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): 6.5F Tesio® Catheter

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

Basic UDI-DI: 00884908281ND

Date First CE Certificate Was Issued for This Device: 1997

Device Grouping and Variants

The devices in scope of this document are all long-term hemodialysis catheter sets. The device part numbers are organized into variant categories. These devices are distributed as procedure trays. The procedure tray is a configuration including accessories.

Variant Devices:

Procedure Trays:

Configurations of Procedure Trays:

2. Intended Use of the Device

Intended Purpose: 6.5F Tesio® Catheters are intended for use in pediatric patients who do not have functional permanent vascular access or are not candidates for permanent vascular access for whom central venous vascular access for 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 6.5F Tesio® Catheter is indicated for short-term or long-term use where vascular access is required for 14 days or more for the purpose of hemodialysis.

Intended Patient Group(s): 6.5F Tesio® Catheters are intended for use in pediatric patients who do not have functional permanent vascular access or are not candidates for permanent vascular access for whom central venous vascular access for hemodialysis is deemed necessary based on the direction of a qualified, licensed physician.

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: 6.5F Tesio® Catheter

Description of Device: The 6.5F Tesio® Catheter is a long-term catheter. The catheter is single tubed. Two catheters are inserted into the target vein. The catheters remove and return blood through two separate lines. Priming volumes are printed on the lumen.

Device Name: 6.5F Tesio® Catheter

Description of Device: The 6.5F Tesio® Catheter is a long-term catheter. The catheter is single tubed. Two catheters are inserted into the target vein. The catheters remove and return blood through two separate lines. Priming volumes are printed on the lumen.

Materials / Substances in Contact with Patient Tissue:

The percentage below is based on catheter weight. The catheter weighs 9.47 grams.

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

Note:Accessories containing stainless steel may contain up to 4% weight of the CMR substance cobalt.

Information on Medicinal Substances in the Device: N/A

How the Device Achieves its Intended Mode of Action: Hemodialysis catheters are centrally placed access tubes. A typical hemodialysis catheter uses a thin, flexible tube. This catheter has two separate tubes. The tubes go into a large vein. The vein is usually the internal jugular vein. Blood withdraws through one tube of the catheter. The blood flows to the dialysis machine through a separate tubing set. The blood is then processed and filtered. The blood returns to the patient through the second tube. This device is used when dialysis must start at once. Patients may not have a functioning AV fistula or graft. Catheter hemodialysis normally happens on a short-term basis. Long-term access may occur in some cases. For example, when there are problems supporting an AV fistula or graft.

Cleaning (Sterilization) Information: Contents sterile and non-pyrogenic 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 if needed.

How Potential Risks Have Been Controlled or Managed

Remaining Risks and Undesirable Effects

These risks are consistent with risks of other dialysis catheters. They are not unique to the Medcomp product. Some of the most common reactions include infection. Infection may be associated with general surgical procedure and hospitalization. Infection may not always be device-related.

Warnings and Precautions

Summary of Any Field Safety Correction Action (FSCA)

There were no recalls for the device between 01 April 2024 to 31 March 2025.

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

Clinical Background of Device

The 6.5F Tesio® was marketed previously as the 7F Tesio® catheter. The 6.5F Tesio® catheter has been available since 1997. The CE Mark was received in 1997. US FDA clearance was in February 1999. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review found 4 articles relating to the safety and/or performance of the subject device when used as intended. These articles include approximately 37 cases. Findings from the clinical literature support the performance of the subject device. All data on the 6.5F Tesio® catheter has been evaluated. The benefits of the subject device outweigh the risks when the device is used as intended. The benefit of the device is allowing hemodialysis in patients in whom other therapies or conservative care are not desirable by the physician.

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. In certain circumstances, patients who may be suitable for home hemodialysis may manipulate the external connections of the catheter. Consult International Society of Hemodialysis guidelines. If home dialysis is recommended, you will undergo thorough training. The objectives of the training program are: 1) Give you information to dialyze safely at home. 2) Enable you to monitor and manage your disease. 3) Help you cope with fears and restrictions of home hemodialysis. The ideal nurse trainer-to-patient ratio is typically 1:1. A training schedule will be created. Training will be individualized to your needs.

Acronyms