MERIT MEDICAL 20 ML SYRINGE

K111091 · Merit Medical Systems, Inc. · FMF · Jun 24, 2011 · General Hospital

Device Facts

• Record ID: K111091
• Device Name: MERIT MEDICAL 20 ML SYRINGE
• Applicant: Merit Medical Systems, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Merit Medical 20 ml Syringe is used to inject fluids into, or withdraw fluids from, the body.

Device Story

The Merit Medical 20 ml Syringe is a manual piston syringe consisting of a calibrated hollow barrel, a movable plunger, and a seal. It features a male Luer Lock connector for attachment to standard female Luer hub devices. Used in clinical settings by healthcare professionals to inject or withdraw fluids. Operation is manual; the user manipulates the plunger to create pressure or vacuum. The device facilitates fluid delivery or aspiration, aiding in various clinical procedures. It is a single-use, sterile device.

Clinical Evidence

Bench testing only. No clinical data. Testing included cleanliness, acidity/alkalinity, extractable metals, lubricant contaminants, graduation accuracy, piston/barrel fit, gauging, separation force, unscrewing torque, nozzle lumen, dead space, air/liquid leakage, ink adhesion, and burst pressure. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility. Packaging performance was validated via accelerated aging, simulated shipping, dye penetration, and seal strength testing.

Technological Characteristics

Piston syringe with male Luer Lock connector. Materials evaluated per ISO 10993-1. Sterilization via ethylene oxide per ANSI/AAMI/ISO 11135-1. Conforms to ISO 7886-1 (manual syringes), ISO 594-1/2 (Luer tapers). Manual operation; no energy source or software.

Indications for Use

Indicated for the injection of fluids into, or withdrawal of fluids from, the body. No specific patient population, age, or disease state restrictions are provided.

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

• Merit Medical 1-mL Syringe (K024052)

Submission Summary (Full Text)

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K 11109 1 JUN 2 4 2011

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| | Section 5 |
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| | 510(k) Summary |
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| General<br>Provisions | Submitter Name:<br>Merit Medical Systems, Inc.<br>Address:<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>Telephone Number:<br>[phone]<br>Fax Number:<br>[phone]<br>Contact Person:<br>Michaela Rivkowich<br>Date of Preparation:<br>April 14, 2011<br>Registration Number: 1721504 |
| Subject<br>Device | Trade Name:<br>To be assigned<br>Common/Usual Name:<br>Merit Medical 20 ml Syringe<br>Classification Name:<br>Syringe, Piston |
| Predicate<br>Device | Trade Name:<br>Merit Medical 1-mL Syringe<br>Classification Name:<br>Syringe, Piston<br>Premarket Notification:K024052<br>Manufacturer:<br>Merit Medical Systems, Inc. |
| Classification | Class II<br>21 CFR § 880.5860<br>General Hospital |
| Intended Use | The Merit Medical 20 ml Syringe is used to inject fluids into, or<br>withdraw fluids from, the body. |
| Device<br>Description | The Merit Medical 20 ml Syringe is a device consisting of a<br>calibrated hollow barrel into which is inserted a closely fitting<br>movable plunger and seal. The barrel contains a male Luer Lock<br>connector which is compatible for attaching devices with standard<br>female Luer hubs. |
| Technological<br>Characteristics | The technological characteristics of the subject Merit Medallion<br>Syringe are substantially equivalent to those of the predicate device,<br>the Merit Medical 1-mL Syringe, 510(k) K024052. |
| | No performance standards have been established under Section 514<br>of the Food, Drug and Cosmetic Act for these devices. Performance<br>testing of the subject Merit Medical 20 ml Syringe was conducted<br>based on the risk analysis and based on the requirements of the<br>following FDA guidance document and international standards: |
| Safety &<br>Performance<br>Tests | • Guidance on the Content of Premarket Notification<br>[510(k)] Submissions for Piston Syringes, April 1993<br>• ISO 7886-1:1993, Sterile hypodermic syringes for single<br>use - Part 1: Syringes for manual use<br>• ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for<br>syringes, needles and certain other medical equipment –<br>Part 1: General requirements<br>• ISO 594-2:1998, Conical fittings with 6% (Luer) taper for<br>syringes, needles and certain other medical equipment –<br>Part 2: Lock fittings<br>• ANSI/AAMI/ISO 11135-1: 2007, Sterilization of health<br>care products - Ethylene oxide – Part 1: Requirements<br>for development, validation and routine control of a<br>sterilization process for medical devices<br>• ISO 10993-1: 2009, Biological Evaluation of Medical<br>Devices Part-1: Evaluation and Testing within a risk<br>management process, and the FDA Modified ISO 10993<br>Test Profile<br>• EN ISO 10993-7:2008, Biological Evaluation of Medical<br>Devices, Part 7: Ethylene Oxide Sterilization Residuals<br>The following is a list of all significant testing that was successfully<br>completed:<br>Cleanliness<br>Limits for acidity and alkalinity<br>Limits for extractable metals<br>Inspection for lubricant contaminants<br>Tolerance on graduation capacity<br>Graduated scale<br>Numbering of scale<br>Overall length of scale to nominal capacity<br>Position of scale<br>Barrel - finger grips<br>Piston/plunger assembly - design<br>Piston/plunger assembly - fit of piston in barrel<br>Piston/plunger assembly - fiducial line<br>Gauging<br>Separation force<br>Unscrewing torque |
| Safety &<br>Performance<br>Tests cont. | Position of nozzle on end of barrel<br>Nozzle lumen.<br>Dead space<br>Freedom from air leakage<br>Freedom from liquid leakage<br>Freedom from liquid leakage with side force<br>Adhesion of ink<br>Biocompatibility tests<br>Cytotoxicity<br>Sensitization<br>Irritation<br>Acute Systemic Toxicity<br>Hemocompatibility |
| | Packaging performance after exposure to accelerated aging and<br>simulated shipping and handling conditions:<br>Visual inspection<br>Dye penetration testing<br>Underwater leak test (bubble emission testing)<br>Seal strength-seal peel tensile strength |
| | Burst pressure testing |
| Safety &<br>Performance<br>Tests cont. | The results of the testing demonstrated that the subject Merit<br>Medical 20 ml Syringe met the pre-determined acceptance criteria<br>applicable to the safety and efficacy of the device. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, and safety and<br>performance testing, the subject Merit Medical 20 ml Syringe meets<br>the requirements that are considered essential for its intended use<br>and is substantially equivalent to the predicate device, the Merit<br>Medical 1-mL Syringe, manufactured by Merit Medical Systems, Inc. |

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Ease of assembly

Resistance to overriding

Resistance to cracking

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Merit Medical 20 ml Syringe
Section 5, 510(k) Summary
Special Premarket Notification 510(k)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and two curved lines representing its legs. The eagle is positioned diagonally within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

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

Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist Merit Medical Systems, Incorporated 1600 West Merit Parkway South Jordan, Utah 84095

JUN 2 4 2011

Re: K111091

Trade/Device Name: Merit Medical 20 ml Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 24, 2011 Received: May 26, 2011

Dear Ms. Rivkowich

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.

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Page 2 - Ms. Rivkowich

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 go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Merit Medical 20 ml Syringe Section 4, Indications for Use Special Premarket Notification 510(k)

## Section 4

## Indications for Use

510(k) Number (if known):

Device Name: Merit Medical 20 ml Syringe

Indications for Use:

The Merit Medical 20 ml Syringe is used to inject fluids into, or withdraw fluids from, the body.

KIII09

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Rick Chapman

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: (11109)