The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or O-Ring. 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 document describes the acceptance criteria and the study conducted for the Merit Syringe, which is a medical device used to inject and withdraw fluids from the body.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the Merit Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2. The performance data for biocompatibility is also mentioned.

Acceptance Criteria (from ISO 7886-1 and ISO 594-2)	Reported Device Performance
ISO 7886-1:	Met acceptance criteria sufficient for its intended use.
Cleanliness	Met (implied by compliance with standard)
Graduated Scale	Met (implied by compliance with standard)
Limits for acidity or alkalinity	Met (implied by compliance with standard)
Barrel	Met (implied by compliance with standard)
Limits for extractable metals	Met (implied by compliance with standard)
Piston/Plunger Assembly	Met (implied by compliance with standard)
Lubricant	Met (implied by compliance with standard)
Nozzle	Met (implied by compliance with standard)
Tolerance on Graduated Capacity	Met (implied by compliance with standard)
Performance - Freedom from air and liquid leakage past piston	Met (implied by compliance with standard)
ISO 594-2:	Met acceptance criteria sufficient for its intended use.
Gauging	Met (implied by compliance with standard)
Unscrewing torque	Met (implied by compliance with standard)
Liquid leakage	Met (implied by compliance with standard)
Ease of assembly	Met (implied by compliance with standard)
Air leakage	Met (implied by compliance with standard)
Resistance to overriding	Met (implied by compliance with standard)
Separation force	Met (implied by compliance with standard)
Stress cracking	Met (implied by compliance with standard)
Biocompatibility (based on ISO 10993-1, 4, 5, 7, 10, 11; AAMI/ANSI ST72; ASTM F756-08; USP 37 NF 32 <151>):	Met acceptance criteria.
Cytotoxicity	Performed and compliant
Sensitization	Performed and compliant
Irritation	Performed and compliant
Acute Systemic Toxicity	Performed and compliant
Pyrogenicity	Performed and compliant
Hemolysis	Performed and compliant
Ethylene oxide sterilization residuals	Performed and compliant (ISO 10993-7)
Sterilization dose (Radiation)	Performed and compliant (ISO 11137-2)
Packaging integrity (for sterile devices)	Performed and compliant (ISO 11607-1, ASTM D4169-14, ASTM F1980-07, ISO 2233:2000)
Bacterial Endotoxins	Performed and compliant (AAMI/ANSI ST72)
Pyrogen Test	Performed and compliant (United States Pharmacopeia 37, National Formulary 32, 2014 <151>)

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 sizes used for each specific test described under ISO 7886-1, ISO 594-2, or the biocompatibility tests. It broadly mentions "A battery of tests was performed." Nor does it specify the country of origin of the data or whether the tests were retrospective or prospective. It is implied these were prospective tests conducted on manufactured units of the Merit Syringe.

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 provided. The compliance is based on meeting the established acceptance criteria of recognized consensus standards (ISO standards) and FDA guidance, rather than ground truth established by human experts in the context of diagnostic interpretation.

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

Not applicable. The tests are based on objective measurements and compliance with specified standards, not on human interpretation requiring adjudication.

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 device is a piston syringe, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device (syringe), not an algorithm. The performance evaluation is based on bench testing and material compatibility, which is analogous to "standalone" performance for a physical device.

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

The "ground truth" for the device's performance is defined by the acceptance criteria specified within the referenced international consensus standards and FDA guidance documents (e.g., ISO 7886-1, ISO 594-2, ISO 10993 series). Compliance means the device's physical and biological properties meet these pre-defined, objectively measurable standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical device undergoing performance and biocompatibility testing, not a machine learning algorithm.

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

Not applicable. There is no training set mentioned for this type of device submission.

Summary

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January 31, 2018

Merit Medical Systems, Inc. Cory Marsh Assoc. Manager, Regulatory Affairs 1600 W Merit Parkway South Jordan, Utah 84045

Re: K173601

Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 20, 2017 Received: November 21, 2017

Dear Cory Marsh:

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. 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.

