TERUMO(R) NEEDLE

K121607 · Terumo (Philippines) Corporation · FMI · Nov 8, 2012 · General Hospital

Device Facts

• Record ID: K121607
• Device Name: TERUMO(R) NEEDLE
• Applicant: Terumo (Philippines) Corporation
• Product Code: FMI · General Hospital
• Decision Date: Nov 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Device Story

Sterile, single-lumen hypodermic needle; stainless steel tube sharpened at one end; attached to female luer connector (hub) at other end. Designed for connection to male nozzle of piston syringe or intravascular administration set. Operated manually by clinicians to inject or withdraw fluids. Biocompatible materials; limited duration of contact (≤24hr).

Clinical Evidence

Bench testing only. Performance testing included protector fit, adhesive hold, conical fitting, and seal strength. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Stainless steel needle; polypropylene hub; adhesive attachment. Manual operation. Various gauges (18G-30G) and lengths (1/2"-1 1/2"). Sterilized via radiation per ANSI/AAMI/ISO 11137 (SAL 10^-5).

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from parts of the body below the skin surface. No specific patient population, age, or gender restrictions stated.

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® NEOLUS® Needle (K001572)
• TERUMO® Hypodermic Needle (K771203)
• TERUMO® Needle (K012646)

Submission Summary (Full Text)

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# 510(k) SUMMARY

1121607

NOV

8 2012

: TERUMO (PHILIPPINES) CORPORATION Prepared for 124 East Main Avenue, Laguna Technopark, Binan, Laguna,Philippines

Prepared by

: Ma. Cristina Faderagao - Supervisor, Regulatory Affairs Tel. [phone] Fax [phone]

Date prepared : February 10, 2012

Contact Person : Sandi Hartka

Regulatory Affairs Manager Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 Phone#: [phone] Fax#: [phone] E-mail: [e-mail]

#### A. DEVICE NAME

Proprietary Name TERUMO® NEEDLE

Classification Name Hypoderinic Single Lumen Needle (880.5570)

Product Code: FMI

Classification: Class II

Common Name: Hypodermic Needle

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# B. INTENDED USE

The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

# C. DEVICE DESCRIPTION

The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe or an intravascular administration set.

| Product<br>Code | Hub<br>Color | Needle Ø<br>(Gauge and<br>mm) | Needle<br>Length<br>(inch - mm) | Wall<br>thickness | Needle<br>Bevel |
|-----------------|--------------|-------------------------------|---------------------------------|--------------------|------------------|
| NN-1825R | Pink | 18G - 1.20mm | 1" – 25mm | Thin Wall | Regular<br>Bevel |
| NN-1838R | Pink | 18G - 1.20mm | 1 ½" – 38mm | Thin Wall | Regular<br>Bevel |
| NN-1925R | Cream | 19G - 1.10mm | 1" – 25mm | Thin Wall | Regular<br>Bevel |
| NN-1938R | Cream | 19G - 1.10mm | 1 ½" – 38mm | Thin Wall | Regular<br>Bevel |
| NN-2025R | Yellow | 20G - 0.90mm | 1" – 25mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2025V | Yellow | 20G - 0.90mm | 1" – 25mm | Regular<br>Wall | Regular<br>Bevel |
| NN-2038R | Yellow | 20G - 0.90mm | 1 ½" – 38mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2125R | Green | 21G - 0.80mm | 1" – 25mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2138R | Green | 21G - 0.80mm | 1 ½" – 38mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2225R | Black | 22G - 0.70mm | 1" – 25mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2238R | Black | 22G - 0.65mm | 1 ½" – 38mm | Ultra Thin<br>Wall | Regular<br>Bevel |

