alfapump System
Device Facts
| Record ID | P230044 |
|---|---|
| Device Name | alfapump System |
| Applicant | Sequana Medical NV |
| Product Code | SDQ · Gastroenterology, Urology |
| Decision Date | Dec 20, 2024 |
| Decision | APPR |
| Device Class | Class 3 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| P230044 · Dec 20, 2024 | alfapump System | Sequana Medical NV | Medicare Inpatient & Outpatient Hospital Standard Analytical Files (SAF) 2017-2019; NACSELD III registry study | Real-world data from Medicare claims and the NACSELD III registry were used to provide context for safety, mortality, and hospitalization rates observed in the pivotal POSEIDON clinical trial, helping to establish the benefit-risk profile of the device in a high-risk patient population. | Medicare claims; Registry data; Comparative analysis; Mortality; Hospitalization |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Medicare SAF Database Analysis; Retrospective analysis of claims data; Follow-up/Duration: Up to 24 months; Study Period: 2017-2020 | Patients 65 and older with refractory ascites (N=701); Sample Size: 701 | POSEIDON pivotal cohort patients (65+) | Mortality rate, inpatient hospitalization rate |
| NACSELD III registry study; Matched 1:1 cohort comparison; Follow-up/Duration: 6 months | Patients with refractory ascites; Sample Size: 37 matched pairs | POSEIDON Pivotal Cohort | Mortality, SAEs resulting in death or hospitalization |
Indications for Use
The alfapump® System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
Device Story
The alfapump® System is an implantable, inductively charged gear pump designed to manage refractory or recurrent ascites in cirrhotic patients. It continuously transports peritoneal fluid to the urinary bladder for elimination via spontaneous urination. The system includes an implanted pump, peritoneal and bladder catheters, a Smart Charger, and external programming software. Used in clinical settings, the device is implanted by a physician. The pump uses pressure sensors to monitor fluid movement, preventing overfilling of the bladder or pumping from an empty cavity. Physicians use the alfapump® Programmer to adjust pump activity and volume settings based on patient needs. Data is transferred via the Smart Charger to Sequana Medical for analysis. By automating fluid removal, the device reduces the need for repeated large-volume paracentesis, potentially improving patient quality of life and reducing the physical and psychosocial burden of standard-of-care treatments.
Clinical Evidence
The pivotal POSEIDON trial was a multicenter, single-arm, within-subject crossover study (N=40 pivotal cohort). Primary endpoints were a 50% reduction in the per-patient ratio of therapeutic paracentesis (post-implant vs. pre-implant) and the proportion of patients achieving a 50% reduction in paracentesis frequency. Results showed a 100% reduction in median monthly paracentesis (p<0.001) and 77% of patients achieving ≥50% reduction (p<0.001). Safety data through 6 months showed a 17.6% primary safety endpoint rate. Secondary endpoints showed significant improvements in SF-36 Physical Component Summary and Ascites-Q scores.
Technological Characteristics
Implantable, inductively charged gear pump (model AFS50.3). Components include pump, bladder catheter, peritoneal catheter (SNCA-5262L), Smart Charger, and docking station. Materials are biocompatible per ISO 10993-1. Sterilization via ethylene oxide (ISO 11135). Connectivity via USB and wireless radiolink (907±1 MHz). Battery capacity supports 1 L/day for 4 days. Software includes FlowControl and FlowTech modules.
Indications for Use
Indicated for adult patients with refractory or recurrent ascites due to liver cirrhosis. Contraindicated for patients with MRI requirements, those requiring hyperbaric oxygen therapy, or those with specific medical conditions precluding surgery or device placement (e.g., active infection, certain malignancies, renal failure).
Regulatory Classification
Identification
The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
Submission Summary (Full Text)
# SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
## I. GENERAL INFORMATION
Device Generic Name: alfapump® System
Device Trade Name: alfapump® System
Device Procode: SDQ
Applicant’s Name and Address:
Sequana Medical NV
Kortrijksesteenweg 1112
Sint-Denijs-Westrem
9051 BE
Sequana Medical US inc.
265 Franklin Street, Suite 1702
Boston, MA 02110 – USA
Date(s) of Panel Recommendation: N/A
Premarket Approval Application (PMA) Number: P230044
Date of FDA Notice of Approval: December 20, 2024
Priority Review: N/A
Breakthrough Device: Granted breakthrough device status on January 16, 2019 because the subject device met the Breakthrough criteria.
## II. INDICATIONS FOR USE
The alfapump® System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
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III. CONTRAINDICATIONS
MRI Safety Information
- The alfapump® is MR unsafe.
- This diagnostic procedure is contraindicated due to possible movement of the alfapump®, damage to the pump circuitry, tissue damage in the vicinity of the alfapump® and/or catheter dislocation.
Hyperbaric oxygen therapy
Hyperbaric oxygen therapy is contraindicated because the environmental conditions entailed in this therapy are out of the defined range of use for the alfapump® System.
