(224 days)
Not Found
No
The 510(k) summary describes a standard mechanical syringe and its performance testing focuses on physical and biocompatibility properties, with no mention of AI or ML.
No
The device is used for the administration or withdrawal of fluids, and is not designed to treat a medical condition or restore health.
No
The device is a syringe for administering or withdrawing fluids, primarily contrast media, which is a tool used in diagnostic procedures but is not itself a diagnostic device that interprets data or provides a diagnosis.
No
The device description clearly outlines a physical syringe with a barrel, plunger, and luer connectors, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intra-arterial or intravenous administration of radiographic contrast media" and for "injecting fluids into, or withdrawing fluids from, the body." This describes a device used directly on or in the patient for therapeutic or diagnostic procedures involving the body's internal systems.
- IVD Definition: In vitro diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description of a syringe with a barrel, plunger, and luer connector is consistent with a device used for administering or withdrawing fluids from the body, not for testing specimens in a lab.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVDs.
The Merit Coronary Control Syringe is a medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be used to inject fluids into, or withdraw fluids from, the body.
Product codes
DXT
Device Description
The Merit Coronary Control Syringe contains a calibrated hollow barrel into which is inserted a closely fitted movable plunger and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector or male luer rotating adaptor, which are 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 Coronary Control 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: Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Lubricant, Tolerance on Graduated, Capacity, Graduated Scale, Barrel, Piston/Plunger Assembly, Nozzle, Performance - Freedom from air and liquid leakage past piston, Gauging, Unscrewing torque, Liquid leakage, Ease of assembly, Air leakage, Resistance to overriding, Separation force, Stress cracking. Biocompatibility testing for the Merit Coronary Control Syringe was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, USP Physicochemical.
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
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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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 eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Merit Medical Systems, Inc. Mr. Cory Marsh Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095
Re: K163084
Trade/Device Name: Merit Coronary Control Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: June 13, 2017 Received: June 14, 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,
Lori A. Wiggins -S6
Lori A. Wiggins, 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
Indications for Use
510(k) Number (if known) K163084
Device Name Merit Coronary Control Syringe
Indications for Use (Describe)
The Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe can also be 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) |
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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
November 2, 2016
1721504 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Merit Coronary Control Syringe
Control Syringe
Injector and Syringe, Angiographic
2
DXT
870.1650
Cardiovascular |
| Primary
Predicate
Device | Trade Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Premarket Notification:
Manufacturer: | NMI Control Syringe
Injector and Syringe, Angiographic
2
DXT
870.1650
K113198
Navilyst Medical, Inc. |
| Secondary
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 Coronary Control Syringe contains a calibrated hollow barrel
into which is inserted a closely fitted movable plunger and tip or seal.
The barrel contains an ISO 594-2 compliant fixed male luer connector
or male luer rotating adaptor, which are compatible with ISO 594-2
compliant female luer hubs. | |
| Indications for
Use | The Merit Coronary Control Syringe is intended to be used for the intra-
arterial or intravenous administration of radiographic contrast media.
The syringe can also be used to inject fluids into, or withdraw fluids
from, the body. | |
4
The proposed Merit Coronary Control Syringe incorporates an expanded Intended Use, as well as similar materials, design and principle of operation as the NMI Control Syringe primary predicate device.
| | Attribute | Subject Device – Merit
Coronary Control
Syringe | Primary Predicate
Device – NMI Control
Syringe |
|-------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Design | 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 or male rotating
adaptor. | 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 or male rotating
adaptor. |
| Comparison to
Primary
Predicate
Device | Material | The barrel is constructed
from clear polycarbonate;
the plunger from ABS
material; the seal is made
of silicone material; the
rotator O-Ring is made of
silicone. | The barrel is constructed
from clear polycarbonate. |
| | 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 6,
8, 10, 12, and 20 mL. | Operational volume of 7,
8, 10, 12, and 20 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 Coronary
Control Syringe is
intended to be used for
the intra-arterial or
intravenous administration
of radiographic contrast
media. The syringe can
also be used to inject
fluids into, or withdraw
fluids from, the body. | The NMI Control Syringe
is intended to be used for
the intra-arterial or
intravenous administration
of radiographic contrast
media. |
·
5
| | Attribute | Subject Device – Merit
Coronary Control
Syringe | Secondary Predicate
Device – Welmed
Hypodermic Syringe |
|---------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Secondary
Predicate
Device | Indications
for Use /
Intended
Use | The Merit Coronary
Control Syringe is
intended to be used for
the intra-arterial or
intravenous administration
of radiographic contrast
media. The syringe can
also be used to inject
fluids into, or withdraw
fluids from, the body. | The intended use of the
Welmed, Inc. piston
syringe is to inject fluids
into or withdraw fluids
from the body. |
The secondary predicate device supports the expanded Indications for Use of the Merit Coronary Control Syringe.
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 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 Coronary Control 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, ● 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
Performance Data
- 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 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
6
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 F756-08:2008, Standard Practice for Assessment of ● Hemolytic Properties of Materials
Performance Data cont'd
- . AAMI/ANSI ST72:2011, 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
Performance Bench Testing
The Merit Coronary Control 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:
7
| 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 | |
| and liquid leakage past piston | ||
| Capacity | ||
| ISO 594-2 | ||
| Gauging | Unscrewing torque | |
| Liquid leakage | Ease of assembly | |
| Air leakage | Resistance to overriding | |
| Separation force | Stress cracking | |
| Performance | ||
| Data cont'd | Biocompatibility testing | |
| The biocompatibility evaluation for the Merit Coronary Control Syringe | ||
| was conducted in accordance with the FDA Blue Book Memorandum | ||
| #G95-1 “Use of International Standard ISO-10993, ‘Biological | ||
| Evaluation of Medical Devices Part 1: Evaluation and Testing,’” May 1, | ||
| 1995, 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 | ||
| • USP Physicochemical |
The Merit Coronary Control Syringe is considered indirect blood
contacting for a duration of less than 24 hours. | |
| Summary of
Substantial
Equivalence | Based on the intended use, materials, design, and performance testing,
the Merit Coronary Control Syringe meets the requirements that are
considered essential for its intended use and is considered substantially
equivalent to the primary predicate device. The secondary predicate
device supports the expanded Indications for Use of the Merit Coronary
Control Syringe | |