00013

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| Product<br>Code | Hub<br>Color | Needle Ø<br>(Gauge and<br>mm) | Needle<br>Length<br>(inch - mm) | Wall<br>thickness | Needle<br>Bevel |
|-----------------|--------------|-------------------------------|---------------------------------|--------------------|------------------|
| NN-2325R | Blue | 23G - 0.65mm | 1" - 25mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2338R | Blue | 23G - 0.65mm | 1 ½" - 38mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2516R | Orange | 25G - 0.50mm | 5/8" - 16mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2522R | Orange | 25G-0.50mm | 7/8" - 22mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2525R | Orange | 25G - 0.50mm | 1" - 25mm | Ultra Thin<br>Wall | Regular<br>Bevel |
| NN-2538R | Orange | 25G - 0.50mm | 1 ½" - 38mm | Regular<br>Wall | Regular<br>Bevel |
| NN-2613R | Brown | 26G - 0.45mm | ½" - 13mm | Regular<br>Wall | Regular<br>Bevel |
| NN-2713R | Gray | 27G - 0.40mm | ½" - 13mm | Regular<br>Wall | Regular<br>Bevel |
| NN-2732R | Gray | 27G - 0.40mm | 1 ¼" - 32mm | Regular<br>Wall | Regular<br>Bevel |
| NN-3025R | Yellow | 30G -0.30mm | 1" - 25mm | Regular<br>Wall | Regular<br>Bevel |
| NN-3013R | Yellow | 30G-0.30mm | ½" - 13mm | Regular<br>Wall | Regular<br>Bevel |

# D. SUBSTANTIAL EQUIVALENCE

The TERUMO® NEEDLE manufactured by Terumo Philippines Corporation is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the following cleared devices:

- 1. K001572 TERUMO® NEOLUS® Necdle manufactured by Terumo Europe, Leuven, Belgium
- 2. K771203 TERUMO® Hypodermic Needle manufactured by Tcrumo Medical Corporation, Elkton, Maryland
- K012646 (30G) TERUMO® Needle manufactured by Terumo Medical Corp, Elkton, MD mi

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### Intended Use

The TERUMO® Needle manufactured from Terumo (Philippines) Corporation and predicate devices cleared under K001572, K771203 and K012646 (30G) are hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

# Principles of Operation / Technology

The TERUMO® Needle manufactured by Terumo (Philippines) Corporation and the predicate devices cleared under K001572 manufactured by Terumo Europe N.V. Belgium, and K771573 and K012646 (30G) manufactured by Terumo Medical Corporation, USA are all operated manually.

## Design and Materials

The TERUMO® Needle manufactured by Terumo (Philippines) Corporation and the predicate devices cleared under K001572 manufactured by Terumo Europe N.V. Belgium, and K771573 and K012646 (30G) manufactured by Terumo Medical Corporation, USA are made up of stainless steel needle that is sharpened at one end and at the other end was attached to a plastic polypropylene hub by means of adhesive.

### Performance

The following performance tests were performed on the TERUMO® Needle manufactured by Terumo (Philippines) Corporation:

- . Protector Pit
- Adhesive Hold .
- Conical Fitting .
- . Seal Strength

None of the data raises any new issues on safety and effectiveness.

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### E. Additional Safety Information

Manufacturing controls include visual, functional and sterility tests.

The sterility of the device is assured using a sterilization method validated in accordance with ANSUAAMI/ISO 11137 - Medical Devices - Validation and Routine Control of Radiation Sterilization. The TERUMO® Needle is sterilized to provide a Sterility Assurance Level (SAL) of 10-5.

The TERUMO® Needle is classified as Externally Communicating Device, Circulating Blood. Limited Duration of Contact (≤24hr.). The device's 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". Results of the testing demonstrate that the blood contacting materials are biocompatible.

### F. Conclusion

In summary, the TERUMO® Needle manufactured by Terumo Philippines Corporation is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the following cleared devices:

- 1. K001572 TERUMO® NEOLUS® Needle manufactured by Terumo Europe, Leuven, Belgium
- 2. K771203 TERUMO® Hypodermic Needle manufactured by Terumo Medical Corporation, Elkton, Maryland
- 3. K012646 (30G) TERUMO® Needle manufactured by Terumo Medical Corporation, Elkton, Maryland

There is no significant change that raises any new issues on safety and effectiveness.

Terumo's statement of substantial equivalence 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.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

# Letter Date: November 8, 2012

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

Re: K121607

Trade/Device Name: Terumo® Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 2, 2012 Received: November 5, 2012

### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Digitally signed by Anthony D. Watson DN: c=US. o=U.S. Government ou=HiHS, ou= Anthony D. Watson eople, cn=Anthony D. Watson, 342.19200300.100.1.1=1300092402 2012.11.08 11:16:45 -05'00

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121607

Device Name: TERUMO® Needle

Indications for Use:

The TERUMO® Needle is a hypodermic single lumen needle intended to inject The TERUMO Necule is a nypousiness and the body below the surface of the skin.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

**510(k) Number:** K121607