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-Split® 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: 00884908298NW

Medical Device Nomenclature: F900201 – Temporary Hemodialysis Catheters and Kits

Class of Device: III

Date First CE Certificate Issued: 5-Jul

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-Split® 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-Split® Catheter is indicated for short-term use where vascular access is required for less than 14 days for the purpose of hemodialysis for Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD).

Target Population(s): Duo-Split® 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-Split® Catheter

Description of Device: Duo-Split® Catheter:The Duo-Split® 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. The catheter lumens are split to form two free floating lumens. 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 500 mL/min. The catheter is available with a straight lumen and straight extensions (straight), pre-curved lumen and straight extensions (pre-curved/IJ), in a variety of lengths to accommodate physician preference and clinical needs. The pre-curved and IJ devices are not suitable for femoral insertion and are not available at the 30cm length.

Device Name: Duo-Split® Catheter

Description of Device: Duo-Split® Catheter:The Duo-Split® 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. The catheter lumens are split to form two free floating lumens. 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 500 mL/min. The catheter is available with a straight lumen and straight extensions (straight), pre-curved lumen and straight extensions (pre-curved/IJ), in a variety of lengths to accommodate physician preference and clinical needs. The pre-curved and IJ devices are not suitable for femoral insertion and are not available at the 30cm length.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 12cm catheter (9.64g) and the 24cm catheter (12.19g).

Note:Per the instructions for use, the device is contraindicated for patients with known or suspected allergies to the above materials.

Note: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.

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-Split® Catheter and the benefits of other similar hemodialysis devices.

Warnings and Precautions:

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

• Warnings listed for the Duo-Split® 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. Precautions listed for Duo-Split® Catheter are as follows:
• 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 13 complaints for 43,251 units sold, giving an overall complaint rate of 0.030%. 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-Split® 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).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-Split® Catheter, 91 catheters had a mean dwell time of 7.1 days [95%CI: 5.9 – 8.3 days] duration of use that has been found in clinical use reported to date. Based on this information, the Duo-Split® catheters have a 30 day lifetime.

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. An equivalency within the manufacturer’s technical documentation demonstrates 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 has been rationalized.

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

Previous clinical evidence literature searches found one published literature article representing 6 Duo-Split® device family specific cases. The most recent clinical evidence search found no additional articles relating to the Duo-Split® device family. The article included an uncontrolled study (Mankus et al.). Bibliography: Mankus R, Ash S, Sutton J, Schweikert T. The Duo Split Acute Hemodialysis Catheter: a Two-Limbed Acute Hemodialysis Catheter with Novel Technique for Insertion. Asaio Journal. 2000;46(2):222.

• Source:PMCF_STHD_231

The dataset was provided by Travis Shadwick, an interventional technologist at Indiana University Health West Hospital in Avon, Indiana, United States of America. The dataset includes information on 92 Duo-Split® insertion cases with dates of insertion ranging from 23 March 2020 to 27 February 2023 and dates of removal (or last known follow-up) ranging from 13 April 2020 to 01 March 2023. All insertion data is from Indiana University Health. The dataset was obtained on 03 March 2023. 92 Straight Duo-Split® cases inclusive of several variant devices across catheter length (15cm, 20cm, 24cm, 30cm) 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 Duo-Split® catheters.

• 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 2 of those respondents using the Duo-Split® 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):

Overall Summary of Clinical Safety and Performance

Upon review of the Duo-Split® 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