TERUMO SURFLASH SAFETY I.V. CATHETER

• K Number: K122544
• Device Name: TERUMO SURFLASH SAFETY I.V. CATHETER
• Manufacturer: TERUMO Corporation
• Date Cleared: 2012-09-05 ( 15 days)
• Product Code: FOZ
• Regulation Number: 880.5200

Intended Use

The SURFLASH® 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 shaft cover and tip 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. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.

Device Description

The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin and catheter hub), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The devices are 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 (<30 days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. Whole length cannula including the sharp end of the inner needle is covered by the needle shielding mechanism as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. The grooved cannula which allows the clinician to visualize flashback detection through the groove indicating that there is confirmation of vessel entry is the same as the TERUMO® Surshield®-PUR Safety I.V. Catheter (K100282) and TERUMO® SURFLASH™ I.V. Catheter (K991406).

Predicate Devices

K100282, K991406, K971339, K923702

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design and safety features of a standard IV catheter, with no mention of AI or ML capabilities.

Therapeutic

No
The device is described as an I.V. catheter for administering fluids, withdrawing blood, or monitoring blood pressure. While these actions are part of medical treatment, the catheter itself is a delivery or access tool, not a device that directly performs a therapeutic action or treats a disease. Its primary function is to provide access to the vascular system, not to provide therapy.

Diagnostic

No

The device is used to withdraw blood samples, administer fluids, or monitor blood pressure. While these activities can be part of a diagnostic process, the device itself does not analyze data or provide a diagnosis; it is a tool for accessing the vascular system.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a catheter assembly, needle assembly, and a passive needle-shielding mechanism, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to insert the catheter into the patient's vascular system for withdrawing blood samples, administering fluids, or monitoring blood pressure. These are direct interactions with the patient's body for therapeutic or monitoring purposes.
• Device Description: The description details a physical device for accessing the vascular system.
• 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 diagnosis, monitoring, or screening. This device is used in vivo (inside the body) to access the vascular system.

The fact that it can be used to withdraw blood samples is a function of accessing the vascular system, not an in vitro diagnostic test performed on the blood sample itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

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

K12254"

5 2012 SEP

510(k) SUMMARY

Prepared by Sandi Hartka Manager Regulatory Affairs Terumo Medical Corporation Tel. [phone] Fax [phone]

Date prepared : August 1, 2012

Prepared for : Owner/Operator

TERUMO CORP. 44-1, 2-Chome, Hatagaya Shibuya-Ku, Tokyo, JAPAN 151-0072 Registration Number: 8010026

Manufacturer and Sterilization Facility

KOFU FACTORY OF TERUMO CORP. 1727-1, Tsuijiarai, Showa-Cho Nakakoma-Gun, Yamanashi, JAPAN 409-3853 Registration Number: 9681835

Contact Person

SANDI HARTKA Regulatory Affairs Manager TERUMO MEDICAL CORP. 950 Elkton, Blvd. Elkton, MD 21921 Phone: [phone] Ext Fax: [phone] [e-mail]

1

A. DEVICE NAME

Proprietary Name SURFLASH® Safety I.V. Catheter

Classification Name Intravascular Catheter

Intravascular Catheter (880.5200) Product Code: FOZ Panel: General Hospital . Classification: Class II

Common Name

Intravascular catheter with needle protection device

INTENDED USE B.

The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (