The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "NIPRO Disposable Syringe with or without needle." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study design for a novel device. Therefore, much of the requested information (sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission and is not present in the provided text.

The core of this submission is a comparison of technical characteristics and performance to legally marketed predicate devices, with the goal of showing they are "substantially equivalent."

Here's the information that can be extracted or derived from the provided text, with explanations where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Similarity in materials, design, and technological characteristics to predicate devices.	The subject and Nipro predicate devices are similar in materials, design and technological characteristics.
Compliance with voluntary standards for syringes.	Performance tests demonstrated that the devices... meet voluntary standards for syringes. (No specific standards or performance metrics are listed, just a general statement of compliance).
Intended use: to inject fluids into or withdraw fluids from the body.	The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body. (This is the stated intended use, and substantial equivalence implies this use case is supported).

2. Sample Size for the Test Set and Data Provenance

Not Applicable. The document describes performance tests to demonstrate substantial equivalence to voluntary standards, but it does not detail a specific "test set" or study in the manner requested (e.g., a clinical trial or a performance study with a distinct sample size of patients/cases). The "performance tests" are likely internal engineering and quality testing to ensure the device meets specified manufacturing and product standards rather than a clinical performance study.
Data Provenance: Not specified, but likely refers to internal testing data generated by Nipro Medical Corporation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This type of information is relevant for studies where expert consensus or interpretation is used to establish "ground truth" (e.g., in diagnostic devices). For a disposable medical device like a syringe, "ground truth" typically relates to its physical and functional performance meeting established engineering and safety standards, rather than expert interpretation of data.

4. Adjudication Method

Not Applicable. As no expert review or "ground truth" adjudication process in the requested sense is described.

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

No. This type of study is typically done for diagnostic imaging devices or algorithms where human readers are making interpretations. It is not relevant for a disposable hypodermic syringe.

6. Standalone (Algorithm Only) Performance Study

No. Syringes are mechanical devices; there is no embedded algorithm. "Standalone performance" here refers to the device's physical function. The document states that "Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes," which implies standalone testing of the device's physical properties and function. However, no specific metrics or study details are provided beyond this general statement.

7. Type of Ground Truth Used

For the performance tests mentioned, the "ground truth" would be established by engineering specifications, recognized voluntary standards (e.g., ISO standards for syringes), and relevant regulatory requirements for physical and mechanical performance (e.g., plunger force, leak-tightness, sterility, material compatibility). The document states the device "meet voluntary standards for syringes," implying these standards serve as the "ground truth" for performance.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not part of a disposable syringe. Device validation for manufacturing would involve process validation and testing of production lots, rather than a "training set."

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

Not Applicable. See point 8.

Summary

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Kos-1574

Image /page/0/Picture/1 description: The image shows the logo and contact information for Nipro Medical Corporation. The logo features a stylized graphic element next to the word "NIPRO" in bold, uppercase letters. Below the logo is the company name, followed by the address 3150 N.W. 107 Avenue, Miami, Florida 33172, and the telephone number (305) 599-7174 and fax number (305) 599-8454.

AUG 2 6 2005

SUMMARY OF SAFETY AND EFFECTIVENESS DISPOSABLE HYPODERMIC SYRINGES

807.92 (a)(1)

Contact Person:

Cary Goldsmith Marketing Manager June 6, 2005

Date of Summary Preparation:

807.92 (a)(2)

Trade Name: Common Name: Classification Name:

Disposable Hypodermic Syringes with or without Needle Sterile Disposable Syringe with/without needle Syringe, Piston (880.5860) Hypodermic Single Lumen Needle (880.5570)

807.92 (a)(3)

Legally Marketed Substantially Equivalent Device:

Nipro Branded Disposable Syringes (K944355 and K030683)

807.92 (a)(4)

Description of Device:

807.92 (a)(5)

Intended Use: The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

807.92 (a)(6)

Comparison of Technical Characteristics:

The subject and Nipro predicate devices are similar in materials, design and technological characteristics. Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that resemble a human figure.

AUG 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nipro Medical Corporation C/O Kaelyn B. Hadley, Ph.D. Regulatory Affairs Consultant 1384 Copperfield Court Lexington, Kentucky 40514-1268

Re: K051574

Trade/Device Name: NIPRO Disposable Syringe with or without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 6, 2005 Received: June 14, 2005

Dear Dr. Hadley:

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 such 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. Hadley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be advisou that I Drivision that your device complies with other requirements of the Act that I Dri Hab intato a and regulations administered by other Federal agencies. You must of any I edetar statuates and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. product ractiation of to begin marketing your device as described in your Section 510(k) rms letter witification. The FDA finding of substantial equivalence of your device to a legally promanted modicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you a seen office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

E. Susan Sumner
Chiu Lin, Ph.D.

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 (if known): ____________________________________________________________________________________________________________________________________________________

K05 1574

Device Name: Disposable Hypodermic Syringes with or without Needles

Indications For Use: The Disposable Hypodermic Syringes and Needles are intended for use to inject fluids into 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)

Chas. Martin

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

Kysls74 510(k) Number:_

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).