(88 days)
AngioDymanic®Pulse* Spray® Pulsed Infusion System, Merit Medical Medallion™ Syringe, Merit Medical Check Relief Valve
No
The description focuses on controlled fluid delivery mechanics and does not mention any AI/ML terms or functionalities.
No
The Squirt™ Fluid Delivery System is a delivery system for therapeutic agents, not a therapeutic device itself. Its function is to administer thrombolytic agents, which perform the therapeutic action.
No
The device is described as a "fluid delivery system" intended for "controlled administration of thrombolytic agents," which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "fluid delivery system, designed to be attached to a syringe and a catheter," indicating it is a physical hardware device.
Based on the provided information, the Squirt™ Fluid Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled administration of thrombolytic agents into the peripheral vasculature." This describes a device used in vivo (within the body) for therapeutic purposes (delivering medication).
- Device Description: The description reinforces this by stating it's "designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature." This is a delivery system for medication within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Squirt™ does not perform any such analysis of specimens.
Therefore, the Squirt™ Fluid Delivery System is a medical device used for drug delivery in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Squirt™ Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.
Product codes
QEY, KRA
Device Description
The Squirt™ is a fluid delivery system, designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature. The Squirt™ facilitates repeatable and accurate delivery of thrombolytic agents where numerous doses of up to 1.0 ml are given as a part of the thrombolysis treatment regimen. The catalog number for the Squirt™ is FDS100. The Squirt™ is packaged sterile, nonpyrogenic and has a one year shelf life. The Squirt™ is intended to be sold as a stand alone device or with the Fountain™ Infusion System, which was cleared under Merit's 510(k) K974067.
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)
AngioDymanic®Pulse* Spray® Pulsed Infusion System, Merit Medical Medallion™ Syringe, Merit Medical Check Relief Valve
Reference Device(s)
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).
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.
February 3, 2022
Merit Medical Systems, Inc. Dennis Reigle Regulatory Affairs Manager 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K981417
Trade/Device Name: Squirt Fluid Delivery System 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 July 17, 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,
Digitally signed by Gregory W. Gregory W. O'connell -5 O'connell -S Date: 2022.02.03 14:38:23 -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 Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 1998
Mr. Dennis Reigle Requlatory Affairs Manager Merit Medical Systems, Inc. 1600 West Merit Parlway South Jordan, UT 84095
Re: K981417 Trade Name: Squirt™ Fluid Delivery System Regulatory Class: II Product Code: KRA Dated: April 16, 1998 Received: April 20, 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 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 aqainst 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 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 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
2
Page 2 - Mr. Dennis Reigle
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.
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),594-4618. 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" (21CFR 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. 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:
Indications For Use:
The Squirt™ Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Taya A. Olu
Division of Cardiovascular, Respiratory, and Neurological C Over-The-Counter Use 510(k) Number JK
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
ﮯ
Prescription Use
4
Image /page/4/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The word "MERIT" is in solid black, while the word "MEDICAL" is outlined in black.
Ment Medical Systems, Inc. 510(k) Notification: Squirt™ Fluid Delivery System April 1998
198141
MI RI PARKWAY
Sount Jordan,
JUL 1 7 1998
510(k) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
April 16, 1998
MERIT MEDICAL This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Systems, Inc. Submitted by Name/Address: Dennis Reigle 1600 Witsi
Regulatory Affairs Manager Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 (801) 253-1600 (801) 253-1684 fax
| Contact Person: | Same as above | UTAH 84095 |
|---|---|---|
| Date Summary Prepared: | April 16, 1998 | |
| Device Name: | Squirt™ Fluid Delivery System | 801-253-1600 |
| Common Name: | Catheter, Continuous Flush | FAX 801 253 1651 |
| Trade Name: | Squirt™ | |
| Classification (if known): | 74 KRA | |
| Predicate Devices: | AngioDymanic®Pulse* Spray® Pulsed Infusion System | |
| Merit Medical Medallion™ Syringe | ||
| Merit Medical Check Relief Valve |
Applicant Device Description:
The Squirt™ is a fluid delivery system, designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature. The Squirt™ facilitates repeatable and accurate delivery of thrombolytic agents where numerous doses of up to 1.0 ml are given as a part of the thrombolysis treatment regimen.
5
Image /page/5/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The letters "MERIT" are solid black, while the letters "MEDICAL" are outlined in black.
Applicant Device Description: - continued
The catalog number for the Squirt™ is FDS100. The Squirt™ is packaged sterile, nonpyrogenic and has a one year shelf life. The Squirt™ is intended to be sold as a stand alone device or with the Fountain™ Infusion System, which was cleared under Merit's 510(k) K974067.
Applicant Device Intended Use:
The Squirt™ Fluid Delivery System is intended for the controlled administration of Systems, Inc. thrombolytic agents into the peripheral vasculature.
Technological Characteristics:
The Squirt™ facilitates repeatable and accurate delivery of thrombolytic agents where MERI! PARKWAY numerous doses of up to 1.0 ml are given as a part of the medical treatment regimen.
Materials Comparison (Squirt™ and Merit Medallion™ Syringe)
| Components | Squirt™ | Merit Medallion™ (Syringe) |
|---|---|---|
| Syringe Body | Polycarbonate | Polycarbonate |
| Syringe Plunger | ABS (Acrylonitrile-Butadiene-Styrene) | ABS (Acrylonitrile-Butadiene-Styrene) |
| Tip Seal | Natural Rubber | Natural Rubber |
| Rotator Assembly | Polycarbonate | Polycarbonate |
Souih Jordan,
MERIT MEDICAL
1600 WEST
Utar 34095
801-253-1600
i Ax 801-253-1651