The Terumo Syringe with/without needle consists mainly of 3 parts or 4 parts: a barrel, a plunger, a gasket and a needle (for the needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material facilitates smooth movement of the plunger and aids the user in controlling dosage. The needle is made from stainless steel and the needlepoint is carefully designed to minimize resistance at the skin surface and aids in smooth, easy insertion. The Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened.

AI/ML Overview

This document describes the 510(k) summary for the Terumo Syringe with/without Needle. It demonstrates substantial equivalence to a predicate device, K980181, rather than proving performance against specific acceptance criteria in a quantitative study. Therefore, some of the requested information, such as sample sizes, expert qualifications, and specific effect sizes, are not applicable or not provided in the given text.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of specific quantitative acceptance criteria with corresponding performance metrics. Instead, it lists various tests performed to demonstrate safety and efficacy and asserts that the device is "safe and effective during handling and for the duration of its expiration." The implicit acceptance criterion for each test is that the new device performs acceptably and equivalently to the predicate device.

Performance Test	Reported Device Performance
Cleanliness	Not explicitly quantified, but implied to be acceptable.
Leakage Test	Not explicitly quantified, but implied to be acceptable.
Sliding Resistance	Not explicitly quantified, but implied to be acceptable.
Plunger and Gasket Fit Force	Not explicitly quantified, but implied to be acceptable.
Nozzle-needle Fit Force	Not explicitly quantified, but implied to be acceptable.
Initial Movement Force	Not explicitly quantified, but implied to be acceptable.
Stopper Force	Not explicitly quantified, but implied to be acceptable.
Dead Space	Not explicitly quantified, but implied to be acceptable.
Equal to Nominal Capacity Graduation Tolerance	Not explicitly quantified, but implied to be acceptable.
Between Main Capacity Graduation Tolerance	Not explicitly quantified, but implied to be acceptable.
Primary Container Seal Strength	Not explicitly quantified, but implied to be acceptable.
Silicone Amount Determination	Not explicitly quantified, but implied to be acceptable.
Elution Test Method	Not explicitly quantified, but implied to be acceptable.
Analysis of Heavy Metals	Not explicitly quantified, but implied to be acceptable.
Determination of pH	Not explicitly quantified, but implied to be acceptable.
Sterility Assurance Level (SAL)	10⁻⁶ (validated in accordance with ISO 11137)
Performance (aged and non-aged devices)	Aging process does not adversely affect device performance.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the various performance tests. The data provenance is Terumo (Philippines) Corporation, and the tests were likely conducted prospectively as part of the device development and validation process.

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

Not applicable. This is a medical device clearance based on substantial equivalence, not an AI or diagnostic tool requiring expert ground truth for a test set. The "ground truth" here is compliance with established performance standards and equivalence to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device clearance based on substantial equivalence, not an assessment requiring adjudication of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a manual syringe, and its performance evaluation does not involve human readers interpreting diagnostic cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a manual syringe, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

Compliance with recognized standards: For tests like cleanliness, leakage, and sterility (ISO 11137).
Engineering specifications and design requirements: For physical and mechanical properties.
Demonstrated performance of the legally marketed predicate device: The new device must perform comparably to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

Summary

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Section II 510(k) Summary Terumo Syringe with/without Needle Terumo (Philippines) Corporation

510(k) Summary

Submitter Information:

Name and Address: Terumo (Philippines) Corporation #124 East Main Ave. Laguna Technopark, Biñan, Laguna, Philippines 4026

Contact Person:

Ms. Sandi Hartka Manager Regulatory Affairs Terumo Medical Corporation 950 Elkton Blvd., 410-392-7243 Phone Number: Fax Number: 410-398-6079

Device Name:

Propriety Name:	Terumo Syringe with/without Needle
Common Name:	Piston Syringe, Disposable Syringe
Classification Name:	Syringe, Piston with or without Hypodermic Single Lumen Needle

Predicate Device:

The Terumo Syringe with/without needle that is the subject of this premarket notification is substantially equivalent to the predicate device, Terumo Medical Corporation Hypodermic Syringe, which is legally marketed and was cleared by FDA (K980181).

Intended Use:

The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Principle of Operation and Technology:

Each Terumo Syringe with/without needle is designed for manual use therefore it is operated manually.

