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): T-3® CT Catheter

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

Basic UDI-DI: 00884908300MQ

Date First CE Certificate Was Issued for This Device: 11-Aug

Device Grouping and Variants

This document talks about hemodialysis tubes [catheter] sets. These tubes are used for a short time and come in different sets. These devices are distributed as procedure trays. Procedure trays come in different configurations.

Variant Devices:

Procedure Trays:

Configurations of Procedure Trays:

2. Intended Use of the Device

Intended Purpose: T-3® CT Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom immediate central venous vascular access for short-term hemodialysis, intravenous administration of fluids or medications, and power injection of contrast media is deemed necessary based on the direction of a qualified, licensed physician. The catheter is intended to be used under the regular review and assessment of qualified health professionals. This catheter is for Single Use Only.

Indication(s): The T-3® CT Catheter is indicated for short-term use where vascular access is required for less than 14 days for the purpose of hemodialysis. The third internal lumen is indicated for intravenous administration of fluids or medications and power injection of contrast media.

Intended Patient Group(s): T-3® CT Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom immediate central venous vascular access for short-term hemodialysis, intravenous administration of fluids or medications, and power injection of contrast media is deemed necessary based on the direction of a qualified, licensed physician. The catheter is not intended for use in pediatric patients.

Contraindications and/or Limitations:

• Known or suspected allergies to any of the components of the catheter or the kit.
• This device is contraindicated for patients exhibiting severe, uncontrolled coagulopathy or thrombocytopenia.

3. Device Description

Device Name: T-3® CT Catheter

Description of Device: The T-3® Catheter is a special tube that doctors use for cleaning blood in some people who are sick. It's made of a special material that can change shape when it's heated up. The tube has three different parts inside it, which let blood flow through it continuously. There are two parts, one that carries blue blood and one that carries red blood, that the doctor can use to clean the blood. The middle part, which is purple, is separate from the other two and can be used to give patients medicine or other fluids. The tube comes in different sizes to make sure it works well for each patient.

Device Name: T-3® CT Catheter

Description of Device: The T-3® Catheter is a special tube that doctors use for cleaning blood in some people who are sick. It's made of a special material that can change shape when it's heated up. The tube has three different parts inside it, which let blood flow through it continuously. There are two parts, one that carries blue blood and one that carries red blood, that the doctor can use to clean the blood. The middle part, which is purple, is separate from the other two and can be used to give patients medicine or other fluids. The tube comes in different sizes to make sure it works well for each patient.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges below are based on catheter weights. The 15cm catheter weighs 15.15 grams. The 32cm catheter weighs 17.91 grams.

The percentage ranges below are based on catheter weights. The 15cm catheter weighs 15.15 grams. The 32cm catheter weighs 17.91 grams.

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: Hemodialysis tubes provide access through the vein or artery. The tube is thin and flexible and goes into a big vein near the center of the body. There are two openings in the tube. One opening takes out the blood and sends it to a machine that cleans it. The other opening puts the clean blood back into the body. This tube is used when someone needs to have their blood cleaned right away, and they can't use a different kind of tube. This tube is only used for a short time.

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 device between 01 January 2019 to 31 December 2023.

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

Clinical Background of Device

The T-3® CT catheter has been around since 2011. The device got approved for use in Europe in August 2011. It was also approved for use by the US FDA in June 2013. All models included are up for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review identified two articles relating to the safety and/or performance of the subject device when used as intended. These articles included approximately 11 cases. Two PMCF data activities received information on 81 catheters. Nineteen user surveys have been received relating to this device. Studies and tests on the T-3® CT catheter show that it can be used safely. 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 Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 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