(76 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML.
No.
The syringe is used to inject or withdraw fluids, which are typically for diagnostic or supportive purposes rather than direct therapeutic treatment in itself.
No
The device is a syringe used to inject or withdraw fluids, which is a therapeutic or procedural action, not a diagnostic one. It does not analyze or interpret data to identify a disease or condition.
No
The device description clearly outlines physical components (barrel, plunger, O-ring seal, luer connector) and mentions biocompatibility testing, which are characteristic of a hardware medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 body for therapeutic or diagnostic purposes, not the testing of samples outside the body.
- Device Description: The description details a mechanical device for fluid transfer, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing in vitro.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to aid in diagnosis, monitoring, or screening. A syringe, while used in healthcare, is a tool for administering or collecting substances directly from the body.
N/A
Intended Use / Indications for Use
The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.
Product codes
FMF
Device Description
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.
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
Performance Bench Testing: The Merit 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:
Biocompatibility testing: A biocompatibility evaluation for the Merit Syringe was conducted in accordance with the FDA Guidance Document “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,’” June 16, 2016, and International Standard ISO 10993-1 “Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process,” as recognized by FDA. The Merit Syringe is an externally communicating device with indirect blood contacting for a duration of less than 24 hours. Testing included the following: Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemolysis.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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
2
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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3
K182279 510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-3724
(801) 826-4112
Dr. John Skousen
August 21, 2018
1721504 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Merit Syringe
Piston Syringe
Syringe, Piston
2
FMF
880.5860
General Hospital |
| Predicate
Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Premarket Notification:
Manufacturer:
Product Code:
21 CFR §:
Review Panel: | Merit 20 mL Syringe
Piston Syringe
Syringe, Piston
2
K152783
Merit Medical Systems, Inc.
FMF
880.5860
General Hospital |
| Device
Description | 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. | |
| Indications
for Use | The Merit Syringe is used to inject fluids into, or withdraw fluids from,
the body. | the body. |
| Comparison
to Predicate
Device | | The proposed Merit Syringe incorporates the same Intended Use with
similar materials, design, and principle of operation as the predicate
device. Differences include the nominal capacity; plunger material;
plunger seal design and material; and lubricant. The safety and
effectiveness of the new materials were verified via biocompatibility |
4
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.
| Comparison
to Predicate
Device | Attribute | Subject Device
- Merit Syringe | Predicate
Device - Merit
20 mL Syringe | Comments |
|---------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| (Continued) | Design | Standard three-
piece piston
syringe
constructed with
a clear hollow
barrel into which
is inserted a
closely fitting
plunger and O-
ring seal. Fitting
offered with male
luer lock
connector. | Standard three-
piece piston
syringe
constructed with
a clear hollow
barrel into which
is inserted a
closely fitting
plunger and
plunger tip seal.
Fitting offered
with male luer
lock connector. | Different
plunger
and
plunger
seal design |
| | Material | The barrel is
constructed from
clear cyclo-olefin
polymer; the
plunger from
glass-filled nylon;
the O-ring is
made of silicone;
fluorocarbon
based non-
silicone lubricant. | The barrel is
constructed from
clear cyclo-olefin
polymer; the
plunger from
polycarbonate or
ABS material;
the plunger tip
seal is made of
silicone; the
lubricant is
silicone. | Same
Barrel
Material
Different
plunger
material
Different tip
seal design
Different
lubricant |
| | 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 |
| | Operational
Volume | 0.25 mL
operational
volume. | 20 mL
operational
volume. | 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 | |
5
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
6
| Performance
Data
(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 of
Hemolytic Properties of Materials AAMI/ANSI ST72:2011/(R) 2016, Bacterial Endotoxins – Test
methods, routine monitoring, and alternatives to batch testing United States Pharmacopeia 40, National Formulary 35,
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 Testing
The Merit 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:
Biocompatibility testing
A biocompatibility evaluation for the Merit Syringe was conducted in
accordance with the FDA Guidance Document “Use of International
Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part
1: Evaluation and Testing within a Risk Management Process,’” June
16, 2016, and International Standard ISO 10993-1 “Biological
Evaluation of Medical Devices - Part 1: Evaluation and Testing
Within a Risk Management Process,” as recognized by FDA. The
Merit Syringe is an externally communicating device with indirect
blood contacting for a duration of less than 24 hours. Testing included
the following:
Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemolysis |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Differences between the technological characteristics of the subject
device as compared to the predicate do not raise different questions
of safety and effectiveness. The performance of the device is
supported by non-clinical testing and risk management activities. The
Merit Syringe is Substantially Equivalent (SE) to the Merit 20 mL
Syringe, cleared under K152783. |