IV. WARNINGS AND PRECAUTIONS
Only trained users should use the alfapump® System. The hazards, warnings and precautions can be found in the labeling. Please refer to the The alfapump® System Instructions for Use for additional applicable warnings and precautions
V. DEVICE DESCRIPTION
The alfapump® System is an implanted device with a rechargeable battery that is designed to slowly and continually transport ascites from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous urination. The implantable system components consist of a subcutaneously implanted pump and two catheters that connect to the pump. The volume of fluid to be removed and frequency of pump activity are set by the physician. The alfapump® System consists of:
i. alfapump®
ii. Bladder Catheter
iii. Peritoneal Catheter SNCA-5262L
iv. Smart Charger and Docking Station
v. alfapump® Programmer IV (with FlowControl Software)
vi. Clinical Specialist Notebook IV (with FlowTech Software)
vii. Implant Accessories Catheter Locking Cap
- Peritoneal Catheter Extension
- Bladder Catheter Extension
- Catheter Extension Connector
viii. Implant Tools Introducer Kit
- Introducer Kit
- Tunneling rod
Figure 1 below illustrates the alfapump® System followed by a brief overview of each system component. The key performance requirements and specifications (hardware and software) of the alfapump® System are derived from applicable performance standards and product development lifecycle.
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Figure 1 alfapump® System Components and Interfaces
As illustrated in Figure 1 above, all individual components are interconnected and linked together through USB (wired) or wireless communication. All communication takes place through the Smart Charger, which serves as the primary interface for communication and charging of the alfapump®.
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Figure 2 alfapump (with catheter connector)
As shown in Figure 2, the alfapump® is a single-use, sterile, implantable, and inductively charged gear pump. The pressure sensors within the pump monitor fluid movement to prevent pumping from an empty peritoneal cavity or overfilling the bladder. The pump has one inlet and one outlet connector for attachment of the Peritoneal Catheter and Bladder Catheter. The Bladder Catheter transports peritoneal fluid from the alfapump® to the bladder. The Peritoneal Catheter SNCA-5262L transports peritoneal fluid from the peritoneal cavity to the alfapump®, where it is pushed to the bladder through a Bladder Catheter. The catheters are fixed to the pump with a locking cap. On the exterior, two polyester patches are attached. The purpose of these patches is to promote fixation to the tissue in the subcutaneous pump pocket.
The alfapump®'s battery is inductively charged transcutaneously via the Smart Charger. The Smart Charger transmits power transcutaneously to and communicates via radiolink with the alfapump®.
Each time the patient charges the alfapump®, its pump data is automatically transferred to the Smart Charger. An integrated cellular modem allows for alfapump® performance data to be transferred to Sequana Medical over mobile phone network for analysis purposes only. The patient must bring the Smart Charger to each follow-up visit so the physician can transfer its pump data to the provided alfapump® Programmer III/IV (notebook/laptop) for review. The communication software on alfapump® Programmer III/IV enables physicians to:
- communicate with the implanted alfapump®;
- adjust the settings based on individual patient needs; and
- retrieve pump data via the patient's Smart Charger.
Please refer to the alfapump® System Instructions for Use for additional details.
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# VI. ALTERNATIVE PRACTICES AND PROCEDURES
There are several other alternatives for the correction of refractory ascites. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.
The alfapump® System is commercially available in the EU and has a CE Mark in accordance with the EU Medical Device Regulation (MDR) 2017/745. As part of the conformity with the EU MDR, a Clinical Evaluation Report (CER) is required to be maintained and updated on an annual basis. As part of this process, a systematic and state of the art literature review was conducted in February 2023 for both safety and performance of the alfapump® System covering the period July 2022 to February 2023 in accordance with the EU MDR for the CER.
A high-level summary of the relevant alternative practices and procedures for patients with refractory ascites is included in this CER and a summary of this information was extracted from this literature review and is included below. Additionally, only liver transplant treats the underlying etiology of ascites development, and thus, does prevent recurrence.
## Large Volume Paracentesis
According to current guidelines, the standard treatment for refractory or recurrent ascites is repeated paracentesis to evacuate the ascites and the administration of albumin (8g/L of ascitic fluid extracted) when the volume of ascites removed exceeds 5 liters [1-3]. The requirement for repeated paracentesis leads to reduced patient quality of life and increases the risk of complications [4].
A possible complication associated with Large Volume Paracentesis (LVP) is paracentesis-induced circulatory dysfunction (PICD) syndrome, which is the result of further reducing effective arterial volume secondary to extracting a large volume of ascitic fluid. This syndrome is associated with a rapid re-accumulation of ascites, the development of renal dysfunction or dilutional hyponatremia, with a reduction in survival [5, 6]. The administration of albumin (as per the quantities mentioned above) is believed to prevent the occurrence of PCID in an important number of cases [7, 8]. Additional complications of ascites include peritonitis and incarceration of abdominal hernias [9].
## Peritoneovenous Shunt
Currently, peritoneovenous shunt plays a minor role in the treatment of refractory ascites due to a higher risk of disseminated intravascular coagulation, sepsis, and heart failure [10]. Current evidence-based clinical practice guidelines recommend that in patients with refractory ascites with no other therapeutic options, peritoneovenous shunt should be performed after cautious assessments and obtaining informed consent. For patients with massive ascites with peritoneal dissemination abdominal-venous shunting is strongly recommended not to be performed, due to frequent and fatal complications [11].
