The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip. The barrel contains a fixed male luer connector, which is compatible with female luer hubs.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Merit Syringe, based on the given requirements:

The document does not contain information about a device that uses AI, or a device that specifically needs human readers to interpret its output. Thus, questions 2, 3, 4, 5, 6, 7, 8, and 9 from your prompt are not applicable to the provided text. The device described, the "Merit Syringe," is a mechanical medical device (a piston syringe) and its evaluation focuses on physical performance, material compatibility, and sterilization.

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

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Material & Design	Same materials as predicate device (K152783): barrel (clear cyclo-olefin polymer), plunger (polycarbonate or ABS), seal (silicone), lubricant (silicone)	Met: Materials of the subject device are identical to the predicate device.
Biocompatibility	Endpoints previously evaluated under K152783: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility. (FDA Guidance, ISO 10993-1)	Met: Biocompatibility testing provided in K081361 demonstrated the biocompatibility of the subject device for the intended use, as materials are identical to the predicate (K152783). The specified biocompatibility endpoints were previously evaluated.
Sterilization	Sterility process cleared under K152783 (ISO 11135:2014, ISO 11607-1:2006, AAMI TIR 28:2009)	Met: The subject device was adopted into existing validated sterility processes (EO sterilization with a 3-year shelf life) per AAMI TIR 2009, with the process validated under K152783 using ISO 11135 and ISO 11607-1.
Performance Bench Testing	ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use)	Met: Testing demonstrated that the subject device met the predetermined acceptance criteria and supports the 3-year shelf life. (For both general performance and dimensional accuracy of graduation lines).
Performance Bench Testing	ISO 594-2:1998 (Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings)	Met: Testing demonstrated that the subject device met the predetermined acceptance criteria and supports the 3-year shelf life. (Specific to luer lock connector performance).
Risk Management	ISO 14971:2007 (Medical devices – Application of risk management to medical devices)	Met: A risk analysis was conducted in accordance with ISO 14971:2007, and in all non-clinical testing, the predetermined acceptance criteria were met, leading to a conclusion of substantial equivalence.
Graduation Accuracy	Compliant with ISO 7886-1	Met: Printed with accurate graduation lines that are compliant with ISO 7886-1. (This is a specific performance aspect within the broader ISO 7886-1 compliance).
Shelf Life	3-year shelf life	Met: Results of performance testing demonstrate support for the 3-year shelf life.

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

Not applicable. This is a medical device (syringe) clearance based on bench testing to established standards and comparison to a predicate device, not on clinical study data involving patients or AI performance on a test set.

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)

Not applicable. Ground truth for a diagnostic device/AI is not relevant for a mechanical syringe. Performance is measured against engineering standards.

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

Not applicable. No expert adjudication is described for a syringe's performance against engineering standards.

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 not an AI-assisted diagnostic tool.

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

Not applicable. There is no algorithm for a mechanical syringe.

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

Not applicable. The "ground truth" for this device's performance is compliance with recognized international and FDA standards for syringes (e.g., ISO 7886-1, ISO 594-2) and biocompatibility standards (ISO 10993-1).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

Not applicable. As above, no training set or ground truth in the context of AI/ML is relevant for this device.

Summary

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November 6, 2018

Merit Medical Systems, Inc John Skousen Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095

Re: K182216

Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 13, 2018 Received: August 15, 2018

Dear John Skousen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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) K182216

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)
Experimental Use (Specific IRB-Approved Research Study)
In-Vivo Diagnostic Use (Specific IRB-Approved Research Study)

|× | Prescription Use (Part 21 CFR 801 Subpart D)

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

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K182216 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) 316-3724(801) 826-4112Dr. John SkousenAugust 13, 20181721504
SubjectDevice	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:	Merit 20 mL SyringePiston SyringeSyringe, Piston2K152783Merit Medical Systems, Inc.FMF880.5860General Hospital
DeviceDescription		The Merit Syringe contains a calibrated hollow barrel into which is inserteda closely fitted movable plunger and tip. The barrel contains a fixed maleluer connector, which is compatible with female luer hubs.
Indicationsfor Use	The Merit Syringe is used to inject fluids into, or withdraw fluids from, thebody.
Comparisonto PredicateDevice	A technological comparison table is provided below that compares thesubject device and predicate device. The proposed Merit Syringeincorporates the same Intended Use with identical materials, similardesign, and identical principle of operation as the predicate device: theMerit 20 mL Syringe (K152783). The only differences are the dimensionalaspects and volume capacity compared to the predicate device.Performance testing of the subject device was completed against FDArecognized consensus standards ISO 7886-1 and ISO 594-2.. Thesedifferences between the subject device and predicate device, do not raise	different questions of safety and effectiveness.

