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): Pro-PICC® Power Injectable Peripherally Inserted Central Catheter

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: 00884908286NP

Medical Device Nomenclature: C010201 – Central I.V. Catheters, Peripheral Access

Class of Device: III

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

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 peripherally inserted central catheter (PICC) 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: 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.

Target Population(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 a variety of lumen configurations and various sizes. The catheter lumen terminates at a molded hub. A proximal lumen (extension) extends from hub and terminates with a female luer-lock connector. Each extension is marked with the lumen gauge size and has a pinch clamp to control fluid flow and an ID Tag marked with the maximum power injection rate. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter. The outer diameter of the lumen increases gradually as it nears the hub. 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 configurations and various sizes. The catheter lumen terminates at a molded hub. A proximal lumen (extension) extends from hub and terminates with a female luer-locking 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 allowing the withdrawal of blood into a syringe. The maximum 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: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:

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. 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.

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.

• Do not insert catheter in thrombosed vessels
• Do not advance the guidewire or catheter if unusual resistance is encountered.
• 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 resterilize the catheter or accessories by any method.
• Contents sterile and non-pyrogenic in unopened, undamaged package. STERILIZED BY ETHYLENE OXIDE
• Do not re-use catheter 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 catheter or accessories if package is opened or damaged.
• Do not use catheter or accessories if any sign of product damage is visible or the use-by date has passed.
• Do not use sharp instruments near the extension lines or catheter lumen.
• Do not use scissors to remove dressing. Precautions listed in the IFUs are as follows:
• The fluid level of the catheter will drop (allowing air entry) if the catheter connector is held above the level of the patient's heart and opened to air. To help prevent a drop in the fluid volume (allowing air entry) while changing injection caps, hold the connector below the level of the patient's heart before removing the injection cap.*
• 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.
• Syringes smaller than ten (10) ml will generate excessive pressure and may damage the catheter. Ten (10) ml or larger syringes are recommended.
• Hydrate guidewire prior to use.
• Always flush catheter prior to removing stylet.**
• Always flush catheter prior to insertion.*
• Catheter will be damaged if clamps other than what is provided with this kit are used.**
• Catheter will be damaged if clamps are used.*
• Clamping of the tubing repeatedly in the same location may weaken tubing. Avoid clamping near the luer(s) and hub of the catheter.**
• Examine catheter lumen and extension(s) before and after each infusion for damage.
• To prevent accidents, assure the security of all caps and connections prior to and between uses.
• Use only Luer Lock (threaded) Connectors with this catheter.
• In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism.
• Repeated overtightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.
• Confirm catheter tip position prior to use. Monitor tip placement routinely per institution policy.
• 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.
• The valve is not a barrier to infection. Strict aseptic technique must be utilized during all actuations and cap changes. A sterile end cap should be applied to the hub of the catheter to prevent contamination when not in use.*
• Discard biohazard according to facility protocol.
• 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. *Precaution only appears in Pro-PICC® Valved IFU (40798BSI) **Precaution only appears in Pro-PICC® IFUs (40795BSI, 40795JBSI, 40795PBSI)

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 30 September 2024 there were 186 complaints for 670,138 units sold, giving an overall complaint rate of 0.028%. There were no death-related events. No events resulted in recalls during the review period.

