The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It is intended to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Device Description

The TERUMO® 30 Gauge hypodermic needle is comprised of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

AI/ML Overview

This document describes the 510(k) submission for the TERUMO® 30 Gauge Hypodermic Needle. This is a claim of substantial equivalence to predicate devices, not for a novel device requiring extensive clinical trials. Therefore, much of the requested information (like multi-reader multi-case studies, effect sizes, expert qualifications, and ground truth establishment for AI models) is not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state quantitative acceptance criteria with numerical targets. Instead, performance is evaluated by demonstrating that the new device performs comparably to the predicate device and does not raise new safety or effectiveness concerns. The "reported device performance" is a qualitative statement of successful testing.

Acceptance Criteria (Implicit)	Reported Device Performance
Cannula Adhesion	Tests performed; no new safety/effectiveness issues raised.
Protector Fit	Tests performed; no new safety/effectiveness issues raised.
Needle Penetration Force	Tests performed; no new safety/effectiveness issues raised.
Leakage	Tests performed; no new safety/effectiveness issues raised.
Blocked Cannula	Tests performed; no new safety/effectiveness issues raised.
Sterility (SAL of 10⁻⁶)	Validated in accordance with ANSI/AAMI/ISO 11137-1994.
Biocompatibility	Same materials and sterilization as cleared predicate (K771203); no further testing deemed necessary.
Pyrogenicity	Performed in accordance with US Pharmacopoeia XXIII and LAL gel clot test.

The study essentially concludes that "None of the data raises any new issues of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for each of the performance tests (Cannula Adhesion, Protector Fit, etc.). The data provenance is not explicitly mentioned as country of origin, retrospective, or prospective. However, based on the nature of the tests, they would be prospective laboratory tests conducted on samples of the newly designed 30 Gauge Hypodermic Needle.

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

Not applicable. This is a submission for a medical device (hypodermic needle), not an AI algorithm requiring expert ground truth in image interpretation or diagnosis. The "ground truth" for these performance tests is derived from standard engineering and biocompatibility testing methodologies.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process is described for the performance tests of a hypodermic needle.

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. The device is a hypodermic needle, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a hypodermic needle, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests comes from:

Engineering Specifications: For tests like Cannula Adhesion, Protector Fit, Needle Penetration Force, Leakage, and Blocked Cannula, the ground truth is against defined engineering standards and acceptable ranges for these physical properties.
Regulatory Standards: For sterility (ANSI/AAMI/ISO 11137-1994) and pyrogenicity (US Pharmacopoeia XXIII, LAL test), the ground truth is adherence to these established regulatory and testing standards.
Predicate Device Equivalence: For biocompatibility, the ground truth is the established biocompatibility of the predicate device (K771203) using the same materials and sterilization methods.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for one.

Summary

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AUG 2 7 2001

SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

A. Device Name

Proprietary Device Name: TERUMO® 30 Gauge Hypodermic Needle

Classification Name: Needle, Hypodermic, Single Lumen

B. Reason for Submission:

This 510k is being submitted to extend the cleared Terumo Hypodermic Needle* (K771203) product line. (*also referred to as the standard Terumo needle.) The size of the 30g needle is smaller than what is currently cleared under the current Hypodermic needle 510k (K771203). This Special 510k is being submitted because of potential issues of safety and effectiveness specific for a smaller/thinner needles. This 510k will provide supporting information that Terumo's 30 Gauge hypodermic needle is safe and effective and an acceptable extension of the current hypodermic needle product line.

C. Intended Use:

Note: This is the same intended use as the predicate device, Terumo Hypodermic Needle - K771203.

D. Description

E. Substantial Equivalence

The TERUMO® 30Gauge Hypodermic Needle is substantially equivalent in intended use. design, technology/principals of operation, materials, and performance to both the following cleared devices:

TERUMO® Hypodermic Needle 1. (K771203)
BD 30 Gauge (Precision Glide) Hypodermic Needle 2. *Pre-amendment

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Unable to identify the 510(k) number for this device through published resources. It is believed to be a pre-amendment device although this could not be confirmed.

Differences between the devices do not raise any significant issues of safety and effectiveness.

