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. This SSCP is not intended to replace the Instructions for Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients.

Applicable Documents

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

Manufacturer Single Registration Number (SRN): US-MF-000008230

Basic UDI-DI: 00884908287NR

Medical Device Nomenclature: C01020499 – Subcutaneous Implantable Venous Access Port Systems - Other

Class of Device: III

Date First CE Certificate Issued: Dignity® - May 2009 Jet Port – September 2008 Pro-Fuse® - January 2008 Jet-Fuse – January 2008

Authorized Representative Name and SRN: Gerhard Frömel European Regulatory Expert Medical Product Service GmbH (MPS) Borngasse 20 35619 Braunfels, Germany SRN: DE-AR-000005009

Notified Body Name and Single Identification Number: BSI Group The Netherlands B.V. NB2797

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, in various configurations inclusive of accessories and adjunctive devices (see section “Accessories intended for use in combination with the Device").

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.

Target Population(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: Dignity® 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 subcutaneously 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: Jet Port 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 subcutaneously 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 subcutaneously 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: Jet-Fuse 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 subcutaneously 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: Per the instructions for use, the device is contraindicated for patients with known or suspected allergies 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.

Sterilization Information: Contents sterile and non-pyrogenic in unopened, undamaged package. Sterilized by Ethylene Oxide.

Previous Generations / Variants:

Accessories Intended for Use in Combination with the Device:

Other Devices or Products Intended for Use in Combination with the Device:

4. Risks and Warnings

Residual Risks and Undesirable Effects: As per product IFUs, All surgical procedures carry risk. Medcomp has implemented risk management processes to proactively find and mitigate these risks as far as possible without adversely affecting the benefit-risk profile of the device. After mitigation, residual risks and the possibility of adverse events from use of this product remain. Medcomp has determined that all residual risks are acceptable.

Warnings and Precautions:

All warnings have been reviewed against the risk analysis, PMS, and usability testing to validate consistency between the sources of information. The devices in scope of this clinical evaluation have the following warnings in the IFUs:

• Do not insert or withdraw the guidewire forcibly from any component. If the guidewire becomes damaged, guidewire and any associated componentry must be removed together.
• Do not bend catheter at sharp angles during implantation. This can compromise catheter patency.
• Do not allow accidental device contact with sharp instruments. Mechanical damage may occur. Use only smooth edged, atraumatic clamps or forceps.
• Do not suture catheter to port. Any damage or constriction of catheter may compromise power injection performance.
• Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure.
• Do not use sutures to secure catheter to the port stem as it could collapse or damage the catheter.
• Do not resterilize the port or accessories by any method.
• Contents sterile and non-pyrogenic in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
• Do not re-use port or accessories as there may be a failure to adequately clean and decontaminate the device which may lead to contamination, catheter degradation, device fatigue, or endotoxin reaction.
• Do not use port or accessories if package is opened or damaged.
• Do not use port or accessories if any sign of product damage is visible or the use-by date has passed.
• Do not use a syringe smaller than 10ml. Prolonged infusion pressure greater than 25 psi may cause damage to a patient's vessels or viscus.
• Failure to warm contrast media to body temperature prior to power injection may result in port system failure.
• Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.
• Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.
• Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement.
• Power Injectable Implantable Infusion Port device indication for power injection of contrast media implies the Port's ability to withstand the procedure but does not imply appropriateness of the procedure for a particular patient nor for a particular infusion set. A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure and for evaluating the suitability of any infusion set used to access the port.
• Do not exceed a 325 psi pressure limit setting, or the maximum flow rate setting on the power injection machine, if power injecting through the Power Injectable Implantable Infusion Port device.
• Medical procedures on a patient's arm in which the system is implanted should be restricted as follows:
• Do not withdraw blood from or infuse medication into any area of the arm where the system is located unless you are using the port.
• Do not measure the patient's blood pressure on this arm.
• Carefully read and follow all instructions prior to use.
• Refer to standards of practice and institutional policies for compatible infusion agents for central venous access.
• Follow all contraindications, warnings, precautions, and instructions for all infusates as specified by their manufacturer.
• Only qualified healthcare practitioners should insert, manipulate, and remove these devices.
• Use only non-coring needles with the port.
• Prior to advancing the catheter lock, ensure that the catheter is properly positioned. A catheter not advanced to the proper region may not seat securely and lead to dislodgment and extravasation. The catheter must be straight with no sign of kinking. A slight pull on the catheter is sufficient to straighten it. Advancing the catheter lock over a kinked catheter may damage the catheter.
• Follow Universal Precautions when inserting and maintaining the catheter.
• Follow all contraindications, warnings, precautions, and instructions for all infusates as specified by their manufacturers.
• Precautions are intended to help avoid catheter damage and/or patient injury.
• When utilizing the port for arm placement, the port should not be placed in the axillary cavity.
• Discard biohazard according to facility protocol.
• Power Injectable Implantable Infusion Ports are only power injectable when accessed with a power injectable needle.
• The CMR substance Cobalt is a naturally occurring component of stainless steel. Based on biocompatibility evaluation it was determined that the main hazards of stainless steels are related to the processing of the material, especially welding, thus not applicable to the intended use of the device. Stainless steels used in these devices are unlikely to reach exposure levels that will elicit carcinogenicity, mutagenicity or reproductive toxicity.
• Inspect kit for presence of all components.
• Check patient's records, and ask patient, whether they have any known allergies to chemicals or materials that will be used during the placement procedure.
• Fill (prime) the device with sterile heparinized saline or normal saline solution to help avoid air embolism. Remember that some patients may be hypersensitive to heparin or suffer from heparin induced thrombocytopenia (HIT) and these patients must not have their port primed with heparinized saline.
• When using an introducer kit, verify that the catheter fits easily through the introducer sheath.
• Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler.
• Avoid vessel perforation.
• Take care not to perforate, tear, or fracture the catheter during placement. After assembling catheter to port, check assembly for leaks or damage.
• During placement through a sheath, hold thumb over exposed opening of sheath to prevent air aspiration. The risk of air aspiration is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver.
• This is not a right atrium catheter. Avoid positioning the catheter tip in the right atrium. Placement or migration of the catheter tip into the right atrium may cause cardiac arrhythmia, myocardia erosion, or cardiac tamponade.
• Carefully follow the connection technique given in these instructions to ensure proper catheter connection and to avoid catheter damage.
• When using peel-apart introducers:
• Carefully insert the introducer and catheter to avoid inadvertent penetration to vital structures in the thorax.
• Avoid blood vessel damage by maintaining a catheter or dilator as internal support when using a peel-apart introducer.
• Avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 30 September 2024 there were 187 complaints for 317,328 units sold, giving an overall complaint rate of 0.06%. There were no death-related events. No events resulted in recalls.

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

Summary of Clinical Data Related to Subject Device

Clinical performance was measured using parameters including but not limited to dwell time, catheter insertion outcomes, and adverse event rates. Critical clinical parameters extracted from these studies met standards set forth in the guidelines for the State of the Art. There were no unforeseen adverse events or other high occurrences of adverse events detected in any of the clinical activities. Survivability of a given implant is a multi-factorial event that depends on numerous factors, including: the limits of the implant, surgical technique, difficulty level of the surgical procedure, patient health, patient activity level, patient medical history, and other factors. In the case of the Dignity® Power Injectable Port, 33 devices had a 140.42 day [95%CI: 106.62-174.23 days] duration of use that has been found in clinical use reported to date. In the case of the Pro-Fuse® Power Injectable Port, 18 devices had a 135.28 day [95%CI: 83.34-187.22 days] duration of use that has been found in clinical use reported to date. Based on this information, the Dignity®/Jet Port/Pro-Fuse®/Jet-Fuse Power Injectable Port has a 12 month lifetime; however, the decision to remove and/or replace the catheter should be based on clinical performance and need, and not any predetermined point in time.

