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 Description

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 handle, a flexible high pressure extension tubing and a three-way stopcock. 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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets detailed performance metrics for the Monarch™ COMPAK Inflation Syringe.

Instead, it relies on a statement of substantial equivalence to predicate devices and general claims about design verification testing. Here's a breakdown of what can be extracted and what information is missing based on your request:

Acceptance Criteria and Reported Device Performance

The provided text does not list specific, quantifiable acceptance criteria or detailed performance results in a table format as requested. The closest available information is a general statement from the "Safety & Performance Tests" section:

"Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria."

This statement confirms that acceptance criteria exist and were met, but it does not provide the criteria themselves or the reported performance data.

Missing Information:

Detailed Acceptance Criteria: Specific numerical thresholds (e.g., pressure accuracy within X mmHg, inflation/deflation time within Y seconds).
Reported Device Performance: Actual measured values from the verification tests to compare against the acceptance criteria.

Therefore, the following points from your request cannot be answered based on the provided text:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (algorithm only) performance study was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

This kind of detailed performance data is typically found in design verification and validation reports, which are usually proprietary and not included in a 510(k) summary. The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing exhaustive performance data.

Summary

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

K083523

FEB - 4 2009 510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 Telephone Number: (801) 208-4748 General Fax Number: (801) 253-6960 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.

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

TechnologicalCharacteristics	Technological characteristics of the subject Monarch™ COMPAK InflationSyringe is equivalent to those of the predicate Monarch™ Inflation Syringe[K011811]. This equivalence extends to the device's basic design, andfunction. Distinguishing differences do not raise any new questions regardingsafety or efficacy of the device.
Safety &PerformanceTests	No performance standards have been established under Section 514 of theFood, Drug and Cosmetic Act for this device. However, design verificationtesting was performed according to protocols based on the recommendations/requirements of applicable FDA guidance and FDA recognized internationalstandards. Verification testing, determined to be applicable to the safety andefficacy of the device, was shown to meet predetermined acceptance criteria.
	Biocompatibility requirements of ISO 10993-1:2003 Biological Evaluation ofMedical Devices Part-1: Evaluation and Testing and the FDA Modified ISO10993 Test Profile for externally communicating, indirect blood contacting,limited-exposure devices have been met.
	Risk management, including a failure modes and effects analysis (FMEA), ofthe subject device was conducted. Subject product testing, based onconclusions from the FMEA, has yielded acceptable safety and performanceoutcomes in accordance with Merit internal protocols.
Summary ofSubstantialEquivalence	Based on the indications for use, technological characteristics, and safety andperformance testing, the subject Monarch™ COMPAK Inflation Syringe meetsthe requirements that are considered adequate for its intended use and issubstantially equivalent in design, materials, sterilization, principles ofoperation and indications for use to Merit's current commercially availableMonarch™ inflation syringe and Viceroy™ Inflation syringe.

{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 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

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

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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

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:

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

Page 1 of

018

Regulation Number and Section

§ 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.