(66 days)
The Merit Medical 20 ml Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit Medical 20 ml Syringe is a device consisting of a calibrated hollow barrel into which is inserted a closely fitting movable plunger and seal. The barrel contains a male Luer Lock connector which is compatible for attaching devices with standard female Luer hubs.
The provided text describes the acceptance criteria and the study conducted for the Merit Medical 20 ml Syringe. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document lists numerous safety and performance tests that were successfully completed. It states: "The results of the testing demonstrated that the subject Merit Medical 20 ml Syringe met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, the specific acceptance criteria values for each test and the quantified reported performance against those criteria are not provided in this summary. The summary only lists the types of tests performed.
Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Material/Construction | Cleanliness, Limits for acidity and alkalinity, Limits for extractable metals, Inspection for lubricant contaminants | Met pre-determined criteria |
| Dimensional/Functionality | Tolerance on graduation capacity, Graduated scale, Numbering of scale, Overall length of scale to nominal capacity, Position of scale, Barrel - finger grips, Piston/plunger assembly - design, Piston/plunger assembly - fit of piston in barrel, Piston/plunger assembly - fiducial line, Gauging, Position of nozzle on end of barrel, Nozzle lumen, Dead space | Met pre-determined criteria |
| Physical/Mechanical | Separation force, Unscrewing torque, Freedom from air leakage, Freedom from liquid leakage, Freedom from liquid leakage with side force, Adhesion of ink, Burst pressure testing, Ease of assembly, Resistance to overriding, Resistance to cracking | Met pre-determined criteria |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility | Met pre-determined criteria |
| Packaging Integrity | Visual inspection, Dye penetration testing, Underwater leak test (bubble emission testing), Seal strength-seal peel tensile strength | Met pre-determined criteria |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the various tests. It also does not provide information regarding the provenance of the data (e.g., country of origin, retrospective or prospective study design).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided in the document. The device is a medical syringe, and the testing described focuses on physical, mechanical, material, and biocompatibility properties rather than clinical interpretations requiring expert radiologists or similar professionals for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document, as the tests are for device performance characteristics, not for diagnostic accuracy or human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not performed as this device is a medical syringe and not an AI-assisted diagnostic tool. Therefore, information on effect size related to human reader improvement with AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not performed for this device, as it is a physical medical device (syringe) and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests described are the specified international standards and FDA guidance documents, which define acceptable ranges and criteria for the physical, chemical, and biological properties of syringes. The device's performance was compared against these established technical specifications.
8. The sample size for the training set
This information is not applicable as the device is a physical product and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and not an AI/machine learning model.
{0}------------------------------------------------
K 11109 1 JUN 2 4 2011
ll
| Section 5 | |
|---|---|
| 510(k) Summary | |
| GeneralProvisions | Submitter Name:Merit Medical Systems, Inc.Address:1600 West Merit ParkwaySouth Jordan, UT 84095Telephone Number:(801) 208-4196Fax Number:(801) 253-6932Contact Person:Michaela RivkowichDate of Preparation:April 14, 2011Registration Number: 1721504 |
| SubjectDevice | Trade Name:To be assignedCommon/Usual Name:Merit Medical 20 ml SyringeClassification Name:Syringe, Piston |
| PredicateDevice | Trade Name:Merit Medical 1-mL SyringeClassification Name:Syringe, PistonPremarket Notification:K024052Manufacturer:Merit Medical Systems, Inc. |
| Classification | Class II21 CFR § 880.5860General Hospital |
| Intended Use | The Merit Medical 20 ml Syringe is used to inject fluids into, orwithdraw fluids from, the body. |
