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): Vascu-PICC® Peripherally Inserted Central Catheter

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

Basic UDI-DI: 00884908288NT

Date First CE Certificate Was Issued for This Device: Vascu-PICC® - June 2005 Jet-PICC - August 2002

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 sets. Sets come in different configurations.

Variant Devices:

Procedure Trays:

Configurations of Procedure Trays:

2. Intended Use of the Device

Intended Purpose: The Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are for use in adult patients requiring needing 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.

Indication(s): The Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheter is for short-term or long-term peripheral access to the central venous system for the intravenous administration of fluids or medications.

Intended Patient Group(s): Vascu-PICC®/Jet-PICC 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.

Contraindications and/or Limitations:

• This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels.
• The presence of skin related problems around the insertion site (infection, phlebitis, scars, etc.)
• The presence of device related bacteremia or septicemia.
• History of mastectomy on insertion side.
• Previous history of venous/subclavian thrombosis or vascular surgical procedures at insertion site.
• Fever of unknown origin.
• 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.
• Past irradiation of prospective insertion site.
• Local tissue factors will prevent proper device stabilization and/or access.

3. Device Description

Device Name: Vascu-PICC®

Description of Device: The Vascu-PICC® Peripherally Inserted Central Catheters are designed for peripheral vein catheterization. The lumen is an open-ended design comprised of a radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a molded hub with integral suture wings for catheter securement. Clamps are provided on the extension tubes to prevent air/fluid mixing. Female connectors provide the connection for intravenous administration. The devices are available in a range of French sizes in single and dual lumen configurations. The lumen has depth marks every centimeter and numerical marks every 5th centimeter and are available in trimmable 60cm for PICC's. The Vascu-PICC® Peripherally Inserted Central Catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

Device Name: Jet-PICC

Description of Device: The Jet-PICC Peripherally Inserted Central Catheters are designed for peripheral vein catheterization. The lumen is an open-ended design comprised of a radiopaque polyurethane material with barium sulfate for radiopacity. The lumen is connected to the extensions via a molded hub with integral suture wings for catheter security. Clamps are provided on the extension tubes to prevent air/fluid mixing. Female connectors provide the connection for intravenous administration. The catheters are available in a range of French sizes in single and dual lumen configurations. The lumen has depth marks every centimeter and numerical marks every 5th centimeter and are available in trimmable 60cm for PICC's. Jet-PICC Peripherally Inserted Central Catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges below are based on catheter weights. The 3F x 60 Single Lumen device weighs 2.70 grams. The 6F x 60cm Double Lumen device weighs 7.86 grams.

The percentage ranges below are based on catheter weights. The 3F x 60 Single Lumen device weighs 2.70 grams. The 6F x 60cm Double Lumen device weighs 7.86 grams.

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 obtain the desired access. The primary difference is one technique utilizes an Introduction Sheath and one does not. The Seldinger techniques for venous access are well-established surgical techniques utilized for insertion of PICC devices. The instructions for use of each catheter are detailed in the respective product IFUs. Catheters are to be inserted, manipulated and removed by a qualified, licensed physician or other qualified health care professional utilizing strict aseptic technique. Once in place, fluids are given or blood is withdrawn via the PICC catheter most commonly with a disposable tubing set or syringe. Catheter care includes use of a locking solution to maintain catheter function. Catheter removal is normally accomplished by gently pulling on the catheter.

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

Warnings and Precautions

Summary of Any Field Safety Correction Action (FSCA)

There were no recalls for the subject device from 01 January 2016 to 30 June 2023.

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

Clinical Background of Device

The subject devices have been available since 2002. The CE Mark was received in August 2002. US FDA clearance was in April 2003. 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 3,147 cases. Two patient level data activities received information on 20 catheters. 28 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 Vascu-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 peripheral access to the central venous system in patients in whom other therapies are not indicated or desirable as determined 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 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