The Merit 10mL Syringe is a device consisting of a calibrated hollow barrel into which is inserted a closely fitted movable plunger and seal. The barrel contains a male Luer lock connector (which conforms to ISO 594-1 & 2 standards) which is compatible for attaching devices with standard female Luer hubs.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Merit 10mL Syringe. It focuses on demonstrating substantial equivalence to a predicate device, the Merit 20mL Syringe (K111091), rather than a comparative effectiveness study involving AI or human readers. Therefore, several of the requested categories related to AI performance, human reader studies, and ground truth establishment for complex datasets are not applicable.

Here's an analysis based on the provided text:

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

Test Standard / Criteria	Reported Device Performance
ISO 7886-1:	Met predetermined acceptance criteria for safety and efficacy.
- Cleanliness	Met predetermined acceptance criteria
- Sufficient/excessive Lubricant	Met predetermined acceptance criteria
- Capacity Tolerance	Met predetermined acceptance criteria
- Graduated Scale	Met predetermined acceptance criteria
- Scale Uniformity	Met predetermined acceptance criteria
- Scale - Evenly spaced	Met predetermined acceptance criteria
- Scale Vertical Alignment	Met predetermined acceptance criteria
- Scale - Increments	Met predetermined acceptance criteria
- Scale Vertical Print	Met predetermined acceptance criteria
- Scale Length	Met predetermined acceptance criteria
- Scale Position	Met predetermined acceptance criteria
- Capacity 10% > Nominal	Met predetermined acceptance criteria
- Finger Grips	Met predetermined acceptance criteria
- Piston/Plunger Assembly	Met predetermined acceptance criteria
- Piston fit in Barrel	Met predetermined acceptance criteria
- Fiducial line on Barrel	Met predetermined acceptance criteria
- Nozzle Placement	Met predetermined acceptance criteria
- Nozzle Lumen	Met predetermined acceptance criteria
- Dead Space	Met predetermined acceptance criteria
- Liquid Leak Test	Met predetermined acceptance criteria
- Air Leak Test	Met predetermined acceptance criteria
- Acidity / Alkalinity	Met predetermined acceptance criteria
- Extractable Metals	Met predetermined acceptance criteria
ISO 594-2:	Met predetermined acceptance criteria for safety and efficacy.
- Luer Gauging	Met predetermined acceptance criteria
- Liquid Leak Test	Met predetermined acceptance criteria
- Air Leak Test	Met predetermined acceptance criteria
- Separation Force	Met predetermined acceptance criteria
- Unscrewing torque	Met predetermined acceptance criteria
- Ease of assembly	Met predetermined acceptance criteria
- Resistance to overriding	Met predetermined acceptance criteria
- Stress Cracking	Met predetermined acceptance criteria
Merit's Risk Analysis:	Met predetermined acceptance criteria for safety and efficacy.
- Plunger Seal Detachment Test	Met predetermined acceptance criteria
- Ink Adhesion Test	Met predetermined acceptance criteria
Biocompatibility (based on ISO 10993 series, ASTM F756-08, USP 37):	Met predetermined acceptance criteria for safety and efficacy.
- Cytotoxicity	Met predetermined acceptance criteria
- Sensitization	Met predetermined acceptance criteria
- Irritation	Met predetermined acceptance criteria
- Acute Systemic Toxicity	Met predetermined acceptance criteria
- Pyrogenicity	Met predetermined acceptance criteria
- Hemocompatibility	Met predetermined acceptance criteria

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 for each test, nor the specific provenance of the data (e.g., country of origin). The testing was conducted by the manufacturer, Merit Medical Systems, Inc., which is based in South Jordan, UT, USA. The nature of these tests (e.g., physical, chemical, and biological performance tests on a medical device) suggests they are prospective, conducted specifically to validate the device against established standards.

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 is not applicable as the study involves physical and biological testing of a medical device against objective standards (ISO, ASTM, USP), not interpretation of subjective data by human experts. The "ground truth" is defined by the acceptance criteria within these established standards.

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

Not applicable. As described above, the study involves objective performance testing against predefined criteria, not subjective interpretation requiring adjudication among experts.

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 510(k) submission for a physical medical device (syringe), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance was involved.

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

Not applicable. This is a 510(k) submission for a physical medical device (syringe), not an AI algorithm.