| DeviceDescription | The Merit Medical 20 ml Syringe is a device consisting of acalibrated hollow barrel into which is inserted a closely fittingmovable plunger and seal. The barrel contains a male Luer Lockconnector which is compatible for attaching devices with standardfemale Luer hubs. |
| TechnologicalCharacteristics | The technological characteristics of the subject Merit MedallionSyringe are substantially equivalent to those of the predicate device,the Merit Medical 1-mL Syringe, 510(k) K024052. |
| No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject Merit Medical 20 ml Syringe was conductedbased on the risk analysis and based on the requirements of thefollowing FDA guidance document and international standards: | |
| Safety &PerformanceTests | • Guidance on the Content of Premarket Notification[510(k)] Submissions for Piston Syringes, April 1993• ISO 7886-1:1993, Sterile hypodermic syringes for singleuse - Part 1: Syringes for manual use• ISO 594-1:1986, Conical fittings with a 6% (Luer) taper forsyringes, needles and certain other medical equipment –Part 1: General requirements• ISO 594-2:1998, Conical fittings with 6% (Luer) taper forsyringes, needles and certain other medical equipment –Part 2: Lock fittings• ANSI/AAMI/ISO 11135-1: 2007, Sterilization of healthcare products - Ethylene oxide – Part 1: Requirementsfor development, validation and routine control of asterilization process for medical devices• ISO 10993-1: 2009, Biological Evaluation of MedicalDevices Part-1: Evaluation and Testing within a riskmanagement process, and the FDA Modified ISO 10993Test Profile• EN ISO 10993-7:2008, Biological Evaluation of MedicalDevices, Part 7: Ethylene Oxide Sterilization ResidualsThe following is a list of all significant testing that was successfullycompleted:CleanlinessLimits for acidity and alkalinityLimits for extractable metalsInspection for lubricant contaminantsTolerance on graduation capacityGraduated scaleNumbering of scaleOverall length of scale to nominal capacityPosition of scaleBarrel - finger gripsPiston/plunger assembly - designPiston/plunger assembly - fit of piston in barrelPiston/plunger assembly - fiducial lineGaugingSeparation forceUnscrewing torque |
| Safety &PerformanceTests cont. | Position of nozzle on end of barrelNozzle lumen.Dead spaceFreedom from air leakageFreedom from liquid leakageFreedom from liquid leakage with side forceAdhesion of inkBiocompatibility testsCytotoxicitySensitizationIrritationAcute Systemic ToxicityHemocompatibility |
| Packaging performance after exposure to accelerated aging andsimulated shipping and handling conditions:Visual inspectionDye penetration testingUnderwater leak test (bubble emission testing)Seal strength-seal peel tensile strength | |
| Burst pressure testing | |
| Safety &PerformanceTests cont. | The results of the testing demonstrated that the subject MeritMedical 20 ml Syringe met the pre-determined acceptance criteriaapplicable to the safety and efficacy of the device. |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, and safety andperformance testing, the subject Merit Medical 20 ml Syringe meetsthe requirements that are considered essential for its intended useand is substantially equivalent to the predicate device, the MeritMedical 1-mL Syringe, manufactured by Merit Medical Systems, Inc. |
. .
{1}------------------------------------------------
Ease of assembly
Resistance to overriding
Resistance to cracking
.
・
{2}------------------------------------------------
Merit Medical 20 ml Syringe
Section 5, 510(k) Summary
Special Premarket Notification 510(k)
・
,
:
:
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and two curved lines representing its legs. The eagle is positioned diagonally within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Michaela Rivkowich Principal Regulatory Affairs Specialist Merit Medical Systems, Incorporated 1600 West Merit Parkway South Jordan, Utah 84095
JUN 2 4 2011
Re: K111091
Trade/Device Name: Merit Medical 20 ml Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 24, 2011 Received: May 26, 2011
Dear Ms. Rivkowich
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.
{4}------------------------------------------------
Page 2 - Ms. Rivkowich
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 go to
http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Merit Medical 20 ml Syringe Section 4, Indications for Use Special Premarket Notification 510(k)
Section 4
Indications for Use
510(k) Number (if known):
Device Name: Merit Medical 20 ml Syringe
Indications for Use:
The Merit Medical 20 ml Syringe is used to inject fluids into, or withdraw fluids from, the body.
KIII09
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Rick Chapman
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: (11109)
§ 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).