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-Line® Power Injectable Central Venous Catheters

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: 00884908290NE

Medical Device Nomenclature: C010203 – Central Venous Catheters, Partially Tunneled

Class of Device: III

Date First CE Certificate Issued: Pro-Line® - October 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 central venous catheter (CVC) sets. The catheter 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 Pro-Line® Power Injectable Central Venous Catheters are intended for use in adult patients requiring frequent needlesticks for whom short-term or 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 Pro-Line® Power Injectable Central Venous Catheter is indicated for short-term or long-term access to the central venous system for intravenous administration of fluids or medications and power injection of contrast media.

Target Population(s): Pro-Line® Power Injectable Central Venous Catheters are intended for use in adult patients requiring frequent needlesticks for whom short- term or 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 not intended for use in pediatric patients.

Contraindications and/or Limitations:

• The presence of device related infection, bacteremia or septicemia is known or suspected.
• This catheter is intended for short- or long-term vascular access and should not be used for any purpose other than indicated in these instructions.
• The patient is known or is suspected to be allergic to materials contained in the device.

3. Device Description

Device Name: Pro-Line® Power Injectable Central Venous Catheters

Description of Device: The Pro-Line® Power Injectable Central Venous Catheters are made from specially formulated biocompatible medical grade materials and are available in a variety of lumen configurations and sizes to accommodate clinical needs. They are packaged in a tray with accessories necessary for percutaneous insertion using a microintroducer (Modified Seldinger or Seldinger technique). The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the Pro-Line® Power Injectable CVC may not exceed 300psi.

Device Name: Pro-Line® Power Injectable Central Venous Catheters

Description of Device: The Pro-Line® Power Injectable Central Venous Catheters are made from specially formulated biocompatible medical grade materials and are available in a variety of lumen configurations and sizes to accommodate clinical needs. They are packaged in a tray with accessories necessary for percutaneous insertion using a microintroducer (Modified Seldinger or Seldinger technique). The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the Pro-Line® Power Injectable CVC may not exceed 300psi.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 5F Single Lumen (3.64g) and 6F Triple Lumen (7.76g) Pro-Line® devices.

The percentage ranges in the table below are based on the weight of the 5F Single Lumen (3.64g) and 6F Triple Lumen (7.76g) Pro-Line® devices.

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 device can be inserted using a standard or modified Seldinger percutaneous surgical technique. Catheter insertion is to be done using aseptic techniques in a sterile field, preferably in an operating room. Once in place, the CVC can be connected to a gravity-feed intravenous (IV) bag, or connected to a pump, for administration of fluids and medications. Catheter care includes use of a locking solution to maintain catheter function. Catheter removal is a surgical procedure intended to be performed by a physician familiar with the appropriate techniques.

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 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 pull tunneler off of catheter. Use scalpel to sever catheter from tunneler.
• 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:
• 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.
• Catheter will be damaged if clamps other than what is provided with this kit 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 by x-ray prior to use. Monitor tip placement routinely per institution policy.
• Discard biohazard according to facility protocol.
• 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.
• 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.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 31 August 2024 there were 47 complaints for 80,809 units sold, giving an overall complaint rate of 0.058%. 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-Line® Power Injectable Central Venous Catheter, 738 catheters had a 95.42 day [95%CI: 83.66 – 107.18 days] duration of use that has been found in clinical use reported to date. Based on this information, the Pro-Line® Power Injectable Central Venous 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 three published literature articles representing 54 cases specific to the Pro-Line® device family. The articles included one randomized controlled trial (Yong et al.), one prospective study (Kehagias et al.), and a case study (Highnell et al.). Bibliography: Hignell, E. R., & Phelps, J. (2020). Recurrent central venous catheter migration in a patient with brittle asthma. The journal of vascular access, 21(4), 533-535. Kehagias, E., & Tsetis, D. (2019). The “Arm-to-Chest Tunneling” technique: A modified technique for arm placement of implantable ports or central catheters. The journal of vascular access, 20(6), 771-777. 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.

• 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. 2 Pro-Line® cases, described as 5F and double lumen, were collected. The following outcome measure was confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp Pro-Line® 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. 8 Pro-Line® cases inclusive of several variant devices across French size (5F and 7F) and lumen configuration (single and dual) 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-Line® 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. 7 responses were acquired relating to the Pro-Line® device family. Across an estimated 580 products used yearly, the mean average dwell time was 126.4 days (Range: 45 – 240 days), and the mean longest dwell time was 405 days (Range: 235 – 547.5 days).

• Source:PMCF_Infusion_222

The University of Pittsburgh Medical Center (UPMC) Database assessed safety and performance outcome information for Pro-Line® and Vascu-Line® SL (referred to in the data set as “LT Silicone CVC”) Medcomp Infusion CVCs. 825 of 1,028 cases (80.25%) are directly from the University of Pittsburgh Medical Center Presbyterian which the investigator notes may be a population prone to infection and chronic illness. The remainder of the cases are from other hospitals in the UPMC system which the investigator notes may have a patient population more similar to a community hospital. The multi-center approach aimed to be representative of the broad spectrum of users within the user population. 739 Pro-Line® cases inclusive of several variant devices across French size (5F and 6F) and lumen configuration (single, double, and 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-Line® devices:

• Source:PMCF_Infusion_231

The King Faisal Specialist Hospital & Research Center dataset was finalized 22 March 2023. The full King Faisal Specialist Hospital & Research Center dataset was acquired on 23 February 2023. The country of origin of the data set is Saudi Arabia. The full dataset included information on 92 Vascu-Line®, 2 Pro-Line®, and 1 Vascu-Line® SL cases with dates of insertion ranging from 22 December 2021 to 11 January 2023 and dates of removal (or last known follow-up) ranging from 09 May 2022 to 23 February 2023. Real-world performance data on the use of two Medcomp Pro-Line® catheters was collected.

• Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp's product offerings. 11 respondents responded that they or their facility have used Medcomp CVCs, with 7 of those respondents using the Pro-Line® device. There were no differences in mean user sentiments within CVCs 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 CVCs (n=11):

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 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 access to the central venous system without requiring frequent needlesticks is 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