The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted, ratcheted plunger, and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 compliant female luer hubs.

AI/ML Overview

The provided text describes the performance testing of the Merit Syringe, a medical device. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from ISO 7886-1)	Reported Device Performance
Cleanliness	Complies with ISO 7886-1
Limits for acidity or alkalinity	Complies with ISO 7886-1
Limits for extractable metals	Complies with ISO 7886-1
Lubricant	Complies with ISO 7886-1
Tolerance on Graduated Capacity (based on graduation scale)	Complies with ISO 7886-1
Tolerance on Graduated Capacity (based on audible/tactile use)	Complies with ISO 7886-1
Graduated Scale	Complies with ISO 7886-1
Barrel	Complies with ISO 7886-1
Piston/Plunger Assembly	Complies with ISO 7886-1
Nozzle	Complies with ISO 7886-1
Performance – Freedom from air and liquid leakage past piston	Complies with ISO 7886-1
Acceptance Criteria (from ISO 594-2)	Reported Device Performance
Gauging	Complies with ISO 594-2
Liquid leakage	Complies with ISO 594-2
Air leakage	Complies with ISO 594-2
Separation force	Complies with ISO 594-2
Unscrewing torque	Complies with ISO 594-2
Ease of assembly	Complies with ISO 594-2
Resistance to overriding	Complies with ISO 594-2
Stress cracking	Complies with ISO 594-2
Biocompatibility (from ISO 10993 series and other standards)	Reported Device Performance
Cytotoxicity	Complies with ISO 10993 series
Sensitization	Complies with ISO 10993 series
Irritation	Complies with ISO 10993 series
Acute Systemic Toxicity	Complies with ISO 10993 series
Pyrogenicity	Complies with USP 39, NF 34, <151>
Hemolysis	Complies with ASTM F756-08:2013
Sterilization (Ethylene Oxide)	Complies with ISO 11135:2014, ISO 10993-7:2008, AAMI TIR 28:2009
Packaging (Terminally Sterilized Medical Devices)	Complies with ISO 11607-1:2006, ASTM D4169-14: 2014, ASTM F1980-07:2007, ISO 2233:2000

Reported Device Performance Summary: The device "met the standards' established acceptance criteria for the device". The text explicitly states, "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set for performance or biocompatibility testing. It only refers to a "battery of tests" being performed. Data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The testing described involves objective, standardized measurements against recognized consensus standards for physical, chemical, and biological properties of a piston syringe, not subjective interpretation by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in clinical trials or diagnostic studies. The performance testing of the Merit Syringe involves objective measurements against predefined criteria.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the evaluation of diagnostic algorithms or AI tools, often in imaging, which is not relevant to the Merit Syringe.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation was done, but it refers to the performance of the syringe itself, not an algorithm. The testing described (bench testing, biocompatibility, sterilization, packaging) assesses the device's inherent properties and adherence to standards without human intervention influencing the device's function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance testing of the Merit Syringe was established by FDA recognized consensus standards (e.g., ISO 7886-1, ISO 594-2, ISO 10993 series, ASTM standards, USP). These standards define objective, measurable criteria for the various aspects of the syringe's function and safety.

8. The sample size for the training set

This information is not applicable. The Merit Syringe is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

August 7, 2017

Merit Medical Systems, Inc. Mr. Cory Marsh Associate Manager, Regulatory Operations 1600 West Merit Parkway South Jordan, Utah 84095

Re: K171362

Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: July 7, 2017 Received: July 7, 2017

Dear Mr. Cory Marsh:

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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

James P. Bertram -S

for

Lori A. Wiggin, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171362

Device Name

Merit Syringe

Indications for Use (Describe)

