(76 days)
The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted, plunger, and O-ring seal. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 compliant female luer hubs. The syringe uses a fluorocarbon based non-silicone lubricant.
This document describes the premarket notification (510(k)) for the Merit Syringe, which is a piston syringe used to inject or withdraw fluids from the body. Given the nature of this submission (a 510(k) for a Class II medical device like a syringe), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to performance bench testing against recognized consensus standards and biocompatibility testing, rather than studies involving human readers or AI algorithms.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct table format for each acceptance criterion with a pass/fail. Instead, it states that the device "complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2" and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."
The general categories of acceptance criteria and the overall reported performance are:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Testing | Complies with ISO 7886-1:2017 (Sterile hypodermic syringes for single use – Part 1: Syringes for manual use) and ISO 594-2:1998 (Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings). |
| Biocompatibility Testing | Evaluation conducted in accordance with FDA Guidance Document “Use of International Standard ISO-10993” and ISO 10993-1. |
| Sterilization | Complies with ISO 11135:2014 (Ethylene oxide sterilization), ISO 10993-7:2008 (Ethylene oxide sterilization residuals), and AAMI TIR 28:2009 (Product adoption and process equivalency for ethylene oxide sterilization). |
| Packaging | Complies with ISO 11607-1:2006 (Packaging for Terminally Sterilized Medical Devices), ASTM D4169-16:2016 (Performance Testing of Shipping Containers and Systems), ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices), and ISO 2233:2000 (Conditioning for testing). |
Specific Biocompatibility Tests Performed:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Hemolysis
- Bacterial Endotoxins (AAMI/ANSI ST72:2011/(R) 2016)
- Pyrogen Test (United States Pharmacopeia 40, National Formulary 35, <151>)
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., number of syringes tested for flow rate, number of samples for biocompatibility). The testing is described generally as "a battery of tests" and "Performance testing... was completed against FDA recognized consensus standards." For device performance (like the Merit Syringe), the "test set" would typically refer to the samples of the manufactured device subjected to the physical and chemical tests, not a dataset of patient images or clinical data.
Data provenance: Not explicitly stated, as this refers to a medical device's physical/chemical performance, not clinical data collection. It's implied the testing was performed by "Merit Medical Systems, Inc." directly or by a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to a 510(k) submission for a piston syringe or the type of performance testing described. "Ground truth" and "experts" in this context typically refer to clinical validation studies, particularly for AI/imaging devices, where expert radiologists/clinicians establish diagnostic labels. For a syringe, the "ground truth" is established by the specifications of the recognized consensus standards (e.g., ISO 7886-1 defines specific dimensions, pressures, and flow rates that the device must meet).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly for interpreting medical images or patient outcomes, not for bench testing of a physical device. The "adjudication" in this context would be the pass/fail criteria defined by the consensus standards themselves, and the testing results are objectively measured.
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. MRMC studies are specific to evaluating the diagnostic performance of medical imaging devices or AI algorithms used in conjunction with human interpretation. This submission is for a physical medical device (syringe) and does not involve imaging or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. "Standalone performance" would refer to the bench testing of the syringe against the specified standards, as described in section 1.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced international consensus standards (e.g., ISO 7886-1, ISO 594-2). These standards stipulate acceptable ranges for attributes like dimensional accuracy, fluid leakage, plunger force, and luer connection integrity. Biocompatibility testing refers to established chemical and biological test methods detailed in standards like ISO 10993.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as #8.
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November 6, 2018
Merit Medical Systems, Inc. John Skousen Senior Regulatory Affairs Specialist 1600W Merit Parkway South Jordan, Utah 84095
Re: K182279
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 22, 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 mav, 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 avare 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, nına 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) K182279
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) |
|---|
| Commercial and/or Industrial OFF-Highway Diesel Engine Oil |
| In Use Fleet Automotive Vehicle OFF-Highway Diesel Engine Oil |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K182279 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 21, 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 isinserted a closely fitted, plunger, and O-ring seal. The barrel containsan ISO 594-2 compliant fixed male luer connector, which iscompatible with ISO 594-2 compliant female luer hubs. The syringeuses a fluorocarbon based non-silicone lubricant. | |
| Indicationsfor Use | The Merit Syringe is used to inject fluids into, or withdraw fluids from,the body. | the body. |
| Comparisonto PredicateDevice | The proposed Merit Syringe incorporates the same Intended Use withsimilar materials, design, and principle of operation as the predicatedevice. Differences include the nominal capacity; plunger material;plunger seal design and material; and lubricant. The safety andeffectiveness of the new materials were verified via biocompatibility |
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testing. Performance testing of the subject device was completed against FDA recognized consensus standards ISO 7886-1 and ISO 594-2. These differences between the subject device and predicate device do not raise different questions of safety and effectiveness.
