MERIT SAFETY INTRODUCER NEEDLE

K140513 · Merit Medical Systems, Inc. · DYB · Jul 9, 2014 · Cardiovascular

Device Facts

• Record ID: K140513
• Device Name: MERIT SAFETY INTRODUCER NEEDLE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jul 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It also incorporates a safety mechanism to minimize needlestick injuries.

Device Story

Merit Safety Introducer Needle is a single-use, sterile, non-pyrogenic device for adult vascular access. It consists of a stainless steel one-wall cannula and a clear female Luer lock hub for immediate bleed-back visualization. Available in 18G and 21G, 7 cm length, with optional Seldinger shield. Clinicians use the device to puncture blood vessels; after use, the clinician manually advances a color-coded safety mechanism to shield the needle bevel. The mechanism automatically locks over the needle tip, providing visual, tactile, and audible confirmation of lockout. The safety feature is non-deactivatable and remains protective through disposal. The device facilitates safe guide wire insertion and reduces accidental needlestick risk.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included dimensions, puncture resistance, force to activate/defeat safety mechanism, hub-to-cannula bond strength, Luer performance (leak, torque, stress cracking), guide wire compatibility, corrosion resistance, and simulated use. Biocompatibility testing followed ISO 10993 standards, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hematology, coagulation, and hemolysis.

Technological Characteristics

Stainless steel one-wall cannula; clear female Luer lock hub; color-coded safety mechanism. Dimensions: 18G/21G, 7 cm length. Sterilization: Ethylene Oxide. Standards: ISO 7864, ISO 594-1/2, ISO 6009, ISO 9626, ISO 11070, ISO 11135-1, ISO 10993 series, ASTM F756-08, USP <151>.

Indications for Use

Indicated for adult patients requiring vascular access; used to provide a puncture site in blood vessels for the introduction of vascular access devices while minimizing needlestick injuries.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• SecureLoc™ Safety Introducer Needle (K050023)

Submission Summary (Full Text)

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5.0 510(k) Summary

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| 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>[phone]<br>[phone]<br>Susan Christensen<br>February 27, 2014<br>1721504 | |
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| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | Merit Safety Introducer Needles<br>Safety Introducer Needle<br>Catheter Introducer | |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | SecureLoc™ Safety Introducer Needle<br>Catheter Introducer<br>K050023<br>Bard Access Systems, Inc. | |
| Classification | Class II<br>21 CFR § 870.1340<br>FDA Product Code: DYB<br>Review Panel: Cardiovascular | | |
| Intended Use | The Merit Safety Introducer Needle is used for providing a puncture site<br>in blood vessels for the introduction of vascular access devices. It also<br>incorporates a safety mechanism to minimize needlestick injuries. | | |

K140513

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The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It incorporates a safety mechanism/quard to minimize needlestick injuries. The needle consists of a stainless steel one wall cannula and a clear standard female Luer lock hub for immediate bleed-back The hub of this introducer needle is designed with an visualization. ergonomic feel for ease of handling and is offered with a standard hub or a Seldinger shield. The needles are available in 18 gauge and 21 gauge with a usable length of 7 cm. The safety mechanism is color coded for needle gauge identification. The design of the Merit Safety Device Introducer Needle allows clinicians to easily activate the safety Description mechanism by advancing it to the end of the needle to shield the needle bevel after use. The safety mechanism automatically senses the end of the needle and locks the safety mechanism covering the needle tip which reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile, and audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The safety mechanism cannot be deactivated and remains protective through disposal into a sharps container. The safety mechanism can be activated over quide wires. The Merit Safety Introducer Needle is a single use device that is supplied sterile and non-pyrogenic for use in the adult population. The technological characteristics of the subject Merit Safety Introducer Needles are substantially equivalent to those of the predicate device. The needle is available in the same gauge sizes 18 and 21, same useable length 7 cm, and same hub styles which include with and without a Seldinger shield. The needle incorporates a clear standard female Luer lock hub for immediate bleed-back visualization and the safety mechanism is color coded for needle gauge identification. . The Merit Safety Introducer Needles are similar in clinical use. Comparison to function, materials and use to the predicate SecureLoc™ Predicate Safety Introducer Needles. Device . The Merit Safety Introducer Needles have a safety feature that locks a safety mechanism over the needle tip after the needle is removed from the patient, as does the SecureLoc Safety Introducer Needle predicate device. . The Merit Safety Introducer Needle's safety mechanism lockout can be confirmed by visual means, tactile feel and audible means, as can the SecureLoc Safety Introducer Needle predicate device cited in this submission.

