FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE

K974067 · Merit Medical Systems, Inc. · QEY · Feb 27, 1998 · Cardiovascular

Device Facts

• Record ID: K974067
• Device Name: FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
• Applicant: Merit Medical Systems, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fountain 104 Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

Device Story

Fountain Infusion System consists of an infusion catheter and an occluding guide wire. Catheter features distal infusion holes and radiopaque marker bands for fluoroscopic positioning. Clinician places catheter over a diagnostic guide wire in peripheral vasculature; removes diagnostic wire; advances occluding guide wire until ball tip occludes catheter distal end. System includes syringes, hemostasis valve, and dual check valve for loading/delivery. Used for continuous infusion (low flow rate) or pulse infusion (quick, repeatable injections). Pulse action mechanically assists in breaking down clots, while therapeutic solution provides enzymatic activity to restore blood flow. Used by clinicians in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

5F catheter with distal infusion holes (0.0025 to 0.005" diameter); radiopaque marker bands for positioning; 0.035" O.D. occluding guide wire with ball tip. System includes hemostasis valve and dual check valve. Mechanical infusion delivery via syringe or pump. No software or electronic components.

Indications for Use

Indicated for the infusion of various therapeutic drugs into the peripheral vasculature of a patient.

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

• Pulse Spray Catheter and Occluding Ball Wire (K961763)
• Medwissen Infusion Catheter (K904788)
• Multi-Sideport Catheter Infusion Set (Cook)

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: K974067

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

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 February 27, 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,

Image /page/0/Picture/9 description: The image shows the name Gregory W. O'connell -S. Next to the name is the text 'Digitally signed by Gregory W. O'connell -S'. The date 2022.02.03 is also present. The time 14:36:36-05'00' is also present.

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

FEB 2 7 1998

Mr. Dennis (Dan) Reigle Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

K974067 Re : Fountain Infusion Catheter and Occluding Guide Wire Regulatory Class: II (two) Product Code: 74 KRA January 22, 1998 Dated: Received: January 23, 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 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 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 regulations.

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Page 2 - Mr. Dennis (Dan) Reigle

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 [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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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: 14 974067

Indications For Use:

The Fountain Infusion Catheter and Occluding Guide Wire will be used for the infusion of various therapeutic drugs 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)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

M. Praye

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

007 1

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Merit Medical Systems, Inc. 510(k) Notification: Fountain™ Infusion Catheter and Occluding Guide Wire October 1997

# FEB Z 7 1998

# 510(k) SUMMARY

K994067

MERIT MEDICAL

# 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: Systems, Inc. Dennis Reigle Regulatory Affairs Manager 1600 West Merit Medical Systems. Inc. 1600 West Merit Parkway South Jordan, UT 84095 MERIT PARKWAY [phone] [phone] fax South Jordan, Contact Person: Same as above UTAH 84095 Date Summary Prepared: October 23, 1997 801-253-1600 Device Name: Infusion Catheter and Occluding Guide Wire FAX [phone] Common Name: Infusion Catheter and Occluding/Guide Wire Fountain™ Trade Name: Classification (if known): Intravascular Catheter Predicate Devices: Pulse Spray Catheter and Occluding Ball Wire K961763 AngioDynamics (07/17/96) Medwissen Infusion Catheter K904788 Medi-Tech (12/17/90) Multi-Sideport Catheter Infusion Set Cook

171 1

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Image /page/5/Picture/0 description: The image shows the logo for Merit Medical. The logo is black and white and features the words "MERIT MEDICAL" in a stylized font. The word "MERIT" is in bold, while the word "MEDICAL" is in a thinner font. There is a registered trademark symbol to the right of the word "MEDICAL".

#### Device Description:

The Fountain™ Infusion Catheter has infusion holes at the distal end. The infusion holes are located at many locations around the catheter. The infusion segment of the catheter is indicated by two radiopaque marker bands.

The Occluding Guide Wire occludes the distal end of the Fountain Infusion Catheter. The proximal end of the occluding wire has a marker for verification of proper placement.

#### Intended Use:

The Fountain 104 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 outer diameter diagnostic guide 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 0.0025 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 infusion delivery syringe. This permits subsequent injection without disconnecting from the delivery catheter. The fluid can be infused by continuous infusion, or pulse. Continuous infusion 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 removed.

Systems, Inc.

1600 West

MERIT PARKWAY

SOUTH JORDAN,

Utah 84095

801-253-1600

FAX [phone]

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# Device Use: - continued

The description above references a Pulse Therapy Kit. The Fountain Infusion Catheter and Occluding Guide Wire will be marketed along with the Pulse Therapy Kit under the name "Fountain Infusion System". The instructions for use (IFU) is written for the Fountain Infusion System.

Merit Medical

## Device Characteristics:

| Catalog Number | Description |
|----------------|--------------------------------------------------------------------------------------------|
| IS5-45-10 | 5F, 45 cm Catheter, 10 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 69 cm long |
| IS5-45-20 | 5F, 45 cm Catheter, 20 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 69 cm long |
| IS5-90-5 | 5F, 90 cm Catheter, 5 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 114 cm long |
| IS5-90-10 | 5F, 90 cm Catheter, 10 cm Infusion length<br>.035" O.D. Occluding Guide Wire 114 cm long |
| IS5-90-20 | 5F, 90 cm Catheter, 20 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 114 cm long |
| IS5-90-30 | 5F, 90 cm Catheter, 30 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 114 cm long |
| IS5-135-5 | 5F, 135 cm Catheter, 5 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 159 cm long |
| IS5-135-10 | 5F, 135 cm Catheter, 10 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 159 cm long |
| IS5-135-20 | 5F, 135 cm Catheter, 20 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 159 cm long |
| IS5-135-30 | 5F, 135 cm Catheter, 30 cm Infusion length<br>0.035" O.D. Occluding Guide Wire 159 cm long |