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.

Device Identification and General Information

Device Trade Name(s): Medcomp® / Jet / Nipro I-Series Peritoneal Dialysis Catheters & Medcomp® / Jet V-Series Peritoneal Dialysis Catheters

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

Basic UDI-DI: 00884908308N8

Date First CE Certificate Was Issued for This Device: I-Series: February 2003 / V-Series: May 2006

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:

Intended Use of the Device

Intended Purpose: I-Series / V-Series Peritoneal Dialysis Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom peritoneal access for peritoneal dialysis 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. This catheter is for Single Use Only.

Indication(s): The I-Series / V-Series Peritoneal Dialysis Catheter is indicated for short-term or long-term use where peritoneal access is required for the purpose of peritoneal dialysis for Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD).

Intended Patient Group(s): I-Series / V-Series Peritoneal Dialysis Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom peritoneal access for peritoneal dialysis 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:

• The catheter is not intended for the Tenckhoff trocar method of insertion.
• The catheter is contraindicated for patients with:
• Infected anterior abdominal wall.
• Active peritonitis.
• Known or suspected allergies to any of the components of the catheter or the kit.

Device Description

Device Name: Medcomp® / Jet / Nipro I-Series Peritoneal Dialysis Catheters

Description of Device: The Peritoneal Dialysis tube (Catheter) is a tool that helps remove and return fluid during treatment. There are two types of catheters, the I-Series and the V-Series. Both have a round shape inside and come in different lengths to fit the patient. The end of the catheter can be straight or curled and has a special material to keep it in place. Doctors can see where the catheter is using an x-ray because it has a special stripe on it. An adaptor can connect the catheter to an outside system.

Device Name: Medcomp® / Jet V-Series Peritoneal Dialysis Catheters

Description of Device: The Peritoneal Dialysis tube (Catheter) is a tool that helps remove and return fluid during treatment. There are two types of catheters, the I-Series and the V-Series. Both have a round shape inside and come in different lengths to fit the patient. The end of the catheter can be straight or curled and has a special material to keep it in place. Doctors can see where the catheter is using an x-ray because it has a special stripe on it. An adaptor can connect the catheter to an outside system.

Materials / Substances in Contact with Patient Tissue:

The numbers in the table below show the percentage for the 18cm catheter (4.34g) and the 63cm catheter (12.40g).

The percentage ranges in the table below are based on the weights of the 39cm catheter (8.37g) and the 63cm catheters (12.91g).

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: N/A

How the Device Achieves its Intended Mode of Action: There are three ways to put the catheter inside your body: through open surgery, laparoscopic surgery, or percutaneous needle stick technique. The procedure should be done in a very clean and sterile place, like an operating room. Peritoneal dialysis is a way to clean waste materials from the blood using a lining in your belly called the peritoneum and a cleaning solution. There are two common types of peritoneal dialysis. One is called continuous ambulatory peritoneal dialysis (CAPD). This way uses gravity to put in and take out the cleaning solution many times a day, including right before bedtime. The other way is called continuous cycler-assisted peritoneal dialysis (CCPD). This way is usually done at night when you're asleep. A special machine puts the cleaning solution in and takes it out after a certain amount of time. This process can happen several times.

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:

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

There have been 194,364 devices sold since January 2019. There are side effects and risks that you should be aware of associated with the device. These include:

These risks are reduced to an acceptable level. The labeling describes the risks. The benefit of the device is peritoneal access when alternatives are not suitable. These benefits outweigh the risks.

Remaining Risks and Undesirable Effects

The catheters are associated with risks. These include:

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

Warnings and Precautions

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

Summary of Any Field Safety Correction Action (FSCA)

There were no recalls for the device since 01 December 2023.

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

Clinical Background of Device

These devices have been around since 2003 and are approved for use in the European Union

Clinical Evidence for CE-Marking

The clinical literature review identified 3 articles relating to the safety and/or performance of the subject devices when used as intended. These articles included approximately 88 cases. Three patient level data activities received information on 242 devices. 8 user surveys have been received relating to this device. The subject device works well according to studies and data analysis. Experts have evaluated all data on the I-Series and V-Series catheters. When used as intended, the benefits of the device are greater than the risks. The device helps patients who can't use other treatments as determined by their doctor.

Safety

There is sufficient data to prove conformity to the applicable requirements. The device is safe and performs as intended. The device is state of the art. Medcomp has reviewed: Post-Market Data, Medcomp Information Materials, Risk Management Documentation. The risks are appropriately displayed and consistent with the state of the art. The risks associated with the device are acceptable when weighed against the benefits. There were 194,364 devices sold from January 1st 2019, to August 31st 2024. Also, during this period there were 95 complaints received resulting in a 0.049% complaint frequency for the product family.

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 and various International Society for Peritoneal Dialysis (ISPD) guidelines have been used to support the below recommendations for treatments.

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. Appropriately trained healthcare professionals, patients, care givers and support workers can access the catheter for clinical use as appropriate. A special doctor or nurse should put in, move, and take out the tube for peritoneal dialysis. Trained healthcare workers, patients, and caregivers can use the tube if they are allowed. People who want to learn how to do peritoneal dialysis need to be healthy, smart, want to do it, and have support. The training should teach them everything they need to know about avoiding germs, taking care of the tube, and talking to doctors. The training should be different for everyone and should be taught again as needed. To see if the training is good, doctors will ask patients and healthcare workers how they liked it and will see how often people get sick and how long the peritoneal dialysis works.

Acronyms