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## Transjugular intrahepatic portosystemic shunt (TIPS)
In selected patients with refractory or recurrent ascites, a transjugular intrahepatic portosystemic shunt (TIPS) is an alternative to serial paracentesis [12]. Although this procedure has reported efficacy in the range of 45% to 63% [13], the therapy has several limitations, including the requirement for careful training to conduct the procedure, the attendant risks associated with the presence of the shunt such as hepatic encephalopathy, and the consideration that a substantial portion of patients with refractory ascites are not candidates for TIPS insertion [9]. The European Association for the Study of the Liver (EASL) guidelines caution that “careful selection of patients for elective TIPS insertion is crucial, as is the experience of the center performing this procedure. TIPS is not recommended in patients with serum bilirubin > 3 mg/dl and a platelet count lower than 75 × 109/L, current hepatic encephalopathy grade ≥2 or chronic hepatic encephalopathy, concomitant active infection, progressive renal failure, severe systolic or diastolic dysfunction, or pulmonary hypertension [2].”
## Liver transplantation
Liver transplantation in patients with cirrhosis is still the long-term treatment of choice, and the definitive cure, in those with recurrent and refractory ascites who are candidates for transplantation, with overall survival greater than 85% at 1 year after transplantation [14, 15]. However, more than 40,000 cirrhosis patients die each year in the US from liver disease and only 6,000 liver transplants are performed each year. In addition, many patients with refractory or recurrent ascites do not qualify for a liver transplant or are at a lower tier on the transplantation waiting list [16].
The lack of sufficient donor organs for transplantation, poor quality of life, repeat paracentesis with albumin requiring repeated hospital visits and resulting in poor quality of life, and the fact that a significant proportion of patients with refractory ascites have contraindications to and/or would not benefit from TIPS highlight the need for new treatment options. The Sequana Medical alfapump® System can offer an alternative treatment option for cirrhotic patients with refractory or recurrent ascites that addresses a significant medical need for management of their disease that facilitates an alternative to LVP.
## VII. MARKETING HISTORY
The alfapump® System received CE mark approval under 90/385/EEC (AIMDD) in 2011 and most recently the alfapump® System has been approved under the MDR (EU) 2017/745 in 2022. The alfapump® System is being actively marketed in Europe. There has been a total of over 420 commercial implants of alfapump® Systems from 2016 until September 30, 2023.
In summary, the alfapump® System has not been withdrawn from marketing for any reason related to its safety or effectiveness.
# VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH
Below is a list of the potential adverse effects (e.g., complications) associated with the use of the alfapump® System. For the specific adverse events that occurred in the clinical study, please see Section X below.
Potential adverse events (AE) which may be associated with the procedures required to place the device (including the procedure to place the catheters and pump and local and/or general anesthesia) include but are not limited to, the following:
- Adverse reaction to sedation, local or general anesthesia
- Pain
- Sore or irritated abdomen
- Bleeding
- Catheter track bleeding
- Wound dehiscence
- Injuries to the digestive tract during placement
- Injuries to blood vessels
- Abdominal wall haematoma
- Persistent leakage of ascitic fluid
- Peritonitis
- Urinary tract infections
- Cardiac or respiratory arrest connected to underlying medical problems
Potential adverse events (AE) that may be specifically associated with the alfapump® therapy include but are not limited to the following:
- Pump pocket
- Hematoma
- Infection
- Skin erosion above the alfapump
- Wound dehiscence
- Pain
- Surgical
- Wound dehiscence (rupture)
- Ascitic fluid leakage
- Bladder perforation
- Seroma
- Catheters
- Kinking
- Clogging
- Disconnection from pump
- Dislocation
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○ Migration
○ Infection
○ Tissue damage over catheter trajectory (including erosion)
- alfapump®
○ Erosion
○ Dysfunction
○ Device migration
○ Discomfort during pumping (sensation over the abdomen, filling of the bladder)
○ Externally mediated damage (trauma, radiation)
○ Clogging (prolonged shake mode)
- Infection
○ Peritonitis (abdominal inflammation)
○ Pump pocket
○ Skin
○ Sepsis (including septic shock)
○ Urinary tract
○ Pneumonia
○ Surgical incision
- Reduced kidney function
○ Electrolyte disturbance
○ Acute kidney injury
○ Hepatorenal syndrome
○ Kidney failure
- Genito-urinary complications
○ Hematuria
○ Urethral stenosis
○ Bladder injury
○ Urinary retention
○ Incontinence/leakage
○ Bladder irritation/spasm
- Hepatic encephalopathy
○ Mild-grade I or II
○ Severe-grade III or IV
- Hepatic
○ Progression of liver disease
- Systemic effects
○ Protein loss (hypoalbuminemia)
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- Circulatory dysfunction (similar to post paracentesis circulatory dysfunction)
- Dehydration
- Death
The above risks may require intervention to address the condition.
IX. SUMMARY OF NON-CLINICAL STUDIES
A. Laboratory Studies
A.1 Performance and Safety Testing
Testing to verify that the alfapump® System functions as intended, and all system level design and functional specifications are met.
A.1.1 alfapump®
Testing was conducted on the alfapump® model AFS50.3, including: mechanical design verification, electrical and firmware design verification testing and electromagnetic compatibility testing. Key testing on the alfapump® is summarized in
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Table 1. Testing demonstrated the alfapump® operated according to specifications after exposure to the tested conditions (i.e., passed testing). In addition, testing and evaluation was performed to verify that the applicable components of the alfapump® System meets its requirement to comply with International Standards Organization (ISO) 14708-1:2014 which specifies requirements that are applicable to active implantable medical devices (AIMD).