F. Principals of Operation/Technology

The TERUMO® 30Gauge Hypodermic Needle, Terumo Hypodermic needle (K771203), and BD 30G Precision Glide Hypodermic Needle (Pre-amendment) are all operated manually.

G. Materials

The TERUMO® 30Gauge Hypodermic Needle, standard Terumo needle, and BD 30G Precision TIFE TEKOMO® 50Gage 113podemic stainless steel tubing attached to a plastic hub by Onec Trypodeline Neduce are an ials used in the proposed 30G needle and the cleared Terumo needle are the same.

H. Specifications

Product Code	Gauge Size	NeedleLength	Hub Color*
NN3013R	30g	1/2"	Yellow

*Per ISO 6009

I. Performance

The following performance tests were performed on the Terumo 30g Hypodermic Needle:

Cannula Adhesion ●
Protector Fit .
Needle Penetration Force ●
Leakage ●
Blocked Cannula .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conduct and there were no risks identified that warranted any design changes.

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J. Additional Safety Information

a. Sterilization
Sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11137-1994 Medical Devices – Validation and Routine Control of Radiation Sterilization. This device is sterilized to a Sterility Assurance Level (SAL) of 10°

b. Biocompatibility Testing

The TERUMO® 30Gauge Hypodermic Needle, like the standard Terumo Hypodermic needle K771203, is an Externally Communicating device, Circulating Blood, Limited Exposure (24 hrs). Blood contacting materials have been tested in accordance with 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. (The yellow colorant is the same colorant used in the cleared Terumo 20g Hypodermic Needle.) The needle in this 510k uses the same materials and method of sterilization as the standard Terumo Hypodermic needle, which has shown to be biocompatible. Therefore, no further testing was deemed necessary.

c. Expiration Dating
Expiration Dating for the Terumo 30g Hypodermic Needle will be 60 months (5 years) which is the same as the standard Terumo needle.
d. Pyrogen Testing
Pyrogen testing is performed in accordance with the requirements of the US Pharmacopoeia XXIII. Additionally, each lot is tested for the absence of endotoxins using the Limulus Amebocyte Lysate (LAL) gel clot test.

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K. Conclusion

In summary, the TERUMO® 30Gauge Hypodermic Needle is substantially equivalent in intended use, design, technology/principals of operation, materials, and performance to both the following cleared devices:

TERUMO® Hypodermic Needle (K771203) 1.
BD 30 Gauge (Precision Glide) Hypodermic Needle (Pre-amendment) 2.

Differences between the devices do not raise any significant issues of safety and effectiveness.

Terumo'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 whatsoever to be the basis for a patent infringement action.

Date Prepared: July 31, 2001

Prepared by: Barbara Smith Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921 Phone#: 410-392-7241 Fax#: 410-398-6079

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your distantial equivalence of your device to a legally marketed nouthoute 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 1 11 you desire books an in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-1500. I radiation f Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monfacturers 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use

Page 1 of 1

510(k) Number (if known):	K012593
Device Name:	VITROS Chemistry Products Magnetic HDL-CholesterolReagentVITROS CHOL SlideVITROS Chemistry Products Calibrator Kit 2
Intended Use:	For in vitro diagnostic use only.The VITROS Magnetic HDL-Cholesterol Reagent and VITROSCHOL Slides quantitatively measure HDL cholesterol (HDLC)concentration in serum and plasma.
	VITROS Calibrator Kit 2
	For in vitro diagnostic use only.VITROS Calibrator Kit 2 is intended for use in calibration of theVITROS Chemistry Systems for the quantitative measurementof CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.
Summary and Explanation ofTest:	HDL cholesterol is used to evaluate the risk of developingcoronary heart disease (CHD). The risk of CHD increases withlower HDL cholesterol concentrations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __

Keria Alexander for Joan Cooper
(Division Sign-Off)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012593

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510(k) Number (if known): K012446

TERUMO® 30 Gauge Hypodermic Needle Device Name:

Indications For Use:

The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or The TEXOMO& 50 garge if pour body below the surface of the skin. It is intended to mate with withidraw from ple) of a piston syringe or an intravascular administration set.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Latour Crescenti

ivision of Dental, Infection Control, and General Hospital Devices

510(k) Number K012046

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).