(21 days)
Not Found
No
The summary describes a physical medical device (catheter and guide wire) and its functional and biocompatibility testing. There is no mention of AI, ML, image processing, or any software-based analytical capabilities that would suggest the use of AI/ML.
Yes
The device is described as "administering infusions of various therapeutic solutions," which indicates it is used for the delivery of treatments, a core function of therapeutic devices.
No
The device is described as an "infusion catheter" intended to "administer infusions of various therapeutic solutions," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "4 French infusion catheter and system," which are physical hardware components. The performance studies also focus on the functional testing and biocompatibility of the catheter itself.
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 device used in vivo (within the body) for treatment, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: It's described as an "infusion catheter and system," which is consistent with a device used for delivering substances into the body.
- Anatomical Site: The anatomical site is "peripheral vasculature," which is within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body, which is a therapeutic or procedural function, not a diagnostic one.
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
QEY, KRA
Device Description
This device is a 4 French infusion catheter and system.
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)
Functional testing was performed on the Merit 4 French Fountain Infusion Catheter to evaluate the integrity and performance of the device. Based upon the results of this testing. Merit has determined that the device is safe and effective and is acceptable in design and construction for its intended use. Clinical testing was not performed on the subject catheter due to the similarities to the predicate device. Biocompatibility testing was performed on the Merit 5 French Fountain Infusion Catheter in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Merit 5 French Fountain Infusion Catheter was found to biocompatible, nontoxic and acceptable for its intended use. The Merit 4 French Fountain Infusion Catheters are manufactured from the same materials as the predicate device so they have also been found to be biocompatible, nontoxic and acceptable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. Chester McCoy Regulatory Affairs Engineer 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K992231
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 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 July 23, 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,
Digitally signed by Gregory W. Gregory W. O'connell O'connell -S Date: 2022.02.03 14:40:16 -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 stylized caduceus symbol, which features three human figures in profile. The figures are arranged in a row, with each figure slightly overlapping the previous one. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 23 1999
Mr. Chester McCoy Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re : K992231 The FOUNTAIN™ Infusion Catheter and Occluding Guide Wire Requlatory Class: II (two) Product Code: 74 KRA Dated: June 25, 1999 Received: July 2, 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 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 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 Failure to comply with the GMP requlation may result in assumptions. 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 regulations.
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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 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 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. Callahan
Thomas J. Cal ahan, 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)
Number
| (if Known) | K992231 |
|---|---|
| Device Name | FOUNTAINT™ 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)
Oristopher M. Al for Callahan
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
Prescription Use
✓
OR
510(k) Number ..
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
4
JUL 2 3 1999
Attachment 4
1) 510(k) summary
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: | June 4, 1999 |
| Device Name: | 4 French FOUNTAINTM Catheter
and Occluding/Guide Wire |
| Common Name: | Infusion Catheter and
Occluding/Guide Wire |
| Trade Name: | FOUNTAINTM Infusion System |
| Classification (if known): | Intravascular Catheter |
| Predicate Device: | 5 French FOUNTAINTM Infusion Catheter
Occluding Guide Wire (K974067) & K991619
Fountain Infusion System |
Device Description:
10
5
This device is a 4 French infusion catheter and system.
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 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 Wire will be advanced through the catheter and hemostasis valve until the cap on the wire snaps into the hemostasis valve. The use of the occluding wire enhances controlled, localized dispersion of therapeutic solution through the infusion holes of the catheter.
Infusion of therapeutic solutions is made via the syringes, a hemostasis valve and a dual check valve or the squirt™ fluid delivery system. The therapeutic solution can be either infused by slow, continuous infusion or pulse infusion. Continuous infusion is the uninterrupted flow of infusion therapy over a period of time. Typically, the therapeutic solution is administered from an IV pump at a very low flow rate. Infusion by pulsing is the administration of small and quick injections of therapeutic solution delivered at repeated intervals. At the completion of the infusion therapy, the occluding wire and infusion catheter are removed.
Technology Comparison:
The Merit 4 French Fountain Infusion Catheter are technologically comparable to the predicate devices (Merit 5F Fountain) in construction and physical specifications. Also, design, manufacturing, and sterilization procedures are representative of current industry practices.
Test Summary, In-vitro:
Functional testing was performed on the Merit 4 French Fountain Infusion Catheter to evaluate the integrity and performance of the device. Based upon the results of this testing. Merit has determined that the device is safe and effective and is acceptable in design and construction for its intended use.
Test summary, In-vivo:
Clinical testing was not performed on the subject catheter due to the similarities to the predicate device.
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Test Summary, Biocompatibility:
Biocompatibility testing was performed on the Merit 5 French Fountain Infusion Catheter in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Merit 5 French Fountain Infusion Catheter was found to biocompatible, nontoxic and acceptable for its intended use. The Merit 4 French Fountain Infusion Catheters are manufactured from the same materials as the predicate device so they have also been found to be biocompatible, nontoxic and acceptable for their intended use.