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

Device Identification and General Information

Device Trade Name(s): Medcomp® / Jet / Nipro I-Series Peritoneal Dialysis Catheters & Medcomp® / Jet V-Series Peritoneal Dialysis Catheters

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: 00884908308N8

Medical Device Nomenclature: F900101 – Peritoneal Dialysis Catheters and Kits

Class of Device: IIb

Date First CE Certificate Issued: I-Series: February 2003 / V-Series: May 2006

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 Group The Netherlands B.V. NB2797

Device Grouping and Variants

The devices in scope of this document are all peritoneal dialysis 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:

Intended Use of the Device

Intended Purpose: I-Series / V-Series Peritoneal Dialysis Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom peritoneal access for peritoneal dialysis is deemed necessary based on the direction of a qualified, licensed physician. The device 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 I-Series / V-Series Peritoneal Dialysis Catheter is indicated for short-term or long-term use where peritoneal access is required for the purpose of peritoneal dialysis for Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD).

Target Population(s): I-Series / V-Series Peritoneal Dialysis Catheters are intended for use in adult patients with Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) for whom peritoneal access for peritoneal dialysis 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:

• The catheter is not intended for the Tenckhoff trocar method of insertion.
• The catheter is contraindicated for patients with:
• Infected anterior abdominal wall.
• Active peritonitis.
• Known or suspected allergies to any of the components of the catheter or the kit.

Device Description

Device Name: Medcomp® / Jet / Nipro I-Series Peritoneal Dialysis Catheters

Description of Device: Medcomp® / Jet / Nipro I-Series Peritoneal Dialysis Catheters:The I-Series Peritoneal Dialysis Catheter is used to remove and return dialysate fluid through single lumen tubing. The lumen inner diameter is of circular design. The distal tip is available in two versions: straight or coiled. The catheters are available with one or two polyester cuffs. The polyester cuffs provide material for tissue in-growth to stabilize the catheter. A wide radiopaque stripe extends throughout the entire length of the catheter. A nylon luer adaptor is used to attach the catheter to the external PD system. The catheter is available in a variety of lengths to accommodate patient anthropometrics, physician preference and clinical needs.

Device Name: Medcomp® / Jet V-Series Peritoneal Dialysis Catheters

Description of Device: Medcomp® / Jet V-Series Peritoneal Dialysis Catheters:The V-Series Peritoneal Dialysis Catheter is used to remove and return dialysate fluid through single lumen tubing. The lumen inner diameter is of circular design. The distal tip is available in two versions: straight or coiled. The polyester cuffs provide material for tissue in-growth to stabilize the catheter. A wide radiopaque stripe extends throughout the entire length of the catheter. The catheters are available with different positioning of the radiopaque stripe to facilitate visualization for left or right side placement. A nylon luer adaptor is used to attach the catheter to the external PD system. The catheter is available in a variety of lengths to accommodate patient anthropometrics, 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 (4.34g) and the 63cm catheter (12.40g).

The percentage ranges in the table below are based on the weights of the 39cm catheter (8.37g) and the 63cm catheters (12.91g).

Note: Accessories containing stainless steel may contain up to 0.4% weight of the CMR substance cobalt.

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

Information on Medicinal Substances in the Device: N/A

How the Device Achieves its Intended Mode of Action: The subject device can be inserted using an open surgical, laparoscopic, or percutaneous technique. Catheter insertion is to be performed using aseptic techniques in a sterile field, preferably in an operating room. Peritoneal dialysis uses the barrier lining of the peritoneum and a cleaning solution (dialysate) to remove soluble waste materials from the blood. The two most common types of peritoneal dialysis are continuous ambulatory peritoneal dialysis (CAPD) and continuous cycler-assisted peritoneal dialysis (CCPD). CAPD is a manual cycling of dialysate in and out of the abdomen for a prescribed number of exchanges per day. The filling and draining is accomplished via gravity. The final filling of the abdomen usually occurs just before bedtime. CCPD is usually performed at night when the patient sleeps. An automated fluid cycler fills the abdomen with dialysate and drains it after the prescribed dwell time to refill it again afterward. This cycling takes place up to several times per night, and the final cycle before morning is not drained.

