The Merit analog inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

Device Description

The Merit analog inflation syringe is a single use disposable device capable of generating and monitoring pressure in angioplasty or other similar interventional devices. It is fitted with a threaded plunger assembly with lock/release bar, flexible high pressure extension tube. It is provided with a 510(k)-cleared three way medium pressure stopcock.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Merit Medical Systems, Inc. Analog Inflation Syringe (BasixCOMPAK). This device is intended to inflate and deflate angioplasty balloons and measure pressure. The submission asserts substantial equivalence to a predicate device, the Merit Monarch COMPAK Inflation Syringe & Universal Fluid Dispensing Device (K083523). The primary difference noted is the display type: analog for the subject device versus digital for the predicate.

The document lists various tests performed to demonstrate safety and efficacy, drawing upon industry standards and guidance. However, it does not provide detailed acceptance criteria values or specific performance data for each test. Instead, it broadly states that "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device."

Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (General Description)	Reported Device Performance (General Description)	Specific Numeric Values/Details from Document
Functional Tests	Ensure proper inflation/deflation and pressure measurement.	Successfully completed.	Not specified.
- Fluid	Ability to function with fluid.	Successfully completed.	Not specified.
- Air	Ability to function with air.	Successfully completed.	Not specified.
Mechanical/Strength Tests	Withstand operational forces, maintain integrity.	Successfully completed.	Not specified.
- Torqueability	Ability for components to withstand rotational forces.	Successfully completed.	Not specified.
- Tensile	Ability for components to withstand pulling forces.	Successfully completed.	Not specified.
Leak/Integrity Tests	Maintain fluid/air containment.	Successfully completed.	Not specified.
- Thermal Shock – Leak Test	Maintain integrity after thermal stress.	Successfully completed.	Not specified.
- Vacuum Capability	Ability to maintain vacuum pressure.	Successfully completed.	Not specified.
Durability/Environmental Tests	Withstand typical handling and transportation.	Successfully completed.	Not specified.
- Transportation Simulation	Maintain integrity and function after simulated shipping.	Successfully completed.	Not specified.
Performance Accuracy/Precision	Accurate and consistent pressure measurement.	Successfully completed.	Not specified.
- Gauge Responsiveness	Speed and accuracy of gauge response to pressure changes.	Successfully completed.	Not specified.
- Volumetric Comparison	Comparison of inflated volume to expected volume.	Successfully completed.	Not specified.
- Greening Effect	(Likely refers to material compatibility or degradation over time)	Successfully completed.	Not specified.
- Gauge Accuracy and Precision	Accuracy and consistency of pressure readings.	Successfully completed.	Not specified.
Biocompatibility	Ensure material safety in contact with biological systems.	Based on ISO 10993-1 and FDA Modified ISO 10993 Test Profile.	Details of specific tests or results not provided.
Sterilization	Ensure effective sterilization and acceptable residuals.	Based on ISO 11135-1 and ISO 10993-7.	Details of specific tests or results not provided.
Aging	Ensure sterile barrier integrity over time.	Based on ASTM F1980-07.	Details of specific tests or results not provided.
Fittings	Ensure proper and secure connections.	Based on ISO 594-1 and ISO 594-2.	Details of specific tests or results not provided.

Important Note: The provided document states generally that the device "met the acceptance criteria necessary to demonstrate the safety and efficacy of the device" for all listed tests. However, it does not provide the specific quantitative acceptance criteria values (e.g., "pressure must be accurate within +/- X mmHg") nor the specific reported performance values (e.g., "the device demonstrated accuracy of +/- Y mmHg"). The document lists the types of tests performed and the standards they were based on, implying that the specific criteria and results are in the full test reports, which are not included here.

Regarding the other requested information, the document unfortunately does not contain details for points 2 through 9:

2. Sample size used for the test set and the data provenance: Not mentioned. The document lists tests but not the number of units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a mechanical instrument, and its performance is evaluated against engineering specifications and industry standards, not subjective expert assessment of data like in an AI diagnostic device.
4. Adjudication method for the test set: Not applicable. Performance is measured objectively.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a standalone medical device, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, by definition, the safety and performance tests described were for the standalone device. However, the term "algorithm only" is more typically associated with software-based devices, which this is not.
7. The type of ground truth used: For this device, the "ground truth" would be established engineering specifications, calibrated measurement standards, and requirements outlined in the referenced ISO and ASTM standards. For example, a "gauge accuracy" test would compare the device's reading to a known, highly accurate reference pressure gauge.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K122321
(pg. 1 of 2

Merit Medical Systems, Inc. Analog Inflation Syringe Premarket Notification 510(k) Section 5
510(k) Summary