The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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5.0 510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-3690(801) 826-4112Mr. Cory MarshMay 8, 20171721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	Merit SyringePiston SyringeSyringe, Piston2FMF880.5860General Hospital
PredicateDevice	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Premarket Notification:Manufacturer:Product Code:21 CFR §:Review Panel:	BD Single Use, Hypodermic SyringePiston SyringeSyringe, Piston2K110771BD Medical - Medical Surgical SystemsFMF880.5860General Hospital
DeviceDescription	The Merit Syringe contains a calibrated hollow barrel into which isinserted a closely fitted, ratcheted plunger, and tip or seal. The barrelcontains an ISO 594-2 compliant fixed male luer connector, which iscompatible with ISO 594-2 compliant female luer hubs.
Indications forUse	The Merit Syringe is used to inject fluids into, or withdraw fluids from,the body.The Indications for Use statement for the Merit Syringe is not identicalto the predicate device; however, the differences do not alter theintended therapeutic use of the device nor do they affect theperformance of the device relative to the predicate. The subject and
	The proposed Merit Syringe incorporates the same Intended Use,materials, similar design and principle of operation as the predicatedevice. Differences between the devices include the nominal capacityand plunger design. Performance testing of the subject device wascompleted against FDA recognized consensus standards ISO 7886-1and ISO 594-2.
Comparison toPredicateDevice	Attribute	Subject Device - MeritSyringe	Predicate Device - BDSingle Use, HypodermicSyringe
	BasicDesign	Standard three-piecepiston syringe constructedusing the same barrel andtip material as thepredicate device. Thesubject device utilizes asingle-piece moldedratcheted plunger. Fittingoffered with male luer lockconnector.	Standard three-piecepiston syringe constructedwith a clear hollow barrelinto which is inserted aclosely fitting movableplunger and tip/seal.Fitting offered with maleluer lock connector.
	Material	The barrel is constructedfrom polypropylene; theplunger frompolypropylene; the seal ismade of silicone.	The barrel is constructedfrom polypropylene; theplunger frompolypropylene; the seal ismade of silicone.
	Principle ofOperation	Manually operated byadvancing andwithdrawing the plungerwithin the barrel.	Manually operated byadvancing andwithdrawing the plungerwithin the barrel.
	OperationalVolume	Operational volume of 10mL.	Operational volume of 1,3, and 5 mL.
	Graduation	Printed with accurategraduation lines that arecompliant with ISO 7886-1.	Printed with accurategraduation lines that arecompliant with ISO 7886-1.
	Indicationsfor Use /IntendedUse	The Merit Syringe is usedto inject fluids into, orwithdraw fluids from, thebody.	The BD Single Use,Hypodermic Syringe isintended for use by healthcare professionals forgeneral purpose fluidaspiration/injection.

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predicate device have the same intended use to inject fluids into, or withdraw fluids from, the body, as stated in 21 CFR 880.5860.

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FDA guidance and recognized consensus standards have beenestablished for Piston Syringes under FDA Product Code FMF and 21CFR 880.5860. A battery of tests was performed based on therequirements of the below recognized consensus standards andguidance, as well as biocompatibility, sterilization, and packagingstandards and guidance. Conformity to these standards demonstratesthat the proposed Merit Syringe met the standards' establishedacceptance criteria for the device.
PerformanceData	ISO 7886-1:1993, Sterile hypodermic syringes for single use – Part1: Syringes for manual use [Including Technical Corrigendum 1(1995)] ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes,needles and certain other medical equipment – Part 2: Lock fittings ISO 11135:2014, Sterilization of health care products – Ethyleneoxide – Requirements for the development, validation, and routinecontrol of a sterilization process for medical devices ISO 10993-7:2008, Biological evaluation of medical devices - Part7: Ethylene oxide sterilization residuals AAMI TIR 28:2009, Product adoption and process equivalency forethylene oxide sterilization ISO 11607-1:2006, Packaging for Terminally Sterilized MedicalDevices – Part 1: Requirements for Materials, Sterile BarrierSystems and Packaging Systems [Including: Amendment 1 (2014)] ASTM D4169-14: 2014, Standard Practice for Performance Testingof Shipping Containers and Systems ASTM F1980-07:2007, Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices (Reapproved 2011) ISO 2233:2000, Packaging – Complete, filled transport packagesand unit loads – Conditioning for testing ISO 10993-1:2009, Biological evaluation of medical devices - Part1: Evaluation and Testing within a risk management process[Including: Technical Corrigendum 1 (2010)] ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medicaldevices - Part 4: Selection of tests for interactions with blood[Including: Amendment 1(2006)] ISO 10993-5:2009, Biological evaluation of medical devices – Part5: Tests for in vitro cytotoxicity ISO 10993-10-2010, Biological evaluation of medical devices –

