Merit Coronary Control Syringe

K163084 · Merit Medical Systems, Inc. · DXT · Jun 15, 2017 · Cardiovascular

Device Facts

• Record ID: K163084
• Device Name: Merit Coronary Control Syringe
• Applicant: Merit Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Jun 15, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body.

Device Story

Manual piston syringe; consists of clear polycarbonate barrel, ABS plunger, and silicone seal/O-ring. Operates by manual advancement/withdrawal of plunger within barrel. Features ISO 594-2 compliant fixed male luer connector or rotating adaptor. Used in clinical settings for administration of radiographic contrast media or fluid management. Provides healthcare providers with controlled delivery/aspiration of fluids. Benefits patient by enabling precise delivery of contrast agents for imaging procedures.

Clinical Evidence

Bench testing only. Testing included ISO 7886-1 (cleanliness, graduation accuracy, leakage, performance) and ISO 594-2 (gauging, torque, leakage, stress cracking). Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemolysis. All results met established acceptance criteria.

Technological Characteristics

Three-piece manual piston syringe. Materials: polycarbonate (barrel), ABS (plunger), silicone (seal/O-ring). ISO 594-2 compliant male luer lock or rotating adaptor. Operational volumes: 6, 8, 10, 12, 20 mL. Sterilization: Ethylene oxide or radiation. Standards: ISO 7886-1, ISO 594-2, ISO 10993 series, ISO 11135, ISO 11137.

Indications for Use

Indicated for intra-arterial or intravenous administration of radiographic contrast media, and for injection or withdrawal of fluids from the body.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• NMI Control Syringe (K113198)
• Welmed Hypodermic Syringe (K070936)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2017

Merit Medical Systems, Inc. Mr. Cory Marsh Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095

Re: K163084

Trade/Device Name: Merit Coronary Control Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: June 13, 2017 Received: June 14, 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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Lori A. Wiggins -S6

Lori A. Wiggins, 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

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## Indications for Use

510(k) Number (if known) K163084

Device Name Merit Coronary Control Syringe

Indications for Use (Describe)

The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body,

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 5.0 510(k) Summary

| 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>[phone]<br>[phone]<br>Mr. Cory Marsh<br>November 2, 2016<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 Coronary Control Syringe<br>Control Syringe<br>Injector and Syringe, Angiographic<br>2<br>DXT<br>870.1650<br>Cardiovascular |
| Primary<br>Predicate<br>Device | Trade Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Premarket Notification:<br>Manufacturer: | NMI Control Syringe<br>Injector and Syringe, Angiographic<br>2<br>DXT<br>870.1650<br>K113198<br>Navilyst Medical, Inc. |
| Secondary<br>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 Coronary Control Syringe contains a calibrated hollow barrel<br>into which is inserted a closely fitted movable plunger and tip or seal.<br>The barrel contains an ISO 594-2 compliant fixed male luer connector<br>or male luer rotating adaptor, which are compatible with ISO 594-2<br>compliant female luer hubs. | |
| Indications for<br>Use | The Merit Coronary Control Syringe is intended to be used for the intra-<br>arterial or intravenous administration of radiographic contrast media.<br>The syringe can also be used to inject fluids into, or withdraw fluids<br>from, the body. | |

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The proposed Merit Coronary Control Syringe incorporates an expanded Intended Use, as well as similar materials, design and principle of operation as the NMI Control Syringe primary predicate device.

| | Attribute | Subject Device – Merit<br>Coronary Control<br>Syringe | Primary Predicate<br>Device – NMI Control<br>Syringe |
|-------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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/seal.<br>Fitting offered with male<br>luer lock or male rotating<br>adaptor. | 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 or male rotating<br>adaptor. |
| Comparison to<br>Primary<br>Predicate<br>Device | Material | The barrel is constructed<br>from clear polycarbonate;<br>the plunger from ABS<br>material; the seal is made<br>of silicone material; the<br>rotator O-Ring is made of<br>silicone. | The barrel is constructed<br>from clear polycarbonate. |
| | 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 6,<br>8, 10, 12, and 20 mL. | Operational volume of 7,<br>8, 10, 12, and 20 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. |
| | Indications<br>for Use /<br>Intended<br>Use | The Merit Coronary<br>Control Syringe is<br>intended to be used for<br>the intra-arterial or<br>intravenous administration<br>of radiographic contrast<br>media. The syringe can<br>also be used to inject<br>fluids into, or withdraw<br>fluids from, the body. | The NMI Control Syringe<br>is intended to be used for<br>the intra-arterial or<br>intravenous administration<br>of radiographic contrast<br>media. |

·

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| | Attribute | Subject Device – Merit<br>Coronary Control<br>Syringe | Secondary Predicate<br>Device – Welmed<br>Hypodermic Syringe |
|---------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Secondary<br>Predicate<br>Device | Indications<br>for Use /<br>Intended<br>Use | The Merit Coronary<br>Control Syringe is<br>intended to be used for<br>the intra-arterial or<br>intravenous administration<br>of radiographic contrast<br>media. The syringe can<br>also be used to inject<br>fluids into, or withdraw<br>fluids from, the body. | The intended use of the<br>Welmed, Inc. piston<br>syringe is to inject fluids<br>into or withdraw fluids<br>from the body. |

The secondary predicate device supports the expanded Indications for Use of the Merit Coronary Control Syringe.

FDA quidance 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 Coronary Control 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, ● 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

### Performance Data

- 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 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

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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 F756-08:2008, Standard Practice for Assessment of ● Hemolytic Properties of Materials

### Performance Data cont'd

- . AAMI/ANSI ST72:2011, 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

## Performance Bench Testing

The Merit Coronary Control 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:

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| | 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<br>and liquid leakage past piston |
| | Capacity | |
| | ISO 594-2 | |
| | Gauging | Unscrewing torque |
| | Liquid leakage | Ease of assembly |
| | Air leakage | Resistance to overriding |
| | Separation force | Stress cracking |
| Performance<br>Data cont'd | Biocompatibility testing<br>The biocompatibility evaluation for the Merit Coronary Control Syringe<br>was conducted in accordance with the FDA Blue Book Memorandum<br>#G95-1 “Use of International Standard ISO-10993, ‘Biological<br>Evaluation of Medical Devices Part 1: Evaluation and Testing,’” May 1,<br>1995, and International Standard ISO 10993-1 “Biological Evaluation of<br>Medical Devices – Part 1: Evaluation and Testing Within a Risk<br>Management Process,” as recognized by FDA. Testing included the<br>following:<br>• Cytotoxicity<br>• Sensitization<br>• Irritation<br>• Acute Systemic Toxicity<br>• Pyrogenicity<br>• Hemolysis<br>• USP Physicochemical<br><br>The Merit Coronary Control Syringe is considered indirect blood<br>contacting for a duration of less than 24 hours. | |
| Summary of<br>Substantial<br>Equivalence | Based on the intended use, materials, design, and performance testing,<br>the Merit Coronary Control Syringe meets the requirements that are<br>considered essential for its intended use and is considered substantially<br>equivalent to the primary predicate device. The secondary predicate<br>device supports the expanded Indications for Use of the Merit Coronary<br>Control Syringe | |