(71 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
A syringe is used for injecting and withdrawing fluids, which are procedures, but it does not inherently provide a therapy or treatment itself.
No
The device, a syringe, is used for injection and withdrawal of fluids, which are functions related to treatment or sample collection, not diagnosis.
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. The performance studies also focus on physical characteristics and biocompatibility.
Based on the provided information, the Merit Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to inject fluids into, and 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 focuses on the mechanical components of a syringe designed for injection and withdrawal of fluids. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Diagnostic interpretation of results from sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Merit Syringe's function is purely for the physical transfer of fluids into or out of the body.
N/A
Intended Use / Indications for Use
The Merit Syringe is used to inject fluids into, and 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 movable plunger and tip or O-Ring. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 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
Prescription Use
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)
Performance Bench Testing:
The Merit Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2. 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:
ISO 7886-1: Cleanliness, Graduated Scale, Limits for acidity or alkalinity, Barrel, Limits for extractable metals, Piston/Plunger Assembly, Lubricant, Nozzle, Tolerance on Graduated Capacity, Performance - Freedom from air and liquid leakage past piston.
ISO 594-2: Gauging, Unscrewing torque, Liquid leakage, Ease of assembly, Air leakage, Resistance to overriding, Separation force, Stress cracking.
Biocompatibility testing:
The 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. Testing included the following:
Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis.
Key results: Based on the intended use, materials, design, and performance testing, the Merit Syringe meets the requirements that are considered essential for its intended use and is considered substantially equivalent to the predicate device, the Welmed Hypodermic Syringe, K070936.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 31, 2018
Merit Medical Systems, Inc. Cory Marsh Assoc. Manager, Regulatory Affairs 1600 W Merit Parkway South Jordan, Utah 84045
Re: K173601
Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 20, 2017 Received: November 21, 2017
Dear Cory Marsh:
We have reviewed vour 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 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.
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Tina
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) K173601
Device Name
Merit Syringe
Indications for Use (Describe)
The Merit Syringe is used to inject fluids into, and 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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3
5.0 510(k) Summary K173601
| 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) 316-3690
(801) 826-4112
Mr. Cory Marsh
November 20, 2017
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:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Premarket Notification:
Manufacturer: | Welmed Hypodermic Syringe
Syringe, Piston
2
FMF
880.5860
K070936
Welmed, Inc. | |
| Device
Description | The Merit Syringe contains a calibrated hollow barrel into which is
inserted a closely fitted movable plunger and tip or O-Ring. The barrel
contains an ISO 594-2 compliant fixed male luer connector, which is
compatible with ISO 594-2 compliant female luer hubs. | | |
| Indications for
Use | The Merit Syringe is used to inject fluids into, and withdraw fluids from, | the body. | |
| Comparison to
Predicate
Device | | The proposed Merit Syringe incorporates the same intended use, as
well as similar materials, design and principle of operation as the
predicate Welmed Hypodermic Syringe. Any differences in materials
used or operating volume are supported by the subject device's
compliance with FDA recognized standards ISO 7886-1 and ISO 594-2.
The subject device is substantially equivalent to the predicate device. | |
| Attribute | Subject Device – Merit
Syringe | Predicate Device –
Welmed Syringe | |
| Comparison to
Predicate
Device cont'd | Design | Standard three-piece
piston syringe constructed
with a clear hollow barrel
into which is inserted a
closely fitting movable
plunger and tip or O-Ring.
Fitting offered with male
luer lock. | Standard three-piece
piston syringe constructed
with a clear hollow barrel
into which is inserted a
closely fitting movable
plunger and tip/seal.
Fitting offered with male
luer lock. |
| | Material | The barrel is constructed
from clear polycarbonate;
the plunger from ABS
material; the seal or O-
Ring is made of silicone
material. | Materials used in the
manufacture of the
Welmed syringe are
typically used in the
manufacture of general-
purpose syringes. |
| | 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
0.25, 1, 3, 6, 10, 20, 30
and 60 mL. | Operational volume of 1,
3, 5, 10, 20, 30, and 60
mL. |
| | Graduation | Printed with accurate
graduation lines that are
compliant with ISO 7886-
-
| Printed with accurate
graduation lines that are
compliant with ISO 7886-
-
|
| | Intended
Use | The Merit Syringe is used
to inject fluids into, and
withdraw fluids from, the
body. | The intended use of the
Welmed piston syringe is
to inject fluids into, and
withdraw fluids from, the
body. |
4
FDA guidance 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 Data guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed Merit 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, .
5
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 [including: technical corrigendum 1 (2009)].
- . 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 Systems and Packaging Systems [Including: Amendment 1 (2014)]
- Performance Data cont'd
- . 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 cvtotoxicitv
- 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
- AAMI/ANSI ST72:2011/(R)2016, Bacterial Endotoxins – Test methods, routine monitoring, and alternatives to batch testing
- United States Pharmacopeia 37, National Formulary 32, 2014 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
6
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:
| ISO 7886-1 | ||
|---|---|---|
| Cleanliness | Graduated Scale | |
| Limits for acidity or alkalinity | Barrel | |
| Limits for extractable metals | Piston/Plunger Assembly | |
| Lubricant | Nozzle | |
| Tolerance on Graduated | Performance - Freedom from air | |
| Capacity | and liquid leakage past piston | |
| ISO 594-2 | ||
| Gauging | Unscrewing torque | |
| Liquid leakage | Ease of assembly | |
| Air leakage | Resistance to overriding | |
| Separation force | Stress cracking |
Biocompatibility testing
Performance Data cont'd
The 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. Testing included the following:
- Cytotoxicity ●
- Sensitization
- Irritation
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- Hemolysis ●
The Merit Syringe is considered indirect blood contacting for a duration of less than 24 hours.
| Summary of | Based on the intended use, materials, design, and performance testing, |
|---|---|
| Substantial | the Merit Syringe meets the requirements that are considered essential |
| Equivalence | for its intended use and is considered substantially equivalent to the |
| predicate device, the Welmed Hypodermic Syringe, K070936. |