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

• K Number: K090973
• Device Name: TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
• Manufacturer: TERUMO CORP.
• Date Cleared: 2009-05-01 ( 25 days)
• Product Code: FOZ
• Regulation Number: 880.5200

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 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 The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries.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.

Predicate Devices

K082362

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design and function of a safety IV catheter, with no mention of AI or ML capabilities. The safety mechanism is described as passive.

Therapeutic

No
The device is described as an I.V. catheter used for withdrawing blood samples, administering fluids, or placing monitoring equipment, which are diagnostic or supportive functions rather than direct therapeutic interventions to treat a disease.

Diagnostic

No

The device is an I.V. catheter used for administering fluids, withdrawing blood samples, or placing monitoring equipment. While it can be used to withdraw blood samples which might then be used for diagnostic purposes, the catheter itself does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like a catheter, hub, cannula, and steel guard, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for insertion into the patient's vascular system for withdrawing blood samples, administering fluids, or placing monitoring equipment. These are all procedures performed on the patient, not on samples outside the body for diagnostic purposes.
• Device Description: The description details a catheter and needle system for accessing the vascular system. This aligns with the intended use and does not describe a device used to analyze biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.

IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) is inserted into the patient's vascular system for short term (

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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.

1

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 (

: 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