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): Duo-Flow® 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: 00884908294NN

Medical Device Nomenclature: F900201 – Temporary Hemodialysis Catheters and Kits

Class of Device: III

Date First CE Certificate Issued: March 2001

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 Netherlands NB2797

Device Grouping and Variants

The devices in scope of this document are all short-term hemodialysis catheter 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 Duo-Flow® Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom immediate central venous vascular access for short-term hemodialysis is deemed necessary based on the direction of a qualified, licensed physician. The catheter 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 Duo-Flow® Catheter is indicated for short-term use where vascular access is required for less than 14 days for the purpose of hemodialysis.

Target Population(s): Duo-Flow® catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom immediate central venous vascular access for short-term hemodialysis is deemed necessary based on the direction of a qualified, licensed physician. The catheter is not intended for use in pediatric patients.

Contraindications and/or Limitations:

• Known or suspected allergies to any of the components of the catheter or the kit.
• This device is contraindicated for patients exhibiting severe, uncontrolled coagulopathy or thrombocytopenia.

3. Device Description

Device Name: Duo-Flow® Catheter

Description of Device: The Duo-Flow® Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 400 mL/min (9F Straight), 300ml/min (9F & 11F IJ), 450ml/min (11.5F Straight). The catheter is available with a straight or pre- curved lumen in a variety of French sizes and lengths to accommodate physician preference and clinical needs. The pre-curved devices are not suitable for femoral insertion.

Device Name: Duo-Jet® Catheter Nikkiso Duo-Flow® Catheter

Description of Device: The Duo-Jet® Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color- coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 300ml/min (11.5F Straight) and 400 mL/min (9F Straight & 11.5F IJ). The catheter is available with a straight or pre-curved lumen in a variety of French sizes and lengths to accommodate physician preference and clinical needs. The pre-curved devices are not suitable for femoral insertion. Nikkiso Duo-Flow® Catheter The Nikkiso Duo-Flow® Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 400 mL/min.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weight of the 11.5F X 12cm (10.21g) and 11.5F X 24cm (11.75g) Duo-Flow catheters.

The percentage ranges in the table below are based on the weight of the 9F X 12cm (9.81g) and 9F X 20cm (10.41g) Duo-Flow catheters.

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: Hemodialysis catheters are centrally placed access tubes. A typical hemodialysis catheter uses a thin, flexible tube. The tube has two openings. The tube goes into a large vein. The vein is usually the internal jugular vein. Blood withdraws through one lumen of the catheter. The blood flows to the dialysis machine through a separate tubing set. The blood is then processed and filtered. The blood returns to the patient through the second lumen. This device is used when dialysis must start at once. Patients may not have a functioning AV fistula or graft. Catheter hemodialysis normally happens on a short-term basis.

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: 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 when considered with respect to the expected clinical benefits of the Duo-Flow® Catheter and the benefits of other similar hemodialysis devices.

Warnings and Precautions:

Warnings listed for the Duo-Flow® Catheter are as follows:

• 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 tubing or catheter lumen.
• Do not use scissors to remove dressing.
• Examine catheter lumen and extensions before and after each treatment for damage.
• To prevent accidents, ensure the security of all caps and bloodline connections prior to and between treatments.
• 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 and remove the catheter.
• Before attempting catheter insertion, ensure that you are familiar with the potential complications and their emergency treatment should any of them occur.
• Repeated overtightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.
• The catheter will be damaged if clamps other than what is provided with this kit are used.
• Avoid clamping near the Luer Lock and hub of the catheter.
• Clamping of the tubing repeatedly in the same location may weaken tubing.
• 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.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 31 December 2023 there were 94 complaints for 208,951 units sold, giving an overall complaint rate of 0.045%. 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. Medcomp® STHD catheters are subjected to, and must pass, simulated use testing intended to replicate 30 days use as part of device development. The Duo-Flow® Catheter passed this testing. Clinical guidelines recommend to limit the use of temporary, noncuffed, nontunneled dialysis catheters to a maximum of 2 weeks (KDOQI 2019), however, duration of use of these catheters has varied in available clinical evidence identified by the manufacturer to date. Although Medcomp® catheters materials contain non-degradable polymers, fully functional catheters may be removed for other reasons, such as intractable infection or change of therapy. Published clinical literature does not always focus on the physical lifetime of a catheter for these reasons. In the case of the Duo-Flow® Catheter, post market clinical follow- up activities and published literature have found mean durations of use ranging from 2 days to 4.53 months reported to date. Based on this information, the Duo-Flow® catheters have a 30 day 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.

Variants Relying on Equivalence:

Variants Contributing Clinical Data:

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 devices were used for the device's clinical evaluation.

