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): Free Flow ST Catheter

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

Basic UDI-DI: 00884908297NU

Date First CE Certificate Was Issued for This Device: Mar-01

Device Grouping and Variants

This document talks about hemodialysis tube [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: Free Flow ST 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 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 Free Flow ST Catheter is indicated for short-term use where vascular access is required for less than 14 days for the purpose of hemodialysis.

Intended Patient Group(s): Free Flow ST 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 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: Medcomp® / Jet Free Flow ST Catheter

Description of Device: The Free Flow ST Catheter has two separate paths to move blood in and out of the body. Each path has a different colored tube. The tubes connect to a part that is shaped like a hub. Both paths have small holes to help the blood flow. The device contains a substance called Barium Sulphate to make it easier to see with X-rays. It comes in various sizes and shapes to fit the needs of the patient as determined by the doctor.

Device Name: Medcomp® / Jet Free Flow ST Catheter

Description of Device: The Free Flow ST Catheter has two separate paths to move blood in and out of the body. Each path has a different colored tube. The tubes connect to a part that is shaped like a hub. Both paths have small holes to help the blood flow. The device contains a substance called Barium Sulphate to make it easier to see with X-rays. It comes in various sizes and shapes to fit the needs of the patient as determined by the doctor.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 12.5F x 15cm catheter (12.33g) and the 15.5F x 28cm catheter (14.66g).

The percentage ranges in the table below are based on the weights of the 12.5F x 15cm catheter (12.33g) and the 15.5F x 28cm catheter (14.66g).

Note:Known or suspected allergies to any of the components of the catheter or the kit.

Note:This device is contraindicated for patients exhibiting severe, uncontrolled coagulopathy or thrombocytopenia.

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

Contact your healthcare professional if you believe you are experiencing side-effects related to the device or its use or if you are concerned about risks. This document does not replace a consultation with your healthcare professional.

How Potential Risks Have Been Controlled or Managed

• There have been 28,908 devices sold since January 2019. There are side effects and risks associated with the device. These include:

• Infection

• Bleeding

• Tube Removal

• Tube Replacement These risks are reduced to an acceptable level. The labeling describes the risks. The benefit of the device is access for hemodialysis when alternatives are not suitable. These benefits outweigh the risks. The Free Flow ST catheter is associated with risks. These include:

• Procedural Delays

• Blood clots in veins (Thrombosis)

• Infections

• Punctures in organs (Perforations)

• Air bubbles in veins (Embolism)

• Heart problems (Cardiac Event)

• Feeling unhappy with the procedure (Dissatisfaction)

Remaining Risks and Undesirable Effects

• The Free Flow ST catheter is associated with risks. These include:

• Procedural Delays

• Blood clots in veins (Thrombosis)

• Infections

• Punctures in organs (Perforations)

• Air bubbles in veins (Embolism)

• Heart problems (Cardiac Event)

• Feeling unhappy with the procedure (Dissatisfaction) The risks of using the Medcomp device are similar to other dialysis tubes. The most common problem is getting an infection. Infections can happen when someone has surgery or stays in the hospital. Infections are not always caused by use of the device. The below tables includes events that can happen when the tube is put in, used, or taken out. Not all device problems are reported.

Warnings and Precautions

• The below are warnings, precautions, or measures to be taken by patient:

• To keep germs away from the catheter, wear a mask over your nose and mouth every time the catheter is used.

• Keep the catheter dressing clean and dry. The dressing should be changed by a medical professional at each dialysis session.

• Avoid getting the catheter or catheter site wet. Moisture near the catheter site can cause infection.

• Ask the doctor to explain the signs and symptoms of catheter infection.

• Never remove the cap at the end of the catheter. The cap and clamps of the catheter must be kept closed when not being used for dialysis.

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 Free Flow ST catheter has been available since 2001. The CE Mark was received in March 2001. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review identified 0 articles relating to the safety and/or performance of the subject device when used as intended. One data activity received information on 284 catheters. 1 user survey has been received relating to this device. Findings from the data activities support the performance of the subject device. All data on the Free Flow ST 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

• There is enough proof to show that the device meets the standards it needs to. The device is safe and does what it is supposed to do, as claimed by Medcomp. It is a modern device that helps access the veins of adults for a short time for hemodialysis. Medcomp has reviewed:

• Post-Market Data

• Medcomp Information Materials

• Risk Management Documentation The device's risks are displayed clearly and are acceptable for this type of product. Compared to the good things the device does, the risks are okay. There were 9 complaints for 28,908 units sold from 01 January 2019 to 31 December 2023. The complaint rate is 0.031%.

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