Summary of Safety and Clinical Performance

Important Information

This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to an updated summary of the main aspects of the safety and clinical performance of the device. The information presented below is intended for patients or lay persons. A more extensive summary of safety and clinical performance prepared for healthcare professionals is found in the first part of this document.

The SSCP is not intended to give general advice on the treatment of a medical condition. Please contact your healthcare professional in case you have questions about your medical condition or about the use of the device in your situation. This SSCP is not intended to replace an Implant Card or the Instructions for Use to provide information on the safe use of the device.

1. Device Identification and General Information

Device Trade Name(s): Vascu-Line® Central Venous Catheters

Manufacturer Name and Address: Medical Components, Inc. 1499 Delp Drive Harleysville, PA 19438 USA

Basic UDI-DI: 00884908291NG

Date First CE Certificate Was Issued for This Device: Vascu-Line® - August 2012

Device Grouping and Variants

This document talks about central venous catheter [tube] (CVC) sets. They help in medical treatment and come in different types. They are often given to doctors in packages that have everything they need for the procedure. These packages can be set up in different ways depending on the needs of the patient.

Variant Devices:

Procedure Trays:

Configurations of Procedure Trays:

2. Intended Use of the Device

Intended Purpose: The Vascu-Line® Central Venous Catheters are for use in adult patients requiring frequent needlesticks for whom short-term or long-term access to the central venous system without the need for many needlesticks is deemed necessary based on the direction of a qualified, licensed physician. The device is intended to be used under the regular review and assessment of qualified health professionals.

Indication(s): The Vascu-Line® Central Venous Catheter is indicated for short-term or long-term access to the central venous system for intravenous administration of fluids or medications.

Intended Patient Group(s): Vascu-Line® Central Venous Catheters are intended for use in adult patients who need frequent needlesticks for whom short-term or long-term access to the central venous system without the need for many needlesticks is necessary based on the direction of a qualified, licensed physician. The device is not for use in pediatric patients.

Contraindications and/or Limitations:

• The presence of device related infection is known or suspected.
• This catheter is for short- or long-term vascular access and should not be used for any purpose other than indicated in these instructions.
• The patient is known or is suspected to be allergic to materials contained in the device.

3. Device Description

Device Name: Vascu-Line® Central Venous Catheters

Description of Device: The Vascu-Line® Central Venous Catheters are made from special materials that are safe for the body and come in different sizes to fit the patient's needs. They are packaged with tools that the doctor needs to use them. The percentage ranges below are based on catheter weights. The 3F Single Lumen Vascu-Line® weighs 2.75 grams. The 5F Dual Lumen Vascu-Line® weighs 5.85 grams.

Device Name: Vascu-Line® Central Venous Catheters

Description of Device:

Materials / Substances in Contact with Patient Tissue:

The percentage ranges below are based on catheter weights. The 3F Single Lumen Vascu-Line® weighs 2.75 grams. The 5F Dual Lumen Vascu-Line® weighs 5.85 grams.

Note:Accessories containing stainless steel may contain up to 0.4% weight of the CMR substance cobalt.

Note:The device should not be used if you are allergic to the above materials.

Information on Medicinal Substances in the Device:

How the Device Achieves its Intended Mode of Action: The device can be placed using a special technique called the Seldinger or modified Seldinger technique. The doctor will put the catheter in a very clean and germ-free environment, such as an operating room, to reduce the risk of infection. After placing the catheter, the doctor can connect it to a bag or a pump to give medicine and fluids. To keep the catheter working properly, a special solution is used. If the catheter needs to be removed, a doctor who knows how to do it will perform a surgical procedure.

Cleaning (Sterilization) Information: Contents are clean and will not cause fever in unopened, undamaged package. Sterilized by Ethylene Oxide.

Accessories Intended for Use in Combination with the Device:

4. Risks and Warnings

If you think something is wrong with how you feel after using the device or you're worried about any problems, talk to your healthcare professional. Remember, this information is not meant to take the place of talking to your doctor if you need to.

How Potential Risks Have Been Controlled or Managed

Remaining Risks and Undesirable Effects

Warnings and Precautions

Summary of Any Field Safety Correction Action (FSCA)

There were no recalls for the subject device from 01 January 2018 to 31 December 2022.

5. Summary of Clinical Evaluation and Post-Market Clinical Follow-Up

Clinical Background of Device

The subject devices have been available since 2012. The CE Mark was received in August 2012. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review did not find articles relating to the safety and/or performance of the subject device when used as intended. Two patient level data activities received information on 95 catheters. 6 user surveys have been received relating to this device. Findings from the data activities support the performance of the subject device. All data on the Vascu-Line® catheter has been evaluated. The advantages of using this item outweigh the dangers when it is used as intended. This device helps people who have kidney problems get hemodialysis when other treatments are not right for them.

Safety

6. Possible Therapeutic Alternatives

When considering alternative treatments, it is recommended to contact your healthcare professional who can consider your individual situation. The Infusion Nurses Society (INS) Standards 2021 clinical practice guidelines have been used to support the below recommendations for treatments.

7. Suggested Profile and Training for Users

The catheter should be inserted, manipulated, and removed by a qualified, licensed physician or other qualified health care professional under the direction of a physician.

Acronyms