MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE

K011811 · Merit Medical Systems, Inc. · DXT · Aug 22, 2001 · Cardiovascular

Device Facts

• Record ID: K011811
• Device Name: MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Aug 22, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 30 ATM Monarch™ syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

Device Story

30 ATM Monarch™ is a 20 ml single-use balloon inflation and fluid dispensing device; features threaded plunger, flexible high-pressure extension tube, and back-lit LCD. Operates by manual rotation of plunger handle to generate/monitor pressures from -1 to +30 atmospheres (-7 to +441 PSI). Used in clinical settings by physicians/technicians during angioplasty. Device provides real-time pressure monitoring via integrated microprocessor and LCD display; assists clinicians in controlling balloon inflation and fluid delivery. Benefits include precise pressure control and monitoring during interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

20 ml single-use syringe; materials include polycarbonate barrel, ABS plunger, natural rubber tip, polyurethane tubing. Features integrated pressure transducer and NEC µPD75328 4-bit CPU for pressure monitoring. Operates via manual mechanical actuation with digital LCD readout. Pressure range: -1 to +30 atmospheres.

Indications for Use

Indicated for patients undergoing balloon angioplasty procedures requiring inflation/deflation of catheters and fluid injection/pressure monitoring.

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

• Monarch™ Inflation Syringe (K943597)
• Universal Fluid Dispensing Syringe (K973230)

Submission Summary (Full Text)

{0}------------------------------------------------

### SAFETY AND EFFECTIVENESS SUMMARY AUG 2 2 2001

This information of 510(k) safety and effectiveness information is being submitted in This micrination the requirements of 21 CFR 807.92.

| Submitted by Name / Address: | Dennis (Dan) Reigle<br>Manager Regulatory Affairs<br>Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone] (direct)<br>[phone] (fax) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Same as above |
| Date Summary Prepared: | July 24, 2001 |
| Device Name: | 30 ATM Monarch Syringe |
| Common Name: | Balloon Inflation Syringe |
| Trade Name: | Monarch™ Inflation Syringe<br>Universal Fluid Dispensing Syringe |
| Classification (if known): | Cardiovascular |
| Predicate Device(s): | Monarch™ Inflation Syringe (K943597)<br>Universal Fluid Dispensing Syringe<br>(K973230) |

{1}------------------------------------------------

# SAFETY AND EFFECTIVENESS SUMMARY

#### Device Description:

The 30 ATM Monarch™ is a 20 ml single use balloon inflation and fluid dispensing I hic 50 ATM Monater - 18 a 20 million of 20 microcomputer, back-lit LCD, threaded device will an intogral problemense bar, a flexible high pressure extension tube and a punger assembly with locas recease our a career of the Monarch™ is capable of generating thice-way incoran pressures over a range of -- 1 to +30 atmospheres (-7 to + 441 PSI). The and montoning pressures over a lange withing the each 360° turn of the syringe plunger handle.

### Intended Use:

The 30 ATM Monarch™ syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

| | | Modified Device | Predicate Devices | |
|---|----------------------------------|-----------------------------|---------------------------------------------|----------------------------------------------------|
| | | 30 ATM Monarch<br>(K011811) | 25 ATM Monarch<br>(K943597) | Universal Fluid<br>Dispensing Syringe<br>(K973230) |
| | Materials | | Polycarbonate | Polycarbonate |
| ● | Barrel | Same as Predicate Devices | Polycarbonate | Polycarbonate |
| ● | Syringe Plunger | Same as Predicate Devices | ABS Plastic | ABS Plastic |
| ● | Syringe Plunger Tip | Same as Predicate Devices | Natural Rubber | Natural Rubber |
| ● | Tubing with<br>Rotating Adaptor | Same as Predicate Devices | Polyurethane tubing | Polyurethane tubing |
| | | | Polycarbonate adaptor | Polycarbonate adaptor |
| ● | Pressure Transducer<br>Interface | Same as Predicate Devices | Black Silicone Gel | Black Silicone Gel |
| ● | Microprocessor | Same as Predicate Devices | NEC Electronics, Inc.<br>µPD75328, 4bit CPU | NEC Electronics, Inc.<br>µPD75328, 4bit CPU |

## Comparison of 30 ATM Monarch™ to Predicate Devices

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, with three curved lines representing the staff and a serpent winding around it.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Mr. Dennis Reigle Manager, Regulatory Affairs Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

K011811 Re:

Trade Name: Monarch™ Syringe Universal Fluid Dispensing Syringe Regulation Number: 870.1650 Regulatory Class: II (two) Product Code: 74 DXT and 74 MAV Dated: July 27, 2001 Received: July 30, 2001

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 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 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.

{3}------------------------------------------------

Page 2 - Mr. Dennis 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 [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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

of_1 Page 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_30 ATM Monarch Syringe

Indications For Use:

The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Device*
510(k) Number K 171811

(Optional Format 3-10-98)