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Table 1 alfapump® Performance and Safety Testing
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Output volume and flow rate | To verify the flowrate and the output volume of alfapump®. | The alfapump® flow rate and output volume are within the specified criteria. | Passed |
| Long time tests / Maximum Daily Volume | To verify the maximum cumulative volume of Ascitic Fluid transport by the alfapump®. | The actual aspirated volume and the volume calculated from the alfapump® are within specified criteria when pumping for 1 hour and the daily volume transport is set to 4 L/per day. | Passed |
| Dimensional Requirements | To demonstrate that alfapump® meet shape and profile requirements. | Alfapump® samples must meet size specifications for IPG width, height, thickness, volume, mass, and radius. | Passed |
| Environmental Conditions / Vibration Test | To demonstrate that alfapump® is able to withstand the mechanical forces which might occur during normal conditions of use, including the time prior to implant. | Testing per ISO 14708-1:2014 clause 23.2. | Passed |
| Environmental Conditions / Shock Test | To demonstrate that alfapump® is constructed so that minor mechanical shocks caused by mishandling during the implant procedure do not damage the implantable parts of the active implantable medical device. | Testing per ISO 14708-1:2014 clause 23.7. | Passed |
| Environmental Conditions / Pressure Test | To demonstrate that alfapump® is constructed to withstand the changes of pressure which can occur during transit or normal conditions of use. | Testing per ISO 14708-1:2014 clause 25. | Passed |
| Protection from excessive temperature | To demonstrate that no outer surface of the alfapump® is greater than 2 °C above the normal surrounding body temperature of 37 °C when implanted, and when the active implantable medical device is in normal operation or in any single component failure. | The surface temperature of the alfapump® implant does not exceed 39°C when implanted, when the implant is operating in a normal condition and when the implant is working in any single-fault condition. | Passed |
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Table 2 alfapump® Performance and Safety Testing continued
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Ultrasound testing | To demonstrate that alfapump® is designed and constructed so that no irreversible change will be caused by exposure to diagnostic levels of ultrasonic energy. | Testing per ISO 14708-1:2014 clause 22.1. | Passed |
| Catheters Interface and Pull-Force | The purpose of this test is to measure the force required to disconnect the catheters from the alfapump®. | Disconnection force >= 10N for Bladder Catheter and Peritoneal Catheter Extension. | Passed |
| Minimum Peritoneal Pressure | To verify that there is no fluid transport if the peritoneal pressure is below the Minimum Peritoneal Cavity Pressure (minPP). | When the peritoneal pressure is below minPP the fluid transport is suspended. | Passed |
| Maximum Bladder Pressure | To verify that there is no fluid transport if the bladder pressure exceeds the Maximum Bladder Pressure (maxBP) relative to the pressure in the peritoneal cavity. | When the bladder pressure is above maxBP the fluid transport is suspended. | Passed |
| Battery | The purpose of this test is to verify the battery used in the alfapump®: Electrical, Visual, Dimensional, Crush, Continuous Charge, External Short Circuit, Free Fall, Thermal Abuse, Forced Discharge and Temperature Abuse. | Testing per International Electrotechnical Commission (IEC) 62133-2:2017/Amd1:2021. | Passed |
| Battery Capacity | To verify alfapump® battery capacity. | The alfapump® shall be able to pump 1 liter per day for at least 4 consecutive days without getting charged when the battery is new and fully charged. | Passed |
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## A.1.2 Smart Charger and Docking Station
Testing was conducted on the Smart Charger model P5 and on the Docking Station, including: mechanical design verification, electrical and firmware design verification testing. Key testing on the Smart Charger model P5 and on the Docking Station is summarized in
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Table 3. Testing demonstrated the alfapump® operated according to specifications after exposure to the tested conditions (i.e., passed testing).
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Table 3 Smart Charger and Docking Station performance and safety testing
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Programming Wireless Radio Frequency | To verify that the radio frequencies communication function perform as intended. | The wireless radio communication between the Smart Charger and the alfapump® is based on a single channel communication at a frequency of 907±1 MHz. | Passed |
| Charge test | To verify that through a simulated battery the charging current is between adequate values. | Charging current in the range of 0.8 - 4A (0.2 - 1C of the 4000 mAh battery). | Passed |
| DC Leakage Current | To demonstrate that the leakage currents are within an acceptable range. | Testing per IEC 60601-1:2005/Amd2:2020 clause 8. | Passed |
| Mechanical resistance | To demonstrate that the Smart Charger and the Docking Station are able to withstand external mechanical forces. | Testing per IEC 60601-1:2005/Amd2:2020 clauses 9 and 15. | Passed |
| Protection from excessive temperature | To demonstrate that the Smart Charger and the Docking Station do not cause any temperature-related harm to the patient. | Testing per IEC 60601-1:2005/Amd2:2020 clause 11. | Passed |
| Battery Protection | To verify that the charge FET switches off with over voltage, charge FET switches off with under voltage and FET switches off with over current. | Over-voltage, under-voltage, over-currents are tested and safety is ensured. | Passed |
| Battery | The purpose of this test is to verify the battery used in the Smart Charger: Electrical, Visual, Dimensional, Crush, Continuous Charge, External Short Circuit, Free Fall, Thermal Abuse, Forced Discharge and Temperature Abuse. | Testing per IEC 62133-2:2017/Amd1:2021. | Passed |
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A.1.3 Bladder Catheter and Peritoneal Catheter SNCA-5262L
Mechanical design verification testing was conducted on the Bladder Catheter and Peritoneal Catheter SNCA-5262L used in conjunction with alfapump® model AFS50.3. Key testing on the Bladder Catheter and the Peritoneal Catheter SNCA-5262L is summarized in
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Table 4. Testing demonstrated the Bladder Catheter and the Peritoneal Catheter SNCA-5262L operated according to specifications after exposure to the tested conditions (i.e., passed testing).
