SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS

K052887 · Terumo Europe N.V. · FPA · Dec 8, 2005 · General Hospital

Device Facts

• Record ID: K052887
• Device Name: SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
• Applicant: Terumo Europe N.V.
• Product Code: FPA · General Hospital
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

Device Story

Sterile, single-use winged infusion set; consists of needle, winged hub, 350 mm tubing, luer adapter, and hinged shield cover. Used by clinicians to access peripheral vascular system for fluid administration or blood withdrawal. After needle withdrawal, user manually rotates shield cover 180 degrees on hinge; shield latches over needle via one- or two-handed technique; audible click confirms activation. Transparent shield allows visual confirmation of needle containment; design keeps user fingers behind needle point to reduce accidental needle stick risk.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards. Sterilization validated per EN 550 and ISO 11135. Ethylene oxide residuals comply with ISO 10993-7 and European Pharmacopeia monograph 3.2.6.

Technological Characteristics

Sterile, single-use winged infusion set. Materials: blood-contacting components biocompatible per ISO 10993. Features 350 mm tubing and hinged, transparent plastic shield cover. Sterilization: Ethylene oxide (EtO) per EN 550/ISO 11135. Shelf life: 5 years.

Indications for Use

Indicated for patients requiring peripheral vascular access for intravenous fluid administration or blood specimen withdrawal. No specific age or gender restrictions noted.

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

• Surshield Safety Winged Infusion Set (K031266)

Submission Summary (Full Text)

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K05-2887

JEC: 8 2005

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

- l . Device Name
## Proprietary Name

SURFLO® Winged Infusion Set with Needle Protection (Surshield")

## 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 with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

- 4. Description
The Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-towing junction.

The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.

The device possesses 350 mm length tubing.

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### ર. Substantial Equivalence

The "Surflo Winged Infusion Set with Needle Protection (Surshield)", manufactured by Tcrumo 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 "Surshield Safety Winged Infusion Set", manufactured by Terumo Medical Products in Hangzhou, China, which is the subject of K031266.

#### Additional Safety Information 6.

The sterility of the Surflo Winged Infusion Set with Needle Protection (Surshield) 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 ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" and do not exceed the level proposed in the European Pharmacopeia monograph 3.2.6:

| Ethylene Oxide | ≤ 10 ppm |
|-----------------------|----------|
| Ethylene Chlorohydrin | ≤ 10 ppm |

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 with Needle Protection (Surshield) has been established at 5 years.

### 7. Conclusion

The Surflo Winged Infusion Set with Needle Protection (Surshield) manufactured by Tcrumo 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 Surshield Safety Winged Infusion Set manufactured by Terumo Medical Products in Hangzhou, China, which is the subject of K031266. Differences between the devices do not raise any new 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 and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the symbol.

2005 DEC 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. M.J. Aerts Manager Regulatory Affairs Terurmo Europe N.V. Researchpark Zone 2, Interleuvenlaan 40, 3001 Leuven BELGIUM

Re: K052887

K032867
Trade/Device Name: Surflo® Winged Infusion Set with Needle Protection (Surshield TM) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 7, 2005 Received: October 13, 2005

Dear Mrs. Aerts:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becares is ne the device is substantially equivalent (for the referenced above and have determined the as neves and the marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to thay 20, 1978, as a secondance with the provisions of Americallients, or to devices that nave ooch (Act) that do not require approval of a premarket the Federal Pood, Drug, and Oosmette : 100 (10) ...
approval application (PMA). You may, therefore, market the device, subject to the general approval application (x may). The general controls provisions of the Act include controls provisions of the Fet. "The genting 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 II your device is classified (500 a0010) into controls. Existing major regulations affecting (PMA), it may be subject to sach additions, Title 21, Parts 800 to 898. In your device can be found in the South vements 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 I Joast that FDA has made a determination that your device complies with other requirements moun that 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal title Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF read 807), equality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form moduct 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) I mis letter will and A your began finding of substantial equivalence of your device to a premaired predicate in - 11 - 11 - 11 - 11 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you democ 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Divisor [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

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# Indications for Use Statement

510(k) Number (if known): K052887

Device Name: Surflo® Winged Infusion Set with Needle Protection (Surshield™)

## Indications for Use:

The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

Prescription Use (Part 21 CFR 801 Subpart D)

MODELER CONSULTION CONSULTION CONSULTION THE THE THE THE THE THE FORMICITED ACCREASE CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION C

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)

William M. Burdick 12/8/65

Sincol Den i Bo

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