Merit 10mL Syringe

{0}------------------------------------------------ Image /page/0/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 image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of a staff with two snakes coiled around it and a pair of wings at the top. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 17, 2014 Merit Medical Systems, Incorporated Ms. Mridi Kumathe 1600 West Merit Parkway South Jordan, UT 84095 Re: K142636 Trade/Device Name: Merit 10mL Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Merit 10mL Syringe Regulatory Class: II Product Code: FMF Dated: 9/15/2014 Received: 9/17/2014 Dear Ms. Kumathe: 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. {1}------------------------------------------------ Page 2 - Mr. Kumathe 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 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 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/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Susan Russo, DDS, MA Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K142636 Device Name Merit 10mL Syringe Indications for Use (Describe) The Merit 10mL Syringe is used to inject fluids into, or withdraw fluids from, the body. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ # 5.0 510(k) Summary | General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>(801) 208-4712<br>(801) 253-6921<br>Mridi Kumathe<br>09/15/2014<br>1721504 | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Merit 10mL Syringe<br>Merit 10mL Syringe<br>Piston Syringe | | Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Merit 20mL Syringe<br>Syringe, Piston<br>K111091<br>Merit Medical Systems, Inc. | | Classification | Class 2<br>21 CFR § 880.5860<br>FDA Product Code: FMF<br>Review Panel: General Hospital | | | Intended Use | The Merit 10mL Syringe is used to inject fluids into, or withdraw fluids<br>from, the body. | | | Device<br>Description | The Merit 10mL Syringe is a device consisting of a calibrated hollow<br>barrel into which is inserted a closely fitted movable plunger and seal.<br>The barrel contains a male Luer lock connector (which conforms to ISO<br>594-1 & 2 standards) which is compatible for attaching devices with<br>standard female Luer hubs. | | | Comparison to<br>Predicate<br>Device | The indications for use, principle of operation and technological<br>characteristics of the subject device are identical to the predicate<br>device. Both devices have been designed and tested to ensure<br>compliance with the same set of consensus standards listed below. The<br>subject device (Merit 10mL Syringe) is substantially equivalent to the<br>predicate device (Merit 20mL Syringe). | | {4}------------------------------------------------ FDA quidance and recognized performance standards have been established for "piston syringes" under Section 514 of the Food, Drug and Cosmetic Act. FDA Guidance Document "Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, April 1993" was consulted in the preparation of this 510(k) submission. A battery of tests was performed based on the requirements of the below recognized performance standards, as well as biocompatibility, sterilization, and labeling standards and quidance. Conformity to these standards demonstrates that the subject Merit 10mL Syringe met the standards' established acceptance criteria applicable to the safety and efficacy of the device. Performance testing was conducted based on the risk analysis and based on the requirements of the following international consensus standards/documents: - ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [Including Technical Corrigendum 1 (1995)] - . ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements - . ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings - . ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - . ISO 10993-7:2008. Biological Evaluation of Medical Devices. Part 7: Ethylene Oxide Sterilization Residuals - . AAMI TIR 28, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization - ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 - . ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices – Part 4: Selection of tests for interaction with blood - ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity - . ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization - ISO 10993-11:2006. Biological evaluation of medical devices -Part 11: Tests for systemic toxicity - ASTM F756-08:2008, Standard Practice for Assessment of . Hemolytic Properties of Materials - United States Pharmacopeia 37, National Formulary 32, 2014 <151> Pyrogen Test Safety & Performance Tests {5}------------------------------------------------ ### Performance Testing-Bench ISO 7886-1 - Cleanliness . - Sufficient/excessive Lubricant ● - Capacity Tolerance ● - Graduated Scale . - Scale Uniformity . - Scale - Evenly spaced - Scale Vertical Alignment . - Scale - Increments - Scale Vertical Print ● - Scale Length . - Scale Position . - Capacity 10% > Nominal . - Finger Grips - Piston/Plunger Assembly ● - . Piston fit in Barrel - Fiducial line on Barrel ● - Nozzle Placement ● - Nozzle Lumen . - Dead Space ● - Liquid Leak Test . - Air Leak Test ● - Acidity / Alkalinity ● - . Extractable Metals #### ISO 594-2 - Luer Gauging . - Liquid Leak Test ● - Air Leak Test . - Separation Force ● - Unscrewing torque . - Ease of assembly ● - Resistance to overriding . - Stress Cracking ● Merit's Risk Analysis - Plunger Seal Detachment Test ● - Ink Adhesion Test ● Safety & Performance Tests cont. {6}------------------------------------------------ ### Biocompatibility - Cytotoxicity ● - Sensitization - Irritation . - Acute Systemic Toxicity ● - Pyrogenicity ● - . Hemocompatibility The results of the testing demonstrated that the subject Merit 10mL Syringe met the predetermined acceptance criteria applicable to the safety and efficacy of the device. # Summary of Substantial Equivalence Based on the indications for use, design, safety and performance testing, the subject Merit 10mL Syringe meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit 20mL Syringe, K111091 manufactured by Merit Medical Systems, Inc..