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Table 4 Bladder Catheter and Peritoneal Catheter SNCA-5262L performance and safety testing
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Dimensional Requirements | To demonstrate that catheters meet shape and profile requirements. | Bladder Catheter and Peritoneal Catheter SNCA-5262L samples must meet size specifications for IPG width, height, thickness, volume, mass, and radius. | Passed. |
| Connector Pull Force | To verify that the Bladder Catheter does not disconnect from the connector under a defined load. | After applying 5 N for 60 seconds and 10 N for 10 seconds, the Bladder Catheter is still attached to the connector. | Passed. |
| Leakage Specification | To verify that the bladder catheter can withstand a fluid pressure of 2 bar for 20 seconds. | The bladder catheter does not burst or have any visible leaks when a fluid pressure of 2 bar is applied for 20 seconds. | Passed. |
| Kink Resistance | To verify that no kinking or flow obstruction occurs when the Bladder Catheter is bent over 180°. | The Bladder Catheter does not kink or get obstructed, when it is bent over 180° on a 25 mm diameter circle. (Minimum of 150 mL transported in 60s when attached to a 100 cm water column). | Passed. |
| alfapump Pull Force | To verify that the Bladder Catheter does not get disconnected from the nipple of the alfapump® when an axial force is applied on the Bladder Catheter. | The Bladder Catheter does not disconnect from the nipple of the alfapump® when a tensile force of 5 N for 60 s and 10 N for 10 s is applied on the Bladder Catheter. | Passed. |
| Tunneling Rod Pull Force | To verify that the Bladder Catheter does not get disconnected from the Tunneling Rod when an axial force is applied on the Bladder Catheter. | The Bladder Catheter does not disconnect from the Tunneling Rod when a tensile force of 5 N for 60 s and 10 N for 10 s is applied on the Bladder Catheter. | Passed. |
| Connector Pull Force | To demonstrate, that the Peritoneal Catheter SNCA-5262L does not disconnect from the catheter connector when a tensile force is applied on the Peritoneal Catheter SNCA-5262L. | After applying 5N for 60 seconds and 10 N for 10 seconds, the Peritoneal Catheter SNCA-5262L is still attached at the connector. | Passed. |
| Leakage Specification | To verify, that no leakage or burst occurs, when applying 2 bar for 20 seconds onto a fluid filled Peritoneal Catheter SNCA-5262L. | No burst or leakage occurs when applying 2 bar for 20 seconds to a fluid filled Peritoneal Catheter SNCA-5262L . | Passed. |
| Kink Resistance | To verify that Peritoneal Catheter SNCA-5262L does not kink, when it is bent over 180°. | The Peritoneal Catheter SNCA-5262L does not kink or get obstructed, when it is bent over 180° on a 25 mm diameter circle. | Passed. |
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# A.1.3 alfapump® System testing
Testing to verify that system-level design requirements were met for interactions between alfapump® System components was performed. All test articles met defined acceptance criteria for the system integration tests conducted. System validation testing demonstrated that the system operated as expected and has been validated for safe and effective use.
# A.2 Human Factors Testing
Sequana Medical executed a comprehensive human factors and usability engineering process that followed and complied with the FDA-recognized standards IEC 62366-1:2015+AMDI:2020 and ANSI/AAMI HE75:2009 as well as the FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016). Table 5 summarizes summative usability evaluations performed to demonstrate safe and effective use of the alfapump® System with intended users in the expected use environments, including associated training (as applicable) and accompanying documentation.
Table 5 Human Factors testing
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| alfapump® System(Implantation) Summative Usability Testing | To evaluate the usability of implantation process of an alfapump® System by the IR and to evaluate the outcomes. | The usability evaluation can be considered passed if no acceptable risks arise from the identified use events. | Passed. |
| FlowTech Software Summative Usability Testing | Main objective was to evaluate the usability of the FlowTech Software by trained physicians, field staff, patients, and unsterile assistants. | The usability evaluation can be considered passed if no acceptable risks arise from the identified use events. | Passed. |
| FlowControl Software Summative Usability Testing | Main objective was to determine the safety and effectiveness of the FlowControl Software by trained physicians, field staff, patients and unsterile assistants. | The usability evaluation can be considered passed if no acceptable risks arise from the identified use events. | Passed. |
| Smart Charger Summative Usability Testing | Main objective was to determine the safety and effectiveness of the Smart Charger by implant physicians, following physicians, field staff (Clinical Specialists) and patients. | The usability evaluation can be considered passed if no acceptable risks arise from the identified use events. | Passed. |
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# A.3 Sterilization Validation
The alfapump® System sterile components are ethylene oxide sterilized per the requirements of ISO 11135:2014_A1:2018, "Medical devices-Validation and routine control of ethylene oxide sterilization," The validation results demonstrated that the sterilization process achieves a minimum sterility assurance level (SAL) of $10^{-6}$ and that residual levels were within the acceptable ranges for an implant according to ISO 10993-7, "Biological evaluation of medical devices --Part7: Ethylene oxide sterilization residuals."