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

The "ground truth" for this device's performance is established by the acceptance criteria defined within recognized international and national consensus standards such as:

ISO 7886-1: Sterile hypodermic syringes for single use
ISO 594-1 & -2: Conical fittings (Luer taper)
ISO 11135: Sterilization
ISO 10993 series: Biological Evaluation of Medical Devices (Biocompatibility)
ASTM F756-08: Hemolytic Properties
United States Pharmacopeia 37: Pyrogen Test

These standards specify measurable parameters and thresholds for acceptable performance.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As explained above, there is no training set. The "ground truth" for the device's acceptable performance is derived from the established consensus standards and FDA guidance.

Summary

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

October 17, 2014

Merit Medical Systems, Incorporated Ms. Mridi Kumathe 1600 West Merit Parkway South Jordan, UT 84095

Re: K142636

Trade/Device Name: Merit 10mL Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Merit 10mL Syringe Regulatory Class: II Product Code: FMF Dated: 9/15/2014 Received: 9/17/2014

Dear Ms. Kumathe:

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.

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Page 2 - Mr. Kumathe

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Russo, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K142636

Device Name Merit 10mL Syringe

Indications for Use (Describe)

The Merit 10mL 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5.0 510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4712(801) 253-6921Mridi Kumathe09/15/20141721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:	Merit 10mL SyringeMerit 10mL SyringePiston Syringe
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Merit 20mL SyringeSyringe, PistonK111091Merit Medical Systems, Inc.
Classification	Class 221 CFR § 880.5860FDA Product Code: FMFReview Panel: General Hospital
Intended Use	The Merit 10mL Syringe is used to inject fluids into, or withdraw fluidsfrom, the body.
DeviceDescription	The Merit 10mL Syringe is a device consisting of a calibrated hollowbarrel into which is inserted a closely fitted movable plunger and seal.The barrel contains a male Luer lock connector (which conforms to ISO594-1 & 2 standards) which is compatible for attaching devices withstandard female Luer hubs.
Comparison toPredicateDevice	The indications for use, principle of operation and technologicalcharacteristics of the subject device are identical to the predicatedevice. Both devices have been designed and tested to ensurecompliance with the same set of consensus standards listed below. Thesubject device (Merit 10mL Syringe) is substantially equivalent to thepredicate device (Merit 20mL Syringe).

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FDA quidance and recognized performance standards have been established for "piston syringes" under Section 514 of the Food, Drug and Cosmetic Act. FDA Guidance Document "Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, April 1993" was consulted in the preparation of this 510(k) submission. A battery of tests was performed based on the requirements of the below recognized performance standards, as well as biocompatibility, sterilization, and labeling standards and quidance. Conformity to these standards demonstrates that the subject Merit 10mL Syringe met the standards' established acceptance criteria applicable to the safety and efficacy of the device. Performance testing was conducted based on the risk analysis and based on the requirements of the following international consensus standards/documents:

ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [Including Technical Corrigendum 1 (1995)]
. ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
. 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 - 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
. AAMI TIR 28, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization
ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
. ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices – Part 4: Selection of tests for interaction with blood
ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: 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 F756-08:2008, Standard Practice for Assessment of . Hemolytic Properties of Materials
United States Pharmacopeia 37, National Formulary 32, 2014 <151> Pyrogen Test

Safety & Performance Tests

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Performance Testing-Bench

ISO 7886-1

Cleanliness .
Sufficient/excessive Lubricant ●
Capacity Tolerance ●
Graduated Scale .
Scale Uniformity .
Scale - Evenly spaced
Scale Vertical Alignment .
Scale - Increments
Scale Vertical Print ●
Scale Length .
Scale Position .
Capacity 10% > Nominal .
Finger Grips
Piston/Plunger Assembly ●
. Piston fit in Barrel
Fiducial line on Barrel ●
Nozzle Placement ●
Nozzle Lumen .
Dead Space ●
Liquid Leak Test .
Air Leak Test ●
Acidity / Alkalinity ●
. Extractable Metals

ISO 594-2

Luer Gauging .
Liquid Leak Test ●
Air Leak Test .
Separation Force ●
Unscrewing torque .
Ease of assembly ●
Resistance to overriding .
Stress Cracking ●

Merit's Risk Analysis

Plunger Seal Detachment Test ●
Ink Adhesion Test ●

Safety & Performance Tests cont.

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Biocompatibility

Cytotoxicity ●
- Sensitization
- Irritation .
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- . Hemocompatibility

The results of the testing demonstrated that the subject Merit 10mL Syringe met the predetermined acceptance criteria applicable to the safety and efficacy of the device.

Summary of Substantial Equivalence

Based on the indications for use, design, safety and performance testing, the subject Merit 10mL Syringe meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit 20mL Syringe, K111091 manufactured by Merit Medical Systems, Inc..

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).