(224 days)
The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body.
The Merit Coronary Control Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector or male luer rotating adaptor, which are compatible with ISO 594-2 compliant female luer hubs.
This document is a 510(k) premarket notification for the Merit Coronary Control Syringe. It focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized consensus standards for medical devices. Therefore, the information provided does not specifically describe a study that proves the device meets acceptance criteria through clinical or AI-based performance metrics. Instead, it relies on bench testing as per established standards for mechanical and material properties.
However, I can extract the acceptance criteria and the "reported device performance" (which in this context refers to the demonstration of compliance with those criteria through testing) from the provided text.
Here's an interpretation of the request using the available information:
Acceptance Criteria and Device Performance (as demonstrated by compliance with standards):
The document states that the Merit Coronary Control Syringe complies with 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 acceptance criteria are implicitly defined by the requirements of these standards and other listed tests. The "reported device performance" is that the device met these criteria.
| Acceptance Criteria Category (from ISO Standards and Biocompatibility Tests) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1 (Sterile hypodermic syringes for manual use) | Met all requirements |
| Cleanliness (Limits for acidity/alkalinity, extractable metals) | Compliant |
| Lubricant | Compliant |
| Tolerance on Graduated Capacity | Compliant |
| Graduated Scale | Compliant |
| Barrel | Compliant |
| Piston/Plunger Assembly | Compliant |
| Nozzle | Compliant |
| Performance - Freedom from air and liquid leakage past piston | Compliant |
| ISO 594-2 (Conical fittings with 6% (Luer) taper) | Met all requirements |
| Gauging | Compliant |
| Liquid leakage | Compliant |
| Air leakage | Compliant |
| Separation force | Compliant |
| Unscrewing torque | Compliant |
| Ease of assembly | Compliant |
| Resistance to overriding | Compliant |
| Stress cracking | Compliant |
| Biocompatibility Testing (ISO 10993 series) | Met all requirements |
| Cytotoxicity | Compliant |
| Sensitization | Compliant |
| Irritation | Compliant |
| Acute Systemic Toxicity | Compliant |
| Pyrogenicity | Compliant |
| Hemolysis | Compliant |
| USP Physicochemical | Compliant |
| Sterilization & Packaging Standards (Various listed ISO, ASTM, AAMI) | Met all requirements |
| Ethylene Oxide Sterilization | Compliant |
| Radiation Sterilization | Compliant |
| Packaging Integrity and Performance | Compliant |
Now, addressing the other specific points:
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each of the performance bench tests. It broadly states that "A battery of tests was performed."
- Data Provenance: The tests are "Performance Bench Testing" conducted on the physical device, indicating this is laboratory testing. The provenance is internal testing by Merit Medical Systems, Inc., to demonstrate compliance with international standards. There is no mention of country of origin for data in the sense of patient data, as this is a physical device rather than an AI/software device. The product is manufactured by Merit Medical Systems, Inc. (South Jordan, Utah, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a hardware product (coronary control syringe) that undergoes mechanical, chemical, and biological performance testing, not a diagnostic AI device requiring expert ground truth for interpretation of images or clinical outcomes.
- Therefore, there are no "experts" in the context of clinical interpretation establishing ground truth for a test set in this document. Ground truth for these tests is based on the quantifiable, measurable criteria defined by the ISO, ASTM, and AAMI standards themselves (e.g., specific thresholds for leakage, force, or biological reactivity). The "experts" would be the engineers and scientists conducting the tests and verifying compliance with the standard specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers or subjective assessments requiring adjudication. The tests are objective and based on measurable parameters defined by the consensus 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 document pertains to a physical medical device (a syringe), not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to the device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance testing is based on predefined, measurable acceptance criteria specified by internationally recognized consensus standards (ISO, ASTM, AAMI). These standards set quantitative limits for performance attributes (e.g., "freedom from air and liquid leakage past piston," specific force for unscrewing torque, cytotoxicity levels). Compliance is determined by objective measurement against these established benchmarks.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that would require a "training set." The focus is on manufacturing control and adherence to established engineering and material science standards.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Merit Medical Systems, Inc. Mr. Cory Marsh Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095
Re: K163084
Trade/Device Name: Merit Coronary Control Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: June 13, 2017 Received: June 14, 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,
Lori A. Wiggins -S6
Lori A. Wiggins, 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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Indications for Use
510(k) Number (if known) K163084
Device Name Merit Coronary Control Syringe
Indications for Use (Describe)
The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be 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) |
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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 MarshNovember 2, 20161721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Merit Coronary Control SyringeControl SyringeInjector and Syringe, Angiographic2DXT870.1650Cardiovascular |
| PrimaryPredicateDevice | Trade Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Premarket Notification:Manufacturer: | NMI Control SyringeInjector and Syringe, Angiographic2DXT870.1650K113198Navilyst Medical, Inc. |
| SecondaryPredicateDevice | Trade Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Premarket Notification:Manufacturer: | Welmed Hypodermic SyringeSyringe, Piston2FMF880.5860K070936Welmed, Inc. |
| DeviceDescription | The Merit Coronary Control Syringe contains a calibrated hollow barrelinto which is inserted a closely fitted movable plunger and tip or seal.The barrel contains an ISO 594-2 compliant fixed male luer connectoror male luer rotating adaptor, which are compatible with ISO 594-2compliant female luer hubs. | |
| Indications forUse | The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.The syringe can also be used to inject fluids into, or withdraw fluidsfrom, the body. |
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The proposed Merit Coronary Control Syringe incorporates an expanded Intended Use, as well as similar materials, design and principle of operation as the NMI Control Syringe primary predicate device.