Table 6 summarizes testing per ISO 11135:2014/A1:2018 for sterilization validation of applicable components alfapump® System with acceptable results.
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Table 6 Sterilization Validation
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Product bioburden | The contamination of the product families was checked by performing bioburden analysis on 3 test units selected randomly for each of the following products: alfapump®, Bladder Catheter, Peritoneal Catheter SNCA-5262L, Introducer Kit and Implant Accessories.
Prior to routine testing, validation of the method was performed according to ISO 11737-1 to determine the adequacy of the laboratory technique to recover the micro-organisms inoculated on the following products: alfapump®, Bladder Catheter, Peritoneal Catheter SNCA-5262L, Introducer Kit and Implant Accessories. | • The corrected bioburden shall not exceed Alert Limit 50 CFU/product and Action Limit 100 CFU / product.
• Bioburden suitability: the recovery efficiency for the bioburden validation shall be ≥ 50%. Correction factor shall be <2%. The products shall be not inhibitory min 50% | Passed. |
| Test of product sterility | A sterility test on 3 samples of alfapump®, Bladder Catheter, Tunneling Rod, Peritoneal Catheter SNCA-5262L, Introducer Kits and Implant Accessories was done after one short cycle run to prove that the Positive Control Devices (PCDs) are more resistant than product bioburden.
Validation of the sterility test method was performed according 11737-2 on all 6 products: alfapump®, Bladder Catheter, Tunneling Rod, Peritoneal Catheter SNCA-5262L, Introducer Kits and Implant Accessories. | • A sterility test following a sub-lethal cycle shall show no growth observed in all product samples.
• Validation of the sterility test method (Bacteriostasis / fungistasis) of each product test shall show no antimicrobial or antifungal activity. | Passed. |
| Bacterial endotoxin test (LAL) | Evaluation of the endotoxin concentration of the selected worst-cases products was determined on 3 samples of alfapump®, Bladder Catheter, Tunneling Rod, Peritoneal Catheter SCNA-526L, Introducer Kit | • Bacterial endotoxin test shall show bacterial endotoxin level <20 EU/device.
• Validation of the LAL test method was performed on each product to determine the Maximum Valid Dilution (MVD). | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | and Implant Accessories each selected from three production lots. | | |
| EO + ECH residual testing (following each of the two full sterilization cycles) for limited contact device (<24h). | The aim of the ethylene oxide (EO)/ethylene chlorohydrin (ECH) residual testing is to find the aeration time at the end of routine sterilization cycle. This aeration time (hot degassing in the aeration cell and / or ambient aeration) shall ensure that the levels of EO/ECH residuals pose a minimal risk to the patient in normal product use. This testing was performed for Introducer Kit and Tunneling rod. | • EtO:
o 4 mg / day
o TCL: 10 μg/cm2
• ECH:
o 9 mg / day
o TCL: 5 mg/cm2 | Passed. |
| EO + ECH residual testing (following each of the two full sterilization cycles) for Long-term contact devices (>30d). | The aim of the EO/ECH residual testing is to find the aeration time at the end of routine sterilization cycle. This aeration time (hot degassing in the aeration cell and / or ambient aeration) shall ensure that the levels of EO/ECH residuals pose a minimal risk to the patient in normal product use. This testing was performed for alfapump®, Bladder Catheter, Peritoneal Catheter SCNA-526L and Implant Accessories | • EtO:
o 2.5 g / lifetime
o 60 mg / first 30 days
o 4 mg / first 24 hours
o 0.1 mg / day
o TCL: 10 μg/cm2
• ECH:
o 10 g / lifetime
o 60 mg / first 30 days
o 9 mg / first 24 hours
o 0.4 mg / day
TCL: 5 mg/cm2 | Passed. |
| Short Cycle | The resistance of PCDs compared to product bioburden should be demonstrated. The resistance of Enhanced Positive Control Devices (EPCDs) should be shown to be equal or greater than the resistance of Internal Positive Control Devices (IPCDs). The following products were tested regarding sterility on 6 samples each: alfapump®, Bladder Catheter, Tunneling Rod, Peritoneal | • Positive BIs should be found to determine the adequacy of laboratory technique
• All the positive growths should be true positives
• Resistance of EPCDs ≥ resistance of IPCDs
• All products must be sterile | Passed |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | Catheter SCNA-526L, Introducer Kit and Implant Accessories | | |
| Half Cycle | A total of three consecutive half cycles in the same Sterox chamber resulting in total inactivation of the biological indicators (with a population not less than 106) were performed to confirm the minimum exposure time. The specified exposure time shall be at least double this minimum time. | • All biological indicators (BIs) should be negative | Passed |
## A.4 Biocompatibility
Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” (September 8, 2023).
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Table 7 summarizes testing conducted to support the biological safety of the alfapump® System (alfapump®, Bladder Catheter, Peritoneal Catheter SNCA-5262L, Implant Accessories, Introducer Kit, Tunneling Rod, Smart Charger, and Docking Station).
