FOUNTAIN Infusion Catheter and Occluding Guide Wire

K991619 · Merit Medical Systems, Inc. · QEY · Jun 9, 1999 · Cardiovascular

Device Facts

• Record ID: K991619
• Device Name: FOUNTAIN Infusion Catheter and Occluding Guide Wire
• Applicant: Merit Medical Systems, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FOUNTAINTM Infusion Catheter and Occluding Guide Wire is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient

Device Story

The Fountain Infusion System consists of an infusion catheter and an occluding guide wire used for localized delivery of thrombolytic agents. The catheter features rotating side holes to create a uniform spray pattern, with radiopaque marker bands for fluoroscopic visualization. The system is placed in the peripheral vasculature over a 0.035-inch diagnostic guide wire. Once positioned, the diagnostic wire is removed and the occluding guide wire is inserted to seal the distal tip, forcing therapeutic solution through the catheter's infusion holes. The system is operated by a clinician in a clinical setting. Infusion is performed via syringes, a hemostasis valve, and a dual check valve, allowing for either continuous infusion via IV pump or pulse infusion. Pulse infusion provides mechanical action to assist in breaking down thrombi, combined with the enzymatic activity of the therapeutic agent to restore blood flow.

Clinical Evidence

No clinical data provided; device relies on bench testing and substantial equivalence to a previously cleared predicate.

Technological Characteristics

The system comprises an infusion catheter with radiopaque marker bands and an occluding guide wire. It utilizes a mechanical infusion mechanism via syringes and valves. The catheter features side holes (0.001" to 0.005" diameter) for dispersion. The device is designed for use with a 0.035-inch diagnostic guide wire. No software or electronic components are involved.

Indications for Use

Indicated for administration of therapeutic solutions into the peripheral vasculature of patients requiring thrombolytic therapy.

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

• FOUNTAIN Infusion Catheter and Occluding Guide Wire (K974067)

Submission Summary (Full Text)

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Merit Medical Systems, Inc. Chester McCoy Regulatory Affairs Engineer 1600 West Merit Pkwy. South Jordan, Utah 84095

Re: K991619

Trade/Device Name: FOUNTAIN Infusion Catheter and Occluding Guide Wire Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

February 17, 2022

Dear Chester McCoy:

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 June 9, 1999. 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,

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.02.17
15:44:33-05'00'

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

9 1999 JUN

Mr. Chester McCoy Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

Re: K991619 FOUNTAIN→ Infusion Catheter and Occluding/Guide Wire Requlatory Class: II (two) Product Code: 74 KRA Dated: May 28, 1999 Received: June 1, 1999

Dear Mr. McCoy:

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 qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 requlations 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 Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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 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.

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Page 2 - Mr. Chester McCoy

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 leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. 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"(21 CFR 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. Collehan

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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# Attachment 2

| Indications for Use Statement | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number<br>(if Known) | |
| Device Name | FOUNTAINTM Infusion Catheter and Occluding Guide Wire |
| Indications for<br>Use | The FOUNTAINTM Infusion Catheter and Occluding Guide Wire is<br>intended to administer infusions of various therapeutic solutions<br>into the peripheral vasculature of a patient |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christoph M. for TJC

(Division Sign-Off) Division of Cardiovas and Neurological Devic 510(k) Number

Prescription Use

OR

Over-The-Counter Use

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# Attachment 4

### 510(k) Summary

# SAFETY AND EFFECTIVENESS SUMMARY

This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Submitted by Name/Address: | Chester McCoy<br>Regulatory Affairs Engineer<br>Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone] ext. 404<br>[phone] fax |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as above |
| Date Summary Prepared: | April 19, 1999 |
| Device Name: | FOUNTAIN ^TM Infusion Catheter<br>and Occluding/Guide Wire |
| Common Name: | Infusion Catheter and<br>Occluding/Guide Wire |
| Trade Name: | FOUNTAIN ^TM Infusion System |
| Classification (if known): | Intravascular Catheter |
| Predicate Device: | FOUNTAIN ^TM Infusion Catheter and<br>Occluding Guide Wire (K974067) |

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#### Device Description:

The Fountain™ Infusion Catheter is designed to provide repeatable doses of solution with a unique spray pattern for optimal thrombolytir procedures. The side hole on the Fountain infusion catheter rotate around the catheter to create a more uniform dispersion of thrombolytic agent. The infusion sep-cent = the catheter is indicated by two radiopaque marker bands.

The Occluding Guide Wire occludes The proximal end of the occluding wire was a marker for verification of proper placement.

#### Intended Use:

The Fountain™ Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

#### Device Use:

The Fountain™ Infusion Catheter will be placed in the peripheral vasculature of a patient over a 0.035 inch oute dia nostic uide wire. The infusion segment of the catheter will be positioned at the intended delivery site. The infusion segment is identified by radiopaque marker bands, and may be visualized under fluoroscopy by the clinician. The diagnostic guide wire will then be removed, while maintaining the position of the catheter. The Occluding Guide Wire will be advanced through the catheter until the ball on the wire "occludes" the distal tip of the infusion catheter. The use of the occluding wire enhances controlled, localized dispersion of therapeutic solution through the 0.001" to 0.005" diameter infusion holes of the infusion catheter.

Infusion of therapeutic solutions is made via the syringes, a hemostasis valve and a dual check valve, all of which are included in the Merit Pulse Therapy Kit. The dual check valve allows for the uncomplicated loading of an infusate from a larger reservoir syringe source to a small 1 ml intusion denvery syringe. This permits subsequent injection without disconnecting from the delivery atheter. The fluid can be infused by continuous infusion, or pulse Continuous fusion is the uninterrupted flow of infusion therapy over a period of time. Typically, the therapeutic solution is administered from an IV pump and at a very low flow rate. Infusion by pulsing is the administration of small and quick injections of therapeutic solution delivered at repeatable time intervals. The mechanical action from pulsing the therapeutic solution helps to break down clots. This mechanical action is also coupled with the enzymatic activity of the therapeutic solution to aid in breaking down the thrombus and restoring blood flow to the area. At the completion of the infusion therapy, the occluding wire and infusion catheter are ren ord.