The Squirt® Fluid Delivery System is a hand held instrument to provide consistent, forceful, pulsed injections for optimal thrombolysis procedures. It's designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Squirt Fluid Delivery System." This notification asserts substantial equivalence to a predicate device, rather than proving performance against predefined acceptance criteria for a novel device or AI algorithm.

Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like MRMC studies) is not applicable in the context of this 510(k) submission. The document explicitly states: "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices."

Instead, the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document does not present specific quantitative acceptance criteria for a novel device performance, nor does it report specific performance metrics for a clinical study comparing the device against such criteria. The "Performance Data" section lists various international standards and specific tests (e.g., Merit Rotational Torque Test, Merit Hydrostatic Pressure Test, Biocompatibility tests) that were performed. The conclusion is that "The results of the testing demonstrated that the subject Squirt® Fluid Delivery System met the predetermined acceptance criteria and thus is substantially equivalent to the predicate device." However, the specific numerical acceptance criteria or performance results for each of these tests are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document summarizes engineering and biocompatibility testing, not a clinical trial with a test set of patient data. Therefore, concepts like sample size for a test set, data provenance (country, retrospective/prospective), or ground truth are not relevant in the context of this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. See point 2. The tests performed are engineering and laboratory-based, not reliant on expert clinical interpretation or ground truth establishment in a medical imaging or diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a fluid delivery system, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The ground truth in this context refers to the defined specifications and standards (e.g., ISO standards, ASTM standards, USP) against which the physical and chemical properties of the device are tested.

8. The sample size for the training set

Not Applicable. This device uses standard engineering and manufacturing processes, not machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary based on the provided document:

The provided document is a 510(k) summary for a "Squirt Fluid Delivery System." The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to prove the performance of a novel device or AI algorithm against predefined clinical acceptance criteria.

The "Performance Data" section indicates that various engineering, chemical, and biological tests were conducted to ensure the device meets safety and performance characteristics in line with established international standards (e.g., ISO 8536-4, ISO 10993 series) and in-house "Merit" tests (e.g., Rotational Torque Test, Hydrostatic Pressure Test, Vacuum Leak Test). The comparison to the predicate device explicitly states that "The technological characteristics of the subject Squirt® Fluid Delivery System are identical to the predicate device... with the exception of the O-Ring... which has undergone a chemical formulation change."

The "acceptance criteria" for this type of submission would relate to meeting the specifications outlined in these standards and internal tests, demonstrating that the design change (O-ring material) does not negatively impact safety or performance, thereby maintaining substantial equivalence to the predicate. However, the specific numerical acceptance criteria and the detailed test results are not included in this high-level summary.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4818(801) 316-4878Angela BradySeptember 30, 20161721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	Squirt® Fluid Delivery SystemFluid Delivery SystemCatheter, Continuous FlushIIKRA870.121074 Cardiovascular
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Squirt® Fluid Delivery SystemCatheter, Continuous FlushK981417Merit Medical Systems, Inc.
The predicate has not been subject to a design-related recall.
DeviceDescription	The Squirt® Fluid Delivery System is a hand held instrument to provideconsistent, forceful, pulsed injections for optimal thrombolysisprocedures. It's designed to be attached to a syringe and a catheter, toinfuse controlled administration of thrombolytic agents into theperipheral vasculature.
Indications forUse	The Squirt® Fluid Delivery System is intended for the controlledadministration of thrombolytic agents into the peripheral vasculature.There is no change in the Indications for Use Statement from thepredicate to the subject device.
Comparison toPredicateDevice	The technological characteristics of the subject Squirt® Fluid DeliverySystem are identical to the predicate device. Both devices use thesame components and materials, with the exception of the O-Ringwithin the rotator assembly that is bonded on the end of the Squirt®Fluid Delivery System which has undergone a chemical formulationchange in the subject device. The indications for use, principle ofoperation, and technological characteristics of the subject device areidentical to the predicate device.Both devices have the same mode of operation and indication for use.
PerformanceData	No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject Squirt® Fluid Delivery System was conductedbased on the risk analysis and based on the requirements of thefollowing international standards:● ISO 8536-4:2010, Infusion equipment for medical use - Part 4:Infusion sets for single use, gravity feed● ISO 8536-10:2015, Infusion equipment for medical use - Part 10:Accessories for fluid lines for single use with pressure infusionequipment● ISO 11135:2014, Sterilization of health care products – Ethyleneoxide - Requirements for development, validation and routinecontrol of a sterilization process for medical devices● ISO 10993-1:2009, Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a risk management process, andFDA guidance Required Biocompatibility Training and ToxicologyProfiles for Evaluation of Medical Devices, May 1, 1995● ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medicaldevices – Part 4: Selection of tests for interaction with blood● ISO 10993-5:2009, Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity● ISO 10993-7:2008, Biological evaluation of medical devices – Part7: Ethylene oxide sterilization residuals● 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 F756-13, Standard Practice for Assessment of HemolyticProperties of Materials● United States Pharmacopeia 38, National Formulary 33, 2015<151> Pyrogen Test● AMMI TIR 28:2009, Product adoption and process equivalency forethylene oxide sterilization
• Merit Rotational Torque Test• Merit Hydrostatic Pressure Test• Merit Vacuum Leak Test• ISO 8536-4 Chemical Requirements• ISO 8536-10 Particulate• ISO 8536-10 Leakage	Biocompatibility• Cytotoxicity• Sensitization• Irritation• Acute Systemic Toxicity• Pyrogenicity• Hemocompatibility• Chemical Characterization
Safety &PerformanceTests cont.
The results of the testing demonstrated that the subject Squirt® FluidDelivery System met the predetermined acceptance criteria and thus issubstantially equivalent to the predicate device.
Summary ofSubstantialEquivalence	Based on the indications for use, design, and performance testing, thesubject Squirt® Fluid Delivery System meets the requirements that areconsidered essential for its intended use and is substantially equivalentto the predicate device, the Squirt® Fluid Delivery System, K981417manufactured by Merit Medical Systems, Inc.

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Performance Testing

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).