The TERUMO® U-100 Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin.

Device Description

The Terumo U-100 Insulin Syringe is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, designed for manual use. The syringe is available in 1/2cc and 3/10cc volumes with a 30 gauge by 3/8 inch fixed hypodermic single lumen needle.

AI/ML Overview

This document refers to a 510(k) premarket notification for a medical device, which seeks to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific, quantitative acceptance criteria through a comparative effectiveness study in the way an AI/ML device might. Therefore, many of the requested categories for AI/ML device studies are not directly applicable.

However, I can extract the relevant information regarding performance and the study conducted to demonstrate equivalence.

Here's an interpretation based on the provided text:

Description of Device: TERUMO® U-100 Insulin Syringe, a sterile, single-use piston syringe with a fixed hypodermic single lumen needle, in 1/2cc and 3/10cc volumes with a 30 gauge by 3/8 inch fixed hypodermic single lumen needle. Intended for manual aspiration and injection of fluids, particularly insulin.

Acceptance Criteria for an AI Device and Reported Device Performance:
Not directly applicable as this is a medical syringe, not an AI device. The acceptance criteria here are focused on demonstrating "substantial equivalence" to predicate devices based on design, technology, materials, and performance. The "performance" aspect is demonstrated through testing that shows it functions comparably to existing, cleared devices.

Table of Acceptance Criteria and Reported Device Performance (as best as can be inferred for a medical device):

Acceptance Criteria (Inferred for Substantial Equivalence)	Reported Device Performance (Demonstrated by Testing)
Intended Use Equivalence: Device intended for medical purposes for manual aspiration of fluids and injection of fluids (especially insulin), matching predicate devices.	The TERUMO® U-100 Insulin Syringe demonstrated substantial equivalence in intended use to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083) and the Becton Dickinson® Ultra Fine II Insulin Syringe (K955235).
Design/Technology/Principles of Operation Equivalence: Device design, technology, and operational principles are similar to predicate devices (manual operation, piston syringe with fixed hypodermic needle).	The TERUMO® U-100 Insulin Syringe demonstrated substantial equivalence in design, technology/principles of operation to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083) and the Becton Dickinson® Ultra Fine II Insulin Syringe (K955235).
Material Equivalence: Materials used in manufacturing are the same as the predicate device.	The materials used in the manufacture of the TERUMO® U-100 Insulin Syringe are the same materials used in the manufacture of the predicate device (K822083). Blood contacting materials were found to be biocompatible (in accordance with ISO-10993).
Performance Equivalence: Device functions comparably to predicate devices, ensuring safe and effective fluid aspiration/injection. This includes sterility, functionality, absence of particulate matter, and biocompatibility.	The performance of the TERUMO® U-100 Insulin Syringe was demonstrated to be equivalent to the cleared TERUMO U-100 Insulin Syringe (K822083) and the Becton-Dickinson® Ultra Fine II Insulin Syringe (K955235). Specific tests include: - Sterilization Validation: Achieved Sterility Assurance Level (SAL) of 10⁻⁶ (EN 556). - Manufacturing Control Tests: Functional and sterility tests performed on every lot. - LAL Testing: Performed on production samples from every lot. - Biocompatibility: Blood contacting materials tested per FDA General Program Memorandum #G95-1 (ISO-10993) and found biocompatible. - Expiration Dating: Established at 5 years (60 months).
No New Issues of Safety or Effectiveness: Differences between the subject device and predicate devices do not introduce new safety or effectiveness concerns.	The conclusion explicitly states that "Differences between the devices cited in this section do not raise any new issues of safety or effectiveness."

Study Details (as they apply to a non-AI medical device submission):

Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI study. Instead, the "testing" involved:
- Validation of sterilization conditions (EN 556).
- Manufacturing control tests (functional and sterility) on "production samples from every lot number."
- LAL testing on "production samples from of every lot number."
- Biocompatibility testing on "blood contacting materials."
  The specific number of units or samples for each of these tests is not quantified in the provided text, nor is the country of origin specified beyond implying manufacturing process validation. This is a retrospective submission based on compliance with standards and ongoing manufacturing controls.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device usually refers to expert-labeled data. Here, "ground truth" is established by adherence to recognized medical device standards and established scientific methods for evaluating sterility, biocompatibility, and functionality. There's no panel of experts reviewing "cases."
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Not an AI study involving human readers.
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 physical medical device (syringe), not an AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" is based on established medical device standards and scientific testing methodologies to ensure sterility, functionality, biocompatibility, and manufacturing quality. For example, a "Sterility Assurance Level (SAL) of 10⁻⁶" is a quantitative standard.
The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

TERUMO® U-100 Insulin Syringe, or similar proprietary name Device Name: Piston syringe with fixed hypodermic single lumen needle Classification Name:

INTENDED USE

DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Terumo U-100 Insulin Syringe submitted in this 510k, is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Medical Corporation U-100 Insulin syringe (K822083). There is no intended change in how this device is used.

With respect to the 30G x 3/8" cannula, the Terumo U-100 Insulin Syringe submitted in this 510k is substantially equivalent to the cleared Becton Dickinson® Ultra Fine II Insulin Syringe with 30G x 5/16" cannula (K955235).

PRINCIPLE OF OPERATION/TECHNOLOGY

The Terumo U-100 Insulin Syringe is operated manually.

MATERIALS

The materials used in the manufacture of the Terumo U-100 Insulin Syringe are the same materials used in the manufacture of the predicate device.

PERFORMANCE

The performance of the TERUMO® U-100 Insulin Syringe submitted in this 510k is equivalent to the performance of the cleared TERUMO U-100 Insulin Syringe (K822083) and to the Becton-Dickinson® Ultra Fine II Insulin Syringe (K955235).

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Testing was performed to demonstrate the substantial equivalence of the TERUMO U-100 Insulin Syringe with 30G x 3/8" cannula to the cleared Terumo U-100 Insulin Syringe and the B-D Ultra Fine II Insulin Syringe with 30G x 5/16" cannula.

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 106.

Manufacturing control test methods include functional and sterility tests. LAL testing is performed on production samples from of every lot number.

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 U-100 Insulin Syringe has been established to be 5 years, or 60 months.

CONCLUSION

The Terumo U-100 Insulin Syringe with 30 gauge x 3/8 inch cannula submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo U-100 Insulin Syringe (K822083), and the B-D Ultra Fine II Insulin Syringe with 30 gauge x 5/16 inch cannula. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Terumo's statement that these devices are 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 whatsoever to be the basis for a patent infringement action.

Date Prepared:	July 30, 1999
Prepared by:	Kristine Wagner
	Regulatory Affairs Specialist
Prepared for:	Terumo Medical Corporation
	125 Blue Ball Road
	Elkton, MD 21921
	Phone (410) 392-7241 or (410) 392-7231
	Fax (410) 398-6079

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K992802 Terumo U-100 Insulin Syringe Trade Name: Requlatory Class: I Product Code: FMF Dated: August 18, 1999 Received: August 19, 1999

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 general 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

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): K992802

TERUMO® U-100 INSULIN SYRINGE Device Name:

Indications For Use:

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

Concurrence of/CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K992802

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use V

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).