(29 days)
Not Found
No
The description focuses on the mechanical design and function of the catheter and guide wire, with no mention of AI or ML capabilities.
No
The device is used to administer therapeutic solutions, but it is not a therapeutic device itself. It is a delivery mechanism for a therapeutic agent.
No
The device is described as an "Infusion Catheter" intended to "administer infusions of various therapeutic solutions," which indicates it is used for treatment delivery, not for diagnosing conditions.
No
The device description clearly details physical components (catheter, guide wire, marker bands) and their mechanical functions, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer infusions of various therapeutic solutions into the peripheral vasculature of a patient." This describes a therapeutic intervention performed within the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter and guide wire designed for delivering solutions and creating a spray pattern within the blood vessels. This is consistent with a device used for treatment, not diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a substance for therapeutic effect.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a larger, bolder font than the rest of the text.
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, (301) 796-6075, 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble fabric or water. The logo is black and white.
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.
2
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 (301) 594-4648. 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"(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 (800) 638-2041 or (301) 443-6597, 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
3
Attachment 2
| Indications for Use Statement | |
|---|---|
| 510(k) | |
| Number | |
| (if Known) | |
| Device Name | FOUNTAINTM Infusion Catheter and Occluding Guide Wire |
| Indications for | |
| 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 |
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
4
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
Regulatory Affairs Engineer
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 253-1600 ext. 404
(801) 253-1684 fax |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as above |
| Date Summary Prepared: | April 19, 1999 |
| Device Name: | FOUNTAIN TM Infusion Catheter
and Occluding/Guide Wire |
| Common Name: | Infusion Catheter and
Occluding/Guide Wire |
| Trade Name: | FOUNTAIN TM Infusion System |
| Classification (if known): | Intravascular Catheter |
| Predicate Device: | FOUNTAIN TM Infusion Catheter and
Occluding Guide Wire (K974067) |
5
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.