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:

Risks and Warnings

Residual Risks and Undesirable Effects: As per product IFUs, 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 Medcomp® / Jet / Nipro I-Series and Medcomp® / Jet V-Series Peritoneal Dialysis Catheters and the benefits of other similar devices. Regardless, informed consent should be obtained from the patient or substitute decision maker, prior to proceeding.

Warnings and Precautions:

All warnings have been reviewed against the risk analysis, PMS, and usability testing to validate consistency between the sources of information. The devices in scope of this clinical evaluation have the following warnings in the IFUs:

• 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 excessive force when inserting the catheter and other components of the Kit. Carefully confirm correct tip placement before beginning the subcutaneous tunnel.
• 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 catheter lumen.
• 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.
• The medical techniques and procedures described in these instructions do not represent all medically acceptable protocols, nor are they intended as a substitute for the physician’s experience and judgment in treating any specific patient.
• The catheter should be inserted and removed only by a qualified, licensed physician or other health care practitioner authorized by and under the direction of such physician.
• Observe sterile technique at all times when handling catheter or insertion components.
• Caution is necessary to avoid injuring the abdominal viscera and bladder, particularly when using the sharp introducer needle. 1
• Use the guidewire straightener to insert the “J” end of the guidewire into the introducer needle.
• Overtightening catheter connections can crack some adapters.
• Clamping the catheter repeatedly in the same spot could weaken the tubing: change the position of the clamp regularly to prolong the life of the tubing. Avoid clamping near the adapter.
• Use only smooth-jawed forceps for clamping when not using the clamp supplied with the catheter.
• Exercise caution when using sharp instruments near the catheter.
• Catheter tubing can tear when subjected to excessive force or rough edges.
• Inspect the catheter frequently for nicks, scrapes, cuts, etc., which could impair its performance.
• Record catheter model and catheter lot number on patient’s chart. This information will allow for the identification of patients at risk in the event of a recall or alert from the manufacturer.
• 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 August 2024 there were 95 complaints for 194,364 units sold, giving an overall complaint rate of 0.049%. No events resulted in recalls during the review period.

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 catheter survival, 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. Survivability of a given implant is a multi-factorial event that depends on numerous factors, including: the limits of the implant, surgical technique, difficulty level of the surgical procedure, patient health, patient activity level, patient medical history, and other factors. In the case of the I-Series Peritoneal Dialysis Catheter, 131 catheters had a 20.71 month [95%CI: 17.76-23.66 months] duration of use that has been found in clinical use reported to date. In the case of the V-Series Peritoneal Dialysis Catheter, 100 catheters had a 403 day [Median: 371 days; Standard Deviation: 297 days] duration of use that has been found in clinical use reported to date. Based on this information, the I-Series and V-Series Peritoneal Dialysis 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. 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 investigations were used for the device’s clinical evaluation.

Summary of Clinical Data from Other Sources

Summary of Published Literature:Clinical evidence literature searches have found three published literature article representing 88 I-Series cases. The articles include three retrospective studies (Chen et al., 2022; Huang et al., 2022; Singh et al., 2023). Bibliography

Chen, K.K., Yeo, G.P., Tham, Z.D., Ching, C.H., Asmee, M.F., Wong, C.M., Ku Md Razi, K.R., Chan, Z.Y. (2022) POS-677 COMPARISON BETWEEN SINGLE AND DOUBLE CUFFED TENCKHOFF CATHETER IN EARLY ONSET EXIT SITE INFECTION AND PERITONITIS - SINGLE CENTER EXPERIENCE. Kidney International Reports.

