Merit Syringe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 31, 2018 Merit Medical Systems, Inc. Cory Marsh Assoc. Manager, Regulatory Affairs 1600 W Merit Parkway South Jordan, Utah 84045 Re: K173601 Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 20, 2017 Received: November 21, 2017 Dear Cory Marsh: We have reviewed vour 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}------------------------------------------------ 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-S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173601 Device Name Merit Syringe Indications for Use (Describe) The Merit Syringe is used to inject fluids into, and 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 K173601 | General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date Prepared:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>(801) 316-3690<br>(801) 826-4112<br>Mr. Cory Marsh<br>November 20, 2017<br>1721504 | | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | Merit Syringe<br>Piston Syringe<br>Syringe, Piston<br>2<br>FMF<br>880.5860<br>General Hospital | | | Predicate<br>Device | Trade Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Premarket Notification:<br>Manufacturer: | Welmed Hypodermic Syringe<br>Syringe, Piston<br>2<br>FMF<br>880.5860<br>K070936<br>Welmed, Inc. | | | Device<br>Description | The Merit Syringe contains a calibrated hollow barrel into which is<br>inserted a closely fitted movable plunger and tip or O-Ring. The barrel<br>contains an ISO 594-2 compliant fixed male luer connector, which is<br>compatible with ISO 594-2 compliant female luer hubs. | | | | Indications for<br>Use | The Merit Syringe is used to inject fluids into, and withdraw fluids from, | the body. | | | Comparison to<br>Predicate<br>Device | | The proposed Merit Syringe incorporates the same intended use, as<br>well as similar materials, design and principle of operation as the<br>predicate Welmed Hypodermic Syringe. Any differences in materials<br>used or operating volume are supported by the subject device's<br>compliance with FDA recognized standards ISO 7886-1 and ISO 594-2.<br>The subject device is substantially equivalent to the predicate device. | | | Attribute | Subject Device – Merit<br>Syringe | Predicate Device –<br>Welmed Syringe | | | Comparison to<br>Predicate<br>Device cont'd | Design | Standard three-piece<br>piston syringe constructed<br>with a clear hollow barrel<br>into which is inserted a<br>closely fitting movable<br>plunger and tip or O-Ring.<br>Fitting offered with male<br>luer lock. | Standard three-piece<br>piston syringe constructed<br>with a clear hollow barrel<br>into which is inserted a<br>closely fitting movable<br>plunger and tip/seal.<br>Fitting offered with male<br>luer lock. | | | Material | The barrel is constructed<br>from clear polycarbonate;<br>the plunger from ABS<br>material; the seal or O-<br>Ring is made of silicone<br>material. | Materials used in the<br>manufacture of the<br>Welmed syringe are<br>typically used in the<br>manufacture of general-<br>purpose syringes. | | | Principle of<br>Operation | Manually operated by<br>advancing and<br>withdrawing the plunger<br>within the barrel. | Manually operated by<br>advancing and<br>withdrawing the plunger<br>within the barrel. | | | Operational<br>Volume | Operational volume of<br>0.25, 1, 3, 6, 10, 20, 30<br>and 60 mL. | Operational volume of 1,<br>3, 5, 10, 20, 30, and 60<br>mL. | | | Graduation | Printed with accurate<br>graduation lines that are<br>compliant with ISO 7886-<br>1. | Printed with accurate<br>graduation lines that are<br>compliant with ISO 7886-<br>1. | | | Intended<br>Use | The Merit Syringe is used<br>to inject fluids into, and<br>withdraw fluids from, the<br>body. | The intended use of the<br>Welmed piston syringe is<br>to inject fluids into, and<br>withdraw fluids from, the<br>body. | {4}------------------------------------------------ FDA guidance and recognized consensus standards have been established for Piston Syringes under FDA Product Code FMF and 21 CFR 880.5860. A battery of tests was performed based on the Performance requirements of the below recognized consensus standards and Data guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed Merit Syringe met the standards' established acceptance criteria for the device. - ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [Including Technical Corrigendum 1 (1995)] - ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, . {5}------------------------------------------------ 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 [including: technical corrigendum 1 (2009)]. - . AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization - . ISO 11137-1:2006. Sterilization of Health Care Products – Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices [Including: Amendment 1 (2013)] - ISO 11137-2:2013, Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose - ISO 11607-1:2006, Packaging for Terminally Sterilized Medical ● Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)] - Performance Data cont'd - . ASTM D4169-14: 2014. Standard Practice for Performance Testing of Shipping Containers and Systems - ASTM F1980-07:2007, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Reapproved 2011) - . ISO 2233:2000. Packaging - Complete, filled transport packages and unit loads – Conditioning for testing - ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process [Including: Technical Corrigendum 1 (2010)] - ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including: Amendment 1(2006)] - ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicitv - 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 - AAMI/ANSI ST72:2011/(R)2016, Bacterial Endotoxins – Test methods, routine monitoring, and alternatives to batch testing - United States Pharmacopeia 37, National Formulary 32, 2014 <151> Pyrogen Test - . FDA Guidance, Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, April 1993 - . FDA Guidance, The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, March 1998 - FDA Guidance, Recognition and Use of Consensus Standards, . September 2007 {6}------------------------------------------------ # Performance Bench Testing The Merit Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Testing included the following from these standards: | | | ISO 7886-1 | |----------------------------------|--------------------------------|------------| | Cleanliness | Graduated Scale | | | Limits for acidity or alkalinity | Barrel | | | Limits for extractable metals | Piston/Plunger Assembly | | | Lubricant | Nozzle | | | Tolerance on Graduated | Performance - Freedom from air | | | Capacity | and liquid leakage past piston | | | | | ISO 594-2 | | Gauging | Unscrewing torque | | | Liquid leakage | Ease of assembly | | | Air leakage | Resistance to overriding | | | Separation force | Stress cracking | | ### Biocompatibility testing Performance Data cont'd > The biocompatibility evaluation for the Merit Syringe was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,"" June 16, 2016, 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. Testing included the following: - Cytotoxicity ● - Sensitization - Irritation - Acute Systemic Toxicity ● - Pyrogenicity ● - Hemolysis ● The Merit Syringe is considered indirect blood contacting for a duration of less than 24 hours. | Summary of | Based on the intended use, materials, design, and performance testing, | |-------------|------------------------------------------------------------------------| | Substantial | the Merit Syringe meets the requirements that are considered essential | | Equivalence | for its intended use and is considered substantially equivalent to the | | | predicate device, the Welmed Hypodermic Syringe, K070936. |