| Comparisonto PredicateDevice | Attribute | Subject Device- Merit Syringe | PredicateDevice - Merit20 mL Syringe | Comments |
|---|---|---|---|---|
| (Continued) | Design | Standard three-piece pistonsyringeconstructed witha clear hollowbarrel into whichis inserted aclosely fittingplunger and O-ring seal. Fittingoffered with maleluer lockconnector. | Standard three-piece pistonsyringeconstructed witha clear hollowbarrel into whichis inserted aclosely fittingplunger andplunger tip seal.Fitting offeredwith male luerlock connector. | Differentplungerandplungerseal design |
| Material | The barrel isconstructed fromclear cyclo-olefinpolymer; theplunger fromglass-filled nylon;the O-ring ismade of silicone;fluorocarbonbased non-silicone lubricant. | The barrel isconstructed fromclear cyclo-olefinpolymer; theplunger frompolycarbonate orABS material;the plunger tipseal is made ofsilicone; thelubricant issilicone. | SameBarrelMaterialDifferentplungermaterialDifferent tipseal designDifferentlubricant | |
| Principle ofOperation | Manuallyoperated byadvancing andwithdrawing theplunger withinthe barrel. | Manuallyoperated byadvancing andwithdrawing theplunger withinthe barrel. | Same | |
| OperationalVolume | 0.25 mLoperationalvolume. | 20 mLoperationalvolume. | Different | |
| Graduation | Printed with accurategraduation linesthat arecompliant withISO 7886-1. | Printed with accurategraduation linesthat arecompliant withISO 7886-1. | Differentgraduationsbut bothfollowsamestandard | |
| Indicationsfor Use /IntendedUse | The MeritSyringe is usedto inject fluidsinto, or withdrawfluids from, thebody. | The MeritMedical 20 mLSyringe is usedto inject fluidsinto, or withdrawfluids from, thebody. | Same |
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FDA quidance 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 guidance, as well as biocompatibility, sterilization, and packaging Data 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 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 28:2009. Product adoption and process equivalency for ethylene oxide sterilization . 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)] ASTM D4169-16: 2016, Standard Practice for Performance ● Testing of Shipping Containers and Systems . ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices . 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
- ISO 10993-4:2017, Biological evaluation of medical devices -● Part 4: Selection of tests for interactions with blood
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| PerformanceData(Continued) | 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 F756-17:2017, Standard Practice for Assessment ofHemolytic Properties of Materials AAMI/ANSI ST72:2011/(R) 2016, Bacterial Endotoxins – Testmethods, routine monitoring, and alternatives to batch testing United States Pharmacopeia 40, National Formulary 35, <151>Pyrogen Test (2017) 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 Performance Bench TestingThe Merit Syringe complies with the FDA recognized consensusstandards ISO 7886-1 and ISO 594-2, as outlined within thissubmission. Results of the testing demonstrate that the subjectdevice met the acceptance criteria sufficient for its intended use.Testing included the following from these standards:Biocompatibility testingA biocompatibility evaluation for the Merit Syringe was conducted inaccordance with the FDA Guidance Document “Use of InternationalStandard ISO-10993, ‘Biological Evaluation of Medical Devices Part1: Evaluation and Testing within a Risk Management Process,’” June16, 2016, and International Standard ISO 10993-1 “BiologicalEvaluation of Medical Devices - Part 1: Evaluation and TestingWithin a Risk Management Process,” as recognized by FDA. TheMerit Syringe is an externally communicating device with indirectblood contacting for a duration of less than 24 hours. Testing includedthe following:Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemolysis |
|---|---|
| Summary ofSubstantialEquivalence | Differences between the technological characteristics of the subjectdevice as compared to the predicate do not raise different questionsof safety and effectiveness. The performance of the device issupported by non-clinical testing and risk management activities. TheMerit Syringe is Substantially Equivalent (SE) to the Merit 20 mLSyringe, cleared under K152783. |
§ 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).