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 Pro-PICC® Power Injectable Peripherally Inserted Central Catheter, 93 catheters had a 55.07 day [95%CI: 43.98-66.18 days] duration of use that has been found in clinical use reported to date. Based on this information, the Pro-PICC® Power Injectable Peripherally Inserted Central Catheter 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 sixteen published literature articles representing 467 Pro-PICC® device family specific cases, and an additional 3,580 mixed cohort cases inclusive of the Pro-PICC® device family. The articles included randomized prospective studies (Paquet et al., Pittiruti et al., Yong et al.), prospective studies (Cotogni et al., Derudas et al., Zerla et al.), retrospective studies (Annetta et al., Annetta et al., Jeon et al., Kim et al., Wortley et al., Yang et al., Yeon et al., Yu and Hong), a hybrid prospective/retrospective study (Biasucci et al.), and a conference proceeding (Casas et al.). Bibliography: Annetta MG, Marche B, Dolcetti L, et al. Ultrasound-guided cannulation of the superficial femoral vein for central venous access. J Vasc Access. 2021 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 Biasucci, D. G., Pittiruti, M., Taddei, A., Picconi, E., Pizza, A., Celentano, D., . . . Conti, G. (2018). Targeting zero catheter-related bloodstream infections in pediatric intensive care unit: a retrospective matched case-control study. The journal of vascular access, 19(2), 119-124. Cotogni, P., Barbero, C., Garrino, C., Degiorgis, C., Mussa, B., De Francesco, A., & Pittiruti, M. (2015). Peripherally inserted central catheters in non-hospitalized cancer patients: 5-year results of a prospective study. Support Care Cancer, 23(2), 403-409. doi:10.1007/s00520-014-2387-9 Cotogni P, Mussa B, Degiorgis C, De Francesco A, Pittiruti M. Comparative Complication Rates of 854 Central Venous Access Devices for Home Parenteral Nutrition in Cancer Patients: A Prospective Study of Over 169,000 Catheter-Days. Journal of Parenteral and Enteral Nutrition. 2021;45(4):768-76. Derudas, D., Massidda, S., Simula, M. P., Dessì, D., Usai, S. V., Longhitano, G., Daniela Ibba, Loredana Aracu, Monica Atzori & La Nasa, G. (2023). Peripherally inserted central catheter insertion and management in Hodgkin and non-Hodgkin lymphomas: a 13-year monocentric experience. Frontiers in Hematology, 2, 1171991. Jeon, E.-Y., Cho, Y. K., Yoon, D. Y., & Hwang, J. H. (2016). Which arm and vein are more appropriate for single-step, non-fluoroscopic, peripherally inserted central catheter insertion? The journal of vascular access, 17(3), 249-255. Kim, H., Cho, S. B., Park, S. E., Jo, S. H., Lim, S. G., Jeong, Y., JH Won, WJ Yang, HC Choi, JH Ahn & Nam, I. C. (2024). A New Equation to Estimate Peripherally Inserted Central Catheter Length. Medicina, 60(3), 417. Paquet, F., Boucher, L. M., Valenti, D., & Lindsay, R. (2017). Impact of arm selection on the incidence of PICC complications: results of a randomized controlled trial. J Vasc Access, 18(5), 408-414. doi:10.5301/jva.5000738 Pittiruti, M., Emoli, A., Porta, P., Marche, B., DeAngelis, R., & Scoppettuolo, G. (2014). A prospective, randomized comparison of three different types of valved and non-valved peripherally inserted central catheters. J Vasc Access, 15(6), 519-523. doi:10.5301/jva.5000280 Sze Yong T, Vijayanathan AA, Chung E, Ng WL, Yaakup NA, Sulaiman N. Comparing catheter related bloodstream infection rate between cuffed tunnelled and non-cuffed tunnelled peripherally inserted central catheter. J Vasc Access. 2022;23(2):225-31. Wortley, V., & Almerol, L. A. (2020). Misplacement of piccs following power-injected CT contrast media. British Journal of Nursing, 29(19), S4-S10. Yang WJ, Kang D, Shin JH, et al. Comparison of different techniques for the management of venous steno-occlusive lesions during placement of peripherally inserted central catheter. Sci Rep. 2021;11(1) Yeon, J. W., Cho, Y. K., Kim, H. M., Song, M. G., Song, S.-Y., Cho, S. B., & Lee, S. Y. (2018). Interventional management of central vein occlusion in patients with peripherally inserted central catheter placement. Journal of Vascular Surgery: Venous and Lymphatic Disorders, 6(5), 566-574. Yu, B., & Hong, J. (2022). Safety and Efficacy of Peripherally Inserted Central Catheter Placement by Surgical Intensivist–Led Vascular Access Team. Vascular Specialist International, 38(4). Zerla, P. A., Canelli, A., Cerne, L., Caravella, G., Gilardini, A., De Luca, G., . . . Venezia, R. (2017). Evaluating safety, efficacy, and cost-effectiveness of PICC securement by subcutaneously anchored stabilization device. The journal of vascular access, 18(3), 238-242.

• Source:PMCF_Infusion_201

The CVAD Registry was acquired from CVAD Resources, LLC on 23 August 2020. All data received was de-identified, but otherwise represented exactly what was entered by clinicians on a consecutive basis. Medcomp received only data pertaining to devices with the manufacturer listed as "Medcomp" and all case information was sourced from two US hospitals. Hospital ID 121 is described as a “Vascular Access team in a Not-for-Profit Community Based Hospital”, and Hospital ID 123 is described as a “PICC (peripherally inserted central catheter) team in an Academic Medical Center”. Insertion of device dates range from 06 August 2012 through 21 April 2015. Removal of device dates from 09 August 2012 through 07 May 2015. 1,826 Pro-PICC® cases inclusive of several variant devices across French size (4F, 5F, and 6F) and lumen configuration (single, double, triple) 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 Pro-PICC® 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. 204 Pro-PICC® cases inclusive of several variant devices across French size (3F, 4F, 5F, and 6F), Valve (with and without), and lumen configuration (single, double, triple) 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 Pro- PICC® devices:

Source:Duration of Use Customer Survey

An email questionnaire was distributed globally to users of Medcomp PICCs and CVCs from 10 October 2019 to 16 October 2019. The questionnaire asked respondents to identify, from their own experience, the number of products used yearly, the average dwell time, and the longest dwell time for each applicable device family. Across the five device families, a total of 69 responses were collected from 14 countries. Means and ranges of responses for each device family were compiled on 16 October 2019. 24 responses were acquired relating to the Pro-PICC® device family. Across an estimated 8,761 products used yearly, the mean average dwell time was 116 days (Range: 14 – 365 days), and the mean longest dwell time was 360 days (Range: 60 – 2,555 days).

• Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp's product offerings. 13 respondents responded that they or their facility have used Medcomp PICCs, with 13 of those respondents using the Pro-PICC® device. There were no differences in mean user sentiments within PICCs 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 PICCs (n=13):

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 blood withdraws for laboratory testing, delivery of fluids and medications for treatments including chemotherapy, and power injection of contrast media for CT examinations in patients in whom short-term or long-term peripheral access to the central venous system without requiring frequent needlesticks deemed necessary based on the direction of a qualified, licensed 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