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| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514 of<br>the Food, Drug and Cosmetic Act for these devices. Performance<br>testing of the subject Merit Safety Introducer Needles was conducted<br>based on the risk analysis and based on the requirements of the<br>following recognized and unrecognized international standards and<br>FDA guidance documents: |
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| | FDA Guidance for Industry and FDA Staff, Medical Devices with<br>Sharps Injury Prevention Features; August 9, 2005. ISO 7864:1993 - Sterile hypodermic needles for single use ISO 7864-2:1993 - Sterile hypodermic needles for single use Part<br>2: Specification for sterile hypodermic needles for single use ISO 594-1:1986 - Conical fittings with 6% (Luer) taper for syringes,<br>needles, and certain other medical equipment Part1: General<br>requirements ISO 594-2:1998 - Conical fittings with 6% (Luer) taper for syringes,<br>needles, and certain other medical equipment Part2: Lock fittings ISO 6009:1992 - Hypodermic needles for single use - Color<br>coding for identification ISO 9626:1992 Amendment 1:2001 - Stainless steel needle tubing<br>for the manufacture of medical devices ISO 11070:1998 - Sterile single use intravascular catheter<br>introducers ISO 11135-1 First Edition 2007, Sterilization of health care<br>products - Ethylene Oxide - part 1: Requirements for<br>development, validation, and routine control of a sterilization<br>process for medical devices ISO 10993-1:2009, Biological Evaluation of Medical Devices Part<br>1: Evaluation and Testing within a risk management process, and<br>FDA guidance Required Biocompatibility Training and Toxicology<br>Profiles for Evaluation of Medical Devices, May 1, 1995 ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical<br>devices - Part 4: Selection of tests for interaction with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part<br>5: Tests for in vitro cytotoxicity ISO 10993-7:2008, Biological evaluation of medical devices - Part<br>7: Ethylene oxide sterilization residuals ISO 10993-10:2010, Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin sensitization ISO 10993-11:2006, Biological evaluation of medical devices -<br>Part 11: Tests for systemic toxicity ASTM F756-08:2008; Standard Practice for Assessment of<br>Hemolytic Properties of Materials United States Pharmacopeia Section <151>, USP 36 Pyrogen<br>Testing, 2013-12-01 |

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### Performance Testing-Bench

- Dimensions .
- Puncture Resistance Testing .
- Force to Defeat Safety Mechanism Testing .
- Force to Activate Safety Mechanism Testing t
- Hub to Cannula Bond Strength Test .
- Visual Inspection .
- Luer Gauging Test .
- Luer Liquid Leak Test .
- Luer Air Aspiration Leak Test .
- Luer Separation Force Test .
- Luer Unscrewing Torque Test .
- Luer Ease of Assembly Test ●
- Luer Resistance to Overriding Test .
- Luer Stress Cracking Test .
- Needle Penetration Testing .
- Guide Wire Compatibility .
- Corrosion Resistance .
- Simulated Use Testing .

#### Biocompatibility

- Cytotoxicity �
- Sensitization ●
- Irritation .
- Acute Systemic Toxicity .
- Pyrogenicity .
- Hematology .
- Coaqulation .
- Hemolysis t
- Chemical Characterization .

Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing, the subject Merit Safety Introducer Needles meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device. SecureLoc Safety Introducer Needle, K050023.

Safety & Performance

Tests cont.

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

July 9, 2014

Merit Medical Systems, Incorporated Ms. Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K140513

Trade/Device Name: Merit Safety Introducer Needles Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: II Product Code: DYB Dated: June 18, 2014 Received: June 19, 2014

Dear Ms. Christensen:

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. Christensen

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 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. 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/Reportal?roblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K140513

Device Name

Merit Safety Introducer Needle

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| Indications for Use (Describe) | | |
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The Merit Safety Introducer Need for providing a puncture site in blood vessels for the introduction of vascular access devices. It also incorporates a safety mechanism to minimize needlestick injuries.

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

2 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.

極織・無料・FORIFDA USE ONLY (新品) (送料・送料・ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman -S Date: 2014.07.09 12:09:08 -04'00'

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