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): Split Cath®

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: 00884908102MJ

Medical Device Nomenclature: F900202 – Permanent Hemodialysis Catheter and Kits

Class of Device: III

Date First CE Certificate Issued: 2-Feb

Authorized Representative Name and SRN: 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 long-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: Split Cath® Catheters are intended for use in pediatric patients who do not have functional permanent vascular access or are not candidates for permanent vascular access for whom central venous vascular access for 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): Split Cath® Catheters are indicated for short-term or long-term use where vascular access is required for 14 days or more for the purpose of hemodialysis.

Target Population(s): Split Cath® Catheters are intended for use in pediatric patients who do not have functional permanent vascular access or are not candidates for permanent vascular access for whom central venous vascular access for hemodialysis is deemed necessary based on the direction of a qualified, licensed physician.

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: Split Cath® Catheter

Description of Device: The Split Cath® Catheter is a long-term double lumen, single access catheter that is used to remove and return blood through two separate passages (lumens). Each lumen is connected through an extension line. The transition between lumen and extension is housed within a molded hub. Each lumen has the priming volume identified by identification rings assembled into the clamps on the extensions. A polyester cuff is placed on the catheter’s lumen for tissue ingrowth to anchor the catheter. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 250 mL/min. The catheter is available in a variety of sizes to accommodate physician preference and clinical needs.

Device Name: Split Cath® Catheter

Description of Device: The Split Cath® Catheter is a long-term double lumen, single access catheter that is used to remove and return blood through two separate passages (lumens). Each lumen is connected through an extension line. The transition between lumen and extension is housed within a molded hub. Each lumen has the priming volume identified by identification rings assembled into the clamps on the extensions. A polyester cuff is placed on the catheter’s lumen for tissue ingrowth to anchor the catheter. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. The catheter has been tested at flow rates of up to 250 mL/min. The catheter is available in a variety of sizes to accommodate physician preference and clinical needs.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 15cm catheter (10.8g) and the 24cm catheter (11.293g).

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

Note:Accessories containing stainless steel may contain up to 4% weight of the CMR substance cobalt.

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. Long-term access may occur in some cases. For example, when there are problems supporting an AV fistula or graft.

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 IFU (IFU 40770BSI), 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. As per product IFU (IFU 40770BSI), the Split Cath® Catheters have the following warnings:

• 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 in the Split Cath® Catheter IFU 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. Additional warnings and cautions listed in the Split Cath® Catheter IFUs are as follows:
• Physician discretion is strongly advised when inserting this catheter in patients who are unable to take or hold a deep breath.
• Patients requiring ventilator support are at increased risk of pneumothorax during subclavian vein cannulation, which may cause complications.
• Extended use of the subclavian vein may be associated with subclavian vein stenosis.
• The incidence of infection may be increased with femoral vein insertion.
• Do not over-expand subcutaneous tissue during tunneling. Over-expansion may delay/prevent cuff in-growth.
• Splitting the lumens beyond this point may result in excess tunnel bleeding, infection, or damage to the catheter lumens.
• DO NOT grasp and pull the guidewire prior to releasing the J-Straightener. Damage to the guidewire may occur if it is pulled against the restraint of the J- Straightener.
• The length of the wire inserted is determined by the size of the patient. Monitor patient for arrhythmia throughout this procedure. The patient should be placed on a cardiac monitor during this procedure. Cardiac arrhythmias may result if guidewire is allowed to pass into the right atrium. The guidewire should be held securely during this procedure.
• Insufficient tissue dilation can cause compression of the catheter lumen against the guidewire causing difficulty in the insertion and removal of the guidewire from the catheter. This can lead to bending of the guidewire.
• Do not leave vessel dilator(s) in place as an indwelling catheter to avoid possible vessel wall perforation.
• DO NOT bend sheath/dilator during insertion as bending will cause the sheath to prematurely tear. Hold sheath/dilator close to the tip (approximately 3cm from tip) when initially inserting through the skin surface. To progress the sheath/dilator towards the vein, regrasp the sheath/dilator a few centimeters (approximately 5cm) above the original grasp location and push down on the sheath/dilator. Repeat procedure until sheath/dilator is fully inserted.
• Never leave sheath in place as an indwelling catheter. Damage to the vein will occur.
• Do not clamp the dual lumen portion of the catheter. Clamp only the extensions. Do not use serrated forceps, use only the in-line clamps provided.
• Do not pull apart the portion of the sheath that remains in the vessel. To avoid vessel damage, pull back the sheath as far as possible and tear the sheath only a few centimeters at a time.
• Assure that all air has been aspirated from the catheter and extensions. Failure to do so may result in air embolism.
• Failure to verify catheter placement may result in serious trauma or fatal complications.
• Care must be taken when using sharp objects or needles in close proximity to catheter lumen. Contact from sharp objects may cause catheter failure.
• Only clamp catheter with in-line clamps provided.
• Extension clamps should only be open for aspiration, flushing, and dialysis treatment.
• Always review hospital or unit protocol, potential complications and their treatment, warnings, and precautions prior to undertaking any type of mechanical or chemical intervention in response to catheter performance problems.
• Only a physician familiar with the appropriate techniques should attempt the following procedures.
• Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens, health care professionals should always use Universal Blood and Body Fluid Precautions in the care of all patients.
• Always review hospital or unit protocol, potential complications and their treatment, warnings, and precautions prior to catheter removal.
• Do not pull distal end of catheter through incision as contamination of wound may occur.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 31 March 2025 there were 14 complaints for 17,118 units sold, giving an overall complaint rate of 0.082%. 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® catheters are subjected to, and must pass, simulated use testing intended to replicate use 3 times per week for 12 months as part of device development. The Split Cath® Catheter passed this testing. Although Medcomp® catheters contain no materials which degrade over time, fully functional catheters may be removed for other reasons, such as intractable infection, change of therapy (such as Renal replacement (transplant) or use of an arterio-venous graft/fistula). Published clinical literature does not always focus on the physical lifetime of a catheter for these reasons. In the case of the Split Cath® Catheter, 19 catheters had a 280-day median duration of use that has been found in clinical use reported to date. Based on this information, the Split Cath® 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 devices 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 four published literature articles representing 45 Split Cath® device family specific cases and an additional 277 mixed cohort cases inclusive of the Split Cath® device family. The articles include four retrospective studies (Onder et al., 2007, Peynircioglu et al., 2007, Adeb et al., 2012, Paglialonga et al., 2012). Bibliography: Adeb M, Baskin KM, Keller MS, et al. Radiologically placed tunneled hemodialysis catheters: a single pediatric institutional experience of 120 patients. Journal of vascular and interventional radiology : JVIR 2012;23:604-12. Onder AM, Chandar J, Saint-Vil M, et al. Catheter survival and comparison of catheter exchange methods in children on hemodialysis. Pediatric nephrology (Berlin, Germany) 2007;22:1355-61. Paglialonga F, Rossetti G, Giannini A, et al. Split catheters in children on chronic hemodialysis: a single-center experience. Hemodialysis international. International Symposium on Home Hemodialysis 2012;16:394-400. Peynircioglu B, Ozkan F, Canyigit M, et al. Radiologically placed tunneled internal jugular catheters in the management of chronic hemodialysis and long-term infusion therapies in the pediatric population. Journal of vascular and interventional radiology : JVIR 2007;18:875-81.

• Source:PMCF_Medcomp_211

The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp’s product offerings. 28 respondents responded that they or their facility have used Medcomp long-term hemodialysis catheters, with 4 of those respondents using the Split Cath device. There were no differences in mean user sentiments within long-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 long-term hemodialysis catheters (n=28):

• 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. 1 Split Cath® case, described as 10F x 18cm, was collected. The following outcome measures were collected for the Medcomp Split Cath device:

• Source:PMCF_LTHD_242

The Long-Term Hemodialysis (LTHD) 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® LTHD devices and LTHD devices distributed and/or manufactured by other companies. 9 Split Cath® cases inclusive of several variant devices were collected. Cases were described as 10F and Straight Cases, configurations (straight), and lengths (15cm, 18cm), representation of 15cm and 18cm length catheters. The following State of the Art safety and performance outcome measures were observed for Medcomp Split Cath® devices:

Overall Summary of Clinical Safety and Performance

Upon review of the Split Cath® Catheter data across all sources, it is possible to conclude that the benefits of the subject device, which is facilitating hemodialysis in patients in whom other therapies or conservative care 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 Split Cath® catheters.

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. In certain circumstances, patients who may be suitable for home hemodialysis may manipulate the external connections of the catheter. As per guidelines stated from the International Society of Hemodialysis, if home dialysis is recommended, each patient will undergo a thorough training in order to obtain optimal results from home dialysis treatments. The objectives of the training program are to (1) provide the appropriate amount of information to ensure that the patient will be able to dialyze safely at home; (2) enable the patient to monitor and manage other elements of his or her chronic kidney disease, such as obtaining samples for lab work and maintaining appropriate nutrition and diet; and (3) help the patient and his or her care partner(s) cope with barriers and fears associated with home HD During training, the patient will also receive technical education on the operations and maintenance of the water treatment system. During training, the ideal nurse trainer-to-patient ratio is typically 1:1. An idealized schedule of training is created, with weekly areas of focus and training objectives. In practice, however, training is individualized to address any identified learning barriers or risks for failure.

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

Revision History