Summary of Clinical Data from Other Sources

Source:Summary of Published Literature

Thirteen published literature articles representing 460 device family specific cases and 45 mixed cohort cases inclusive of the Duo-Flow® device family have been sourced by the manufacturer to date. The articles include five randomized controlled trials (Weijmer et al., 2008, Weijmer et. al., 2005, and Kukavica et al., 2009, Masolitin et al., 2022, Ratanarat et al., 2023), four prospective studies (Bingol et al., 2007, Elaldi et. al., 2001, Sramek et al., 2002, Baird et al., 2010), three retrospective studies (Demirkilic et. al., 2004, Haller et. al., 2009, Novak et. al., 1997), and one case study (Ekinci et al., 2018).

Bibliography:

Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp’s product offerings. 20 respondents responded that they or their facility have used Medcomp short-term hemodialysis catheters, with 0 of those respondents using the Duo-Flow® 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 short-term hemodialysis catheters (n=20):

Source:PMCF_STHD_211 (Retrospective Patient-Level Usage Data Survey)

The Short-Term Hemodialysis (STHD) Product Line Data Collection Survey aimed to assess safety and performance outcome information for all variants of Medcomp STHD catheters. 19 survey responses were collected from 10 countries representing 381 device cases. 15 Duo-Flow® cases inclusive of several variant devices were collected. All cases were described as 11.5F and Pre-Curved, with representation of 15cm and 20cm length catheters.

The following outcome measures were confirmed to be within State of the Art safety and performance outcome measures from published literature for Medcomp Duo-Flow® devices:

Source:PMCF_DLOCK_211 (Retrospective Database Analysis)

The Netherlands 2021A data report is intended to assess safety and performance outcome information from collected data on Medcomp Long-Term Hemodialysis Catheters, Short-Term Hemodialysis Catheters, and 30.0% Duralock-C Locking Solution for use in EU MDR clinical evaluation. These outcome measures include dwell time, reasons for removal, exit site infection rates, catheter related blood stream infection (CRBSI) rates, and catheter associated venous thrombosis (CAVT) rates. Product family identification information was also included in the collected data. The dataset was provided by Marcel C. Weijmer, MD, PhD the head of the Department of Internal Medicine and Nephrology at OLVG located in Amsterdam, Netherlands. The dataset is comprised of consecutive cases from January 2010 to October 2019. The dataset was obtained 26 February 2021 and copied into a password protected un-editable format per QA-CL-400. 4 Duo-Flow® cases, described as 11.5F and Pre-Curved, were collected.

The following outcome measures were collected for Medcomp Duo-Flow® devices:

Source:PMCF_Infusion_211 (Retrospective Patient-Level Usage Data Survey)

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. 4 Duo-Flow® cases inclusive of several variant devices across French size (9F, 11.5F) and length (12cm, 15cm, 20cm) were collected.

The following outcome measures were collected for Medcomp Duo-Flow® devices:

Source:PMCF_STHD_242 (Short-Term Hemodialysis Truveta Data Analysis)

The Short-Term Hemodialysis (STHD) Truveta data analysis assessed safety and performance outcome information for Medcomp® and competitor devices present in Truveta Studio. Truveta data comes from a growing collective of more than 30 health systems that provide 17% of the daily clinical care across all 50 U.S. states from 800 hospitals and 20,000 clinics, representing the full diversity of the United States. The population used for data analysis was derived utilizing Truveta Studio’s proprietary coding language (Prose) and unique device identifier (UDI) codes representing all saleable Medcomp® STHD devices and STHD devices distributed and/or manufactured by other companies. 6 Duo-Flow® cases inclusive of several variant devices were collected. Cases were described as 11.5F and Pre-Curved Cases included multiple French sizes (9F, 11.5F), configurations (straight, pre-curved), and lengths (12cm, 15cm, 20cm).

The following State of the Art safety and performance outcome measures were observed for Medcomp Duo-Flow® devices:

The catheter brand logistic regression model did not find that any Medcomp® catheter brands were statistically significantly associated with the incidence of CRBSI. The brand agnostic logistic regression found that Triple Lumen catheters OR: 1.63 (95%CI: 1.17 – 2.28) (as compared to the reference category of Double Lumen catheters) and Pre-Curved catheters OR: 7.26 (95%CI: 1.32 – 32.69) (as compared to the reference category of straight catheters) were statistically significantly associated with the incidence of CRBSI.

Overall Summary of Clinical Safety and Performance

Upon review of the Duo-Flow® catheter data across all sources, it is possible to conclude that the benefits of the subject device 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 Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 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