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): Symetrex®

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: 00884908307N6

Medical Device Nomenclature: F900202 — Permanent Hemodialysis Catheter and Kits

Class of Device: III

Date First CE Certificate Issued: 16-Oct

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: As per product IFU (IFU 40818-1BSI), Symetrex® Catheters are intended for use in adult 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): As per product IFU (IFU 40818-1BSI), the Symetrex® Catheter is 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): Symetrex® Catheters are intended for use in adult 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 not intended for use in pediatric patients.

Contraindications and/or Limitations:

3. Device Description

Device Name: Symetrex®

Description of Device: The Symetrex® Catheter is a 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions. The catheter has been tested at flow rates of up to 500 mL/min. The catheter is available in a variety of lengths and with or without sideholes to accommodate physician preference and clinical needs.

Device Name: Symetrex®

Description of Device:

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 15.5F x 19cm catheter without sideholes (11.88g), 15.5F x 19cm catheter with sideholes (11.87g), 15.5F x 42cm catheter without sideholes (15.60g) , and 15.5F x 42cm catheter with sideholes (15.59g).

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 40818-1BSI), 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 40818-1BSI), the Symetrex® 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 clamp the shaft of the catheter. Use only the line extension clamps which have been provided with the catheter. • Do not insert the valved pull-apart sheath/introducer further than necessary. Depending upon patient size and access site, it may not be necessary to insert the entire length of the introducer into the vessel. • 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. • Do not suture through any part of the catheter. There is a danger of tearing the catheter tubing or damaging the suture wing from the bifurcate if excessive force is applied to the catheter. • Do not use excessive force to flush obstructed lumen. Precautions listed in the Symetrex® Catheter IFU are as follows: • Before attempting procedure, ensure that you are familiar with the potential complications and their emergency treatment should any of them occur. • 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. • 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 catheter. • To minimize the risk of air embolism or extravasation, keep the catheter clamps closed at all times when not in use or when attached to a syringe, IV tubing, or bloodlines. • Before attempting catheter insertion, ensure that you are familiar with the potential complications and their emergency treatment should any of them occur. • To help avoid air embolism, fill (prime) the device with sterile, anticoagulant lock solution or normal saline solution prior to catheter insertion. • Avoid sharp or acute angles that could compromise the opening of the catheter lumens. • 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. • Health care professionals should always use universal blood and body fluid precautions in the care of all patients to minimize the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens. Sterile technique must be strictly adhered to during any handling of the device. • Peel-away introducer must only be advanced over a guidewire. • The valved pull-apart sheath/introducer is designed to reduce blood loss and the risk of air intake. • The valved pull-apart sheath/introducer is not intended for arterial use. • Discard biohazard according to facility protocol. • Examine the device after it is removed from the patient to ensure no foreign material remains inside the patient.

Other Relevant Aspects of Safety: For a period of 01 January 2020 to 31 March 2025 there were 34 complaints for 27,900 units sold, giving an overall complaint rate of 0.122%. 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® catheters are subjected to, and must pass, simulated use testing intended to replicate 12 months use as part of device development. The Symetrex® Catheter passed this testing. 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 Symetrex® Catheter, 46 catheters had a 87 day [95%CI: 61.7 – 112.3 days] duration of use that has been found in clinical use reported to date. Based on this information, the Symetrex® 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 clinical evaluation report 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 is rationalized in the 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:LTHD Data Collection Survey Report

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. At least partial data was collected on 64 Symetrex® catheter product family cases totalling 4,004 catheter days. Of these 64 cases, 55 described as with sideholes and 13 described as without sideholes. There were 26 catheters of 19cm length, 31 catheters of 23cm length, 6 catheters of 28cm length, and 1 catheters of 33cm. Information was collected on Insertion Success (98.4%, n=64) and dwell time (mean 87 days, 95% CI: 61.7 112.3, n=46). There were eight reports of catheter associated venous thrombus (2 per 1,000 catheter days), and no reports of tunnel infection, exit site infection, or catheter related blood stream infection. These outcomes, aside from catheter associated venous thrombus, were concluded to be within State of the Art safety and performance outcome measures from published literature. This is likely attributable to the limited catheter days available for statistical testing, as the sample rate (2 per 1,000 catheter days) is better than the potential acceptance criteria of 3.04 per 1,000 catheter days.

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 2 of those respondents using the Symetrex® 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): • (Mean Likert Scale Response) Catheters function as intended – 4.8 / 5 • (Mean Likert Scale Response) Packaging allows for aseptic presentation – 4.8 / 5 • (Mean Likert Scale Response) Benefit outweighs the risk – 4.7 / 5 • Dwell Time (n=26) – 167 days (95%CI: 130 203) The following data points were collected from users of Medcomp Symetrex® catheters (n=2): • (Mean Likert Scale Response) Catheters function as intended – 5 / 5 • (Mean Likert Scale Response) Packaging allows for aseptic presentation – 5 / 5 • (Mean Likert Scale Response) Benefit outweighs the risk – 5 / 5 • Dwell Time – 198 days (Range: 1-2 Months Approximately 1 Year)

Source:Symetrex® Survey Report

The Symetrex® Catheter Survey Report was intended to review and tabulate responses to ensure the device remains safe and effective when used as intended. Symetrex Survey Protocol was finalized on 08 February 2019. The Symetrex® Catheter Survey was provided electronically to clinicians who use the product worldwide by the product distributors. The survey received responses from 36 clinicians. Symetrex Survey Report was finalized on 30 March 2019. The survey report concluded that the Medcomp® Symetrex® catheter is safe and effective when used as directed, that the features incorporated within the design of the Symetrex® catheter have aided clinicians in its use, and few complications were reported.

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. 1 Symetrex® case inclusive of several variant devices were collected. The case was described as 15.5F and Straight Case, configurations (straight), and length (42cm), representation of 42cm length catheters. The following State of the Art safety and performance outcome measures were observed for Medcomp Symetrex® devices: • Catheter Related Blood Stream Infection – 0 per 1,000 catheter days (95%CI: 0 – 40.99) • Catheter Associated Venous Thrombus – 0 per 1,000 catheter days (95%CI: 0 – 40.99) • Exit Site Infection – 0 per 1,000 catheter days (95%CI: 0 – 40.99) • Tunnel Infection – 0 per 1,000 catheter days (95%CI: 0 – 40.99) • Dwell Time – No Days Reported The catheter brand logistic regression model did not find that any Medcomp® catheter brands were statistically significantly associated with an increase of the incidence of CRBSI. The brand agnostic logistic regression found that pediatric age group (0–19 years), femoral vein insertion site, catheters that were the fourth or beyond in sequence for a given patient, split-tip designs, and pre-curved configurations were statistically significantly associated with the incidence of CRBSI. The Split Cath® III was associated with a statistically significant decrease in CRBSI incidence in the brand model (OR: 0.46 95%CI: 0.33 - 0.63), and both shorter catheter length (<=24cm) and smaller French size (<14.5F) in the brand agnostic model.

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