SURFLO WINGED INFUSION SET

K070362 · Terumo Europe N.V. · FPA · May 7, 2007 · General Hospital

Device Facts

• Record ID: K070362
• Device Name: SURFLO WINGED INFUSION SET
• Applicant: Terumo Europe N.V.
• Product Code: FPA · General Hospital
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a symng, luer adapter, or other compatible/appropriate devices.

Device Story

Sterile, single-use winged infusion set; consists of needle, winged hub, 300 mm tubing, adapter, and cap. Used to access peripheral vascular system for IV fluid administration or blood withdrawal via syringe or luer adapter. Operated by healthcare professionals in clinical settings. Provides physical conduit for fluid/blood transfer. Biocompatible materials; ethylene oxide sterilized.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per EN ISO 10993. Sterilization validated per EN 550 and ISO 11135.

Technological Characteristics

Sterile, single-use winged needle assembly with 300 mm tubing. Materials biocompatible per EN ISO 10993. Sterilization: Ethylene oxide (EtO) per EN 550, ISO 11135, and EN 556-1. EtO residuals compliant with ISO 10993-7.

Indications for Use

Indicated for accessing the peripheral vascular system for intravenous fluid administration or blood specimen withdrawal in patients requiring such access.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Surflo Winged Infusion Set (K891063)

Submission Summary (Full Text)

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K070362

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

- I . Device Name
## Proprietary Name

SURFLO® Winged Infusion Set

## Classification Name

Intravascular Administration Set (80FPA) 21CFR, Section 880.5440 Classification: Class II

- 2. Reason for Submission
New Device

- 3. Intended Use
The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a symng, luer adapter, or other compatible/appropriate devices.

- 4. Description
The Terumo Surflo Winged Infusion Set is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap.

The device possesses 300 mm length tubing.

#### 5. Substantial Equivalence

The "Surflo Winged Infusion Set", manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the cleared "Surflo Winged Infusion Set", manufactured by Terumo Medical Corporation, which is the subject of 1111553

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K070362

### 6. Additional Safety Information

The sterility of the Surflo Winged Infusion Set 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 104 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 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 EN ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing, Results of the testing demonstrate that the blood contacting materials are biocompatible.

The expiration dating for the Surflo Winged Infusion Set has been established at 5 years.

- 7. Conclusion
The Surflo Winged Infusion Set manufactured by Terumo Europe N.V. and submitted in this 510(k) file is substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance to the cleared "Surflo Winged Infusion Set'', manufactured by Terumo Medical Corporation, which is the subject of K891063.

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY - 2007

Re: K070362

Trade/Device Name: Surflo® Winged Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 31, 2007 Received: February 7, 2007

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 such additional controls. Existing major regulations affecting vour 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. 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 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.

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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K070362

# Indications for Use

510(k) Number (if known):

Device Name: Surflo® Winged Infusion Set

Indications for Use:

The Surflo Winged Infusion Set is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimans using a syringe, luer adapter, or other compatible/appropriate devices.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

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