The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.

Device Description

The Terumo Disposable Hypodermic Syringe, with or without a hypodermic single lumen needle, is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in 3, 5, 10, 20, 30 and 60 cc/ml volumes, with luer slip, luer lock, eccentric slip tip, or catheter tip configurations.

AI/ML Overview

The provided text describes the Terumo Disposable Hypodermic Syringe and its substantial equivalence to a previously cleared device (K771205). The information primarily focuses on design, materials, and compliance with various international standards, rather than a clinical study with a detailed test set, ground truth, and expert evaluation for AI performance. Therefore, many of the requested categories related to AI performance, expert validation, and advanced study designs cannot be fully addressed from the given text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is stated to meet the same range of performance acceptance criteria as its predicate device and complies with several international standards. Specific quantitative criteria and exact reported performance values are not provided, only compliance statements.

Acceptance Criteria / Standard	Reported Device Performance
ISO 594-1:1986	Complies
ISO 594-2:1986	Complies
Japan Ministry of Health and Welfare Notification No. 442: 12/28/70 (Section II, Item #3 barrel volume)	Complies
ISO 7886-1 (Leakage)	Complies
ISO 7886-1 (Aspiration)	Complies
ISO 7886-1 (Injection)	Complies
ISO 7886-1 (Plunger Mobility/Gasket Slide)	Complies
ISO 7886-1 (Dead Space)	Complies
ISO 7886-1 (Silicone Quantity)	Complies
ISO 7886-1 (Graduation Location)	Complies
ISO 594-1, ISO 594-2 (Conical Fitting/Luer Taper)	Complies
Japan Ministry of Health & Welfare, No. 442: 12/28/70 (Barrel Volume)	Complies
Sterility Assurance Level (SAL)	10^-6 (validated per EN 556)
Biocompatibility (Blood contacting materials)	Found to be biocompatible (per FDA G95-1)
Expiration Dating	5 years (60 months)

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

Not applicable in the context of a substantial equivalence submission for a hypodermic syringe. This submission relies on engineering and manufacturing tests against standards, not a clinical test set with patient data.

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

Not applicable. Ground truth for the mechanical and material performance of a syringe is established by testing against engineering specifications and international standards, not by expert consensus on clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies for interpretation of ambiguous cases, which is not relevant for the performance testing of a syringe.

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 a medical device for manual fluid injection/withdrawal, not an AI-powered diagnostic or assistive tool.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is compliance with established international and national standards (e.g., ISO 594-1, ISO 7886-1, Japan Ministry of Health and Welfare Notification No. 442) for mechanical, material, and safety aspects, as well as validated sterility and biocompatibility testing.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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APR = 2 1998

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Terumo Disposable Hypodermic Syringe or similar proprietary Proprietary Device Name: name

Classification Name: Syringe, piston

INTENDED USE

Note: This is the same intended use as the Terumo Hypodermic Syringe cleared under K771205.

DESCRIPTION

The Terumo Disposable Hypodermic Syringe will be sold by prescription only and labeling will bear the statement "Caution: Federal law restricts this device to sale by or on the order of a physician."

SUBSTANTIAL EQUIVALENCE

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PRINCIPLE OF OPERATION/TECHNOLOGY

The Terumo Disposable Hypodermic Syringe and the cleared Terumo Hypodermic Syringe (K771205) are both operated manually.

DESIGN/MATERIALS

The materials used to construct the Terumo Disposable Hypodermic Syringe are the same materials used for the cleared Terumo Hypodermic Syringe (K771205). The Terumo Disposable Hypodermic is substantially equivalent in design to the cleared Terumo Hypodermic Syringe (K771205).

SPECIFICATIONS

The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is available in 3, 5, 10, 20, 30 and 60 cc/ml volumes, with luer slip, luer lock, eccentric slip tip or catheter tip configurations.

Minor design changes have been implemented to produce The Terumo Disposable Hypodermic Syringe. These minor design changes are as follows:

The outer diameter of the barrel has decreased .
The overall length of the barrel has decreased .
The wall of the barrel is slightly thinner ●
The flange height is slightly less .
The plunger rib cross section has been very slightly reduced .
The gasket height has been lessened .

NOTE: The inner diameter of the Terumo Disposable Hypodermic Syringe barrel has not changed from the cleared predicate device barrel inner diameter (Terumo Hypodermic Syringe K771205).

PERFORMANCE

The performance of the Terumo Disposable Hypodermic Syringe is substantially equivalent to the performance of the cleared Terumo Hypodermic Syringe (K771205), and will meet the same range of performance acceptance criteria.

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SECTION II: Summary of Safety and Effectiveness

The Terumo Disposable Hypodermic Syringe complies with ISO 594-1:1986. Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment--Part 1: General requirements and Part 2: Lock fittings.

The Terumo Disposable Hypodermic Syringe complies with Section II, Item #3 (barrel volume) of the Standard for Disposable Hypodermic Syringes, Notification No. 442 of the Japan Ministry of Health and Welfare: December 28, 1970.

The Terumo Disposable Hypodermic Syringe also complies with specific sections of ISO 7886-1 Guidance for Sterile Hypodermic Syringes for Single Use, Part 1: Syringes for manual use, as indicated in the table below.

	APPLICABLE STANDARD
Leakage
Aspiration
Injection	ISO 7886-1
Plunger Mobility/Gasket Slide	ISO 7886-1
Dead Space	ISO 7886-1
Silicone Quantity	ISO 7886-1
Graduation Location	ISO 7886-1
Conical Fitting/Luer Taper	ISO 594-1, ISO 594-2
Barrel Volume	Japan Ministry of Health & Welfare, No. 442: 12/28/70

ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the European Standard, EN 556: Sterilization of Medical Devices - Requirements for Medical Devices to Be Labeled Sterile, to provide a Sterility Assurance Level (SAL) of 10-6.

Manufacturing control test methods include: functional and sterility tests.

LAL testing is performed on production samples from of every lot number.

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Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." [External Communicating Devices, Blood Path Indirect, Limited Duration of Contact ( < 24 hours).] The blood contacting materials were found to be biocompatible.

The expiration dating for the Terumo Disposable Hypodermic Syringe has been established to be 5 years, or 60 months.

CONCLUSION

The Terumo Disposable Hypodermic Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Hypodermic Syringe. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Date Prepared:	January 16, 1998
Prepared by:	Kristine WagnerRegulatory Affairs Specialist
Prepared for:	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone (410) 392-7241 or (410) 392-7231Fax (410) 398-6079

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a staff entwined by a serpent and topped with wings. The seal is in black and white.

APR - 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristine Wagner Regulatory Affairs Specialist Terumo® Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921

K980181 Re : Terumo Disposable Hypodermic Syringe Trade Name: Regulatory Class: II Product Code: FMF Dated: January 16, 1998 Received: January 20, 1998

Dear Ms. Wagner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A - substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Wagner

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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510(k) Number (if known): _ K 980181

Device Name: Terumo Disposable Hypodermic Syringe

Indications For Use:

(Per 21 CFR 801.109)

The Terumo Disposable Hypodermic Syringe, with or without hypodermic single The Terumo Disposable Hypoderal Syringe, With or withdrawing fluids from the The syringe is designed for manual use. body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Sign-Off)
	Dental Infection Control
	and General Hospital Devices
510(k) Number	K980181
Prescription Use		OR	Over-The-Counter Use

(Optional Format 1-2-96)

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).