(90 days)
The Universal Fluid Dispensing Syringe is Merit Medical's Monarch Syringe and Intellisystem Syringe intended to be used by healthcare professionals to inject fluids into the body and monitor the pressure of that fluid.
This is a general purpose syringe and inflation device with pressure monitoring capability.
This document is a 510(k) summary for a Universal Fluid Dispensing Syringe (Merit Medical's Monarch Syringe and Intellisystem Syringe) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria related to AI/ML performance.
The document discusses:
- Device Name: Universal Fluid Dispensing Syringe
- Common Name: Piston Syringe
- Trade Name: Intellisystem Inflation Device and Fluid Dispensing Syringe, Monarch Inflation Device and Fluid Dispensing Syringe
- Intended Use: To be used by healthcare professionals to dispense fluids to the body and monitor the pressure of that fluid.
- Technological Characteristics: Describes two models (Monarch and Intellisystem) which are 20ml volume syringes with electronic pressure monitoring capabilities and fluid dispensing mechanisms.
- Predicate Device: Merit Medical Medallion Syringe
- Regulatory Classification: Class II (Product Code: DXT)
- FDA Decision: Found substantially equivalent to pre-amendment devices, allowing market entry.
Therefore, I cannot provide the requested information as it is not present in the given text. The questions you posed are typically relevant for AI/ML-based medical devices, which this document does not describe.
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Image /page/0/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 text "MERIT MEDICAL" in a unique font. The letters "MER" are solid black, while the letters "IT MEDICAL" are outlined in black.
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Merit Medical Systems, Inc. 510(k) Notification: Universal Fluid Dispensing Syringe August 1997
NOV 2 5 1997
510(k) SUMMARY
| SAFETY AND EFFECTIVENESS SUMMARY | MERIT MEDICAL |
|---|---|
| August 25, 1997 | SYSTEMS, INC. |
| This information of 510(k) safety and effectiveness information is being submittedin accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | 1600 WEST |
| Submitted by Name/Address: | MERIT PARKWAY |
| Dennis ReigleRegulatory Affairs ManagerMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095 | SOUTH JORDAN, |
| UTAH 84095 | |
| (801) 253-1600 | |
| (801) 253-1684 fax | 801-253-1600 |
| Contact Person: | FAX 801-253-1651 |
| Same as above | |
| Date Summary Prepared: | |
| Device Name: Universal Dispensing Syringe | |
| Common Name: | |
| Piston Syringe | |
| Trade Name: | |
| Intellisystem Inflation Device and Fluid Dispensing SyringeMonarch Inflation Device and Fluid Dispensing Syringe | |
| Classification (if known): | |
| 80 FMF | |
| Predicate Devices: | |
| Merit Medical Medallion Syringe |
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Image /page/1/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 in "MERIT" are solid black, while the letters in "MEDICAL" are outlined in black.
Merit Medical Systems, Inc. 510(k) Notification: Universal Fluid Dispensing Syringe August 1997
Applicant Device Description: This is a general purpose syringe and inflation device with pressure monitoring capability.
Applicant Device Intended Use: To be used by healthcare professionals to dispense fluids to the body and monitor the pressure of that fluid.
Technological Characteristics:
| Device Options | |||
|---|---|---|---|
| Device: | Description: | Sterile: | Disposable: |
| Monarch | 20 ml volume syringe with anelectronic (transducer) pressuremeasurement monitor, batterypowered, attached to the barrel of thesyringe which has an operating rangeof -1 to 25 ATM. It can also dispense0.25ml of fluid for each 180°clockwise turn of the syringe plungerhandle. | Yes | Yes |
| Intellisystem | 20 ml volume syringe with anelectronic (transducer) connected to anexternal monitor (120 VAC) by meansof a wire. It has an operating range of-1 to 25 ATM. It can also dispense0.25ml of fluid for each 180°clockwise turn of the syringe plungerhandle. | Syringe: YesMonitor: No | Syringe: YesMonitor: No |
MERIT MEDICAL
Systems, Inc.
1 600 West
200
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1997
Mr. Dennis Reigle Requlatory Affairs Manager Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095
Re: K973230 Universal Fluid Dispensing Syringe Requlatory Class: II (two) Product Code: DXT Dated: Auqust 25, 1997 August 27, 1997 Received:
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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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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/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
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INDICATIONS FOR USE STATEMENT
Merit Medical Systems, Inc. 510(k) Notification:
Indications For Use:
The Universal Fluid Dispensing Syringe is Merit Medical's Monarch Syringe and Intellisystem Syringe intended to be used by healthcare professionals to inject fluids into the body and monitor the pressure of that fluid.
PA
(Division Sign-Off)
Division of Cardiovascular, Respirati
and Neurological Devices
510(k) Numi
510(k) Number
(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)
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§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.