The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Nipro Disposable Syringes (K030683). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the information required to populate the table and answer the study-related questions is not present in the provided text. The document states that "Performance tests demonstrated that the devices are substantially equivalent," but it does not elaborate on these tests, their acceptance criteria, or the specific results.

Here's why the information is missing based on the nature of the document:

510(k) Summary: A 510(k) summary (or statement, as this appears to be part of) primarily aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technical characteristics and showing that any differences do not raise new questions of safety or effectiveness.
Performance Tests Mentioned but Not Detailed: While "Performance tests demonstrated that the devices are substantially equivalent" is stated, the summary does not include the specifics of these tests, such as the actual criteria, methodologies, or outcomes. These details would typically be in a more comprehensive testing report submitted to the FDA, but not necessarily in the publicly available summary.
Device Type: The device is a "Piston Syringe, Hypodermic, Single Lumen Syringe" and is classified as Class II. For such straightforward, well-understood devices, the "performance tests" likely refer to standard engineering and biocompatibility tests (e.g., sterilization validation, material strength, leakage, plunger force) that confirm it performs as expected for its intended use, rather than complex clinical studies involving human readers or AI algorithms.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because this information is not included in the 510(k) summary.

If this were a submission for a sophisticated AI/ML-based device, the content would be vastly different and would include detailed clinical validation studies addressing these points.

Summary

{0}------------------------------------------------

K030683

10/31/03

IIPRO MEDICAL CORPORATION 3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454

SUMMARY OF SAFETY AND EFFECTIVENESS NIPRO DISPOSABLE SYRINGES

$807.92 (a)(1)

Contact Person:

Cary Goldsmith Product Manager March 4, 2003

Date of Summary Preparation:

5807.92 (a)(2) Trade Name: Common Name: Classification Name:

Nipro Disposable Syringes Sterile Disposable Syringe with/without needle Piston Syringe, Hypodermic Single Lumen Syringe ($880.5860)

$807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes (K944355)

S807.92 (a)(4)

Description of Device:

9807.92 (a)(5)

Intended Use: The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

9807.92 (a){6)

Comparison of Technical Characteristics:

The Nipro subject and predicate devices are very similar in materials, design and technological characteristics. Performance tests demonstrated that the devices are substantially equivalent.

-13-

{1}------------------------------------------------

PublicHealth Service

Image /page/1/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird-like symbol with three curved lines forming its body and wings. The bird is facing right. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA' in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

OCT 31 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030683

Trade/Device Name: Nipro Disposable Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 22,2003 Received: September 23,2003

Dear Ms. 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.

{2}------------------------------------------------

Page 2 - Ms. Hadley

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use Statement

510(k) number (if known): K030 c 93

Device name: Nipro Disposable Syringes

Device name: Nipro Disposable Syringes
Indications for use: The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

Patricia Cicceretti

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

510(k) Number. K030682

(Do not write below this line- continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation(ODE )

Prescription Use v (Ber 21 CFR 801.109)

Over-The- Counter-Use -(optional Format 1-2-9 )

Nipro® Disposable Syringes

210(k)

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).