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): 1.9F & 2.6F Vascu-PICC® Peripherally Inserted Central Catheter

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

Basic UDI-DI: 00884908289NV

Date First CE Certificate Was Issued for This Device: 1.9F & 2.6F Vascu-PICC®- October 2008 1.9F & 2.6F Jet-PICC- October 2008

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: The 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are intended for use in pediatric and neonate 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 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheter is indicated 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): 1.9F and 2.6F Vascu-PICC®/Jet-PICC Peripherally Inserted Central Catheters are for use in pediatric and neonate 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:

• This catheter is not 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 infection.
• Previous history of venous/subclavian blood clots or vascular surgeries at insertion site.
• Fever of unknown origin.
• The patient's body size is too small 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 security and/or access.
• Known tape or Zinc Oxide adhesive allergies.
• This catheter is not suitable for insertion through non-superficial veins.

3. Device Description

Device Name: 1.9F & 2.6F Vascu-PICC® Peripherally Inserted Central Catheter

Description of Device: The 1.9F and 2.6F Jet-PICC Peripherally Inserted Central Catheter is used for short- or long-term central venous access, via peripheral insertion, during the administration of fluids, medication and nutritional therapy for neonates, infants and children. The lumen inner and outer sizes are the same throughout the entire length of the lumen tubing. Each catheter lumen terminates through an extension to a female connector. Each extension has an in-line clamp to control fluid flow and is marked with the lumen gauge size. The transition between the lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The lumen is marked with depth markers every centimeter.

Device Name: 1.9F & 2.6F Vascu-PICC® Peripherally Inserted Central Catheter

Description of Device: The 1.9F and 2.6F Jet-PICC Peripherally Inserted Central Catheter is used for short- or long-term central venous access, via peripheral insertion, during the administration of fluids, medication and nutritional therapy for neonates, infants and children. The lumen inner and outer sizes are the same throughout the entire length of the lumen tubing. Each catheter lumen terminates through an extension to a female connector. Each extension has an in-line clamp to control fluid flow and is marked with the lumen gauge size. The transition between the lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The lumen is marked with depth markers every centimeter.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 1.9F x 20cm Single Lumen (2.85g) and 2.6F x 50cm Double Lumen w/ Cuff (4.16g) Vascu-PICC® devices.

The percentage ranges in the table below are based on the weight of the 1.9F x 20cm Single Lumen (2.85g) and 2.6F x 50cm Double Lumen w/ Cuff (4.16g) Vascu-PICC® 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 devices utilize a Seldinger or Modified Seldinger technique to obtain 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. Once in place, fluids are delivered 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 patency. Catheter removal is normally done by gently pulling on the catheter, but removal may require that a surgical procedure be performed by a physician familiar with the appropriate techniques in some circumstances.

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 June 2009. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review identified 9 articles relating to the safety and/or performance of the subject device when used as intended. These articles included approximately 844 cases. Two patient level data activities received information on 11 catheters. 2 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 1.9F & 2.6F 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 delivery of fluids and medications in patients with small blood vessels, including neonates. These benefits are for patients in 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.

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