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): Dignity®, Jet Port, Pro-Fuse®, Jet-Fuse Power Injectable Ports

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

Basic UDI-DI: 00884908287NR

Date First CE Certificate Was Issued for This Device: Dignity® - May 2009 Jet Port - September 2008 Pro-Fuse® - January 2008 Jet-Fuse - January 2008

Device Grouping and Variants

The devices in scope of this document are all implantable port sets. The device 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 Dignity®/Pro-Fuse®/Jet Port/Jet-Fuse Power Injectable Ports are intended for use in adult patients requiring frequent needlesticks for whom long-term 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 Dignity®/Pro-Fuse®/Jet Port/Jet-Fuse Power Injectable Port is indicated for long-term access to the central venous system for intravenous administration of fluids or medications, power injection of contrast media, and withdrawal of blood samples.

Intended Patient Group(s): The Dignity®/Pro-Fuse®/Jet Port/Jet-Fuse Power Injectable Ports are intended for use in adult patients requiring frequent needlesticks for whom long-term 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.

Contraindications and/or Limitations:

• When the presence of device related infection, bacteremia, or septicemia is known or suspected.
• When the patient's body size is insufficient for the size of the implanted device.
• When the patient is known or is suspected to be allergic to materials contained in the device.
• If severe chronic obstructive lung disease exists.
• If the prospective insertion site has been previously irradiated.
• If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures.
• If local tissue factors will prevent proper device stabilization and/or access.

3. Device Description

Device Name: Dignity®

Description of Device: The Dignity® Power Injectable Ports are an implantable venous access device. Port access is performed by percutaneous needle insertion using a non-coring needle. The Dignity® Power Injectable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Dignity® Power Injectable Ports can be identified under the skin by feeling the top of the septum and the top rim of the port housing. Dignity® Power Injectable Ports can be identified by the letters “CT” under radiographic imaging. Sizes include Dignity® Mini Profile, Dignity® Mid-Sized and Dignity® Low Profile. Power injection is performed using a power injectable needle only. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19- or 20-gauge non-coring power injectable needle. The maximum recommended infusion rate is 2ml/s with a 22-gauge non-coring power injectable needle.

Device Name: Jet Port

Description of Device: The Jet Port Power Injectable Ports are an implantable venous access device. Port access is performed by percutaneous needle insertion using a non-coring needle. The Jet Port Power Injectable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Jet Port Power Injectable Ports can be identified under the skin by feeling the top of the septum and the top rim of the port housing. Jet Port Power Injectable Ports can be identified by the letters “CT” under radiographic imaging. Sizes include Jet Port Mini Profile, Jet Port Mid-Sized and Jet Port Low Profile. Power injection is performed using a power injectable needle only. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19- or 20-gauge non-coring power injectable needle. The maximum recommended infusion rate is 2ml/s with a 22-gauge non-coring power injectable needle.

Device Name: Pro-Fuse®

Description of Device: Pro-Fuse® The Pro-Fuse® Power Injectable Ports are an implantable venous access device. Port access is performed by percutaneous needle insertion using a non-coring needle. The Pro-Fuse® Power Injectable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Pro-Fuse® Power Injectable Ports can be identified under the skin by feeling the top of the septum and the top rim of the port housing. Pro-Fuse® Power Injectable Ports can be identified by the letters “CT” under radiographic imaging. Sizes include Pro-Fuse® & Pro-Fuse® Low Profile. Power injection is performed using a power injectable needle only. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19- or 20-gauge non-coring power injectable needle. The maximum recommended infusion rate is 2ml/s with a 22-gauge non-coring power injectable needle.

Device Name: Jet-Fuse

Description of Device: The Jet-Fuse Power Injectable Ports are an implantable venous access device. Port access is performed by percutaneous needle insertion using a non-coring needle. The Jet-Fuse Power Injectable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Jet-Fuse Power Injectable Ports can be identified under the skin by feeling the top of the septum and the top rim of the port housing. Jet-Fuse Power Injectable Ports can be identified by the letters “CT” under radiographic imaging. Sizes include Jet-Fuse & Jet-Fuse Low Profile. Power injection is performed using a power injectable needle only. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19- or 20-gauge non-coring power injectable needle. The maximum recommended infusion rate is 2ml/s with a 22-gauge non-coring power injectable needle.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the assembled 5F (5.52g) and 9.6F (6.44g) Power Injectable Dignity Ports.

The percentage ranges in the table below are based on the weight of the assembled 5F (5.32g) and 9.6F (14.22g) Pro-Fuse Power Injectable Ports.

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: The subject device can be inserted using a percutaneous or cutdown surgical technique. Catheter insertion is to be performed using aseptic techniques in a sterile field, preferably in an operating room. Once the port placement site is healed sufficiently following implantation, port access is done by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. Subject devices consist of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Implanted ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power injectable ports can be identified by the letters “CT” under radiographic imaging.

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

There have been 317,328 devices sold since January 2019. There are side effects and risks 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 central venous access when alternatives are not suitable. These benefits outweigh the risks.

Remaining Risks and Undesirable Effects

The Ports are associated with risks. These include:

These risks are consistent with risks of other implantable ports. They are not unique to the Medcomp product. Some of the most common reactions include infection. Infection may be associated with general surgical procedure and hospitalization. Infection may not always be device-related.

Warnings and Precautions

The below are warnings, precautions, or measures to be taken by patient: Explain the insertion procedure, signs and symptoms of complications and general maintenance to the patient. Ensure all information is presented with respect to patient's level of understanding, culture, and language.

Summary of Any Field Safety Correction Action (FSCA)

There were four recalls for the device since 01 January 2017. All recalls were related to incorrect componentry included during packaging.

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 January 2008. US FDA clearance was in May 2007. All models included are planned for distribution in the European Union.

Clinical Evidence for CE-Marking

The clinical literature review identified 15 articles relating to the safety and/or performance of the subject devices when used as intended. These articles included approximately 5,434 cases. Two patient level data activities received information on 195 devices. 24 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 Dignity® and Pro-Fuse® ports 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 access to the central venous system in patients in whom other therapies are not indicated or desirable as determined by the physician

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:

The risks are appropriately displayed and consistent with the state of the art. The risks associated with the device is acceptable when weighed against the benefits. There were 317,328 devices sold from January 1st 2019, to September 30th, 2024. Also, during this period there were 187 complaints received resulting in a 0.06% complaint frequency for the Ports product family.

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