MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE

K063613 · Terumo Medical Corp. · FMF · Dec 26, 2006 · General Hospital

Device Facts

• Record ID: K063613
• Device Name: MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
• Applicant: Terumo Medical Corp.
• Product Code: FMF · General Hospital
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Device Story

Manual piston syringe; 30cc and 60cc capacities; consists of polypropylene barrel, plunger, and thermoplastic elastomer gasket. Used by clinicians to inject or withdraw fluids. Manually operated; no electronic components or software. Single-use; sterile; electron beam sterilized. Provides clear graduations for volume measurement.

Clinical Evidence

Bench testing only. Testing included leakage (aspiration/injection), plunger mobility, tip-hub fitting, gasket fit, nominal graduation capacity, plunger stopper strength, dead space, and conical fitting. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Polypropylene barrel; thermoplastic elastomer gasket. Manual piston operation. Available in 30cc and 60cc sizes with luer slip, luer lock, eccentric luer, or catheter tip configurations. Sterilized via electron beam to SAL 10^-6 per ISO 11137-1995.

Indications for Use

Indicated for medical purposes to inject fluids into or withdraw fluids from the body. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

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.

Predicate Devices

• Terumo Syringe with/without needle (K023271)
• Terumo Syringe with/without needle (K051864)
• Terumo Syringe with/without needle (K052034)

Submission Summary (Full Text)

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KO63613

Section II. 510 (k) Summary and Certification Terumo® Syringe with/without needle Terumo (Philippines) Corporation

DEC 2 6 2006

# 510k Summary

# Device Name

Proprietary Name: TERUMO® Syringe without Needle

Classification Name: Syringe, Piston with or without hypodermic single lumen needle

Common Name: Hypodermic Syringe with/without needle

## Intended Use

The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

# Note: This is the same intended use as the predicate device, Terumo Syringe with/without needle cleared under K023271 and K051864.

## Device Description

The Terumo 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material. The syringes are individually packed in a peel blister that ensures the sterility of the device until the package is opened. The product is sterilized by electron beam sterilization. The product is for single use only and is not intended for reuse.

#### Principles of Operation/Technology

The 30 and 60cc/mL Terumo Syringes without needle are manually operated.

# Materials

The materials used in the 30 and 60cc/mL Terumo Syringes without needle are substantially equivalent to the materials used in the predicate Terumo Syringe with/without needle devices cleared under K023271 and K052034.

#### Specifications

| PRODUCT DESCRIPTION |
|--------------------------------|
| 30cc/ml luer slip syringe |
| 30cc/ml luer lock syringe |
| 30cc/ml eccentric luer syringe |
| 60cc/ml luer lock syringe |
| 60cc/ml eccentric luer syringe |
| 60cc/ml catheter tip syringe |

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Section II. 510 (k) Summary and Certification Terumo® Syringe with/without needle Terumo (Philippines) Corporation

# Performance

The Terumo Syringe without needle, 30 and 60cc/mL submitted in this premarket notification was subjected to the following tests:

- Leakage (Aspiration and Injection) ●
- Plunger Mobility .
- Tip-hub fitting �
- . Gasket fit
- Nominal graduation capacity .
- Plunger stopper strength .
- Dead Space .
- Conical fitting .

# Substantial Equivalence

The 30 and 60cc/mL Terumo Syringes without needle are substantially equivalent in intended use, materials, design, technology and principles of operation and performance to cleared Terumo Syringes with/without needle cleared under K023271 and K052034. Any differences raise no new issues of safety and effectiveness.

# Additional Safety Information

Manufacturing controls included visual, functional, dimensional and sterility tests.

The Terumo Syringe without needle 30 and 60cc/mL are classified as an Externally Communicating Device, Limited contact. 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 10993-1' "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible.

Sterilization conditions have been validated in accordance with ISO 11137-1995, Medical Devices - Validation and Routine control of Radiation Sterilization. The device is sterilized to a SAL of 10 -6 .

# Submitter Information

| Prepared by: | Barbara Smith<br>Sr. Regulatory Affairs Specialist<br>Terumo Medical Corporation<br>950 Elkton Boulevard<br>Elkton, Maryland 21921 |
|---------------|------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Terumo (Philippines) Corporation<br>#124 East Main Ave., Laguna Technopark |

Biñan, Laguna, Philippines 4026

December 4, 2006 Date Prepared:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K063613

Trade/Device Name: TERUMO Syringe with/without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 4, 2006 Received: December 12, 2006

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.

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

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, 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): _

_TERUMO® Syringe with/without Needle_ Device Name:

Indications For Use:

The Terumo syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

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

Over-The-Counter Use (21 CFR 807 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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