TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)

K090973 · Terumo Corp. · FOZ · May 1, 2009 · General Hospital

Device Facts

• Record ID: K090973
• Device Name: TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
• Applicant: Terumo Corp.
• Product Code: FOZ · General Hospital
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm and 20G × 51mm catheter sizes) 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 hub; stainless steel cannula provides rigidity during insertion. Manual operation by clinician; cannula withdrawn after placement. Passive safety mechanism: sharp end of inner needle automatically covered by steel guard upon withdrawal to prevent needle stick injuries. Used for blood sampling, fluid administration, or monitoring equipment placement. Benefits include reduced risk of accidental needle sticks for healthcare providers.

Clinical Evidence

Bench testing only. Performance testing adhered to design control requirements and standards to confirm substantial equivalence to the predicate device.

Technological Characteristics

Peripheral over-the-needle catheter; radio-opaque plastic; stainless steel cannula. Passive needle safety guard. Manual operation. 18G and 20G gauges; 51mm length. No software or electronic components.

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, provided vascular anatomy and therapy duration are appropriate.

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® Surshield® SAFETY I.V. CATHETER (K082362)

Submission Summary (Full Text)

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Koromb

Terumo Corporation SPECIAL 510(K) - TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

MAY - 1 2009

# Section II. 510(k) SUMMARY

### A. Device Name

## Proprietary Name

TERUMO® Surshield® SAFETY I.V. CATHETER (51mm 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 (51mm catheter) manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance:

- K082362 TERUMO® Surshield® SAFETY I.V. CATHETER .
The differences between the devices do not raise any new issues of safety or effectiveness.

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Terumo Corporation

SPECIAL 510(K) - TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

### C. Intended Use

The TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter length) 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 (51mm catheter length) are devices consisting of an over-the needle, peripheral catheter made of 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 (51mm catheter length) is operated manually.

### Design / Materials F.

.

- 1. The materials are the same materials as used in the TERUMO® Surshield® SAFETY I.V. CATHETER (K082362).

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Terumo Corporation SPECIAL 510(K) - TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

### 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*SFA1851A | 18G | Deep Green | 2"(51mm) | 1.3mm | 0.95mm | 20G | 90mL/min | 36 $\mu$ L |
| SR*SFA2051A | 20G | Pink | 2"(51mm) | 1.1mm | 0.80mm | 22G | 55mL/min | 26 $\mu$ L |

*Catheter O.D. is fabeled value. ** Catheter only

#### H. Performance

The testing was conducted in order to adhere to the performance standards and design control requirements. All pcrformance testing conducted on the TERUMO® Surshield® SAFETY IV CATHETER (51mm sizes length) manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate.

#### I. Substantial Equivalence

The TERUMO® Surshield® SAFETY I.V. CATHETER (51mm length catheter) manufactured by Terumo Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, safety feature, manufacturing process, materials and performance:

- K082362 TERUMO® Surshield® SAFETY I.V. Catheter .
The differences between the devices do not raise any new issues of safety or effectiveness.

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Terumo Corporation SPECIAL 510(K) -- TERUMO® Surshicld® Safety I.V. Catheter (51mm catheter length) Section II. 510(k) Summary

### K. Submitter Information

.

Date Prepared: 03/01/2009

Lynne Witkowski Prepared by: Sr. 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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Terumo Corporation C/o Ms. Lynne Witkowski Terumo Medical Corporation 125 Blue Ball Road Elkton, Maryland 21921

Re: K090973

Trade/Device Name: TERUMO®Surshield®Safety I.V. Catheter (18G x 51mm & 20G x 51mm sizes)

Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 3, 2009 Received: April 6, 2009

Dear Ms. Witkowski:

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2- Ms. Witkowski

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 vours,

Susan Rose

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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## Indications for Use

510(k) Number (if known): _

Device Name: TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm & 20G × 51mm sizes)

Indications For Use:

The TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm and 20G × 51mm catheter sizes) 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.

Prescription Use (Part 21 CFR 801 Subpart D)

.

AND/OR

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

: ØGØØ5

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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signature

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

510(k) Number: K030973