(73 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a standard syringe, with no mention of AI/ML or related concepts.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is a syringe used for injection or withdrawal of fluids, which is a delivery mechanism, not a treatment itself.
No
The device, a syringe, is intended for injecting or withdrawing fluids, which are actions associated with treatment or sampling, not with diagnosing a medical condition.
No
The device description clearly outlines a physical syringe with a barrel, plunger, and luer connector, indicating it is a hardware device, not software-only.
Based on the provided information, the Merit Medical 20 mL Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, the body." This describes a direct interaction with the human body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a syringe for fluid handling, consistent with its intended use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The standards listed are related to the physical properties, sterilization, and biocompatibility of a medical device that interacts with the body, not the analytical performance of an IVD.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This syringe is a tool for administering or collecting substances directly to or from the body.
N/A
Intended Use / Indications for Use
The Merit Medical 20 mL Syringe is used to inject fluids into, or withdraw fluids from, the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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:
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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3
5.0 510(k) Summary
| General
Provisions | Submitter Name: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway
South Jordan, UT 84095
Telephone Number: (801) 316-3690
Fax Number: (801) 826-4112
Contact Person: Mr. Cory Marsh
Date of Preparation: September 24, 2015
Registration Number: 1721504 | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name: | Merit 20 mL Syringe
Merit 20 mL Syringe
Piston Syringe |
| Predicate
Device | Trade Name: Merit 20 mL Syringe
Classification Name: Piston Syringe
Premarket Notification: K111091
Manufacturer: Merit Medical Systems, Inc. | |
| Classification | Class 2
21 CFR § 880.5860
FDA Product Code: FMF
Review Panel: General Hospital | |
| Intended Use | The Merit Medical 20 mL Syringe is used to inject fluids into, or
withdraw fluids from, the body. | |
| Device
Description | 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. | |
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 to | |||
| Predicate | |||
| Device | Design | Standard three piece | |
| piston syringe | |||
| constructed with a clear | |||
| hollow barrel into which is | |||
| inserted a closely fitting | |||
| movable plunger and | |||
| tip/seal. | Standard three piece | ||
| piston syringe | |||
| constructed with a clear | |||
| hollow barrel into which is | |||
| inserted a closely fitting | |||
| movable plunger and | |||
| tip/seal. | |||
| Material | The barrel is constructed | ||
| from clear cyclo-olefin | |||
| polymer; the plunger from | |||
| polycarbonate or ABS | |||
| material; the seal is made | |||
| of silicone elastoseal | |||
| material. | The barrel is constructed | ||
| from clear cyclo-olefin | |||
| polymer; the plunger from | |||
| polycarbonate or ABS | |||
| material; the seal is made | |||
| of silicone elastoseal | |||
| material. | |||
| 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. | |||
| Operational | |||
| Volume | Operational volume of 20 | ||
| mL. | Operational volume of 20 | ||
| mL. | |||
| Graduation | Printed with accurate | ||
| graduation lines that are | |||
| numbered at 5 mL | |||
| increments (5, 10, 15, | |||
| 20), with graduation | |||
| marks every 1 mL. | Printed with accurate | ||
| graduation lines that are | |||
| numbered at 5 mL | |||
| increments (5, 10, 15, | |||
| 20), with graduation | |||
| marks every 1 mL. | |||
| Intended | |||
| Use | The Merit 20 mL Syringe | ||
| is used to inject fluids | |||
| into, or withdraw fluids | |||
| from, the body. | The Merit 20 mL Syringe | ||
| is used to inject fluids | |||
| into, or withdraw fluids | |||
| from, 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 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 of
Substantial
Equivalence | Based on the indications for use, design, and performance testing, the
subject 20 mL Syringe meets the requirements that are considered
essential for its intended use and is substantially equivalent to the
predicate device, the 20 mL Syringe, K111091, manufactured by Merit
Medical Systems, Inc. |
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|