50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB

K070264 · Terumo Europe N.V. · FMF · May 29, 2007 · General Hospital

Device Facts

• Record ID: K070264
• Device Name: 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
• Applicant: Terumo Europe N.V.
• Product Code: FMF · General Hospital
• Decision Date: May 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.

Device Story

Single-use, sterile hypodermic piston syringe; 50 ml capacity with scale extension to 60 ml; 6% luer lock tip. Barrel features opaque coloring to block UV light transmission, protecting UV-sensitive medications during administration. Operated manually or via power-driven syringe pumps in clinical settings. Provides a delivery mechanism for fluids/blood; opaque barrel prevents drug degradation from light exposure. Benefits patients by maintaining integrity of light-sensitive therapeutic agents.

Clinical Evidence

Bench testing only. Device tested per EN ISO 7886-1 (1997) and EN ISO 7886-2 (1997). Additional testing performed on barrel light transmission and UV protection efficacy. Biocompatibility of blood-contacting materials confirmed per ISO 10993.

Technological Characteristics

Piston syringe; plastic barrel with synthetic rubber gasket; 6% luer lock tip. Opaque barrel material for UV light blocking. Sterilized via ethylene oxide (EtO) per EN 550/ISO 11135. Biocompatible materials per ISO 10993. 5-year shelf life.

Indications for Use

Indicated for patients requiring aspiration of fluids/blood or injection of fluids via hypodermic syringe, specifically for administration of UV-sensitive medications. Suitable for manual use or with power-driven syringe pumps.

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 for Administration of UV Sensitive Medicines (K053413)
• 60 mL BD syringe with BD Luer-Lok tip (K980987)

Submission Summary (Full Text)

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K070264

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

- 1. Device Name
## MAY 2 9 2007

## Proprietary Name

50 ml Terumo Syringe for Administration of UV Sensitive Medicines

## Classification Name

Piston Syringe (80FMF) 21CFR, Section 880.5860 Classification: Class II

#### 2. Reason for Submission

New device

#### 3. Intended Use

The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines are hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.

#### 4. Description

The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines is a hypodermic standard piston syringe for single use, with a 6 % luer lock tip, made of plastic material and a synthetic rubber gasket. The barrel of the syringes has an opaque color to avoid the transmission of UV light. The 6% luer lock tip allows the use with power driven syringe pumps.

#### న్. Performance

The 50 ml Terumo Syringe was tested in accordance with EN ISO 7886-1 (1997) and EN ISO 7886-2 (1997). Other testing included barrel transmission and UV protection of the opaque barrel.

### 6. Substantial Equivalence

The 50 ml (with scale extension up to 60 ml) Terumo Syringe for administration of UV sensitive medicines is substantially equivalent in intended use, design, technology/principals of operation, materials and performance to the following cleared devices:

- Terumo Syringe for Administration of UV Sensitive Medicines, manufactured by 1. Terumo Europe N.V. (K053413)
- 60 mL BD syringe with BD Luer-Lok tip, manufactured by Becton Dickinson & 2. Company (Note: we presume that this syringe is covered by the 510(k) number K980987, but we were unable to verify this based on the published resources)

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KU70a64

#### 6. Additional Safety Information

The sterility of the 50 ml Terumo Syringe for Administration of UV Sensitive Medicines 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" 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 resulting from EtO sterilization are in compliance with EN ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"

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 testine". Results of the testing demonstrate that the blood contacting materials are biocompatible.

The expiration dating for the 50 ml Terumo Syringe for Administration of UV Sensitive Medicines has been established at 5 years.

#### 7. Conclusion

In summary, the 50 ml (with scale extension up to 60 ml) Terumo Syringe for Administration of UV Sensitive Medicines are substantially equivalent in intended use, design, technology/principals of operation, materials and performance to the following cleared devices:

- Terumo Syringe for Administration of UV Sensitive Medicines, manufactured by 1. Terumo Europe N.V. (K053413)
- 2. 60 mL BD syringe with BD Luer-Lock tip, manufactured by Becton Dickinson & Company (Note: we presume that this syringe is covered by the 510(k) number K980987, but we were unable to verify this based on the published resources)

Differences between the devices do not raise any new or different issues of safety or effectiveness.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2007

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

Re: K070264

Trade/Device Name: 50 ml Terumo® Syringe for Administration of UV Sensitive Medicines Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 21, 2007 Received: May 23, 2007

Dear Mrs. Acrts:

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 - Mrs. Aerts

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 CIFR 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 vours,

Chris Lins, Ph.D.

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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K070264

# Indications for Use

510(k) Number (if known):

Device Name: 50 ml Terumo® Syringe for administration of UV sensitive medicines

## Indications for Use:

The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. m

ா Sign-Off) on of Anesthesiology, General Hospital, Control, Dental Devices

(k) Number _______________________________________________________________________________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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