(37 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.
A therapeutic device is one that treats or heals a disease or medical condition. This device's intended use is to inject or withdraw fluids, which could be for diagnostic or other purposes, but is not inherently therapeutic.
No
The syringe is described as a device "to inject or withdraw fluids from the body," which is a therapeutic or procedural function, not a diagnostic one. Diagnostic devices are typically used to identify a condition or disease.
No
The device description clearly outlines physical components (barrel, plunger, gasket) made of materials like polypropylene and thermoplastic elastomer. The performance studies also focus on physical characteristics and material properties, not software functionality.
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 or withdraw fluids from the body." This describes a direct interaction with the body for therapeutic or diagnostic purposes on the patient, not for testing samples outside the body.
- Device Description: The description details a standard syringe for fluid handling within the body. There is no mention of components or functions related to analyzing biological samples in vitro.
- Lack of IVD-specific elements: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents
- Assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic interpretation of results from sample analysis
The syringe is a medical device used for administering or collecting substances directly from a patient, which falls under the category of general medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The syringe is intended to inject or withdraw fluids from the body.
Product codes
FMF
Device Description
The Monoject 12 mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and attached gasket. The barrel is made from polypropylene and is designed with clear graduation for easy use. The barrel nozzle has an ISO 594 compliant male 6% taper luer lock tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 100 devices, and the outer box contains 10 inner boxes. This syringe is sterilized by gamma irradiation.
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
Non-clinical tests submitted: Performance testing was conducted to verify that the device is safe and effective for its intended use. These tests include: liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking, tolerance on graduation capacity, maximum dead space, air leakage past syringe piston during aspiration and for separation of piston and plunger, air and liquid leakage at piston under compression, minimum over length of scale to nominal capacity mark, force required to operate plunger, individual package integrity, chemical testing, bacterial endotoxin testing and biocompatibility testing. These tests along with their associated results and conclusions are included in this submission.
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
3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 Fax: 305,592,4621
510(k) Summary: Monoject 12mL Syringe
807.92(a)(1)
Applicant:
Nipro Medical Corporation 3150 NW 107" Ave. Miami FL 33172 Tel: 305-599-7174 1056186
Establishment Reg .:
Contact Person:
Jessica Oswald-McLeod Regulatory Affairs Specialist
Date of summary preparation:
January 9, 2013
807.92(a)(2)
Trade Name: Monoject 12mL Syringe Common Name: syringe, piston Classification Name: piston syringe Regulation Number: 21 CFR 880.5860 Panel: 80 Product Code: FMF
807.92(a)(3)
Legally marketed substantial equivalent device: K944355 - NIPRO Disposable Syringe
807.92(a)(4)
Description of device:
The Monoject 12 mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and attached gasket. The barrel is made from polypropylene and is designed with clear graduation for easy use. The barrel nozzle has an ISO 594 compliant male 6% taper luer lock tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 100 devices, and the outer box contains 10 inner boxes. This syringe is sterilized by gamma irradiation.
807.92(a)(5)
Indications for Use:
The syringe is intended to inject or withdraw fluids from the body.
1
807.92(a){6)
Comparison of technological characteristics:
The syringe is substantially equivalent to the predicate device in the following technological characteristics:
- Physical characteristics .
- . Operational mode
- Basic Scientific Technology ●
- Intended Use .
807.92(b)(1)
Non-clinical tests submitted:
Performance testing was conducted to verify that the device is safe and effective for its intended use. These tests include: liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking, tolerance on graduation capacity, maximum dead space, air leakage past syringe piston during aspiration and for separation of piston and plunger, air and liquid leakage at piston under compression, minimum over length of scale to nominal capacity mark, force required to operate plunger, individual package integrity, chemical testing, bacterial endotoxin testing and biocompatibility testing. These tests along with their associated results and conclusions are included in this submission.
807.92(b)(2)
Clinical tests:
This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.
807.92(b)(3)
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Monoject 12mL Syringe performs equivalent to the predicate device and is safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2013
Nipro Medical Corporation Ms. Jessica Oswald-Mcleod Regulatory Affairs Specialist North American Division 3150 N.W. 107th Avenue MIAMI. FL 33172
Re: K130049
Trade/Device Name: Monoject 12ml Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: January 4, 2013 Received: January 17, 2013
Dear Ms. Oswald-Mcleod:
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
3
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.gov/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.
Image /page/3/Figure/6 description: The image shows a logo with the letters "FDA" in a stylized, outlined font. Above the letters, there is some handwritten text that is difficult to read due to the handwriting style. The logo appears to be a black and white image with a simple design.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K | 300UQ
Device Name: Monoject 12mL Syringe
Indications for Use:
The syringe is intended to inject or withdraw fluids from the body.
Prescription Use _ > (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)
Tejashri Rurohit-Sheth, M.D.
Clinical Deputy Direction, Direction, DAGRID
2013.02.15 13:17:23 -05-17:23 - 05:50
2013.02.15 13:17:23 - 05:17:23 - 05:50:00
(Division Sign-Off)
)ivision of Anesthesiology, General Hospital nfection Control, Dental Devices
K130049 510(k) Number:
Monoject 12mL Syringe