(123 days)
Not Found
No
The summary describes a mechanical device (catheter and guide wire) for drug infusion and makes no mention of AI or ML.
Yes
The device is used for the infusion of therapeutic drugs and solutions into the peripheral vasculature, which directly contributes to a therapeutic effect.
No
The device is intended for the infusion of therapeutic drugs, not for diagnosing conditions. It facilitates treatment delivery rather than identifying diseases.
No
The device description clearly details physical components (catheter, guide wire) and their functions, indicating it is a hardware medical 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 clearly states the device is for the "infusion of various therapeutic drugs 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 patient.
- Device Description: The description details a catheter and guide wire designed for delivering substances into blood vessels. This aligns with a therapeutic delivery device, not a diagnostic test.
- 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 substances into the body for therapeutic effect.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
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.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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, (301) 796-6075, 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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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
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.
2
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 (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/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
3
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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Image /page/4/Picture/0 description: The image shows the logo for MENTMEDICAL. The logo is in black and white, with the word "MENTMEDICAL" in a stylized font. The "M" in "MENTMEDICAL" is stylized and bolded. There is a small circle above the "A" in "MEDICAL".
Merit Medical Systems, Inc. 510(k) Notification: Fountain™ Infusion Catheter and Occluding Guide Wire October 1997
FEB Z 7 1998
510(k) SUMMARY
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 (801) 253-1600 (801) 253-1684 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 801-253-1651 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 801-253-1651
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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 |
| 0.035" O.D. Occluding Guide Wire 69 cm long | |
| IS5-45-20 | 5F, 45 cm Catheter, 20 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 69 cm long | |
| IS5-90-5 | 5F, 90 cm Catheter, 5 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 114 cm long | |
| IS5-90-10 | 5F, 90 cm Catheter, 10 cm Infusion length |
| .035" O.D. Occluding Guide Wire 114 cm long | |
| IS5-90-20 | 5F, 90 cm Catheter, 20 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 114 cm long | |
| IS5-90-30 | 5F, 90 cm Catheter, 30 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 114 cm long | |
| IS5-135-5 | 5F, 135 cm Catheter, 5 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 159 cm long | |
| IS5-135-10 | 5F, 135 cm Catheter, 10 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 159 cm long | |
| IS5-135-20 | 5F, 135 cm Catheter, 20 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 159 cm long | |
| IS5-135-30 | 5F, 135 cm Catheter, 30 cm Infusion length |
| 0.035" O.D. Occluding Guide Wire 159 cm long |