| Attribute | Subject Device – MeritCoronary ControlSyringe | Primary PredicateDevice – NMI ControlSyringe | |
|---|---|---|---|
| Design | Standard three-piecepiston syringe constructedwith a clear hollow barrelinto which is inserted aclosely fitting movableplunger and tip/seal.Fitting offered with maleluer lock or male rotatingadaptor. | Standard three-piecepiston syringe constructedwith a clear hollow barrelinto which is inserted aclosely fitting movableplunger and tip/seal.Fitting offered with maleluer lock or male rotatingadaptor. | |
| Comparison toPrimaryPredicateDevice | Material | The barrel is constructedfrom clear polycarbonate;the plunger from ABSmaterial; the seal is madeof silicone material; therotator O-Ring is made ofsilicone. | The barrel is constructedfrom clear polycarbonate. |
| Principle ofOperation | Manually operated byadvancing andwithdrawing the plungerwithin the barrel. | Manually operated byadvancing andwithdrawing the plungerwithin the barrel. | |
| OperationalVolume | Operational volume of 6,8, 10, 12, and 20 mL. | Operational volume of 7,8, 10, 12, and 20 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 CoronaryControl Syringe isintended to be used forthe intra-arterial orintravenous administrationof radiographic contrastmedia. The syringe canalso be used to injectfluids into, or withdrawfluids from, the body. | The NMI Control Syringeis intended to be used forthe intra-arterial orintravenous administrationof radiographic contrastmedia. |
·
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| Attribute | Subject Device – MeritCoronary ControlSyringe | Secondary PredicateDevice – WelmedHypodermic Syringe | |
|---|---|---|---|
| Comparison toSecondaryPredicateDevice | Indicationsfor Use /IntendedUse | The Merit CoronaryControl Syringe isintended to be used forthe intra-arterial orintravenous administrationof radiographic contrastmedia. The syringe canalso be used to injectfluids into, or withdrawfluids from, the body. | The intended use of theWelmed, Inc. pistonsyringe is to inject fluidsinto or withdraw fluidsfrom the body. |
The secondary predicate device supports the expanded Indications for Use of the Merit Coronary Control Syringe.
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 requirements of the below recognized consensus standards and guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed Merit Coronary Control 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, ● 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
Performance Data
- 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 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
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Systems and Packaging Systems [Including: Amendment 1 (2014)]
- 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 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
Performance Data cont'd
- . AAMI/ANSI ST72:2011, 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
Performance Bench Testing
The Merit Coronary Control 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:
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| Cleanliness | Graduated Scale | |
|---|---|---|
| Limits for acidity or alkalinity | Barrel | |
| Limits for extractable metals | Piston/Plunger Assembly | |
| Lubricant | Nozzle | |
| Tolerance on Graduated | Performance - Freedom from airand liquid leakage past piston | |
| Capacity | ||
| ISO 594-2 | ||
| Gauging | Unscrewing torque | |
| Liquid leakage | Ease of assembly | |
| Air leakage | Resistance to overriding | |
| Separation force | Stress cracking | |
| PerformanceData cont'd | Biocompatibility testingThe biocompatibility evaluation for the Merit Coronary Control Syringewas conducted in accordance with the FDA Blue Book Memorandum#G95-1 “Use of International Standard ISO-10993, ‘BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing,’” May 1,1995, and International Standard ISO 10993-1 “Biological Evaluation ofMedical Devices – Part 1: Evaluation and Testing Within a RiskManagement Process,” as recognized by FDA. Testing included thefollowing:• Cytotoxicity• Sensitization• Irritation• Acute Systemic Toxicity• Pyrogenicity• Hemolysis• USP PhysicochemicalThe Merit Coronary Control Syringe is considered indirect bloodcontacting for a duration of less than 24 hours. | |
| Summary ofSubstantialEquivalence | Based on the intended use, materials, design, and performance testing,the Merit Coronary Control Syringe meets the requirements that areconsidered essential for its intended use and is considered substantiallyequivalent to the primary predicate device. The secondary predicatedevice supports the expanded Indications for Use of the Merit CoronaryControl Syringe |
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.