TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

K100282 · Terumo Corp. · FOZ · Feb 26, 2010 · General Hospital

Device Facts

• Record ID: K100282
• Device Name: TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
• Applicant: Terumo Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Feb 26, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The TERUMO Surshield-PUR Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. 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; slender, flexible, radio-opaque polyurethane; stainless steel cannula provides rigidity during insertion. Manual operation by clinician; cannula withdrawn after placement; passive safety mechanism covers sharp needle tip with steel guard to prevent needle stick injuries. Used for blood withdrawal, fluid administration, or blood pressure monitoring. Benefits include vascular access and reduced risk of accidental needle sticks for healthcare providers.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with consensus standards and design control requirements confirmed substantial equivalence to predicate devices.

Technological Characteristics

Polyurethane catheter; stainless steel cannula; passive needle-shield safety mechanism; radio-opaque; various gauges (18G-24G) and lengths (19mm-51mm); manual operation; sterile.

Indications for Use

Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling, intravenous fluid administration, or blood pressure monitoring, provided vascular anatomy is adequate and therapy is 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 Surflash I.V. Catheter (K991406)
• TERUMO Hybria Closed System Safety I.V. Catheter (K082997)
• TERUMO Surshield Safety I.V. Catheter (K082362)
• TERUMO Surshield Safety I.V. Catheter (K090973)

Submission Summary (Full Text)

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K100282

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### Section II: 510(k) Summary FEB 2 6 2010

Page

| A. | Device Name | 16 |
|----|----------------------------------------------------------------------------------------|----|
| B. | Predicate Device | 16 |
| C. | Intended Use | 17 |
| D. | Description | 17 |
| E. | Principle of Operation / Technology | 17 |
| F. | Design / Materials | 17 |
| G. | Specifications | 18 |
| H. | Performance | 18 |
| I. | Substantial Equivalence | 18 |
| J. | Submitter Information | 19 |
| | List of Tables | |
| | Table II-1: Device Specifications for the<br>TERUMO Surshield-PUR Safety I.V. Catheter | 18 |

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#### Device Name A.

## Proprietary Name

TERUMO Surshield-PUR Safety I.V. Catheter

## Classification Name

Intravascular Catheter (880.5200)

Panel & Product Code: 80FOZ

Classification: Class II

## Common Name

Intravascular catheter with needle protection device

#### B. Predicate Device

The TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent with respect to intended use, safety mechanism, design, materials, manufacturing, sterilization, technology/principles of operation, and performance to the following:

Polyurethane catheter material

-K991406 TERUMO Surflash I.V. Catheter

AND

-K082997 TERUMO Hybria Closed System Safety I.V. Catheter

## Ethylene Terafluoro Ethylene catheter material

-K082362 TERUMO Surshield Safety I.V. Catheter

AND

¹ A statement of substantially equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used a evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits' 42 Fed. Reg. 42,520, et seq. (1977)

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-K090973 TERUMO Surshield Safety I.V. Catheter (51mm catheter

length)

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

#### C. Intended Use

The TERUMO Surshield-PUR Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. 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.

#### Description D.

The TERUMO Surshield-PUR Safety I.V. Catheters are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. 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 the catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

#### Principle of Operation / Technology IC.

The TERUMO Surshield-PUR Safety I.V. Catheter is operated manually.

#### Design / Materials F.

The design of the TERUMO Surshield-PUR Safety I.V. Catheter and the materials used to manufacture the TERUMO Surshield-PUR Safety I.V. Catheter are identical to the currently marketed TERUMO Surshield Safety I.V. Catheter (K082362 and K090973) except for the catheter portion. Polyurethane is the catheter material used in the manufacture of the currently marketed TERUMO Surflash I.V. Catheter (K991406) and TERUMO Hybria Closed System Safety I.V. Catheter (K082997). The catheter gauge,

11:14

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length and diameter ranges are all within the range of the currently marketed predicate devices.

#### G. Specifications

| TABLE II-1: Device Specifications for TERUMO Surshield -PUR Safety I.V. Catheter | | | | | | |
|----------------------------------------------------------------------------------|-------------------|------------|-----------------|-----------------------|-----------|------------------|
| Product code | Catheter<br>gauge | Color code | Catheter length | Catheter<br>O.D*(I.D) | Flow rate | Lumen<br>volume* |
| SR*SFF1832A | 18G | Deep Green | 1-1/4""(32mm) | 1.3 (0.95) mm | 100mL/min | 23µL |
| SR*SFF1851A | 18G | Deep Green | 2"(51mm) | 1.3 (0.95) mm | 90mL/min | 36µL |
| SR*SFF2025A | 20G | Pink | 1""(25mm) | 1.1(0.80)mm | 65mL/min | 13µL |
| SR*SFF2032A | 20G | Pink | 1-1/4""(32mm) | 1.1(0.80)mm | 60mL/min | 16µL |
| SR*SFF2051A | 20G | Pink | 2"(51mm) | 1.1(0.80)mm | 55mL/min | 26µL |
| SR*SFF2225A | 22G | Deep blue | 1""(25mm) | 0.9(0.60)mm | 35mL/min | 7µL |
| SR*SFF2232A | 22G | Deep blue | 1-1/4""(32mm) | 0.9 (0.60)mm | 30mL/min | 9µL |
| SR*SFF2419A | 24G | Yellow | 3/4"(19mm) | 0.7(0.47)mm | 15mL/min | 3µL |

Product code numbers and specifications are provided in Table II-1.

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

#### ਜ਼. Performance

Performance testing was conducted in accordance with the consensus standards and design control requirements. All performance testing conducted on the TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate devices.

#### Substantial Equivalence I.

The TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation is substantially equivalent with respect to intended use, safety mechanism, design, materials, manufacturing, sterilization, technology/principles of operation, and performance to the following predicate devices:

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## Polyurethane catheter material

-K991406 TERUMO Surflash I.V. Catheter

AND

.

. .

ું

-K082997 TERUMO Hybria Closed System Safety I.V. Catheter

Ethylene Tetrafluoro Ethylene catheter material

-K082362 TERUMO Surshield Safety I.V. Catheter

AND

-K090973 TERUMO Surshield Safety I.V. Catheter (51mm catheter length)

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

> Phone: [phone] Fax: [phone]

#### Submitter Information J.

01/28/2010 Date Prepared:

Christina Flanagan Prepared by: Regulatory Affairs Specialist ﻨﺪ Terumo Medical Corporation . 950 Elkton Boulevard .' ··· Elkton, MD 21921

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

# MAR 2 2 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Terumo Corporation C/O Ms. Christina Flanagan Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921

Re: K100282

Trade/Device Name: TERUMO® Surshield® -PUR SAFETY I.V. CATHETER Regulation Number: 211CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 28, 2010 Received: February 01, 2010

Dear Ms. Flanagan:

This letter corrects our substantially equivalent letter of February 26, 2010.

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 (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.

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Page 2- Ms. Flanagan

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthsiology, 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®-PUR SAFETY I.V. CATHETER

Indications For Use:

The TERUMO® Surshield®-PUR 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 monitor blood pressure by attaching a monitoring line. 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)

Charles R. Bogle

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

510(k) Number. k100282

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