(73 days)
The Merit Medical 20 mL Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit 20 mL Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or seal. The barrel contains an ISO 594-1/2 compliant fixed male luer connector, which is compatible with ISO 594-1/2 compliant female luer hubs.
This document describes the 510(k) summary for the "Merit 20 mL Syringe". The acceptance criteria and the study proving the device meets these criteria are related to the performance of syringes as defined by international standards, especially after a minor material change to the silicone plunger tip/seal.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| 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 | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995 | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed type hypersensitivity | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ASTM F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| United States Pharmacopeia 37, National Formulary 32, 2014 <151> Pyrogen Test | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
| ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings | "Summary level test results have been provided... and demonstrate that the subject 20 mL Syringe met the predetermined acceptance criteria applicable to the performance of the device." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions that "Design verification testing of the subject 20 mL Syringe was conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described focuses on compliance with international standards for device performance and biocompatibility, rather than clinical evaluation with expert-established ground truth.
4. Adjudication method for the test set
This information is not provided. The testing appears to be objective, based on established standards, rather than requiring expert 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
This is not applicable as the device is a medical syringe, not an AI-powered diagnostic tool, and the submission does not mention any MRMC study or AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical syringe, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is defined by international standards and guidance documents for syringe performance, sterility, and biocompatibility. The tests conducted verify the physical, chemical, and biological properties of the device against these established criteria.
8. The sample size for the training set
This is not applicable as the device is a medical syringe undergoing physical and biological testing, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned in point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure in profile, with three faces overlapping to suggest a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2015
Merit Medical Systems, Inc. Mr. Cory Marsh Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095
Re: K152783
Trade/Device Name: Merit 20 mL Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 6, 2015 Received: November 9, 2015
Dear Mr. 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.
{1}------------------------------------------------
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 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 vours.
Tina Kiang
-s
for 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
Enclosure
{2}------------------------------------------------
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number ( if known ) | K152783 |
|---|---|
| Device Name | Merit 20 mL Syringe |
| Indications for Use (Describe) | The Merit Medical 20 mL 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
t
{3}------------------------------------------------
5.0 510(k) Summary
| GeneralProvisions | Submitter Name: Merit Medical Systems, Inc.Address: 1600 West Merit ParkwaySouth Jordan, UT 84095Telephone Number: (801) 316-3690Fax Number: (801) 826-4112Contact Person: Mr. Cory MarshDate of Preparation: September 24, 2015Registration Number: 1721504 | |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name: | Merit 20 mL SyringeMerit 20 mL SyringePiston Syringe |
| PredicateDevice | Trade Name: Merit 20 mL SyringeClassification Name: Piston SyringePremarket Notification: K111091Manufacturer: Merit Medical Systems, Inc. | |
| Classification | Class 221 CFR § 880.5860FDA Product Code: FMFReview Panel: General Hospital | |
| Intended Use | The Merit Medical 20 mL Syringe is used to inject fluids into, orwithdraw fluids from, the body. | |
| DeviceDescription | The Merit 20 mL Syringe contains a calibrated hollow barrel into whichis inserted a closely fitted movable plunger and tip or seal. The barrelcontains an ISO 594-1/2 compliant fixed male luer connector, which iscompatible with ISO 594-1/2 compliant female luer hubs. |
{4}------------------------------------------------
This submission addresses a minor material change to the silicone plunger tip/seal. The indications for use, principle of operation, and technological characteristics of the subject device are identical to the predicate device. The subject device is substantially equivalent to the predicate device.
| Attribute | Predicate Device 20 mL Syringe | Subject Device 20 mL Syringe | |
|---|---|---|---|
| Comparison toPredicateDevice | Design | Standard three piecepiston syringeconstructed with a clearhollow barrel into which isinserted a closely fittingmovable plunger andtip/seal. | Standard three piecepiston syringeconstructed with a clearhollow barrel into which isinserted a closely fittingmovable plunger andtip/seal. |
| Material | The barrel is constructedfrom clear cyclo-olefinpolymer; the plunger frompolycarbonate or ABSmaterial; the seal is madeof silicone elastosealmaterial. | The barrel is constructedfrom clear cyclo-olefinpolymer; the plunger frompolycarbonate or ABSmaterial; the seal is madeof silicone elastosealmaterial. | |
| Principle ofOperation | Manually operated byadvancing andwithdrawing the plungerwithin the barrel. | Manually operated byadvancing andwithdrawing the plungerwithin the barrel. | |
| OperationalVolume | Operational volume of 20mL. | Operational volume of 20mL. | |
| Graduation | Printed with accurategraduation lines that arenumbered at 5 mLincrements (5, 10, 15,20), with graduationmarks every 1 mL. | Printed with accurategraduation lines that arenumbered at 5 mLincrements (5, 10, 15,20), with graduationmarks every 1 mL. | |
| IntendedUse | The Merit 20 mL Syringeis used to inject fluidsinto, or withdraw fluidsfrom, the body. | The Merit 20 mL Syringeis used to inject fluidsinto, or withdraw fluidsfrom, the body. |
{5}------------------------------------------------
Merit performed a risk analysis on the impact of the modifications made to the subject 20 mL Syringe. A cross-functional team, including members with clinical experience in the use of the type of device, assessed the potential clinical hazards to ensure risks have been addressed. Appropriate control and prevention mechanisms were defined to mitigate the risks. Design verification testing of the subject 20 mL Syringe was conducted to mitigate risks identified from the risk analysis and to comply with the following international standards/documents:
- . ISO 7886-1:1993, Sterile hypodermic syringes for single use -Part 1: Syringes for manual use [Including Technical Corrigendum 1 (1995)]
- . 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 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
- 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
Performance Tests
- . ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for irritation and delayed type hypersensitivity
- . 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
- AAMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization
- . 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
Summary level test results have been provided in this submission and demonstrate that the subject 20 mL Svringe met the predetermined acceptance criteria applicable to the performance of the device.
{6}------------------------------------------------
| Summary ofSubstantialEquivalence | Based on the indications for use, design, and performance testing, thesubject 20 mL Syringe meets the requirements that are consideredessential for its intended use and is substantially equivalent to thepredicate device, the 20 mL Syringe, K111091, manufactured by MeritMedical Systems, Inc. |
|---|---|
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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).