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): Pro-Line® Power Injectable Central Venous Catheters

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

Basic UDI-DI: 00884908290NE

Date First CE Certificate Was Issued for This Device: Pro-Line® - October 2008

Device Grouping and Variants

The devices in scope of this document are all central venous catheter (CVC) sets. The catheter 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 Pro-Line® Power Injectable Central Venous Catheters are for use in adult patients requiring frequent needlesticks for whom short-term or long-term access to the central venous system without requiring many needlesticks 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 Pro-Line® Power Injectable Central Venous Catheter is for short- term or long-term access to the central venous system for intravenous administration of fluids or medications and power injection of contrast media.

Intended Patient Group(s): Pro-Line® Power Injectable Central Venous Catheters are intended for use in adult patients requiring many needlesticks for whom short-term or long-term access to the central venous system without the need for many needlesticks is deemed necessary based on the direction of a qualified, licensed physician. The device is not intended for use in pediatric patients.

Contraindications and/or Limitations:

• The presence of device related infection is known or suspected.
• This catheter is intended for short- or long-term vascular access and should not be used for any purpose other than indicated in these instructions.
• The patient is known or is suspected to be allergic to materials contained in the device.

3. Device Description

Device Name: Pro-Line® Power Injectable Central Venous Catheters

Description of Device: The Pro-Line® Power Injectable Central Venous Catheters are made from specially formulated biocompatible medical grade materials and are available in a variety of lumen shapes and sizes to accommodate clinical needs. They are packaged in a tray with accessories necessary for percutaneous insertion using a microintroducer (Modified Seldinger or Seldinger technique). The highest recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the Pro-Line® Power Injectable CVC may not exceed 300psi.

Device Name: Pro-Line® Power Injectable Central Venous Catheters

Description of Device: The Pro-Line® Power Injectable Central Venous Catheters are made from specially formulated biocompatible medical grade materials and are available in a variety of lumen shapes and sizes to accommodate clinical needs. They are packaged in a tray with accessories necessary for percutaneous insertion using a microintroducer (Modified Seldinger or Seldinger technique). The highest recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the Pro-Line® Power Injectable CVC may not exceed 300psi.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 5F Single Lumen (3.64g) and 6F Triple Lumen (7.76g) Pro-Line® devices.

The percentage ranges in the table below are based on the weight of the 5F Single Lumen (3.64g) and 6F Triple Lumen (7.76g) Pro-Line® devices.

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:

How the Device Achieves its Intended Mode of Action: The subject device can be inserted using a standard or modified Seldinger percutaneous surgical technique. Catheter insertion is to be done using aseptic techniques in a sterile field, preferably in an operating room. Once in place, the CVC can be connected to a gravity-feed intravenous (IV) bag, or connected to a pump, for administration of fluids and medications. Catheter care includes use of a locking solution to maintain catheter function. Catheter removal is a surgical procedure intended to be performed by a physician familiar with the appropriate techniques.

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 is not intended to replace a consultation with your healthcare professional if needed.

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 December 2023 to 31 August 2024.

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

Clinical Background of Device

The subject devices have been available since 2008. The CE Mark was received in October 2008. US FDA clearance was in November 2009. All models included are planned for distribution 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 device when used as intended. These articles included approximately 54 cases. Three patient level data activities received information on 751 catheters. 14 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 Pro-Line® 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 facilitating delivery of fluids and medications for treatments including chemotherapy and power injection of contrast media for CT examinations. These benefits are for patients in whom short- term or long-term access to the central venous system without requiring frequent needlesticks is deemed necessary based on the direction of a qualified, licensed 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 Infusion Nurses Society (INS) Standards 2021 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