Singh, V., Mishra, S. C., Singh, P., & Rout, B. B. (2023). The Influence of Peritoneal Dialysis Catheter Tip Design on Technique Survival: A Retrospective Observational Study. Indian Journal of Nephrology, 33(2), 119.

Huang, J., Bao, S., Bao, L., Zhang, A., Gu, L., Dai, L., & Bian, X. (2022). The efficacy and safety of an improved percutaneous peritoneal dialysis catheter placement technique in urgent start peritoneal dialysis patients: a retrospective cohort study. Annals of Palliative Medicine, 11(11), 3455-3463.

PMCF_PD_202:The PD Data Collection Survey aimed to acquire responses from healthcare personnel familiar with use and/or care of the I-Series, V-Series, and X-Series peritoneal dialysis catheter product families. The surveys were distributed globally to existing Medcomp customers and responses were collected from 25 November 2020 to 26 March 2021. At least partial data was collected on 134 catheter insertion cases from five respondents, spanning three countries (Greece, Portugal, and Sweden). 134 I-Series with 2 cuffs cases inclusive of several variant categories across lengths (37cm, 42cm, 47cm, 57cm, 63cm) and tip configuration (straight, coiled) 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 I-Series catheters

Practical Peritoneal Dialysis Study:The Vanderbilt University Practical Peritoneal Dialysis Study was a retrospective observational study with the primary objective to collect clinical data on the safety and efficacy of the Medcomp V-Series Peritoneal Dialysis Catheter Kits. The sample is from 100 sequential peritoneal dialysis catheter placements in adults at the Vanderbilt University Medical Center (VUMC) June 2018 – March 2021. The Vanderbilt peritoneal dialysis program uses exclusively Medcomp catheters, specifically Model MC20VC63LS. Data was abstracted from the EPIC electronic medical record system.100 V-Series cases all described as 63cm in length, with a coiled tip 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 V-Series catheters

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. 8 I-Series catheters cases, all described as 15F, inclusive of several variant devices across length (32.25cm, 37cm, 40.25cm, 57.5cm), tip configuration (straight, coiled), and number of cuffs (1,2) were collected. The following outcome measures were collected for Medcomp Peritoneal Dialysis devices

PMCF_Medcomp_211:The Medcomp User Survey acquired responses from healthcare personnel familiar with any number of Medcomp’s product offerings. 8 respondents responded that they or their facility have used Medcomp Peritoneal Dialysis catheters, with 5 of those respondents using the I-Series device and 4 of those respondents using V-Series device. There were no differences in mean user sentiments within peritoneal dialysis 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 Peritoneal Dialysis catheters (n=8)

The following data points were collected from users of I-Series Peritoneal Dialysis catheters (n=5):

The following data points were collected from users of V-Series Peritoneal Dialysis catheters (n=4):

Overall Summary of Clinical Safety and Performance

Upon review of the data across all sources, it is possible to conclude that the benefits of the subject device, which is facilitating peritoneal dialysis 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 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.

Possible Therapeutic Alternatives

The Kidney Disease Outcomes Quality Initiative (KDOQI) 2019 clinical practice guidelines and various International Society for Peritoneal Dialysis (ISPD) guidelines have been used to support the below recommendations for treatments.

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. Appropriately trained healthcare professionals, patients, care givers and support workers can access the catheter for clinical use as appropriate. As per 2016 International Society for Peritoneal Dialysis (ISPD) guidelines for teaching peritoneal dialysis to patients and caregivers, training programs should recognize physical and psychological stability, as well as cognitive ability, motivation, and support. The training for these patients should be comprehensive, including both theoretical and practical components, with regular retraining as needed. The training should cover topics such as infection prevention, catheter care, and communication with healthcare providers, and should be tailored to the individual patient's needs. The effectiveness of this training should be evaluated through patient and healthcare provider satisfaction, as well as infection rates and longevity of PD as a treatment.

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

Revision History