MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)

K973230 · Merit Medical Systems, Inc. · DXT · Nov 25, 1997 · Cardiovascular

Device Facts

• Record ID: K973230
• Device Name: MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
• Applicant: Merit Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Nov 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Universal Fluid Dispensing Syringe (Monarch and Intellisystem models) functions as a 20 ml piston syringe with integrated pressure monitoring. Device enables controlled fluid delivery (0.25 ml per 180° plunger turn) and pressure monitoring (-1 to 25 ATM). Monarch model features battery-powered electronic transducer on syringe barrel; Intellisystem model utilizes electronic transducer connected via wire to external 120 VAC monitor. Used by healthcare professionals in clinical settings for fluid injection and pressure tracking. Output allows clinicians to monitor fluid pressure during delivery, aiding in procedural control and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

20 ml piston syringe; electronic pressure transducer; operating range -1 to 25 ATM; Monarch: battery-powered, integrated monitor; Intellisystem: wired connection to external 120 VAC monitor; sterile, disposable syringe components.

Indications for Use

Indicated for use by healthcare professionals to inject fluids into the body and monitor fluid pressure.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Merit Medical Medallion Syringe

Submission Summary (Full Text)

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Merit Medical Systems, Inc. 510(k) Notification: Universal Fluid Dispensing Syringe August 1997

K973230

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 submitted<br>in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | 1600 WEST |
| Submitted by Name/Address: | MERIT PARKWAY |
| Dennis Reigle<br>Regulatory Affairs Manager<br>Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095 | SOUTH JORDAN, |
| | UTAH 84095 |
| [phone] | |
| [phone] fax | 801-253-1600 |
| Contact Person: | FAX [phone] |
| Same as above | |
| Date Summary Prepared: | |
| Device Name: Universal Dispensing Syringe | |
| Common Name: | |
| Piston Syringe | |
| Trade Name: | |
| Intellisystem Inflation Device and Fluid Dispensing Syringe<br>Monarch 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 an<br>electronic (transducer) pressure<br>measurement monitor, battery<br>powered, attached to the barrel of the<br>syringe which has an operating range<br>of -1 to 25 ATM. It can also dispense<br>0.25ml of fluid for each 180°<br>clockwise turn of the syringe plunger<br>handle. | Yes | Yes |
| Intellisystem | 20 ml volume syringe with an<br>electronic (transducer) connected to an<br>external monitor (120 VAC) by means<br>of a wire. It has an operating range of<br>-1 to 25 ATM. It can also dispense<br>0.25ml of fluid for each 180°<br>clockwise turn of the syringe plunger<br>handle. | Syringe: Yes<br>Monitor: No | Syringe: Yes<br>Monitor: 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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