FDA guidance and recognized consensus standards have beenestablished for Piston Syringes under FDA Product Code FMF and 21CFR 880.5860. A battery of tests was performed based on therequirements of the below recognized consensus standards andguidance, as well as biocompatibility, sterilization, and packagingstandards and guidance. Conformity to these standards demonstratesthat the proposed Merit Syringe met the standards' establishedacceptance criteria for the device.

PerformanceData

ISO 7886-1:1993, Sterile hypodermic syringes for single use – Part1: Syringes for manual use [Including Technical Corrigendum 1(1995)] ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes,needles and certain other medical equipment – Part 2: Lock fittings ISO 11135:2014, Sterilization of health care products – Ethyleneoxide – Requirements for the development, validation, and routinecontrol of a sterilization process for medical devices ISO 10993-7:2008, Biological evaluation of medical devices - Part7: Ethylene oxide sterilization residuals AAMI TIR 28:2009, Product adoption and process equivalency forethylene oxide sterilization ISO 11607-1:2006, Packaging for Terminally Sterilized MedicalDevices – Part 1: Requirements for Materials, Sterile BarrierSystems and Packaging Systems [Including: Amendment 1 (2014)] ASTM D4169-14: 2014, Standard Practice for Performance Testingof Shipping Containers and Systems ASTM F1980-07:2007, Standard Guide for Accelerated Aging ofSterile Barrier Systems for Medical Devices (Reapproved 2011) ISO 2233:2000, Packaging – Complete, filled transport packagesand unit loads – Conditioning for testing ISO 10993-1:2009, Biological evaluation of medical devices - Part1: Evaluation and Testing within a risk management process[Including: Technical Corrigendum 1 (2010)] ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medicaldevices - Part 4: Selection of tests for interactions with blood[Including: Amendment 1(2006)] ISO 10993-5:2009, Biological evaluation of medical devices – Part5: Tests for in vitro cytotoxicity ISO 10993-10-2010, Biological evaluation of medical devices –

Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006, Biological evaluation of medical devices ● Part 11: Tests for systemic toxicity
. ASTM F756-08:2013, Standard Practice for Assessment of Hemolytic Properties of Materials
. AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing
United States Pharmacopeia 39, National Formulary 34, <151> . Pyrogen Test (2016)

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FDA Guidance, Guidance on the Content of Premarket Notification ● [510(k)] Submissions for Piston Syringes, April 1993
. FDA Guidance, The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, March 1998
FDA Guidance, Recognition and Use of Consensus Standards, ● September 2007
. FDA Guidance, Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, June 2016

Performance Bench Testing

The Merit Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Testing included the following from these standards:

ISO 7886-1
Cleanliness	Graduated Scale
Limits for acidity or alkalinity	Barrel
Limits for extractable metals	Piston/Plunger Assembly
Lubricant	Nozzle
Tolerance on Graduated Capacity (based on graduation scale)	Performance – Freedom from air and liquid leakage past piston
Tolerance on Graduated Capacity (based on audible/tactile use)
ISO 594-2
Gauging	Unscrewing torque
Liquid leakage	Ease of assembly
Air leakage	Resistance to overriding
Separation force	Stress cracking

Biocompatibility testing

The biocompatibility evaluation for the Merit Syringe was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,"" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk

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Management Process," as recognized by FDA. Testing included the following:

Cytotoxicity
Sensitization o
Irritation ●

Merit Syringe

Acute Systemic Toxicity ●
Pyrogenicity
Hemolysis ●

The Merit Syringe is an externally communicating device with indirect blood contacting for a duration of less than 24 hours.

Based on the intended use, materials, design, and performance testing, Summary of the Merit Syringe meets the requirements that are considered essential Substantial for its intended use and is considered substantially equivalent to the Equivalence predicate device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).