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): Tri-Flow Catheter

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

Basic UDI-DI: 00884908304MY

Date First CE Certificate Was Issued for This Device: 1-Mar

Device Grouping and Variants

The devices in scope of this document are all short-term hemodialysis catheter sets. The device part numbers are organized into variant categories. 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: The Tri-Flow 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 and intravenous administration of fluids or medications 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 Tri-Flow 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.

Intended Patient Group(s): Tri-Flow 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 and intravenous administration of fluids or medications 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: Tri-Flow Catheter

Description of Device: The Tri-Flow catheter is a tube that helps move blood through your body for dialysis. It has three different parts that keep blood flowing smoothly. Two of the parts are blue and red and can be used for dialysis. The third part is clear and can be used to give medicine or fluids. The catheter can be different lengths and shapes depending on what the doctor thinks is best.

Device Name: Jet Tri-Flow Catheter; Nikkiso Tri-Flow Catheter; Nipro Tri-Flow Catheter

Description of Device: The Tri-Flow catheter is a tube that helps move blood through your body for dialysis. It has three different parts that keep blood flowing smoothly. Two of the parts are blue and red and can be used for dialysis. The third part is clear and can be used to give medicine or fluids. The catheter can be different lengths and shapes depending on what the doctor thinks is best.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 11.5F x 12cm catheter (8.96g) and the 12F x 24cm catheter (10.04g).

Note:The CMR substance Cobalt is a naturally occurring component of stainless steel. Based on biocompatibility evaluation it was determined that the main hazards of stainless steels are related to the processing of the material, especially welding, thus not applicable to the intended use of the device. Stainless steels used in these devices are unlikely to reach exposure levels that will elicit carcinogenicity, mutagenicity, or reproductive toxicity.

Note:The device should not be used if you have known or suspected allergies to any of the components of the catheter or the kit.

Information on Medicinal Substances in the Device: N/A

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 2023 to 31 December 2023.

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

Clinical Background of Device

The Tri-Flow catheter has been available since 1998. The CE Mark was received in March 2001. US FDA clearance was in May 1998. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review identified 2 articles relating to the safety and/or performance of the subject device when used as intended. These articles included approximately 162 cases. PMCF data activity received 183 cases on the catheter. 2 user surveys have been received relating to this device. Findings from the clinical literature and data activities support the performance of the subject device. All data on the Tri-Flow catheter has been evaluated. When you use the device as intended, the good things it does are more than the bad things it might cause. 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