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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 of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina
Kiang-S

Tina Kiang, Ph.D. 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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Indications for Use

510(k) Number (if known) K173601

Device Name

Merit Syringe

Indications for Use (Describe)

The Merit Syringe is used to inject fluids into, and 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)

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5.0 510(k) Summary K173601

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 MarshNovember 20, 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:Classification Name:Regulatory Class:Product Code:21 CFR §:Premarket Notification:Manufacturer:	Welmed Hypodermic SyringeSyringe, Piston2FMF880.5860K070936Welmed, Inc.
DeviceDescription	The Merit Syringe contains a calibrated hollow barrel into which isinserted a closely fitted movable plunger and tip or O-Ring. 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, and withdraw fluids from,	the body.
Comparison toPredicateDevice		The proposed Merit Syringe incorporates the same intended use, aswell as similar materials, design and principle of operation as thepredicate Welmed Hypodermic Syringe. Any differences in materialsused or operating volume are supported by the subject device'scompliance with FDA recognized standards ISO 7886-1 and ISO 594-2.The subject device is substantially equivalent to the predicate device.
Attribute	Subject Device – MeritSyringe	Predicate Device –Welmed Syringe
Comparison toPredicateDevice cont'd	Design	Standard three-piecepiston syringe constructedwith a clear hollow barrelinto which is inserted aclosely fitting movableplunger and tip or O-Ring.Fitting offered with maleluer lock.	Standard three-piecepiston syringe constructedwith a clear hollow barrelinto which is inserted aclosely fitting movableplunger and tip/seal.Fitting offered with maleluer lock.
	Material	The barrel is constructedfrom clear polycarbonate;the plunger from ABSmaterial; the seal or O-Ring is made of siliconematerial.	Materials used in themanufacture of theWelmed syringe aretypically used in themanufacture of general-purpose syringes.
	Principle ofOperation	Manually operated byadvancing andwithdrawing the plungerwithin the barrel.	Manually operated byadvancing andwithdrawing the plungerwithin the barrel.
	OperationalVolume	Operational volume of0.25, 1, 3, 6, 10, 20, 30and 60 mL.	Operational volume of 1,3, 5, 10, 20, 30, and 60mL.
	Graduation	Printed with accurategraduation lines that arecompliant with ISO 7886-1.	Printed with accurategraduation lines that arecompliant with ISO 7886-1.
	IntendedUse	The Merit Syringe is usedto inject fluids into, andwithdraw fluids from, thebody.	The intended use of theWelmed piston syringe isto inject fluids into, andwithdraw fluids from, thebody.

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FDA guidance and recognized consensus standards have been established for Piston Syringes under FDA Product Code FMF and 21 CFR 880.5860. A battery of tests was performed based on the Performance requirements of the below recognized consensus standards and Data guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed Merit Syringe met the standards' established acceptance criteria for the device.

ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [Including Technical Corrigendum 1 (1995)]
ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, .

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needles and certain other medical equipment – Part 2: Lock fittings

. ISO 11135:2014. Sterilization of health care products – Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices
ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [including: technical corrigendum 1 (2009)].
. AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization
. ISO 11137-1:2006. Sterilization of Health Care Products – Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices [Including: Amendment 1 (2013)]
ISO 11137-2:2013, Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose
ISO 11607-1:2006, Packaging for Terminally Sterilized Medical ● Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)]
Performance Data cont'd
. ASTM D4169-14: 2014. Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1980-07:2007, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Reapproved 2011)
. ISO 2233:2000. Packaging - Complete, filled transport packages and unit loads – Conditioning for testing
ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process [Including: Technical Corrigendum 1 (2010)]
ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including: Amendment 1(2006)]
ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cvtotoxicitv
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 F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials
AAMI/ANSI ST72:2011/(R)2016, Bacterial Endotoxins – Test methods, routine monitoring, and alternatives to batch testing
United States Pharmacopeia 37, National Formulary 32, 2014 <151> Pyrogen Test
. 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

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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	Performance - Freedom from air
Capacity	and liquid leakage past piston
		ISO 594-2
Gauging	Unscrewing torque
Liquid leakage	Ease of assembly
Air leakage	Resistance to overriding
Separation force	Stress cracking

Biocompatibility testing

Performance Data cont'd

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

Cytotoxicity ●
Sensitization
Irritation
Acute Systemic Toxicity ●
Pyrogenicity ●
Hemolysis ●

The Merit Syringe is considered indirect blood contacting for a duration of less than 24 hours.

Summary of	Based on the intended use, materials, design, and performance testing,
Substantial	the Merit Syringe meets the requirements that are considered essential
Equivalence	for its intended use and is considered substantially equivalent to the
	predicate device, the Welmed Hypodermic Syringe, K070936.

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).