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): Free Flow ST 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: 00884908297NU

Medical Device Nomenclature: F900201 – Temporary Hemodialysis Catheters and Kits

Class of Device: III

Date First CE Certificate Issued: Mar-01

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: Free Flow ST 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 Free Flow ST 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): Free Flow ST 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: Medcomp® / Jet Free Flow ST Catheter

Description of Device: Medcomp® / Jet Free Flow ST Catheter:The Free Flow ST Catheter removes and returns blood through two segregated lumen passages in a coaxial configuration. 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 is packaged with a stylet installed to the venous lumen. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. 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.

Device Name: Medcomp® / Jet Free Flow ST Catheter

Description of Device: Medcomp® / Jet Free Flow ST Catheter:The Free Flow ST Catheter removes and returns blood through two segregated lumen passages in a coaxial configuration. 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 is packaged with a stylet installed to the venous lumen. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. 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.

Materials / Substances in Contact with Patient Tissue:

The percentage ranges in the table below are based on the weights of the 12.5F x 15cm catheter (12.33g) and the 15.5F x 28cm catheter (14.66g).

The percentage ranges in the table below are based on the weights of the 12.5F x 15cm catheter (12.33g) and the 15.5F x 28cm catheter (14.66g).

Note:Known or suspected allergies to any of the components of the catheter or the kit.

Note:This device is contraindicated for patients exhibiting severe, uncontrolled coagulopathy or thrombocytopenia.

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 Free Flow ST Catheter and the benefits of other similar hemodialysis devices.

Warnings and Precautions:

Warnings listed for the Free Flow ST 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 Free Flow ST 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.

Other Relevant Aspects of Safety: For a period of 01 January 2019 to 31 December 2023 there were 9 complaints for 28,908 units sold, giving an overall complaint rate of 0.031%. 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 Free 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 Free Flow ST Catheter, 284 catheters had a mean 77 days [95% CI: 68.36 – 85.64 days] duration of use that has been found in clinical use reported to date. Based on this information, the Free-Flow ® ST 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. An equivalency rationale 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 no published literature articles for the Free Flow device. The most recent clinical evidence search found no published literature articles relating to the Free Flow device family.

• 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 1 of those respondents using the Free 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):

• (Mean Likert Scale Response) Catheters function as intended – 4.8 / 5

• (Mean Likert Scale Response) Packaging allows for aseptic presentation – 4.9 / 5

• (Mean Likert Scale Response) Benefit outweighs the risk – 4.7 / 5

• Dwell Time (n=19) – 15.74 days (95%CI: 6.3 – 25.1) The following data points were collected from users of Medcomp Free Flow catheters (n=1):

• (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 (n=1) – 3 days

• 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. 284 Free Flow cases, all described as 15.5F and Raulerson IJ with representation of 15cm, 20cm, and 24cm lengths, 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 Free Flow devices:

• Dwell Time – 77 days (95%CI: 68.36 – 85.64 days)

• Catheter Related Blood Stream Infection – 0.64 per 1,000 catheter days

• Catheter Associated Venous Thrombus – 4.6 per 1,000 catheter days

• Exit Site Infection – 0.13 per 1,000 catheter days

Overall Summary of Clinical Safety and Performance

Upon review of the Free-Flow® ST 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