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-PICC® Power Injectable Peripherally Inserted Central Catheter

Manufacturer Name and Address: Medical Components, Inc. 1499 Delp Drive Harleysville, PA 19438, United States of America (USA)

Basic UDI-DI: 00884908286NP

Date First CE Certificate Was Issued for This Device: Pro-PICC® - October 2007 Pro-PICC® Valved - May 2013 Jet-PICC - July 2009 PFM-PICC - December 2015

Device Grouping and Variants

The devices in scope of this document are all peripherally inserted central catheter (PICC) 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: Pro-PICC®/Jet-PICC/PFM-PICC Power Injectable Peripherally Inserted Central Catheters are intended for use in adult and pediatric patients requiring frequent needlesticks for whom short-term or long-term peripheral access to the central venous system without requiring frequent 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. Pro-PICC® Valved Pro-PICC® Valved Power Injectable Peripherally Inserted Central Catheters are intended for use in adult patients requiring frequent needlesticks for whom short-term or long-term peripheral access to the central venous system without requiring frequent 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-PICC®/Pro-PICC® Valved/PFM-PICC/Jet-PICC Power Injectable Peripherally Inserted Central Catheter is indicated for short- term or long-term peripheral access to the central venous system for blood sampling, intravenous administration of fluids or medications, central venous pressure monitoring and power injection of contrast media.

Intended Patient Group(s): Pro-PICC®, Jet-PICC, and PFM-PICC Pro-PICC®/Jet-PICC/PFM-PICC Power Injectable Peripherally Inserted Central Catheters are intended for use in adult and pediatric patients requiring frequent needlesticks for whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks is deemed necessary based on the direction of a qualified, licensed physician.

Contraindications and/or Limitations:

• Pro-PICC® Valved Pro-PICC® Valved Power Injectable Peripherally Inserted Central Catheters are intended for use in adult patients requiring frequent needlesticks for whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks is deemed necessary based on the direction of a qualified, licensed physician. The device is not intended for use in pediatric patients.
• The presence of device related local infection, bacteremia or septicemia is known or suspected.
• The patient's body size is insufficient to accommodate the size of the implanted device.
• The patient is known or is suspected to be allergic to materials contained in the device.
• There has been past irradiation of prospective insertion site.
• There have been previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
• There are local tissue factors that may prevent proper device stabilization and/or access.

3. Device Description

Device Name: Pro-PICC®

Description of Device: The Pro-PICC® Power Injectable Peripherally Inserted Central Catheter product family is available in many of lumen shapes and various sizes. The catheter lumen ends at a molded hub. A proximal lumen (extension) extends from hub and ends with a female connector. Each extension is marked with the lumen gauge size and has a pinch clamp to control fluid flow and an identification (ID) Tag marked with the highest power injection rate. The outer diameter of the lumen gets bigger as it nears the hub. The highest recommended infusion rate varies by catheter French size and is printed on the catheter. The lumen is marked with depth marks every centimeter and numerical markings every fifth centimeter.

Device Name: Pro-PICC® Valved

Description of Device: The Pro-PICC® Valved Power Injectable Peripherally Inserted Central Catheter family is available in a variety of lumen shapes and various sizes. The catheter lumen ends at a molded hub. A proximal lumen (extension) extends from hub and ends with a female valve which controls the flow of fluids to provide clamp free infusion therapy. Positive pressure into the catheter (gravity, pump, syringe) will open the valve. When negative pressure (aspiration) is applied, the valve opens as allows blood to be drawn into a syringe. The highest recommended infusion rate varies by catheter French size and is printed on the catheter.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 3F Single Lumen (2.56g) and 6F Triple Lumen (7.45g) Pro-PICC® Power Injectable PICCs.

The percentage ranges in the table below are based on the weight of the 4F Single Lumen (3.17g) and 6F Triple Lumen (7.26g) Pro-PICC® Valved Power Injectable PICCs.

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 devices utilize a Seldinger or Modified Seldinger technique to gain access. The main difference is one technique utilizes an Introduction Sheath and one does not. The Seldinger techniques for venous access are well-known surgical techniques used for inserting PICC devices. The instructions for use of each catheter are detailed in the IFUs. Catheters are to be inserted, manipulated and removed by a qualified, licensed physician or other qualified health care professional utilizing strict aseptic technique.

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 30 September 2024.

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

Clinical Background of Device

The subject devices have been available since 2007. The CE Mark was received in October 2007. US Food and Drug Administration (FDA) clearance was in September 2009. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review identified 16 articles relating to the safety and/or performance of the subject device when used as intended. These articles included approximately 4,047 cases. Two patient-level data activities received information on 2,030 catheters. 37 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-PICC® 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 blood withdraw for laboratory testing, delivery of fluids and medications for treatments including chemotherapy, and power injection of contrast media for CT examinations without requiring frequent needlesticks. These benefits are for patients in whom short-term or long-term peripheral access to the central venous system 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