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): Hemo-Cath® LT

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: 00884908106MS

Medical Device Nomenclature: F900202 – Permanent Hemodialysis Catheter and Kits

Class of Device: III

Date First CE Certificate Issued: Nov-97

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: Hemo-Cath® LT Catheters are intended for use in adult and 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 and apheresis 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): Hemo-Cath® LT 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 and apheresis.

Target Population(s): Hemo-Cath® LT Catheters are intended for use in adult and 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 and apheresis 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: Hemo-Cath® LT Catheter Sets Product Family

Description of Device: The Hemo-Cath® LT 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 400 mL/min (12.5F) and 250 mL/min (8F). The catheter is available in a variety of sizes to accommodate physician preference and clinical needs.

Device Name: Hemo-Cath® LT Catheter Sets Product Family

Description of Device: The Hemo-Cath® LT 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 400 mL/min (12.5F) and 250 mL/min (8F). 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 18cm catheter (11.44g) and the 24cm catheter (11.81g).

The percentage ranges in the table below are based on the weights of the 15cm catheter (12.08g) and the 32cm catheter (13.89g).

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. The catheter may also be used for apheresis. Apheresis can happen in a blood bank facility or hemodialysis center. Like hemodialysis, apheresis treatments withdraw blood from the catheter and then return blood through the catheter. There are different types of apheresis. Where hemodialysis cleans blood, apheresis separates and removes a component of blood.

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 40767BSI), 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 40767BSI), the Hemo-Cath LT 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.
• DO not use iodine or iodine-based disinfectants on this catheter. Failure of catheter will occur. Alcohol based solutions are recommended as the antiseptic solution that can be used on this catheter. Precautions listed in the Hemo-Cath LT Catheter IFUs 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 Hemo-Cath® LT 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.
• Do not over-expand subcutaneous tissue during tunneling. Over-expansion may delay/prevent cuff in-growth.
• Do not pull tunneler out at an angle. Keep tunneler straight to prevent damage to catheter tip.
• 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.
• DO NOT bend the 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.
• 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 30 September 2024 there were 134 complaints for 36,417 units sold, giving an overall complaint rate of 0.368%. There were zero 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® 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 Hemo-Cath® LT 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 Hemo-Cath® LT Catheter, 401 catheters had a 49.1 day [95%CI: 40.7 – 57.5 days] duration of use that has been found in clinical use reported to date. Based on this information, the Hemo-Cath® LT 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 eleven published literature articles representing 342 Hemo-Cath® LT device family specific cases and an additional 4,870 mixed cohort cases inclusive of the Hemo-Cath® LT device family. The articles include two prospective studies (Lucas et al., 2014, Mohamed et al., 2022), nine retrospective studies (Stravropoulos et al., 2003, Onder et al., 2007, Haas et al., 2010, Granata et al., 2018, Silva et al., 2020, Kumar et al., 2021, Novljan et al., 2023, Prakash et al., 2023, Salah et al., 2024), and two case studies (Lin et al., 2013, Lin et al., 2024). Bibliography: Granata A, Zanoli L, Trezzi M, et al. Anatomical variations of the left anonymous trunk are associated with central venous catheter dysfunction. Journal of Nephrology. 2018;31(4):571-576. Lin ZC, Wu DK, Lin WC, Jaw TS, Chen HS, Liu GC. Stent-graft treatment of iatrogenic vertebral artery pseudoaneurysm and arteriovenous fistula. Chinese Journal of Radiology (Taiwan). 2013;38(4):135-138. Lucas TC, Tessarolo F, Veniero P, et al. Quantification of fibrin in blood thrombi formed in hemodialysis central venous catheters: A pilot study on 43 CVCs. Journal of Vascular Access. 2014;15(4):278-285. Haas B, Chittams JL, Trerotola SO. Large-bore Tunneled Central Venous Catheter Insertion in Patients with Coagulopathy. Journal of Vascular and Interventional Radiology. 2010;21(2):212-217. Kumar G. Catheter‑related blood stream infections among children on hemodialysis over 7 years: A single‑center experience. Asian J Pediatr Nephrol 2021;4:22-5. 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. Jesus-Silva SGd, Oliveira JdS, Ramos KTF, et al. Análise das taxas de infecção e duração de cateteres de hemodiálise de curta e longa permanência em hospital de ensino. J vasc bras. 2020;19. Stavropoulos SW, Pan JJ, Clark TWI, et al. Percutaneous transhepatic venous access for hemodialysis. Journal of Vascular and Interventional Radiology. 2003;14(9 I):1187-1190. Prakash, R., Ohri, A., Udani, A., & Ali, U. S. (2023). Survival of Tunneled Double Lumen Cuffed Catheters in Children on Maintenance Hemodialysis–A Retrospective Cohort Study. Indian Journal of Nephrology, 33(5), 348-355. Salah, D. M., Fadel, F. I., Abdel Mawla, M. A., Mooty, H. N., Ghobashy, M. E., Salem, A. M., ... & Abd Alazem, E. A. (2024). Vascular access challenges in hemodialysis children. Italian Journal of Pediatrics, 50(1), 11. Novljan, G., Rus, R. R., &. Battelino, N. (2023). Comparison of cuffed and uncuffed catheter-related bloodstream infection rates in small hemodialysis patients. Pediatr Nephrol 38, 2255–2491 Lin, T. C., Huang, H. E., Liu, C. A., Na, M. Y., Tsai, H. L., & Chang, J. W. (2024). Bidirectional approach of vascular access for balloon angioplasty in permcath-associated superior vena cava syndrome presenting with transudative chylothorax. Pediatrics & Neonatology, 65(5), 506-508. Mohamed, E. G., Ahmed, S., Mostafa, G., & Bazaraa, M. (2022). Image Guided Techniques for Central Venous Access in Critically Ill Pediatric Patients. The Medical Journal of Cairo University, 90(12), 2131-2141.