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Section II 510(k) Summary Terumo Syringe with/without Needle Terumo (Philippines) Corporation

Design and Materials

Performance Evaluations:

The Terumo Syringe with/without needle submitted in this premarket notification was subjected to the following tests to demonstrate the safety and efficacy of the device:

. Cleanliness
Leakage Test .
Sliding Resistance ●
Plunger and Gasket Fit Force ●
Nozzle-needle Fit Force .
Initial Movement Force .
Stopper Force .
Dead Space .
Equal to Nominal Capacity Graduation Tolerance .
Between Main Capacity Graduation Tolerance .
Primary Container Seal Strength .
Silicone Amount Determination .
Elution Test Method .
Analysis of Heavy Metals .
Determination of pH .

Specifications:

PRODUCT	SYRINGE SIZES	NEEDLEGAUGE	EXPOSED NEEDLELENGTH
Terumo SyringeWith/without Needle	3 cc, 5 cc, 10 cc and20 cc Terumo syringe	Gauges 20 - 27	16 mm (5/8") to 38 mm (1 ½)
Terumo DisposableHypodermic Syringe(predicate device,K980181)	3 cc, 5cc, 1020 cc hypodermicsyringe	Gauges 18 - 24Gauges 25 - 27	19 mm (3/4) to 38 mm (1 ½)13 mm (1/2") to 25 mm (1")

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510(k) Summary Section II Terumo Syringe with/without Needle Terumo (Philippines) Corporation

Substantial Equivalence Comparison:

The Terumo Syringe with/without needle is substantially equivalent to the precicate Terumo Medical Corporation Hypodermic Syringe as follows:

Intended Use: Both Terumo Syringe with/without Needle and the predicate Terumo . Disposable Hypodermic Syringe, with or without hypodermic single lumen needle is intended to be used for injecting fluids or withdrawing fluids from the body.
Principles of Operation: Terumo Syringe with/without Needle and the cleared Terumo . Disposable Hypodermic Syringe (K980181) are operated manually.
Design and Materials: The design of the Terumo Syringe with/without Needle and the . predicate Terumo Disposable Hypodermic Syringe is basically the same. Both devices are comprised of a barrel, plunger and gasket (and needle) that are blister packed.

Both Terumo Syringe with/without Needle and the predicate Terumo Disposable Hypodermic Syringe is made of polypropylene and thermoplastic elastomer. The materials used in the molding of the devices are the same relative to device functioning. Any difference in these materials does raise any new issues of safety and/or effectiveness.

Performance: The Terumo Syringe with/without Needle has been demonstrated to be safe . and effective during handling and for the duration if its expiration. The Terumo Syringe with/without Needle is substantially equivalent to the predicate Terumo Disposable Hypodermic Syringe.

Substantial Equivalence Summary:

In summary, the Terumo Syringe with/without Needle and the predicate Terumo Disposable Hypodermic Syringe are substantially equivalent in intended use, principles of operation, design and materials, and performance. Any noted differences between the two devices do not raise new issues of safety or effectiveness.

Additional Safety Information:

Sterilization conditions have been validated in accordance with ISO 11137 to provide a . Sterility Assurance Level (SAL) of 10to.
. Performance evaluations were conducted on aged and non-aged devices to ensure that the aging process does not adversely affect the performance of the device.

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Section II 510(k) Summary Terumo Syringe with/without Needle Terumo (Philippines) Corporation

Conclusion:

In summary, the Terumo Syringe with/without Needle is substantially equivalent in intended use, operational principle, design and materials, and performance to the predicate Terumo Disposable Hypodermic Syringe (K980181).

Terumo (Phils.) Corporation's Statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended to be the basis for patent infringement action.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2002

Ms. Sandi Hartka Manager Regulatory Affairs Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921

Re: K023271

Trade/Device Name: Terumo Syringe with/without Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 9, 2002 Received: October 1, 2002

Dear Ms. Hartka:

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.

Image /page/4/Picture/10 description: The image shows a partial view of a circular seal or emblem. The text "DEPARTMENT OF HEALTH" is visible along the left side of the circle. To the right, there is a stylized graphic of three human profiles facing the same direction, stacked one above the other. The overall impression is that of an official or organizational symbol related to health services.

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Page 2 - Ms. Hartka

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Sina Punpe

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K02 327)

Device Name:

Terumo Syringe with/without Needle

Indications For Use:

The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. . .

G. Adolfo A. Pacheco

Geraldine A. Pasaba Regulatory Affairs Officer Terumo (Philippines) Corporation

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrone Cucurati

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

510(k) Number: K

02327

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

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).