SURSHIELD SAFETY I.V. CATHETER

K082362 · Terumo Medical Corp. · FOZ · Sep 17, 2008 · General Hospital

Device Facts

• Record ID: K082362
• Device Name: SURSHIELD SAFETY I.V. CATHETER
• Applicant: Terumo Medical Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Device Story

Peripheral over-the-needle catheter; flexible radio-opaque plastic catheter with stainless steel cannula. Manual operation by clinician. Cannula maintains rigidity during insertion; withdrawn after placement. Passive safety mechanism: steel guard covers sharp needle tip upon withdrawal to prevent needle stick injuries. Used for blood withdrawal, fluid administration, or monitoring equipment placement. Benefits patient by providing vascular access while reducing risk of clinician needle stick injury.

Clinical Evidence

Bench testing only. Tests included reactive force to close shutter, force to detach safety cover, initial sliding friction, tensile strength of safety cover/needle, puncture resistance of needle shield, and flow rate. Sterilization validated per ISO 11135-2007.

Technological Characteristics

Peripheral catheter; radio-opaque plastic. Stainless steel cannula. Passive safety needle shield. Sterilized via ethylene oxide (ISO 11135-2007). Biocompatibility per ISO 10993-7. Manual operation; no software or electronics.

Indications for Use

Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling, intravenous fluid administration, or placement of monitoring equipment. Contraindicated based on inadequate vascular anatomy or inappropriate solution/therapy duration.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• TERUMO® SURFLO® I.V. Catheter (K891087)
• TERUMO® SURFLASH® I.V. Catheter (K991406)
• B.BRAUN Introcan Safety™ I.V. Catheter (K020785)

Submission Summary (Full Text)

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SEP 1 7 2008

K082362 (P. 1 of 4)

# Section II. 510(k) SUMMARY

#### A. Device Name

# Proprietary Name

TERUMO® Surshield® SAFETY I.V. CATHETER or similar proprietary name

# Classification Name

Intravascular Catheter (880.5200) Panel & Product Code: FOZ Classification: Class II

# Common Name

Intravascular catheter with needle protection device

## B. Predicate Device

The TERUMO® Surshield® SAFETY I.V. CATHETER manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance:

- 1. K891087 TERUMO® SURFLO® I.V. Catheter for the catheter portion only
- 2. K991406 TERUMO® SURFLASH® I.V. Catheter for the needle portion only
- 3. K020785 B.BRAUN Introcan Safety" I.V. Catheter

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

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K 482362 (P. 2 of 4)

#### C. Intended Use

The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

#### D. Description

The TERUMO® Surshield® Safety I.V. Catheter are devices consisting of an over-the needle, peripheral catheter made of an a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

#### E. Principle of Operation / Technology

The TERUMO® Surshield® SAFETY IV CATHETER is operated manually.

#### Design / Materials F.

The materials are the same materials as used in the TERUMO® SURFLO® I.V. Catheter (K891087) and the TERUMO® SURFLASH® I.V. Catheter (K991406).

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Terumo Corporation TERUMO® Surshield® SAFETY I.V. CATHETER II. 510(k) Summary

K482362 (P.3 of 4)

### G Specifications

| Product code | Catheter<br>gauge | Color code | Catheter<br>length | Catheter<br>O.D | Catheter<br>I.D | Cannula<br>gauge | Flow rate | Lumen<br>volume* |
|--------------|-------------------|------------|--------------------|-----------------|-----------------|------------------|-----------|------------------|
| SR*SFA1832A | 18G | Deep Green | 1-1/4"(32mm) | 1.3mm | 0.95mm | 20G | 100mL/min | 23 µL |
| SR*SFA2032A | 20G | Pink | 1-1/4"(32mm) | 1.1mm | 0.80mm | 22G | 60mL/min | 16 µL |
| SR*SFA2225A | 22G | Deep Blue | 1"(25mm) | 0.9mm | 0.60mm | 24G | 35mL/min | 7 µL |
| SR*SFA2419A | 24G | Yellow | 3/4"(19mm) | 0.7mm | 0.47mm | 27G | 15mL/min | 3 µL |

*Catheter only

#### H. Performance

The following tests were performed on the TERUMO® Surshield® SAFETY IV CATHETER manufactured by Terumo Corporation:

- 1. Reactive force to close shutter (Reaction force generated by the safety mechanism)
- 2. Force to detach safety cover from catheter hub (Force to activate safety feature)
- 3. Initial sliding friction (Catheter and Needle attachment)
- 4. Tensile strength of safety cover and needle (Break strength of safety mechanism)
- 5. Force to needle breaking safety cover (Puncture resistance of the needle shield)
- 6. Flow rate

#### I. Additional Safety Information

The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135-2007. The Surshield® Safety IV Catheter is sterilized to provide a Sterility Assurance Level (SAL) of 10-6.

Ethylene oxide residual levels (EtO and ECH) resulting from EtO sterilization will not exceed the maximum residue limits in accordance with ISO 10993-7: Biological Evaluation of Medical Devices -- Part 7: Ethylene Oxide Sterilization Residuals and AAMI TIR19 Guidance for ANSI / AAMI / ISO 10993-7:1995, Biological Evaluation for Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (and amendment).

The addition of the safety devices requires no additional biocompatibility testing, because there is no blood/fluid contact.

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Terumo Corporation TERUMO® Surshield® SAFETY I.V. CATHETER II. 510(k) Summary

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### J. Substantial Equivalence

The TERUMO® Surshield® SAFETY I.V. CATHETER manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance:

- 1. K891087 TERUMO® SURFLO® I.V. Catheter for the catheter portion only
- 2. K991406 TERUMO® SURFLASH® I.V. Catheter for the needle portion only
- 3. K020785 B.BRAUN Introcan Safety™ I.V. Catheter

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

## K. Submitter Information

Date Prepared: 08/06/2008

Prepared by: Eileen Dorsey Regulatory Affairs Specialist Terumo Medical Corporation 950 Blue Ball Road Elkton, MD 21921 Phone: [phone] Fax: [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 a stylized representation of a human figure embracing another person, symbolizing care and protection.

SEP 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corporation C/O Mr. Mark Job Responsible Third Party Officer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K082362

Trade/Device Name: TERUMO® Surshield® SAFETY I.V. CATHETER Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 3, 2008 Received: September 4, 2008

Dear Mr. Job:

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 Eederal Register.

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Page 2 – Mr. Job

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 clectronic 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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): K432362

TERUMO® Surshield® SAFETY I.V. CATHETER Device Name:

Indications For Use:

The TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

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)

Artur Lem

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

510(k) Number: _