Source:LTHD Data Collection Survey Report_B

The Long-Term Hemodialysis Catheter Data Collection Survey was intended to gather safety and performance outcome information from sites that purchase Medcomp long-term hemodialysis catheters for use in EU MDR clinical evaluation. Responses were requested to be completed by physicians or other site employees with oversight and direction from a physician. The surveys were distributed globally to existing Medcomp customers. Responses were collected from twenty-one sites, spanning nine countries (Colombia, Croatia, El Salvador, Greece, Italy, Netherlands, Panama, Uruguay, and USA) across North America, South/Latin America, and Europe. All patients described in this survey listed hemodialysis as the indication for treatment, with an average age of 70.9 years. Patient gender was not recorded in the survey. All 57 catheters described in the study were 12.5F Hemo-Cath® LT Catheters of 28cm length. Parameter:Value:Standard Deviation:95% Confidence Interval Dwell Time (Mean Days):104.6:65.7:43.8 – 165.4 Procedural Outcomes (Insertion Success):100%:N/A:100% - 100% Catheter Related Blood Stream Infection (CRBSI) (number per 1,000 catheter days):0:N/A:N/A Tunnel Infection Rate (number per 1,000 catheter days):0:N/A:N/A Exit Site Infection Rate (number per 1,000 catheter days):1.37:N/A:N/A Catheter Associated Venous Thrombus (CAVT) (number per 1,000 catheter days):1.37:N/A:N/A

Source:Dr. Trerotola Data Report_B

The dataset was provided by Scott O. Trerotola, MD an Interventional Radiologist at the Hospital of the University of Pennsylvania. Dr. Trerotola is also Stanley Baum Professor of Radiology, Professor of Radiology in Surgery, Vice Chair for Quality, Radiology, Associate Chair and Chief, Interventional Radiology, and Director, Penn HHT Center of Excellence at the Perelman School of Medicine at the University of Pennsylvania. The dataset is consecutive, comprehensive, and includes catheter placements by interventional radiology Attending and Fellowship Physicians, as well as Residents under Attending supervision. All 401 Hemo-Cath® LT catheters described in the study were 12.5F Hemo-Cath® LT Catheters of variable lengths inserted percutaneously. There were 324 catheters of 28cm length, 73 catheters of 32cm length, and 4 catheters of unknown length. 399 catheters were indicated for apheresis, and 2 catheters were indicated for hemodialysis. 73 catheters were placed with the Left Internal Jugular, 324 catheters were placed in the Right Internal Jugular, and the insertion site of 1 catheter was unknown. Parameter:Value:Standard Deviation:95% Confidence Interval Dwell Time (Mean Days):49.1:86:40.7 – 57.5 Procedural Outcomes (Insertion Success):99.3%:N/A:98.5% - 100% Catheter Related Blood Stream Infection (CRBSI) (number per 1,000 catheter days):1.83:N/A:N/A Tunnel Infection Rate (number per 1,000 catheter days):0.36:N/A:N/A Exit Site Infection Rate (number per 1,000 catheter days):0.05:N/A:N/A Catheter Associated Venous Thrombus (CAVT) (number per 1,000 catheter days):0:N/A:N/A

• 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 3 of those respondents using the Hemo-Cath LT 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. 2 Hemo-Cath® LT cases, inclusive of several variant categories across French size (8F, 12.5F) and length (18cm, 24cm) were collected. The following outcome measures were collected for the Medcomp Hemo-Cath® LT 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. 35 Hemo-Cath® LT cases inclusive of several variant devices were collected. All cases were described as 8F and 12.5F and Straight and Pre-Curved Cases, configurations (straight, pre-curved), and lengths (18cm, 24cm, 28cm, 32cm), representation of 18cm, 24cm, 28cm and 32cm length catheters. The following State of the Art safety and performance outcome measures were observed for Medcomp Hemo-Cath® LT devices:

Overall Summary of Clinical Safety and Performance

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