(37 days)
The syringe is intended to inject or withdraw fluids from the body.
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.
The provided text describes the 510(k) summary for the Monoject 12mL Syringe (K130049). It details the device's characteristics, intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted. It implies that the acceptance criteria for these tests would be compliance with established standards or achieving results comparable to the predicate device. The reported performance is that the device meets these criteria and performs equivalently to the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Characteristics | Equivalent to predicate device |
| Liquid Leakage | Tests conducted, results and conclusions included (implying compliance) |
| Air Leakage | Tests conducted, results and conclusions included (implying compliance) |
| Separation Force | Tests conducted, results and conclusions included (implying compliance) |
| Unscrewing Torque | Tests conducted, results and conclusions included (implying compliance) |
| Ease of Assembly | Tests conducted, results and conclusions included (implying compliance) |
| Resistance to Overriding | Tests conducted, results and conclusions included (implying compliance) |
| Stress Cracking | Tests conducted, results and conclusions included (implying compliance) |
| Tolerance on Graduation Capacity | Tests conducted, results and conclusions included (implying compliance) |
| Maximum Dead Space | Tests conducted, results and conclusions included (implying compliance) |
| Air Leakage past Syringe Piston (during aspiration and for separation of piston and plunger) | Tests conducted, results and conclusions included (implying compliance) |
| Air and Liquid Leakage at Piston (under compression) | Tests conducted, results and conclusions included (implying compliance) |
| Minimum Over Length of Scale to Nominal Capacity Mark | Tests conducted, results and conclusions included (implying compliance) |
| Force Required to Operate Plunger | Tests conducted, results and conclusions included (implying compliance) |
| Material/Sterility | |
| Individual Package Integrity | Tests conducted, results and conclusions included (implying compliance) |
| Chemical Testing | Tests conducted, results and conclusions included (implying compliance) |
| Bacterial Endotoxin Testing | Tests conducted, results and conclusions included (implying compliance) |
| Biocompatibility Testing | Tests conducted, results and conclusions included (implying compliance) |
| Operational Mode | Equivalent to predicate device |
| Basic Scientific Technology | Equivalent to predicate device |
| Intended Use | Equivalent to predicate device |
| Overall Conclusion | Performs equivalent to the predicate device and is safe and effective when used as intended. |
2. Sample size used for the test set and the data provenance:
The document states that "Performance testing was conducted to verify that the device is safe and effective for its intended use." However, it does not specify the sample size used for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. This information is typically detailed in the full test reports that are part of the submission but not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes non-clinical performance testing, which generally refers to laboratory or bench testing of the device itself against established standards or specifications. This type of testing typically does not involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies would. Therefore, this information is not applicable to the described study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As mentioned above, the testing described is non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where subjective interpretation of results might be involved. Since this is for a syringe, a physical medical device, such adjudication methods are not applicable. The results of the performance tests are generally objective measurements against predefined specifications.
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:
This is a physical medical device (syringe), not an AI or diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Again, this is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance tests, the "ground truth" is established by technical specifications, industry standards (e.g., ISO 594 for luer taper), and internal design requirements. For example, the "ground truth" for liquid leakage is "no leakage" when tested under specified conditions, or for force required to operate plunger, it's a specific range of force. There isn't a "pathology" or "outcomes data" type of ground truth for a syringe's physical performance.
8. The sample size for the training set:
As this is a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are honed through engineering principles and quality control, not through training data.
9. How the ground truth for the training set was established:
Since there is no training set (as per point 8), this question is not applicable.
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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.
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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.
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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
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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
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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
§ 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).