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Table 7 Biocompatibility testing
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| alfapump | | | |
| Cytotoxicity | The purpose of this Good Laboratory Practices (GLP) study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. alfapump shall be non-cytotoxic. | Passed. |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). alfapump shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. alfapump shall be non-sensitizing. | Passed. |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP | alfapump shall be non-pyrogenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | | |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | alfapump shall be non-pyrogenic. | Passed. |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Genotoxicity endpoint (Bacterial Reverse Mutation) | Bacterial reverse mutation tests have been used for the determination of mutagenic and potential carcinogenic hazards of the alfapump®. This study was conducted according to ISO 10993-3:2014. This study was also conducted according to the Organization for Economic Cooperation and Development (OECD) 471 (2020), Guideline for Testing of Chemicals, Bacterial Reverse Mutation Test. | The SC and DMSO test article extracts shall be considered to be non-mutagenic to S. typhimurium tester strains TA98, TAI00, TA1535, and TA1537, and to E. coli WP2uvrA tester strain.
The test article shall be not mutagenic. | Passed. |
| Genotoxicity (In Vitro Mouse Lymphoma Assay) | The purpose of this non-clinical GLP study was to evaluate the mutagenic potential of the test article extracts using the mouse lymphoma forward mutation assay procedures utilizing 4 hours treatments in the absence and presence of exogenous metabolic activation and 24 hours treatment (in the absence of exogenous metabolic activation). This study was conducted according to ISO 10993-3:2014. This study was also | The RPMI_{0} and DMSO test article extracts shall not cause any increase in the mean mutant frequency of the L5178Y/TK^{+/+} cell line greater than the mutant frequency of the control blank + the Global Evaluation Factor (126), in the presence or absence of metabolic activation.
The test article shall be not mutagenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | conducted according to the Organization for Economic Cooperation and Development (OECD) 490 (2016), Guideline for Testing of Chemicals, In Vitro Mammalian Cell Gene Mutation Tests using the Thymidine Kinase Gene. | | |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| 4 weeks and 13 weeks Implantation Study | The purpose of this nonclinical GLP study was to evaluate the local tissue effects of an ingrowth patch and two implant accessories belonging to the alfapump® System. The ingrowth patch (Test Article 1) was compared to a CE-marked ingrowth patch (Control Article) and to a negative control (High Density PolyEthylene, HDPE) and the peritoneal catheter extension (Test Article 2) and catheter extension connector (Test Article 3) were compared to the negative control article only following subcutaneous implantation in the rabbit.
The local tissue effects were evaluated macroscopically and histopathologically 4 and 13 weeks post-implantation. This study was conducted according to ISO 10993-6:2016. | Null to minimal reaction when compared to control or the negative control article. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Chemical characterization | The purpose of this study was to perform a chemical characterization to identify and quantitate the extractables and/or leachables that may be released from the test article. This study was conducted according to ISO 10993-18:2020 / Amd1:2022. | Identify and quantitate the extractables and/or leachables that may be released from the test article | Passed. |
| Compound and element analysis of alfapump after exhaustive extraction using ICP-MS/-OES | The purpose of this study was to perform a Compound and element analysis after exhaustive extraction (ICP-MS/-OES) to identify and quantify the extractables and/or leachables that may be released from the test article. This study was conducted based on guidance provided in ISO 10993-18:2020 / Amd1:2022. | Identify and quantify the extractables and/or leachables that may be released from the test article (alfapump®). | Passed. |
| Peritoneal Catheter SNCA-5262L | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. Peritoneal Catheter SNCA-5262L shall be non-cytotoxic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). Peritoneal Catheter SNCA-5262L shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. Peritoneal Catheter SNCA-5262L shall be non-sensitizing. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | Peritoneal Catheter SNCA-5262L shall be non-pyrogenic. | Passed. |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
| Genotoxicity (Bacterial Reverse Mutation Study) | Bacterial reverse mutation tests have been used for the determination of mutagenic and potential carcinogenic hazards of the Peritoneal Catheter SNCA-5262L. This study was conducted according to ISO 10993-3:2014. This study was also | The SC and DMSO test article extracts shall be considered to be non-mutagenic to S. typhimurium tester strains TA98, TA100, TA1535, and TA1537, and to E. coli WP2uvrA tester strain. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | conducted according to the Organization for Economic Cooperation and Development (OECD) 471 (2020), Guideline for Testing of Chemicals, Bacterial Reverse Mutation Test. | The test article shall be not mutagenic. | |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Genotoxicity (In Vitro Mouse Lymphoma Assay) | The purpose of this non-clinical GLP study was to evaluate the mutagenic potential of the test article extracts using the mouse lymphoma forward mutation assay procedures utilizing 4 hours treatments in the absence and presence of exogenous metabolic activation and 24 hours treatment (in the absence of exogenous metabolic activation). This study was conducted according to ISO 10993-3:2014. This study was also conducted according to the Organization for Economic Cooperation and Development (OECD) 490 (2016), Guideline for Testing of Chemicals, In Vitro Mammalian Cell Gene Mutation Tests using the Thymidine Kinase Gene. | The RPMI_{0} and DMSO test article extracts shall not cause any increase in the mean mutant frequency of the L5178Y/TK^{+/+} cell line greater than the mutant frequency of the control blank + the Global Evaluation Factor (126), in the presence or absence of metabolic activation.