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Attribute	Subject Device –Merit Syringe	Predicate Device –Merit 20 mLSyringe	Comparison
Design	Standard three-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting plunger and tip/seal. Fitting offered with male luer lock connector. Design is consistent with dimensions of a 1 mL syringe.	Standard three-piece piston syringe constructed with a clear hollow barrel into which is inserted a closely fitting plunger and tip/seal. Fitting offered with male luer lock connector. Design is consistent with dimensions of a 20 mL syringe.	Same general design except the operational volume
Material	The barrel is constructed from clear cyclo-olefin polymer; the plunger from polycarbonate or ABS material; the seal is made of silicone; the lubricant is silicone.	The barrel is constructed from clear cyclo-olefin polymer; the plunger from polycarbonate or ABS material; the seal is made of silicone; the lubricant is silicone.	Same
Principle of Operation	Manually operated by advancing and withdrawing the plunger within the barrel.	Manually operated by advancing and withdrawing the plunger within the barrel.	Same
OperationalVolume	Operational volume of 1 mL.	Operational volume of 20 mL.	Different
Graduation	Printed with accurate graduation lines that are compliant with ISO 7886-1.	Printed with accurate graduation lines that are compliant with ISO 7886-1.	Different graduations but both follow same standard
Indications for Use / Intended Use	The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.	The Merit Medical 20 mL Syringe is used to inject fluids into, or withdraw fluids from, the body.	Same

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Non-Clinical Testing

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 requirements of the below recognized consensus standards and guidance, as well as biocompatibility, sterilization, and packaging standards and guidance.

ISO 7886-1: 2017, Sterile hypodermic syringes for single use -● Part 1: Syringes for manual use
. ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
. AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization
FDA Guidance, Guidance on the Content of Premarket Notification . [510(k)] Submissions for Piston Syringes, April 1993
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

Device Biocompatibility:

The Merit Syringe is an externally communicating device with indirect blood contacting for a duration of less than 24 hours. The materials used in the subject device in its final finished form are identical to the materials used in the predicate device, cleared under K152783. Therefore, testing provided in K081361 demonstrated the biocompatibility of the subject device for the intended use. The biocompatibility endpoints that were previously evaluated under K152783 are the following:

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

Device Sterilization :

The subject device is a sterile, non-pyrogenic, single use 1 ml syringe sterilized by EO, with a 3 year shelf life. It is packaged in an EVA blister/Tyvek pouch. The subiect device was adopted into exisiting validated sterility process per AAMI TIR: 2009: Adoption and Process Equivalency for Ethylene Oxide Sterilization. The sterility process was cleared under K152783 and was validated under K152783 using:

. 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 11607-1:2006, Packaqing for Terminally Sterilized Medical . Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)]:

Device Performance Bench Testing

The Merit Syringe performance was tested in accordance with the FDA recognized consensus standards ISO 7886-1:2017 and ISO 594-2:1998.

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	Results of the testing demonstrate that the subject device met the pre-determined acceptance criteria and supports the 3 year shelf life of thedevice.
Non-ClinicalTesting	A risk analysis was conducted in accordance with ISO 14971: 2007 -Medical devices Application of risk management to medical devices.
	In all non-clinical testing, the pre-determined acceptance criteria was met.
Summary ofSubstantialEquivalence	Differences between the technological characteristics of the subject deviceas compared to the predicate do not raise different questions of safety andeffectiveness. The performance of the device is supported by non-clinicaltesting and risk management activities. The Merit Syringe is SubstantiallyEquivalent (SE) to the Merit 20 mL Syringe, cleared under K152783.

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).