Who is the manufacturer of Merit Syringe?

Merit Medical Systems, Inc. filed the 510(k) submission for Merit Syringe (K171362).

What is the FDA product code for Merit Syringe?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Merit Syringe?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Merit Syringe?

BD Single Use, Hypodermic Syringe (K110771).

Who can help prepare an FDA 510(k) submission like Merit Syringe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Merit Syringe

K171362 · Merit Medical Systems, Inc. · FMF · Aug 7, 2017 · General Hospital

Device Facts

Record ID	K171362
Device Name	Merit Syringe
Applicant	Merit Medical Systems, Inc.
Product Code	FMF · General Hospital
Decision Date	Aug 7, 2017
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.5860
Device Class	Class 2

Intended Use

The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.

Device Story

Merit Syringe is a manual piston syringe used for fluid injection or aspiration. Device consists of a calibrated hollow polypropylene barrel, a single-piece molded ratcheted polypropylene plunger, and a silicone seal. Features an ISO 594-2 compliant fixed male luer connector for secure attachment to female luer hubs. Operated manually by a clinician or healthcare professional by advancing or withdrawing the plunger within the barrel. Used in clinical settings for general fluid management. Output is the controlled delivery or removal of fluids. Benefits include accurate fluid measurement via graduation lines and secure connection to standard luer-compatible devices.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 7886-1 (cleanliness, acidity/alkalinity, extractable metals, lubricant, graduated capacity, performance/leakage) and ISO 594-2 (gauging, liquid/air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking). Biocompatibility testing conducted per ISO 10993-1 for externally communicating, indirect blood-contacting devices (<24 hours), including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemolysis.

Technological Characteristics

Materials: Polypropylene (barrel, plunger), Silicone (seal). Design: Three-piece piston syringe with single-piece ratcheted plunger. Connector: ISO 594-2 compliant male luer lock. Operation: Manual. Sterilization: Ethylene oxide (ISO 11135). Standards: ISO 7886-1 (manual syringes), ISO 594-2 (luer fittings), ISO 10993 (biocompatibility), ISO 11607 (packaging).

Indications for Use

Indicated for use in injecting fluids into or withdrawing fluids from the body for patients requiring fluid administration or aspiration.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

BD Single Use, Hypodermic Syringe (K110771)

Related Devices

K182279 — Merit Syringe · Merit Medical Systems, Inc. · Nov 6, 2018
K173601 — Merit Syringe · Merit Medical Systems, Inc. · Jan 31, 2018
K182216 — Merit Syringe · Merit Medical Systems, Inc. · Nov 6, 2018
K024052 — MERIT MEDICAL 1-ML SYRINGE · Merit Medical Systems, Inc. · Feb 21, 2003
K111091 — MERIT MEDICAL 20 ML SYRINGE · Merit Medical Systems, Inc. · Jun 24, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 7, 2017 Merit Medical Systems, Inc. Mr. Cory Marsh Associate Manager, Regulatory Operations 1600 West Merit Parkway South Jordan, Utah 84095 Re: K171362 Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: July 7, 2017 Received: July 7, 2017 Dear Mr. Cory Marsh: 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. 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 {1}------------------------------------------------ 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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, James P. Bertram -S for Lori A. Wiggin, MPT, CLT 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}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K171362 Device Name Merit Syringe Indications for Use (Describe) The Merit 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 5.0 510(k) Summary | General Provisions | Submitter Name: Address: Telephone Number: Fax Number: Contact Person: Date Prepared: Registration Number: | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 (801) 316-3690 (801) 826-4112 Mr. Cory Marsh May 8, 2017 1721504 | | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name: Common/Usual Name: Classification Name: Regulatory Class: Product Code: 21 CFR §: Review Panel: | Merit Syringe Piston Syringe Syringe, Piston 2 FMF 880.5860 General Hospital | | | Predicate Device | Trade Name: Common/Usual Name: Classification Name: Regulatory Class: Premarket Notification: Manufacturer: Product Code: 21 CFR §: Review Panel: | BD Single Use, Hypodermic Syringe Piston Syringe Syringe, Piston 2 K110771 BD Medical - Medical Surgical Systems FMF 880.5860 General Hospital | | | Device Description | The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted, ratcheted plunger, and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 compliant female luer hubs. | | | | Indications for Use | The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body. The Indications for Use statement for the Merit Syringe is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the performance of the device relative to the predicate. The subject and | | | | | The proposed Merit Syringe incorporates the same Intended Use, materials, similar design and principle of operation as the predicate device. Differences between the devices include the nominal capacity and plunger design. Performance testing of the subject device was completed against FDA recognized consensus standards ISO 7886-1 and ISO 594-2. | | | | Comparison to Predicate Device | Attribute | Subject Device - Merit Syringe | Predicate Device - BD Single Use, Hypodermic Syringe | | | Basic Design | Standard three-piece piston syringe constructed using the same barrel and tip material as the predicate device. The subject device utilizes a single-piece molded ratcheted plunger. Fitting offered with male luer lock connector. | Standard three-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting movable plunger and tip/seal. Fitting offered with male luer lock connector. | | | Material | The barrel is constructed from polypropylene; the plunger from polypropylene; the seal is made of silicone. | The barrel is constructed from polypropylene; the plunger from polypropylene; the seal is made of silicone. | | | Principle of Operation | Manually operated by advancing and withdrawing the plunger within the barrel. | Manually operated by advancing and withdrawing the plunger within the barrel. | | | Operational Volume | Operational volume of 10 mL. | Operational volume of 1, 3, and 5 mL. | | | Graduation | Printed with accurate graduation lines that are compliant with ISO 7886- 1. | Printed with accurate graduation lines that are compliant with ISO 7886- 1. | | | Indications for Use / Intended Use | The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body. | The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | {4}------------------------------------------------ predicate device have the same intended use to inject fluids into, or withdraw fluids from, the body, as stated in 21 CFR 880.5860. {5}------------------------------------------------ | 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 requirements of the below recognized consensus standards and 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. | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data | 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, 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 28:2009, Product adoption and process equivalency for ethylene oxide sterilization 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)] 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 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 F756-08:2013, Standard Practice for Assessment of Hemolytic Properties of Materials - . AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing - United States Pharmacopeia 39, National Formulary 34, <151> . Pyrogen Test (2016) {6}------------------------------------------------ - 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 - . FDA Guidance, Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, June 2016 ## 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 Capacity (based on graduation scale) | Performance – Freedom from air and liquid leakage past piston | | Tolerance on Graduated Capacity (based on audible/tactile use) | | | ISO 594-2 | | | Gauging | Unscrewing torque | | Liquid leakage | Ease of assembly | | Air leakage | Resistance to overriding | | Separation force | Stress cracking | ## Biocompatibility testing 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 {7}------------------------------------------------ Management Process," as recognized by FDA. Testing included the following: - Cytotoxicity - Sensitization o - Irritation ● Merit Syringe - Acute Systemic Toxicity ● - Pyrogenicity - Hemolysis ● The Merit Syringe is an externally communicating device with indirect blood contacting for a duration of less than 24 hours. #### Based on the intended use, materials, design, and performance testing, Summary of the Merit Syringe meets the requirements that are considered essential Substantial for its intended use and is considered substantially equivalent to the Equivalence predicate device.