TERUMO SYRINGE WITH/WITHOUT NEEDLE

K083514 · Terumo Europe N.V. · FMF · May 22, 2009 · General Hospital

Device Facts

• Record ID: K083514
• Device Name: TERUMO SYRINGE WITH/WITHOUT NEEDLE
• Applicant: Terumo Europe N.V.
• Product Code: FMF · General Hospital
• Decision Date: May 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.

Device Story

Manual hypodermic piston syringe; used for aspiration of fluids/blood or injection of fluids. Available in 1, 2, 5, 10, and 50 ml volumes; includes luer taper tip. Needle gauges 20-26G; lengths 12-40 mm. Operated manually by clinicians or patients. Device provides fluid delivery/collection mechanism; no electronic or automated components. Benefits include sterile, single-use fluid management.

Clinical Evidence

Bench testing only. Device tested for performance per EN ISO 7886-1 (1993). Biocompatibility testing performed per EN ISO 10993-1. Hemocompatibility testing performed per EN ISO 10993-4 (2002/2006). Sterilization validated per EN 550/ISO 11135.

Technological Characteristics

Plastic piston syringe with synthetic rubber gasket; stainless steel needle. Sizes: 1, 2, 5, 10, 50 ml. Luer taper tip. Sterilization: Ethylene oxide (EtO) per EN 550/ISO 11135. Biocompatibility per EN ISO 10993-1. Hemocompatibility per EN ISO 10993-4.

Indications for Use

Indicated for single-use aspiration of fluids and blood, or injection of fluids immediately after filling. No specific patient population or contraindications 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, K052034, K063613)
• 50 ml Terumo Syringe for administration of UV sensitive medicines (K070264)

Reference Devices

• Neolus Needles (K001572)

Submission Summary (Full Text)

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K083514

ﺎﻟﻔ

# 510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information

### Submitter Information

| Prepared for: | TERUMO EUROPE N.V.<br>Researchpark Zone 2,<br>Interleuyenlaan 40,<br>3001 Leuven,<br>BELGIUM |
|----------------|-------------------------------------------------------------------------------------------------|
| Prepared by: | Mrs. M.J. Aerts – Manager Regulatory Affairs<br>Tel. [phone]<br>Fax [phone] |
| Date prepared: | November 2008 |

- 1. Device Name
## Proprietary Name

Terumo® Syringe with/without Needle

## Classification Name

Piston syringe (80FMF)

21CFR, Section 880.5860

Classification: Class II

### Common Name

Sterile hypodermic syringe with/without needle

### 2. Reason for Submission New Device

#### 3. Intended Use

The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.

#### 4. Description & Materials

The Terumo Syringe with/without needle is a hypodermic standard piston syringe, available in volumes from 1 ml, 2 ml, 10 ml and 50 ml, with a luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The needle is made from stainless steel.

| Syringe sizes | Needle gauges | Exposed needle lengths |
|-------------------------------------------------------|---------------|-------------------------------|
| 1, 2 (including special<br>graduations), 5, 10, 50 ml | 20 - 26G | 12 mm (1/2") - 40 mm (1 1/2") |

**MAY 22 2009**

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#### 5. Technology/Principles of operation

The Terumo Syringe with/without needle is operated manually.

#### 6. Performance

ﻟﻨﻘ

The Terumo syringe with/without needle was tested in accordance with EN ISO 7886-1 (1993).

For the needle properties, reference is made to the cleared Neolus Needles compared to in the submitted file K001572. In accordance with the new requirements stipulated in EN ISO 10993-4 (2002) and its amendment (2006) the hypodermic needles were also subjected to additional hemocompatibility testing. A declaration for compliance with the requirements of these tests can be found on page 177.

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

#### 7. Substantial Equivalence

The "Terumo Syringe with/without Needle", manufactured by Terumo Europe N.V., is submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following devices:

- 1. Terumo Syringe with/without needle", manufactured by Terumo (Philippines) Corporation (K023271, K052034, K063613).
- 2. 50 ml Terumo Syringe for administration of UV sensitive medicines, manufactured by Terumo Europe N.V. (K070264)

Any differences raise no new issues of safety and effectiveness.

#### 8. Additional Safety Information

The sterility of the Terumo Syringe with/without needle is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide sterilization" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 10 as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices".

Ethylene oxide residual levels and Ethylene Chlorohydrin residual levels resulting from EtO sterilization are in compliance with ISO 10993-7: "Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals".

The device is tested for biocompatibility requirements in accordance with the tests stipulated in EN ISO 10993-1, "Biological Evaluation of Medical Devices. Part-1: Evaluation and testing." The results of the testing demonstrate that the device is biocompatible.

The expiration dating for the Terumo Syringe with/without needle has been established at 5 years.

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### III. DRAFT LABELLING

- Blister paper unit packaging III.1.
- Ш.2. Unit box

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- Label unit box Ш.3.
- III 4.
III 5.
- Shipping carton
Label shipping carton

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Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. M.J. Aerts Regulatory Affairs Manager Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 LEUVEN - BELGIE BELGIUM

MAY 2 2 2009

Re: K083514

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: May 7, 2009 Received: May 11, 2009

Dear Ms. Aerts:

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 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.

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

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Page 2- Ms. Aerts

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Susan Penner

Susan Runner, D.D.S., MA Acting 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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# Indication for Use

510(k) Number (if known):

Device Name: Terumo® Syringe with/without needle

Indication For Use:

The Terumo Syringe with/without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling.

Prescription Use x (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)***_*****_** and the other side is the signature

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

510(k) Number:

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