Nipro Syringe

{0}------------------------------------------------ ### 510(k) Summary: Nipro Syringe ## 807.92(a)(1) | Applicant: | Nipro Medical Corporation<br>3150 NW 107th Ave.<br>Miami FL 33172 | |------------------------------|---------------------------------------------------------------------------| | Establishment Reg.: | 1056186 | | Contact Person: | Jessica Oswald-McLeod<br>Director, Quality Assurance & Regulatory Affairs | | Date of summary preparation: | March 29, 2018 | | | Tel: 305-599-7174 | #### 807.92(a)(2) Trade Name: Nipro Syringe Common Name: Disposable syringe with or without Needle Classification Name: piston syringe Regulation Number: 880.5860 Regulatory Class: II Panel: General Hospital (80) Product Code: FMF #### 807.92(a)(3) Legally marketed substantial equivalent device: Nipro Branded Disposable Syringes, Needles - K944355 #### 807.92(a)(4) Description of device: The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-25G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years. This device is not intended for patients less than 2 years of age. {1}------------------------------------------------ #### 807.92(a)(5) Indications for Use: to inject fluids into or withdraw fluids from the body #### 807.92(a)(6) Comparison of technological characteristics: The syringe is substantially equivalent to the predicate device in the following technological characteristics: | Element of Comparison | Subject device | Predicate device | |----------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Materials | Polypropylene – different grade than predicate to accommodate Ebeam sterilization. Elastomer Stainless steel | Same | | Design: Operational mode | Mechanical | Same | | Design: Physical characteristics | Hollow graduated barrel Plunger rod gasket | Same components; dimensions slightly different than subject device | | Design: Device Configurations | Luer lock Luer slip Eccentric tip With needle Without needle | Same | | Intended Use | to inject fluids into or withdraw fluids from the body | Same | | Sterilization Method | Ebeam Radiation | Ethylene Oxide gas | | Expiry dating | 5 years | Same | | Energy Source | NA | Same | Table 4: Comparison of technological characteristics #### 807.92(b)(1) Non-clinical tests submitted are outlined below. All of these tests were performed within the specifications of the standards listed. - 1. Visual Inspection (ISO 7886-1, ISO 7864-1) - 2. Dimensional Specifications (ISO 7886-1) - 3. Gauging (ISO 594-1) - 4. Mechanical and Performance Characteristic (ISO 7886-1, ISO 7864-1, ISO 594-1, ISO 594-2) - 5. Chemical and biological characteristic (ISO 7886-1, ISO 11137-1) - 6. Sterilization validation (ISO 11137-1, ISO 11137-2, ISO 11137-3) - 7. Transportation tests (ASTM-D4169-09) {2}------------------------------------------------ - 8. Biocompatibility (ISO 10993) - a. Cytotoxicity: MEM Elution - b. Sensitization: Kligman Maximization - Intracutaneous Irritation ﻥ - d. ISO Systemic Toxicity Study in Mice - e. USP Rabbit Pyrogen Study, Material Mediated - f. ASTM Hemolysis Study - g. USP Limulus Amebocyte Lysate (LAL) testing, Kinetic-Chromogenic Method - h. Particulate Analysis Device fluid pathway - 9. Pyrogen testing (ISO 10993-11, USP 39-NF34: 2016, <151> ) - 10. Shelf-life testing (ASTM F1980-07) #### 807.92(b)(2) This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission. #### 807.92(b)(3) Conclusions drawn from non-clinical and clinical tests: There are no differences in fundamental scientific technology and operational mode. There are non-significant differences in materials and physical specifications. The material change is due to the predicate materials not being able to withstand Ebeam sterilization and although there are slight dimensional changes the predicate and the subject device both remain in compliance with all aspects of ISO 7886-1 substantiating the claim of equivalence. The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro Syringe with and without Needle performs equivalent to the predicate device when used as intended. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 30, 2018 Nipro Medical Corporation Jessica Oswald-Mcleod Director, OA/RA 3150 NW 107th Ave. Miami, Florida 33172 Re: K173029 Trade/Device Name: Nipro Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 20, 2018 Received: February 22, 2018 Dear Jessica Oswald-Mcleod: 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. {4}------------------------------------------------ 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 of medical 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.