Summary of Clinical Data Related to the Equivalent Device

Clinical evidence from published literature and PMCF activities has been generated specific to known and unknown variants of the subject device. The equivalency rationale in the updated clinical evaluation report will demonstrate that the clinical evidence available for these variants is representative of the range of device variants in the device family. There are no clinical or biological differences between variants within the subject device family, and the potential impact of the technical differences will be rationalized in the updated clinical evaluation report.

Summary of Clinical Data from Pre-Market Investigations (if applicable)

No pre-market clinical investigations were used for the device's clinical evaluation.

Summary of Clinical Data from Other Sources

Source:Summary of Published Literature

Clinical evidence literature searches have found fifteen published literature articles representing 209 Pro-Fuse® device family specific cases, 444 Dignity® device family specific cases, and an additional 4,781 mixed cohort cases inclusive of the Dignity® device family. The articles included a randomized controlled trial (Chen et al., 2022), prospective studies (Fonseca et al., 2016, Son et al., 2020), retrospective studies (Annetta et al., 2021, Bertoglio et al., 2022, Chou et al., 2019, Li et al., 2022, Pike et al., 2021, Salawu et al., 2022, Tumay et al., 2021, Yang et al., 2018, Yun et al., 2021, Zhang et al., 2018), a technical study (Wu et al.), and a procedure explanation (Kim et al.). Bibliography: Annetta MG, Ostroff M, Marche B, et al. Chest-to-arm tunneling: A novel technique for medium/long term venous access devices. J Vasc Access. 2021 Bertoglio S, Annetta MG, Brescia F, et al. A multicenter retrospective study on 4480 implanted PICC-ports: A GAVeCeLT project. J Vasc Access. 2022 Chen, Y. B., Bao, H. S., Hu, T. T., He, Z., Wen, B., Liu, F. T., & Wu, J. N. (2022). Comparison of comfort and complications of Implantable Venous Access Port (IVAP) with ultrasound guided Internal Jugular Vein (IJV) and Axillary Vein/Subclavian Vein (AxV/SCV) puncture in breast cancer patients: a randomized controlled study. BMC cancer, 22(1), 1-9. Chou, P. L., Fu, J. Y., Cheng, C. H., Chu, Y., Wu, C. F., Ko, P. J., . . . Wu, C. Y. (2019). Current port maintenance strategies are insufficient: View based on actual presentations of implanted ports. Medicine (Baltimore), 98(44). doi:10.1097/md.0000000000017757 Fonseca, I. Y. I., Krutman, M., Nishinari, K., Yazbek, G., Teivelis, M. P., Bomfim, G. A. Z., . Wolosker, N. (2016). Brachial insertion of fully implantable venous catheters for chemotherapy: complications and quality of life assessment in 35 patients. Einstein (Sao Paulo), 14(4), 473-479. doi:10.1590/s1679-45082016ao3606 Kim, S. H., Choi, B. G., Oh, J. S., Chun, H. J., & Lee, H. G. (2018). Para-Axial Central Venous Stent Placement in Patients with Malignant Central Venous Obstruction with a Venous Port. Journal of Vascular and Interventional Radiology, 29(11), 1567-1570. Li Y, Guo J, Zhang Y, Kong J. Complications from port-a-cath system implantation in adults with malignant tumors: A 10-year single-center retrospective study. Journal of Interventional Medicine. 2022;5(1):15-22. Pike S, Tan K, Burbridge B. Complications Associated With Totally Implanted Venous Access Devices in the Arm Versus the Chest: A Short-Term Retrospective Study. Can Assoc Radiol J. 2021 Salawu, K., Arowojolu, O., Afolaranmi, O., Jimoh, M., Nworgu, C. and Falase, B., 2022. Totally implantable venous access ports and associated complications in sub-Saharan Africa: a single-centre retrospective analysis. ecancermedicalscience, 16. Son, R. S., Song, Y. G., Jo, J., Park, B.-H., Jung, G.-s., & Yun, J. H. (2020). Power contrast injections through a totally implantable venous power port: A retrospective multicenter study. Phlebology, 35(4), 268-272. Tumay LV, Guner OS. Availability of totally implantable venous access devices in cancer patients is high in the long term: a seven-year follow-up study. Support Care Cancer. 2021;29(7):3531-8. Wu, C. Y., Fu, J. Y., Wu, C. F., Cheng, C. H., Liu, Y. T., Ko, P. J., . . . Chu, Y. (2018). Initial experiences with a new design for a preattached intravenous port device. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 106(3), 1017-1027. Yang, S.-S., & Ahn, M. S. (2018). A comparison between upper arm and chest for optimal site of totally implanted venous access ports in patients with female breast cancer. Annals of vascular surgery, 50, 128-134. Yun W, Yang S. Comparison of peripherally inserted central catheters and totally implanted venous access devices as chemotherapy delivery routes in oncology patients: A retrospective cohort study. Science Progress. 2021;104(2):003685042110118. Zhang, S., Kobayashi, K., Faridnia, M., Skummer, P., Zhang, D., & Karmel, M. I. (2018). Clinical predictors of port infections in adult patients with hematologic malignancies. Journal of Vascular and Interventional Radiology, 29(8), 1148-1155.

