(90 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is used to inject or withdraw fluids, which are actions often related to administering or removing substances, but the syringe itself is a tool for delivery/extraction and not a treatment modality that directly applies a therapeutic effect to a disease or condition. Its function is mechanical.
No
The Merit Syringe is described as a device used to inject or withdraw fluids from the body, and its performance studies relate to testing its physical properties and biocompatibility, not its ability to diagnose conditions. There is no mention of it providing information about a patient's health status that would lead to a diagnosis.
No
The device description clearly describes a physical syringe with a barrel, plunger, and luer connector, which are hardware components. The performance studies also focus on bench testing and biocompatibility of the physical device.
Based on the provided information, the Merit Syringe is not an IVD (In Vitro Diagnostic) 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 focuses on the mechanical components of a syringe used for injection/withdrawal. There is no mention of reagents, test strips, or any components typically associated with analyzing biological samples in vitro.
- Lack of IVD-Specific Information: The document does not contain any information related to the analysis of biological samples, such as:
- Specific analytes being measured.
- Performance metrics like sensitivity, specificity, or accuracy in detecting or quantifying substances in a sample.
- Calibration or quality control procedures for in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnostic, monitoring, or screening purposes. The Merit Syringe's function is to manipulate fluids within 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 (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted, ratcheted plunger, and tip or seal. 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
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)
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:
ISO 7886-1 tests: Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Lubricant, Tolerance on Graduated Capacity (based on graduation scale), Tolerance on Graduated Capacity (based on audible/tactile use), Graduated Scale, Barrel, Piston/Plunger Assembly, Nozzle, Performance – Freedom from air and liquid leakage past piston.
ISO 594-2 tests: Gauging, Liquid leakage, Air leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, 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 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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2017
Merit Medical Systems, Inc. Mr. Cory Marsh Associate Manager, Regulatory Operations 1600 West Merit Parkway South Jordan, Utah 84095
Re: K171362
Trade/Device Name: Merit Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: July 7, 2017 Received: July 7, 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
1
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,
James P. Bertram -S
for
Lori A. Wiggin, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
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)
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 PRAStaff@fda.hhs.gov
"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
3
5.0 510(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) 316-3690
(801) 826-4112
Mr. Cory Marsh
May 8, 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:
Common/Usual Name:
Classification Name:
Regulatory Class:
Premarket Notification:
Manufacturer:
Product Code:
21 CFR §:
Review Panel: | BD Single Use, Hypodermic Syringe
Piston Syringe
Syringe, Piston
2
K110771
BD Medical - Medical Surgical Systems
FMF
880.5860
General Hospital | |
| Device
Description | The Merit Syringe contains a calibrated hollow barrel into which is
inserted a closely fitted, ratcheted plunger, and tip or seal. 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, or withdraw fluids from,
the body.
The Indications for Use statement for the Merit Syringe is not identical
to the predicate device; however, the differences do not alter the
intended therapeutic use of the device nor do they affect the
performance of the device relative to the predicate. The subject and | | |
| | The proposed Merit Syringe incorporates the same Intended Use,
materials, similar design and principle of operation as the predicate
device. Differences between the devices include the nominal capacity
and plunger design. Performance testing of the subject device was
completed against FDA recognized consensus standards ISO 7886-1
and ISO 594-2. | | |
| Comparison to
Predicate
Device | Attribute | Subject Device - Merit
Syringe | Predicate Device - BD
Single Use, Hypodermic
Syringe |
| | Basic
Design | Standard three-piece
piston syringe constructed
using the same barrel and
tip material as the
predicate device. The
subject device utilizes a
single-piece molded
ratcheted plunger. 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 movable
plunger and tip/seal.
Fitting offered with male
luer lock connector. |
| | Material | The barrel is constructed
from polypropylene; the
plunger from
polypropylene; the seal is
made of silicone. | The barrel is constructed
from polypropylene; the
plunger from
polypropylene; the seal is
made of silicone. |
| | 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 10
mL. | Operational volume of 1,
3, and 5 mL. |
| | Graduation | Printed with accurate
graduation lines that are
compliant with ISO 7886-
-
| Printed with accurate
graduation lines that are
compliant with ISO 7886-
-
|
| | Indications
for Use /
Intended
Use | The Merit Syringe is used
to inject fluids into, or
withdraw fluids from, the
body. | The BD Single Use,
Hypodermic Syringe is
intended for use by health
care professionals for
general purpose fluid
aspiration/injection. |
4
predicate device have the same intended use to inject fluids into, or withdraw fluids from, the body, as stated in 21 CFR 880.5860.
5
| 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
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 Syringe met the standards' established
| acceptance criteria for the device. | |
|---|---|
| Performance | |
| Data | 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 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 D4169-14: 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 F756-08:2013, Standard Practice for Assessment of Hemolytic Properties of Materials
- . AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods, routine monitoring, and alternatives to batch testing
- United States Pharmacopeia 39, National Formulary 34, . Pyrogen Test (2016)
6
- 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
- . 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:
| 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 (based on graduation scale) | Performance – Freedom from air and liquid leakage past piston |
| Tolerance on Graduated Capacity (based on audible/tactile use) | |
| 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
7
Management Process," as recognized by FDA. Testing included the following:
- Cytotoxicity
- Sensitization o
- Irritation ●
Merit Syringe
- Acute Systemic Toxicity ●
- Pyrogenicity
- Hemolysis ●
The Merit Syringe is an externally communicating device with indirect blood contacting for a duration of less than 24 hours.