The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-25G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years. This device is not intended for patients less than 2 years of age.

AI/ML Overview

The Nipro Syringe is a medical device and thus the provided document is a 510(k) summary, which outlines its substantial equivalence to a predicate device rather than a study proving unmet acceptance criteria in the context of AI/ML performance. Therefore, most of the requested information regarding AI/ML clinical study specifics (such as expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria related to the device's physical and performance characteristics, and how the device's performance was evaluated against these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical tests performed to ensure the Nipro Syringe meets established standards. The acceptance criteria are implicit in the "specifications of the standards listed," and the reported device performance is that these tests were "performed within the specifications" and that the device "performs equivalent to the predicate device."

Acceptance Criteria (Standards Met)	Reported Device Performance
Visual Inspection (ISO 7886-1, ISO 7864-1)	Performed within specifications of the standards; no significant differences.
Dimensional Specifications (ISO 7886-1)	Performed within specifications of the standards; slight dimensional changes from predicate, but both devices remain in compliance with all aspects of ISO 7886-1.
Gauging (ISO 594-1)	Performed within specifications of the standards.
Mechanical and Performance Characteristic (ISO 7886-1, ISO 7864-1, ISO 594-1, ISO 594-2)	Performed within specifications of the standards; results demonstrate equivalent performance to the predicate device.
Chemical and Biological Characteristic (ISO 7886-1, ISO 11137-1, and specific biological tests)	Performed within specifications of the standards. Includes: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Pyrogen testing (Material Mediated & LAL), Hemolysis, Particulate Analysis.
Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO 11137-3)	Performed within specifications of the standards; Ebeam sterilization validated.
Transportation Tests (ASTM-D4169-09)	Performed within specifications of the standards.
Biocompatibility (ISO 10993)	Performed within specifications; tests conducted: MEM Elution (Cytotoxicity), Kligman Maximization (Sensitization), Intracutaneous Irritation, ISO Systemic Toxicity Study in Mice, USP Rabbit Pyrogen Study, ASTM Hemolysis Study, USP Limulus Amebocyte Lysate (LAL) testing, Particulate Analysis Device fluid pathway.
Pyrogen Testing (ISO 10993-11, USP 39-NF34: 2016, <151>)	Performed within specifications of the standards.
Shelf-life Testing (ASTM F1980-07)	Performed within specifications of the standards; 5-year shelf-life determined.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not explicitly provided in the document. The document refers to non-clinical tests performed to specific standards, but it doesn't detail the sample sizes used for each test or the provenance of any data (e.g., country of origin, retrospective/prospective). As this is a physical medical device, not an AI/ML system, "test set" in the context of data for model evaluation is not directly applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a physical syringe, not an AI/ML system requiring expert consensus for ground truth establishment. The "ground truth" for this device's performance is determined by meeting the specifications of established engineering and biological standards.

4. Adjudication Method for the Test Set:

Not applicable for a physical device. The compliance with standards and their specifications serves as the evaluation basis, not human adjudication of AI output.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI-assisted diagnostic or treatment device, so there is no human-in-the-loop performance improvement with or without AI to measure.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through non-clinical testing against established standards.

7. Type of Ground Truth Used:

The "ground truth" for the Nipro Syringe is compliance with internationally recognized and industry-accepted standards (ISO, ASTM, USP) for medical devices, specifically for piston syringes and needles. This includes performance benchmarks for:

Physical dimensions and integrity
Mechanical function
Sterility
Biocompatibility
Chemical characteristics
Shelf-life

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant in this context.

Summary

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510(k) Summary: Nipro Syringe

807.92(a)(1)

Applicant:	Nipro Medical Corporation3150 NW 107th Ave.Miami FL 33172
Establishment Reg.:	1056186
Contact Person:	Jessica Oswald-McLeodDirector, Quality Assurance & Regulatory Affairs
Date of summary preparation:	March 29, 2018
	Tel: 305-599-7174

807.92(a)(2)

Trade Name: Nipro Syringe Common Name: Disposable syringe with or without Needle Classification Name: piston syringe Regulation Number: 880.5860 Regulatory Class: II Panel: General Hospital (80) Product Code: FMF

807.92(a)(3)

Legally marketed substantial equivalent device: Nipro Branded Disposable Syringes, Needles - K944355

807.92(a)(4)

Description of device:

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807.92(a)(5)

Indications for Use: to inject fluids into or withdraw fluids from the body

807.92(a)(6)

Comparison of technological characteristics:

The syringe is substantially equivalent to the predicate device in the following technological characteristics:

Element of Comparison	Subject device	Predicate device
Materials	Polypropylene – different grade than predicate to accommodate Ebeam sterilization. Elastomer Stainless steel	Same
Design: Operational mode	Mechanical	Same
Design: Physical characteristics	Hollow graduated barrel Plunger rod gasket	Same components; dimensions slightly different than subject device
Design: Device Configurations	Luer lock Luer slip Eccentric tip With needle Without needle	Same
Intended Use	to inject fluids into or withdraw fluids from the body	Same
Sterilization Method	Ebeam Radiation	Ethylene Oxide gas
Expiry dating	5 years	Same
Energy Source	NA	Same

Table 4: Comparison of technological characteristics

807.92(b)(1)

Non-clinical tests submitted are outlined below. All of these tests were performed within the specifications of the standards listed.

1. Visual Inspection (ISO 7886-1, ISO 7864-1)
1. Dimensional Specifications (ISO 7886-1)
1. Gauging (ISO 594-1)
1. Mechanical and Performance Characteristic (ISO 7886-1, ISO 7864-1, ISO 594-1, ISO 594-2)
1. Chemical and biological characteristic (ISO 7886-1, ISO 11137-1)
1. Sterilization validation (ISO 11137-1, ISO 11137-2, ISO 11137-3)
1. Transportation tests (ASTM-D4169-09)

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1. Biocompatibility (ISO 10993)
- a. Cytotoxicity: MEM Elution
- b. Sensitization: Kligman Maximization
- Intracutaneous Irritation ﻥ
- d. ISO Systemic Toxicity Study in Mice
- e. USP Rabbit Pyrogen Study, Material Mediated
- f. ASTM Hemolysis Study
- g. USP Limulus Amebocyte Lysate (LAL) testing, Kinetic-Chromogenic Method
- h. Particulate Analysis Device fluid pathway
1. Pyrogen testing (ISO 10993-11, USP 39-NF34: 2016, <151> )
1. Shelf-life testing (ASTM F1980-07)

807.92(b)(2)

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:

There are no differences in fundamental scientific technology and operational mode.

There are non-significant differences in materials and physical specifications. The material change is due to the predicate materials not being able to withstand Ebeam sterilization and although there are slight dimensional changes the predicate and the subject device both remain in compliance with all aspects of ISO 7886-1 substantiating the claim of equivalence.

The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro Syringe with and without Needle performs equivalent to the predicate device when used as intended.

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Image /page/3/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 30, 2018

Nipro Medical Corporation Jessica Oswald-Mcleod Director, OA/RA 3150 NW 107th Ave. Miami, Florida 33172

Re: K173029

Trade/Device Name: Nipro Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 20, 2018 Received: February 22, 2018

Dear Jessica 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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina Kiang, Ph.D. Acting 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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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).