TERUMO 30 GAUGE HYPODERMIC NEEDLE

K012646 · Terumo Medical Corp. · FMI · Aug 27, 2001 · General Hospital

Device Facts

• Record ID: K012646
• Device Name: TERUMO 30 GAUGE HYPODERMIC NEEDLE
• Applicant: Terumo Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The Terumo 30 Gauge Hypodermic Needle consists of a stainless steel cannula sharpened at one end and attached to a plastic hub at the other. It is designed to mate with the male nozzle of a piston syringe or intravascular administration set. The device is operated manually by a clinician to inject or withdraw fluids from the body. It serves as a size extension to the existing Terumo hypodermic needle product line, providing a thinner needle option for patient procedures.

Clinical Evidence

Bench testing only. Performance testing included cannula adhesion, protector fit, needle penetration force, leakage, and blocked cannula. Biocompatibility testing was conducted per ISO-10993. Sterilization validated per ANSI/AAMI/ISO 11137-1994.

Technological Characteristics

Stainless steel tubing; plastic hub; manual operation; 30 gauge size; 1/2 inch length; yellow hub color (ISO 6009); radiation sterilization (SAL 10^-6).

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from body parts below the skin surface; intended for use with piston syringes or intravascular administration sets.

Regulatory Classification

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.

Predicate Devices

• TERUMO® Hypodermic Needle (K771203)
• BD 30 Gauge (Precision Glide) Hypodermic Needle (Pre-amendment)

Submission Summary (Full Text)

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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:

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.

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

#### D. 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.

#### 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 | Needle<br>Length | 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#: [phone] Fax#: [phone]

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. I radiation f Compliance at [phone]. 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 [phone] or [phone] 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-Cholesterol<br>Reagent<br>VITROS CHOL Slide<br>VITROS Chemistry Products Calibrator Kit 2 |
| Intended Use: | For in vitro diagnostic use only.<br>The VITROS Magnetic HDL-Cholesterol Reagent and VITROS<br>CHOL Slides quantitatively measure HDL cholesterol (HDLC)<br>concentration in serum and plasma. |
| | VITROS Calibrator Kit 2 |
| | For in vitro diagnostic use only.<br>VITROS Calibrator Kit 2 is intended for use in calibration of the<br>VITROS Chemistry Systems for the quantitative measurement<br>of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG. |
| Summary and Explanation of<br>Test: | HDL cholesterol is used to evaluate the risk of developing<br>coronary heart disease (CHD). The risk of CHD increases with<br>lower 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)

OR

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