DEC 1 9 2012

ಿ

Section 5 510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:	Merit Medical Systems, Inc.1600 West Merit Parkway,South Jordan, UT 84095(801) 208-4349(801) 253-6967Stephanie Erskine1721504
	Correspondent Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Ireland Ltd.Parkmore Business Park,Galway, Ireland(353) 91 703 761(353) 91 771 888Mark MullaneyDecember 19th, 20129616662
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	BasixCOMPAKInflation Syringe74 MAV Balloon Inflation Syringe
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Merit Monarch COMPAK Inflation Syringe &Universal Fluid Dispensing74 MAV Balloon Inflation SyringeK083523Merit Medical Systems, Inc.
Classification	Class II21 CFR § 870.1650, 74 MAVDivision of Cardiovascular Devices
Intended Use	The Merit analog inflation syringe is used to inflate and deflate anangioplasty balloon or other interventional device, and to measure thepressure within the balloon
DeviceDescription	The Merit analog inflation syringe is a single use disposable device capableof generating and monitoring pressure in angioplasty or other similarinterventional devices. It is fitted with a threaded plunger assembly withlock/release bar, flexible high pressure extension tube. It is provided with a510(k)-cleared three way medium pressure stopcock.
	Comparison toPredicate	The Technological characteristics of the subject Merit analog inflationdevice are substantially equivalent to those of the predicate, the MeritMonarch COMPAK Inflation Syringe & Universal Fluid Dispensing Device.The significant difference between the devices relate to the pressure gaugedisplay. The Merit analog inflation device has an analog gauge display. Thepredicate device has a digital display.
	Safety &PerformanceTests	No applicable mandatory performance standards or special controls havebeen established under Section 514 of the Food, Drug and Cosmetic Act forthis device. However, a battery of tests was performed according toprotocols based on the requirements of industry standards and guidanceand the device met the acceptance criteria necessary to demonstrate thesafety and efficacy of the device.
		Where appropriate, the tests were based on the requirements of thefollowing documents:ISO 11135-1:2007 Sterilization of health care products - Ethyleneoxide - Part 1: Requirements for the development, validation, androutine control of a sterilization process for medical devices. ISO 10993-7:2008 - Biological Evaluation of Medical Devices - Part7: Ethylene Oxide Sterilization Residuals ASTM F1980-07 Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices. ASTM D4169 - 09 Standard Practice for Performance Testing ofShipping Containers and Systems ISO 10993-1: 2009 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing within a risk management process, and theFDA Modified ISO 10993 Test Profile FDA Memo G95-1. ISO 594-1:1996 Conical Fittings with a 6% (Luer) taper for syringes,needles and certain other medical equipment - generalrequirements ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes,needles and certain other medical equipment - Part 2: Lock fittings
	Safety &PerformanceTests	The following is a list of all significant testing that has been successfullycompleted for this device:Functional Test (Fluid and Air) Torqueability Test Tensile Test Thermal Shock - Leak Test Transportation Simulation Gauge Responsiveness Test Volumetric Comparison Test Greening Effect Vacuum Capability Test Gauge Accuracy and Precision
	Summary ofSubstantialEquivalence	Based on the indications for use, design, safety, and performance testing,the subject Merit analog inflation device meets the requirements that areconsidered essential for its intended use and is substantially equivalent tothe predicate device, the Merit Monarch Inflation Syringe (K083523)manufactured by Merit Medical Systems, Inc. Differences between thedevices do not raise any different questions of safety or effectiveness.

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K122321
(pg. 282)

Merit Medical Systems, Inc.
Analog Inflation Syringe
Premarket Notification 510(k)

Section 5
510(k) Summary

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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 consists of a stylized human figure with three arms reaching upwards, symbolizing growth and development. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Merit Medical Systems, Inc. c/o Stephanie Erskine 1600 West Merit Parkway South Jordan, UT 84095

DEC 1 9 2012

Re: K122321

Trade/Device Name: BasixCOMPAK Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: MAV Dated: November 29, 2012 Received: November 30, 2012

Dear Ms. Erskine:

We have reviewed your 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Matthew G. Hillebrenner

for

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

Enclosure

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Merit Medical Systems, Inc. Analog Inflation Syringe Premarket Notification 510(k)

Section 4

Indications for Use Statement

510(k) Number (if known):

K12232

Device Name: BasixCOMPAK

Indications for Use:

The Merit analog inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

× 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)

M.Y. Hillel

n Sign-C (Division Sign-Oh)
Division of Cardiovascular Devices 510(k) Numbe

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.