MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE

K083523 · Merit Medical Systems, Inc. · DXT · Feb 4, 2009 · Cardiovascular

Device Facts

• Record ID: K083523
• Device Name: MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE
• Applicant: Merit Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Monarch™ COMPAK Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices, and to measure the pressure within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.

Device Story

Single-use balloon inflation and fluid dispensing device; features integrated pressure transducer, microprocessor, LED display, threaded plunger assembly with lock/release handle, flexible high-pressure extension tubing, and three-way stopcock. Used in clinical settings by physicians to inflate/deflate angioplasty balloons and dispense fluids; monitors pressure from -0.4 to +30 ATM. Microprocessor processes transducer signals to display real-time pressure on LED screen; assists clinicians in precise balloon inflation and fluid delivery during interventional procedures. Benefits include accurate pressure control and monitoring, reducing risk of over-inflation or improper fluid delivery.

Clinical Evidence

No clinical data. Device safety and performance established through bench testing, design verification, and risk management (FMEA) in accordance with FDA guidance and international standards.

Technological Characteristics

Integrated pressure transducer, microprocessor, and LED display. Threaded plunger assembly with lock/release handle. Flexible high-pressure extension tubing and three-way stopcock. Biocompatibility per ISO 10993-1:2003. Pressure range: -0.4 to +30 ATM.

Indications for Use

Indicated for inflation/deflation of balloon angioplasty catheters or interventional devices and fluid dispensing in patients undergoing interventional procedures requiring 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 (K011811)
• Viceroy™ Inflation Syringe with Gauge (K040138)

Submission Summary (Full Text)

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# K083523

#### FEB - 4 2009 510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 Telephone Number: [phone] General Fax Number: [phone] Provisions Registration Number: 1721504 Contact Person: Susan Scott November 25, 2008 Date of Preparation: Trade Name: Monarch™ COMPAK Inflation Syringe & Universal Fluid Dispensing Syringe Sublect Common Name: Balloon Inflation & Fluid Dispensing Syringe Device Classification Name: 74 MAV - Balloon Inflation Syringe 74 DXT - Angiographic Injector & Syringe Classification: Class II, 21 CFR § 870.1650 Monarch™ Inflation Syringe & Universal Fluid Trade Name: Dispensing Syringe 74 MAV - Balloon Inflation Syringe Classification Name: 74 DXT - Angiographic Injector & Syringe Premarket Notification: K011811, clearance date Aug. 22, 2001 Manufacturer: Merit Medical Systems, Inc Predicate Devices Viceroy™ Inflation Syringe with Gauge Trade Name: 74 MAV - Angiographic Injector & Syringe Classification Name: Premarket Notification: K040138, clearance date Feb. 13, 2004 Manufacturer: Merit Medical Systems, Inc The subject Monarch™ COMPAK Inflation Syringe is a single use, balloon inflation and fluid dispensing device with an integrated pressure transducer, microprocessor, LED display, threaded plunger assembly with lock/release Device handle, a flexible high pressure extension tubing and a three-way stopcock. Description The Monarch™ COMPAK has a shorter barrel than the standard Monarch™ device. It is designed to generate and monitor pressures over a range of -0.4 to +30 ATM. The Monarch™ COMPAK Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices, and to measure Intended Use the pressure within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.

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| Technological<br>Characteristics | Technological characteristics of the subject Monarch™ COMPAK Inflation<br>Syringe is equivalent to those of the predicate Monarch™ Inflation Syringe<br>[K011811]. This equivalence extends to the device's basic design, and<br>function. Distinguishing differences do not raise any new questions regarding<br>safety or efficacy of the device. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety &<br>Performance<br>Tests | No performance standards have been established under Section 514 of the<br>Food, Drug and Cosmetic Act for this device. However, design verification<br>testing was performed according to protocols based on the recommendations/<br>requirements of applicable FDA guidance and FDA recognized international<br>standards. Verification testing, determined to be applicable to the safety and<br>efficacy of the device, was shown to meet predetermined acceptance criteria. |
| | Biocompatibility requirements of ISO 10993-1:2003 Biological Evaluation of<br>Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO<br>10993 Test Profile for externally communicating, indirect blood contacting,<br>limited-exposure devices have been met. |
| | Risk management, including a failure modes and effects analysis (FMEA), of<br>the subject device was conducted. Subject product testing, based on<br>conclusions from the FMEA, has yielded acceptable safety and performance<br>outcomes in accordance with Merit internal protocols. |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Monarch™ COMPAK Inflation Syringe meets<br>the requirements that are considered adequate for its intended use and is<br>substantially equivalent in design, materials, sterilization, principles of<br>operation and indications for use to Merit's current commercially available<br>Monarch™ inflation syringe and Viceroy™ Inflation syringe. |

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## 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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

FEB = 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Merit Medical Systems Inc. c/o Ms. Susan D. Scott Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K083523

Trade/Device Name: Monarch Compak Inflation Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: injector and syringe, angiographic Regulatory Class: Class II Product Code: DXT. MAV Dated: January 5, 2009 Received: January 6, 2009

### Dear Ms. Scott:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Susan D. Scott

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

una R. Holmes

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Merit Medical Systems, Inc. Monarch™ COMPAK Inflation: Syringe Special 510(k) Premarket Notification

## Indications for Use Statement

510(k) Number (if known):

K083523

Device Name:

Monarch™ COMPAK Inflation Syringe & Universal Fluid Dispensing Syringe

Indications for Use:

The Monarch™ COMPAK Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices, and to measure the pressure within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.

Prescription Use (Part 21 CFR §801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR §801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R.V. Ahrnes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K083523

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