Squirt Fluid Delivery System by MERIT MEDICAL SYSTEMS, INC.

The Squirt™ is a fluid delivery system, designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature. The Squirt™ facilitates repeatable and accurate delivery of thrombolytic agents where numerous doses of up to 1.0 ml are given as a part of the thrombolysis treatment regimen. The catalog number for the Squirt™ is FDS100. The Squirt™ is packaged sterile, nonpyrogenic and has a one year shelf life. The Squirt™ is intended to be sold as a stand alone device or with the Fountain™ Infusion System, which was cleared under Merit's 510(k) K974067.

AI/ML Overview

This document is a 510(k) summary for the "Squirt™ Fluid Delivery System" from Merit Medical Systems, Inc. It details the device's description, intended use, and a comparison to predicate devices, focusing on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The document concerns a 510(k) submission for a physical medical device, the "Squirt™ Fluid Delivery System," which is a fluid delivery system for thrombolytic agents. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than setting specific performance acceptance criteria for a new clinical study. Therefore, a table of acceptance criteria and reported device performance, as one would see for a diagnostic AI device, is not applicable in this context.

Instead, the submission primarily relies on:

Technological Characteristics Comparison: Showing that the materials and functional features are similar to predicate devices.
Predicate Device Equivalence: Asserting that the device is substantially equivalent to legally marketed predicate devices, which implies it will perform similarly and safely.

The key performance aspect mentioned is "repeatable and accurate delivery of thrombolytic agents where numerous doses of up to 1.0 ml are given." However, the document does not provide quantitative acceptance criteria (e.g., +/- 0.05 ml accuracy, X% repeatability) or specific study results for these performance metrics. The equivalence to existing devices is the primary "performance" argument.

2. Sample size used for the test set and the data provenance:

Not Applicable: This 510(k) summary does not describe a clinical study with a "test set" and "data provenance" in the way one would for an AI diagnostic algorithm. The primary "test" is an assessment of substantial equivalence to existing predicate devices. The document does not provide details of any specific performance testing on human subjects or patient data.
The safety and effectiveness are established through comparison of design, materials, and intended use with established legally marketed devices (AngioDynamic® Pulse*Spray® Pulsed Infusion System, Merit Medical Medallion™ Syringe, Merit Medical Check Relief Valve).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: As there is no described test set requiring ground truth establishment by experts for performance evaluation, this question does not apply.

4. Adjudication method for the test set:

Not Applicable: As there is no described test set, no adjudication method is mentioned.

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:

No: This is a 510(k) submission for a physical medical device (fluid delivery system), not an AI diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

No: This is for a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

Not Applicable: Ground truth, in the context of diagnostic performance, is not discussed as this is a medical device clearance based on substantial equivalence. The "truth" here is essentially the recognized safety and performance profile of the predicate devices.

8. The sample size for the training set:

Not Applicable: This is a 510(k) submission for a re-categorization of a physical medical device, not an AI or machine learning algorithm requiring a training set.

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

Not Applicable: As there is no training set for an algorithm, this question does not apply.

Summary

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February 3, 2022

Merit Medical Systems, Inc. Dennis Reigle Regulatory Affairs Manager 1600 West Merit Pkwy. South Jordan, Utah 84095

Re: K981417

Trade/Device Name: Squirt Fluid Delivery System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Dennis Reigle:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 17, 1998. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -5 O'connell -S Date: 2022.02.03 14:38:23 -05'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 1998

Mr. Dennis Reigle Requlatory Affairs Manager Merit Medical Systems, Inc. 1600 West Merit Parlway South Jordan, UT 84095

Re: K981417 Trade Name: Squirt™ Fluid Delivery System Regulatory Class: II Product Code: KRA Dated: April 16, 1998 Received: April 20, 1998

Dear Mr. Reigle:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Dennis Reigle

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301),594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Merit Medical Systems, Inc. 510(k) Notification:

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Taya A. Olu

Division of Cardiovascular, Respiratory, and Neurological C Over-The-Counter Use 510(k) Number JK

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

ﮯ

Prescription Use

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Image /page/4/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The word "MERIT" is in solid black, while the word "MEDICAL" is outlined in black.

Ment Medical Systems, Inc. 510(k) Notification: Squirt™ Fluid Delivery System April 1998

198141

MI RI PARKWAY

Sount Jordan,

JUL 1 7 1998

510(k) SUMMARY

SAFETY AND EFFECTIVENESS SUMMARY

April 16, 1998

MERIT MEDICAL This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Systems, Inc. Submitted by Name/Address: Dennis Reigle 1600 Witsi

Regulatory Affairs Manager Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 (801) 253-1600 (801) 253-1684 fax

Contact Person:	Same as above	UTAH 84095
Date Summary Prepared:	April 16, 1998
Device Name:	Squirt™ Fluid Delivery System	801-253-1600
Common Name:	Catheter, Continuous Flush	FAX 801 253 1651
Trade Name:	Squirt™
Classification (if known):	74 KRA
Predicate Devices:	AngioDymanic®Pulse* Spray® Pulsed Infusion SystemMerit Medical Medallion™ SyringeMerit Medical Check Relief Valve

Applicant Device Description:

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Image /page/5/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The letters "MERIT" are solid black, while the letters "MEDICAL" are outlined in black.

Applicant Device Description: - continued

The catalog number for the Squirt™ is FDS100. The Squirt™ is packaged sterile, nonpyrogenic and has a one year shelf life. The Squirt™ is intended to be sold as a stand alone device or with the Fountain™ Infusion System, which was cleared under Merit's 510(k) K974067.

Applicant Device Intended Use:

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

Technological Characteristics:

The Squirt™ facilitates repeatable and accurate delivery of thrombolytic agents where MERI! PARKWAY numerous doses of up to 1.0 ml are given as a part of the medical treatment regimen.

Materials Comparison (Squirt™ and Merit Medallion™ Syringe)

Components	Squirt™	Merit Medallion™ (Syringe)
Syringe Body	Polycarbonate	Polycarbonate
Syringe Plunger	ABS (Acrylonitrile-Butadiene-Styrene)	ABS (Acrylonitrile-Butadiene-Styrene)
Tip Seal	Natural Rubber	Natural Rubber
Rotator Assembly	Polycarbonate	Polycarbonate

Souih Jordan,

MERIT MEDICAL

1600 WEST

Utar 34095

801-253-1600

i Ax 801-253-1651

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).