The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.

AI/ML Overview

The provided text describes a 510(k) summary for the NIPRO® Disposable Syringe. It outlines the device's purpose, materials, and intended use, and states that non-clinical tests were submitted to demonstrate substantial equivalence to a predicate device (K944355). However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that explicitly proves the device meets such criteria.

The submission focuses on establishing substantial equivalence based on what the device is and that it performs similarly to a predicate, rather than providing quantitative performance data against defined thresholds.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Acceptance Criteria and Study to Prove Device Meets Criteria

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. The submission focuses on demonstrating "substantial equivalence" to a predicate device (NIPRO® Disposable Syringe K944355). This implies that the 'acceptance criteria' are implicitly tied to performing similarly to the predicate in terms of "intended use, materials of construction, labeling, and overall performance characteristics," but no specific quantitative thresholds are given.
Reported Device Performance: Not explicitly detailed with quantitative metrics. The document states:

"Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence."
"The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics device and is a from and ff device and is safe and effective when used as intended."

This indicates that performance testing was done, but the results (e.g., specific measurements, values) are not reported in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a simple mechanical piston syringe, and the "ground truth" concept (e.g., for diagnostic accuracy) does not apply in the same way it would for an AI/diagnostic device. Performance testing likely involved engineering and quality control assessments against recognized standards or internal specifications, rather than expert-derived ground truth. No experts for ground truth establishment are mentioned.

4. Adjudication method for the test set

Not applicable for this type of device and submission.

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

Not applicable. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used

Given the device is a piston syringe, "ground truth" would likely be established through engineering specifications, material standards, and functional performance benchmarks (e.g., fluid delivery accuracy, plunger force, seal integrity, sterility, non-pyrogenicity, non-toxicity). The document mentions "Biocompatibility data" and "performance testing," which would relate to these types of ground truths, but specific methods are not detailed.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets.

9. How the ground truth for the training set was established

Not applicable.

Summary of available information:

The provided 510(k) summary for the NIPRO® Disposable Syringe (Gamma) confirms that:

The device is a piston syringe for injecting or withdrawing fluids.
It is sterile, single-use, non-toxic, non-pyrogenic, and sterilized by Gamma radiation.
The applicant performed "Biocompatibility data, performance testing and comparison testing with the predicate" (NIPRO® Disposable Syringe K944355) to demonstrate substantial equivalence.
The conclusion is that the device is "safe and effective when used as intended."

However, the detailed quantitative results of these tests, specific acceptance criteria (beyond "substantial equivalence"), sample sizes, and methodologies for establishing ground truth (in the context of advanced diagnostic or AI systems) are not present in this document. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.

Summary

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K091279 p. lot 2

Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol on the left and the word "NIPRO" in bold, sans-serif font on the right. The symbol is composed of two interlocked, curved shapes, creating a sense of movement and connection. The overall design is clean and modern, with a focus on simplicity and visual impact.

Florida 33172 05) 599-7174 (305) 599-8454

AUG 1 2 2009

510(k) Summary NIPRO® Disposable Syringe

807.92(a) (1)

Applicant: Establishment Reg.:

Nipro Medical Corporation 1056186

Contact Person:

Jessica Oswald Regulatory Affairs Specialist

Date of summary preparation: April 30, 2009

807.92(a) (2)

NIPRO® Disposable Syringe Trade Name: Common Name: disposable syringe Classification Number: 880.5860 Classification Name: Piston syringe Panel: 80 Product Code: FMF

807.92(a) (3)

Legally marketed substantial equivalent device: NIPRO Disposable Syringe (K944355)

807.92(a) (4)

Description of device:

807.92(a) (5)

Indications for Use:

The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

NIPRO® Disposable Syringe (Gamma) 5 510(k) Summary

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K091277 p.20f2

807.92(a) (6)

Comparison of technological characteristics:

Nipro Medical Corporation considers the modified NIPRO® Disposable Syringe Gamma to be substantially equivalent to the current NIPRO® Disposable Syringe (K944355) with regard to intended use, materials of construction, labeling, and overall performance characteristics.

807.92(b) (1)

Non-clinical tests submitted:

Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence,

807.92(b) (3)

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics
device and is a from and ff device and is safe and effective when used as intended.

NIPRO® Disposable Syringe (Gamma) 5 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Jessical Oswald Regulatory Affairs Specialist Nipro Medial Corporation 3150 North West 107th Avenue Miami. Florida 33172

AUG 1 2 2009

Re: K091279

Trade/Device Name: NIPRO® Disposable Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 13, 2009 Received: July 15, 2009

Dear Ms. Oswald:

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.

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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Page 2- Ms. Oswald

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.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony V. Mastrofini

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, 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: NIPRO® Disposable Syringe

Indications for Use:

The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K0912-

NIPRO® Disposable Syringe (Gamma)

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).