Source:Dr Trerotola Data Report

The dataset was provided by Scott O. Trerotola, MD an Interventional Radiologist at the Hospital of the University of Pennsylvania. Dr. Trerotola is also Stanley Baum Professor of Radiology, Professor of Radiology in Surgery, Vice Chair for Quality, Radiology, Associate Chair and Chief, Interventional Radiology, and Director, Penn HHT Center of Excellence at the Perelman School of Medicine at the University of Pennsylvania. The dataset is consecutive, comprehensive, and includes catheter placements by interventional radiology Attending and Fellowship Physicians, as well as Residents under Attending supervision. 100 Dignity Port® cases, all identified as 8F Dignity® Mid-Sized ports, were collected. The following outcome measures were confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp Dignity® devices:

Source:PMCF_Infusion_211

The Infusion Product Line Data Collection Survey aimed to assess safety and performance outcome information for all variants of Medcomp Infusion Ports, PICCs, Midlines, and CVCs. 70 survey responses were collected from 17 countries representing 471 device cases. 41 Dignity® Port and 54 Pro-Fuse® cases inclusive of several variant devices across French size (5F, 6.6F, 8F, and 9.6F) and port configuration (Dignity® Mini, Dignity® Low Profile, Dignity® Mid-Sized, Pro-Fuse® Standard) were collected. The following outcome measures were confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp Port devices: Dignity® Port:

Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp’s product offerings. 24 respondents responded that they or their facility have used Medcomp implantable ports, with 22 of those respondents using the Dignity® device and 5 of those respondents using the Pro-Fuse® device. There were no differences in mean user sentiments within short-term hemodialysis catheters across State of the Art Performance and Safety Outcome Measures or between device types relating to safety or performance. The following data points were collected from users of Medcomp implantable ports (n=24):

Overall Summary of Clinical Safety and Performance

Upon review of the data across all sources, it is possible to conclude that the benefits of the subject device, which is facilitating access to the central venous system in patients in whom other therapies are not indicated or desirable as determined by the physician, outweigh the overall and individual risks when the device is used as intended by the manufacturer. It is the manufacturer's and clinical expert evaluator's opinion that activities both complete and ongoing are sufficient to support the safety, efficacy, and acceptable benefit/risk profile of the subject devices.

On-going or Planned Post-Market Clinical Follow-Up (PMCF)

No emerging risks, complications or unexpected device failures have been detected from PMCF activities.

6. Possible Therapeutic Alternatives

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.

8. Reference to Any Harmonized Standards and Common Specifications (CS) Applied

Revision History