Squirt Fluid Delivery System

K981417 · Merit Medical Systems, Inc. · QEY · Jul 17, 1998 · Cardiovascular

Device Facts

• Record ID: K981417
• Device Name: Squirt Fluid Delivery System
• Applicant: Merit Medical Systems, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• 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

Squirt Fluid Delivery System is a manual fluid delivery device designed to attach to a syringe and catheter; facilitates repeatable, accurate delivery of thrombolytic agents in doses up to 1.0 ml. Used in clinical settings for peripheral vasculature thrombolysis treatment. Operated by clinicians to administer medication. Device is packaged sterile and nonpyrogenic. Can be used as a standalone device or in conjunction with the Fountain Infusion System. Benefits include controlled, repeatable dosing during thrombolysis regimens.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid delivery system; manual operation. Materials: Polycarbonate (syringe body, rotator assembly), ABS (plunger), Natural Rubber (tip seal). Sterile, nonpyrogenic. Standalone or integrated with Fountain Infusion System. No software or electronic components.

Indications for Use

Indicated for patients requiring 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

• AngioDymanic®Pulse* Spray® Pulsed Infusion System
• Merit Medical Medallion™ Syringe
• Merit Medical Check Relief Valve

Reference Devices

• Fountain™ Infusion System (K974067)

Submission Summary (Full Text)

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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, [phone], 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 [phone]. 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 [phone] or [phone] 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 [phone] [phone] 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 [phone] |
| Trade Name: | Squirt™ | |
| Classification (if known): | 74 KRA | |
| Predicate Devices: | AngioDymanic®Pulse* Spray® Pulsed Infusion System<br>Merit Medical Medallion™ Syringe<br>Merit Medical Check Relief Valve | |

Applicant Device Description:

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.

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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