SURSHIELD SAFETY I.V. CATHETER

• K Number: K082362
• Device Name: SURSHIELD SAFETY I.V. CATHETER
• Manufacturer: TERUMO MEDICAL CORP.
• Date Cleared: 2008-09-17 ( 30 days)
• Product Code: FOZ
• Regulation Number: 880.5200

Intended 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.

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 The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries.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

Predicate Devices

K891087, K991406, K020785

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical aspects of an IV catheter and its safety mechanism, with no mention of AI or ML.

Therapeutic

Yes
The device is used to administer fluids intravenously, which is a therapeutic function.

Diagnostic

No

The device is an I.V. catheter used for administering fluids, withdrawing blood samples, or placing monitoring equipment, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical medical device (catheter, needle, hub, safety mechanism) and the performance studies focus on physical properties and functionality, not software performance.

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 purposes like withdrawing blood samples, administering fluids, or placing monitoring equipment. These are direct interactions with the patient's body for therapeutic or monitoring purposes.
• Device Description: The description details a physical device (catheter and needle) designed for insertion into the body.
• Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or testing of specimens outside the body.

The device is a medical device used in vivo (within the body) for accessing the vascular system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TERUMO® Surshield® SAFETY I.V. CATHETER 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

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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.

1

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 (