The Monoject 60mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and an attached gasket. It is available in three nozzle types: Luer lock, luer slip and catheter tip. The barrel is made from polypropylene and is designed with clear graduation for easy use. The luer barrel nozzle has an ISO 594 compliant male luer 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 30 devices, and the master case contains 12 inner boxes. This syringe is sterilized by gamma irradiation.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, specifically the Monoject 60mL Syringe. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study with acceptance criteria and a detailed report of how a device meets those criteria in the context of an AI-powered system or a study involving human readers.

Therefore, most of the requested information (points 1, 2, 3, 4, 5, 6, 7, 8, 9) is not applicable or cannot be extracted from the given text because:

This is a traditional medical device (syringe), not an AI/ML-powered device. The 510(k) summary details performance tests for a physical product (syringe), not an algorithm's performance.
The document focuses on non-clinical performance testing for safety and effectiveness, not clinical trials with human subjects or AI-assisted performance.
The concept of "ground truth," "experts," "adjudication," "training set," and "test set" as typically understood in the context of AI/ML or comparative effectiveness studies of diagnostic algorithms is not relevant here. The "ground truth" for a syringe is its physical specifications and functionality.

However, I can extract information related to the performance testing and conclusions based on the provided text, aligning with the spirit of "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific type of device.

Acceptance Criteria and Device Performance (Interpreted for a Syringe Device)

The "acceptance criteria" for the Monoject 60mL Syringe are implicitly defined by the successful completion of the non-clinical performance tests, proving the device is safe and effective and comparable to predicate devices. The "reported device performance" is that it met these test requirements.

Acceptance Criteria (Implicit from tests performed)	Reported Device Performance (Conclusion)
Physical Characteristics:
Liquid leakage	Testing conducted and successful.
Air leakage	Testing conducted and successful.
Separation force	Testing conducted and successful.
Unscrewing torque	Testing conducted and successful.
Ease of assembly	Testing conducted and successful.
Resistance to overriding	Testing conducted and successful.
Stress cracking	Testing conducted and successful.
Tolerance on graduation capacity	Testing conducted and successful.
Maximum dead space	Testing conducted and successful.
Air leakage past syringe piston during aspiration	Testing conducted and successful.
Separation of piston and plunger	Testing conducted and successful.
Air and liquid leakage at piston under compression	Testing conducted and successful.
Minimum over length of scale to nominal capacity mark	Testing conducted and successful.
Force required to operate plunger	Testing conducted and successful.
Functional/Safety Characteristics:
Individual package integrity	Testing conducted and successful.
Chemical testing	Testing conducted and successful.
Bacterial endotoxin testing	Testing conducted and successful.
Biocompatibility testing	Testing conducted and successful.
Overall Conclusion:	The Monoject 60mL Syringe performs equivalently to the predicate device and is safe and effective when used as intended, based on the results of the performance testing and comparison of technological characteristics. This demonstrates that it meets the implicit acceptance criteria for substantial equivalence.

Here's a breakdown of the specific points related to the provided 510(k) summary, acknowledging the context of a traditional medical device:

A table of acceptance criteria and the reported device performance:
- See the table above. The acceptance criteria are implicitly met by successful completion of the listed non-clinical tests, and the reported performance is that these tests were passed, leading to the conclusion of safety, effectiveness, and substantial equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample size for each performance test. It only states that "Performance testing was conducted."
- Data Provenance: Not specified. This typically refers to the testing done by the manufacturer (Nipro Medical Corporation) or a contracted lab. The country of origin of the data is not mentioned, nor is whether the data is retrospective or prospective, as these terms are less relevant in the context of physical product performance testing for regulatory submission.
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):
- Not applicable. For a physical device like a syringe, "ground truth" is established by adherence to engineering standards, material specifications, and performance requirements. There are no "experts" in the sense of medical reviewers establishing ground truth for diagnostic accuracy, as this is not a diagnostic device. The tests themselves, conducted by qualified engineers/technicians following standardized protocols, serve as the verification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical trials or expert reviews, especially for diagnostic outputs. For objective performance tests of a physical device, the outcome is measured by instrumentation against defined limits, not adjudicated by human consensus.
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:
- No. This is not an AI-powered device, nor is it a diagnostic device that involves human "readers." Therefore, an MRMC study is completely irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device (syringe), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is objective, defined by established engineering and performance standards for syringes (e.g., ISO 594 compliance, specified limits for force, leakage, etc.) and the material properties required for biocompatibility.
The sample size for the training set:
- Not applicable. This term relates to machine learning (AI), which is not involved in the development or testing presented for this syringe.
How the ground truth for the training set was established:
- Not applicable. As above, this is an AI/ML concept and does not apply to this traditional medical device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, resembling an infinity symbol or a twisted ribbon. To the right of the symbol is the text "NIPRO" in bold, sans-serif font, with the words "MEDICAL CORPORATION" in a smaller font size underneath.

510(k) Summary: Monoject 60mL Syringe

807.92(a)(1)
Applicant:	Nipro Medical Corporation3150 NW 107th Ave.Miami FL 33172Tel: 305-599-7174
Establishment Reg.:	1056186
Contact Person:	Jessica Oswald-McLeodRegulatory Affairs Specialist
Date of summary preparation:	May 31, 2013
807.92(a)(2)
Trade Name:	Monoject 60mL Syringe
Common Name:	syringe, piston

AUG 28 2013

Classification Name: piston syringe Regulation Number: 21 CFR 880.5860 Panel: 80 Product Code: FMF

807.92(a)(3)

・

Legally marketed substantial equivalent device: Becton Dickinson Syringes K980987 Terumo Syringe with/without Needle K063613

807.92(a)(4)

Description of device:

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 60mL Syringe performs equivalent to the predicate device and is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 28, 2013

Nipro Medical Corporation Ms. Jessica Oswald-Mcleod Regulatory Affairs Specialist 3150 N.W 107" Avenue DORAL FL 33172

Re: K131641

Trade/Device Name: MONOJECT 60mL Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 1, 2013 Received: August 20, 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.

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/Picture/5 description: The image shows the name "Mary S. Runner" in a bold, sans-serif font. The text is black and appears to be printed on a white background. There is some noise or artifacts around the text, possibly from scanning or compression.

Kwame Ulmer M.S. Acting Division 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:________________________________________________________________________________________________________________________________________________________________

Device Name: Monoject 60mL Syringe

Indications for Use:

The syringe is intended to inject or withdraw fluids from the body.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (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)

	Richard C.
	Chapman
	2013.08.28 15:26:11
	-04'00'

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Respiratory, Infection Control and
Dental Devices

510(k) Number:	K131641
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Monoject 60mL Syringe

Regulation Number and Section

§ 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).