Squirt Fluid Delivery System

K162777 · Merit Medical Systems, Inc. · QEY · Oct 31, 2016 · Cardiovascular

Device Facts

• Record ID: K162777
• Device Name: Squirt Fluid Delivery System
• Applicant: Merit Medical Systems, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Oct 31, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Squirt Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.

Device Story

Hand-held instrument for consistent, forceful, pulsed injections during thrombolysis procedures; attaches to syringe and catheter to infuse thrombolytic agents into peripheral vasculature. Device facilitates controlled delivery of medication to aid in clot dissolution. Used by clinicians in clinical settings. Benefits include optimized thrombolysis through controlled, pulsed administration.

Clinical Evidence

Bench testing only. Performance testing conducted per ISO 8536-4, ISO 8536-10, and ISO 10993 series. Tests included rotational torque, hydrostatic pressure, vacuum leak, particulate, leakage, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility). Results demonstrated compliance with all predetermined acceptance criteria.

Technological Characteristics

Hand-held fluid delivery system. Materials evaluated per ISO 10993 and ASTM F756-13. Sterilization via ethylene oxide (ISO 11135). Mechanical components include a rotator assembly with an O-ring. No electronic or software components.

Indications for Use

Indicated for the controlled administration of thrombolytic agents into the peripheral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Squirt Fluid Delivery System (K981417)

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

October 31, 2016

Merit Medical Systems, Inc. Ms. Angela Brady Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K162777

Trade/Device Name: Squirt Fluid Delivery System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: September 30, 2016 Received: October 4, 2016

Dear Ms. Brady:

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 devicerelated 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.

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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" (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.

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,

# Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K162777

Device Name Squirt Fluid Delivery System

Indications for Use (Describe)

The Squirt Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

| 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>Angela Brady<br>September 30, 2016<br>1721504 |
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| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | Squirt® Fluid Delivery System<br>Fluid Delivery System<br>Catheter, Continuous Flush<br>II<br>KRA<br>870.1210<br>74 Cardiovascular |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Squirt® Fluid Delivery System<br>Catheter, Continuous Flush<br>K981417<br>Merit Medical Systems, Inc. |
| The predicate has not been subject to a design-related recall. | | |
| Device<br>Description | The Squirt® Fluid Delivery System is a hand held instrument to provide<br>consistent, forceful, pulsed injections for optimal thrombolysis<br>procedures. It's designed to be attached to a syringe and a catheter, to<br>infuse controlled administration of thrombolytic agents into the<br>peripheral vasculature. | |
| Indications for<br>Use | The Squirt® Fluid Delivery System is intended for the controlled<br>administration of thrombolytic agents into the peripheral vasculature.<br>There is no change in the Indications for Use Statement from the<br>predicate to the subject device. | |
| Comparison to<br>Predicate<br>Device | The technological characteristics of the subject Squirt® Fluid Delivery<br>System are identical to the predicate device. Both devices use the<br>same components and materials, with the exception of the O-Ring<br>within the rotator assembly that is bonded on the end of the Squirt®<br>Fluid Delivery System which has undergone a chemical formulation<br>change in the subject device. The indications for use, principle of<br>operation, and technological characteristics of the subject device are<br>identical to the predicate device.<br>Both devices have the same mode of operation and indication for use. | |
| Performance<br>Data | 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 Squirt® Fluid Delivery System was conducted<br>based on the risk analysis and based on the requirements of the<br>following international standards:<br>● ISO 8536-4:2010, Infusion equipment for medical use - Part 4:<br>Infusion sets for single use, gravity feed<br>● ISO 8536-10:2015, Infusion equipment for medical use - Part 10:<br>Accessories for fluid lines for single use with pressure infusion<br>equipment<br>● ISO 11135:2014, Sterilization of health care products – Ethylene<br>oxide - Requirements for development, validation and routine<br>control of a sterilization process for medical devices<br>● 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<br>● ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical<br>devices – Part 4: Selection of tests for interaction with blood<br>● ISO 10993-5:2009, Biological evaluation of medical devices - Part<br>5: Tests for in vitro cytotoxicity<br>● ISO 10993-7:2008, Biological evaluation of medical devices – Part<br>7: Ethylene oxide sterilization residuals<br>● ISO 10993-10:2010, Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin sensitization<br>● ISO 10993-11:2006, Biological evaluation of medical devices -<br>Part 11: Tests for systemic toxicity<br>● ASTM F756-13, Standard Practice for Assessment of Hemolytic<br>Properties of Materials<br>● United States Pharmacopeia 38, National Formulary 33, 2015<br><151> Pyrogen Test<br>● AMMI TIR 28:2009, Product adoption and process equivalency for<br>ethylene oxide sterilization | |
| • Merit Rotational Torque Test<br>• Merit Hydrostatic Pressure Test<br>• Merit Vacuum Leak Test<br>• ISO 8536-4 Chemical Requirements<br>• ISO 8536-10 Particulate<br>• ISO 8536-10 Leakage | Biocompatibility<br>• Cytotoxicity<br>• Sensitization<br>• Irritation<br>• Acute Systemic Toxicity<br>• Pyrogenicity<br>• Hemocompatibility<br>• Chemical Characterization | |
| Safety &<br>Performance<br>Tests cont. | | |
| The results of the testing demonstrated that the subject Squirt® Fluid<br>Delivery System met the predetermined acceptance criteria and thus is<br>substantially equivalent to the predicate device. | | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, design, and performance testing, the<br>subject Squirt® Fluid Delivery System meets the requirements that are<br>considered essential for its intended use and is substantially equivalent<br>to the predicate device, the Squirt® Fluid Delivery System, K981417<br>manufactured by Merit Medical Systems, Inc. | |

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### Performance Testing