral/Enteral Srvinge with BD UniVia Connection (K112434). Therefore the proposed device can be considered substantially equivalent to a legally marketed device. ### Non-Clinical Test Summary Verification of functional performance of the MED-RX® Oral/Enteral Syringes has been performed. The MED-RX® Oral/Enteral Syringes were subject to numerous performance tests including device functionality, device compatibility with luer and other small bore non-luer devices, cap resistance to leakage, separation of the cap during typical storage conditions, and for natural rubber latex content. All bench testing was successfully completed on both configurations of the MED-RX® Oral/Enteral Syringe: the overmold enteral tip syringe and the enteral tip syringe. #### Summary of Sterilization Each MED-RX® Patient Delivery Set is individually packaged using a medical grade film pouch and sterilized using gamma radiation to a sterility assurance level of 1 x 10°. The radiation dose has been validated as per ANSI/AAMI/ISO 11137-1: 2006. #### Summary of Biocompatibility Tests Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX® Oral/Enteral Syringes are classified as limited duration, mucosal membrane contacting devices. Both configurations of the MED-RX® Oral/Enteral Syringe were tested for biocompatibility. A summary of the testing completed and the relevant standards are listed in Table 1. #### Table 1: Biocompatibility Test Summary | Standard | Test Description . | Results | |--------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------| | ISO 10993-5: 2009 | ISO MEM Elution with L-929 Mouse<br>Fibroblast Cells (Cytotoxicity) | Device is considered non-<br>cytotoxic. | | ISO 10993-10: 2010 | Guinea Pig Maximization Sensitization<br>Test (Method of Biomaterial Extracts) | Device did not elicit a<br>sensitization response. | | ISO 10993-10: 2010 | Intracutaneous Reactivity Test | The requirements of the test<br>have been met by the test<br>article. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a person embracing or supporting another person, with flowing lines representing movement or support. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 June 3, 2014 Benlan, Inc. Cheryl Brown Director of Quality Assurance & Regulatory Affairs 2760 Brighton Road Oakville, Ontario L6H 5T4 Canada Re: K131183 Trade/Device Name: MED-RX® Oral/Enteral Syringes Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 30, 2014 Received: June 3, 2014 Dear Cheryl Brown, 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. {3}------------------------------------------------ Page 2 - Cheryl Brown 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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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. Sincerely yours. Benjamin Fisher-S 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 {4}------------------------------------------------ # SECTION 4 - INDICATIONS FOR USE 510(K) Number (If Known): K131183 Device Name: MED-RX® Oral/Enteral Syringes Indications For Use: The MED-RX® Oral/Enteral Syringes are to be used by a healthcare professional to measure and administer oral medication and enteral nutrition. The MED-RX® Oral/Enteral Syringes are sterile, single use, and for pediatric use only. | Prescription Use: | <div> ✓ </div> | |-----------------------------|---------------------| | (Part 21 CFR 801 Subpart D) | | | AND/OR | | | Over-the-Counter Use | | | (21 CFR 801 Subpart C) | | | N/A | | (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH, Office of Device Evaluation (ODE) Benjamin R. Fisher -S 2014.06.03 17:55:19 -04'00' Page 1 of __ 1