The test article shall be not mutagenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Chemical characterization | The purpose of this study was to perform a chemical characterization to identify and quantitate the extractables and/or leachables that may be released from the test article. This study was conducted according to ISO 10993-18:2020 / Amd1:2022. | Identify and quantitate the extractables and/or leachables that may be released from the test article (Peritoneal Catheter SNCA-5262L). | Passed. |
| **Bladder Catheter** | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. Bladder Catheter shall be non-cytotoxic. | Passed. |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | Bladder Catheter shall be non-pyrogenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Pyrogenicity (USP) e | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | Bladder Catheter shall be non-pyrogenic. | Passed. |
| Chemical characterization | The purpose of this study was to perform a chemical characterization to identify and quantitate the extractables and/or leachables that may be released from the test article. This study was conducted according to ISO 10993-18:2020 / Amd1:2022. | Identify and quantitate the extractables and/or leachables that may be released from the test article (Bladder Catheter). | Passed. |
| Implant Accessories | | | |
| Peritoneal Catheter Extension | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. Peritoneal Catheter Extension shall be non-cytotoxic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). Peritoneal Catheter Extension shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. Peritoneal Catheter Extension shall be non-sensitizing. | Passed. |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | Peritoneal Catheter Extension shall be non-pyrogenic. | Passed. |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate | Peritoneal Catheter Extension shall be non-pyrogenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | | |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
| Genotoxicity (Bacterial Reverse Mutation) | Bacterial reverse mutation tests have been used for the determination of mutagenic and potential carcinogenic hazards of the Peritoneal Catheter Extension. This study was conducted according to ISO 10993-3:2014. This study was also conducted according to the Organization for Economic Cooperation and Development (OECD) 471 (2020), Guideline for Testing of Chemicals, Bacterial Reverse Mutation Test. | The SC and DMSO test article extracts shall be considered to be non-mutagenic to S. typhimurium tester strains TA98, TA100, TA1535, and TA1537, and to E. coli WP2uvrA tester strain.
The test article shall be not mutagenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Genotoxicity (In Vitro Mouse Lymphoma Assay | The purpose of this non-clinical GLP study was to evaluate the mutagenic potential of the test article extracts using the mouse lymphoma forward mutation assay procedures utilizing 4 hours treatments in the absence and presence of exogenous metabolic activation and 24 hours treatment (in the absence of exogenous metabolic activation). This study was conducted according to ISO 10993-3:2014. This study was also conducted according to the Organization for Economic Cooperation and Development (OECD) 490 (2016), Guideline for Testing of Chemicals, In Vitro Mammalian Cell Gene Mutation Tests using the Thymidine Kinase Gene. | The RPMI_{0} and DMSO test article extracts shall not cause any increase in the mean mutant frequency of the L5178Y/TK^{+/+} cell line greater than the mutant frequency of the control blank + the Global Evaluation Factor (126), in the presence or absence of metabolic activation.
The test article shall be not mutagenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Chemical characterization | The purpose of this study was to perform a chemical characterization to identify and quantitate the extractables and/or leachables that may be released from the test article. This study was conducted according to ISO 10993-18:2020 / Amd1:2022. | Identify and quantitate the extractables and/or leachables that may be released from the test article (Peritoneal Catheter Extension). | Passed. |
| **Catheter Extension Connector** | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. Catheter Extension Connector shall be non-cytotoxic. | Passed. |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). Catheter Extension Connector shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate | The topical application of the SC extract shall not | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. Catheter Extension Connector shall be non-sensitizing. | |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | Catheter Extension Connector shall be non-pyrogenic. | Passed. |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | Catheter Extension Connector shall be non-pyrogenic. | Passed. |
| Chemical characterization | The purpose of this study was to perform a chemical characterization to | Identify and quantitate the extractables and/or leachables that may | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | identify and quantitate the extractables and/or leachables that may be released from the test article. This study was conducted according to ISO 10993-18:2020 / Amd1:2022. | be released from the test article (Catheter Extension Connector). | |
| Implantation study Peritoneal Catheter Extension & Catheter Extension Connector | The purpose of this nonclinical GLP study was to evaluate the local tissue effects of an ingrowth patch and two implant accessories belonging to the alfapump® System. The ingrowth patch (Test Article 1) was compared to a CE-marketed ingrowth patch (Control Article) and to a negative control (High Density PolyEthylene, HDPE) and the Peritoneal Catheter Extension (Test Article 2) and Catheter Extension Connector (Test Article 3) were compared to the negative control article only following subcutaneous implantation in the rabbit.
The local tissue effects were evaluated macroscopically and histopathologically 4 and 13 weeks post- | Null to minimal reaction when compared to control or the negative control article. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | implantation. This study was conducted according to ISO 10993-6:2016. | | |
| Introducer Kit | | | |
| (0.038 Double-Ended Guidewire) | | | |
| Cytotoxicity(0.038 Double-Ended Guidewire) | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. 0.038 Double-Ended Guidewire shall be non-cytotoxic. | Passed. |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). 0.038 Double-Ended Guidewire shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. 0.038 Double-Ended | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | to the ISO 10993-10:2021. | Guidewire shall be non-sensitizing. | |
| Pyrogenicity (EP) (0.038 Double-Ended Guidewire) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | 0.038 Double-Ended Guidewire shall be non-pyrogenic. | Passed. |
| Pyrogenicity (USP) (0.038 Double-Ended Guidewire) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | 0.038 Double-Ended Guidewire shall be non-pyrogenic. | Passed. |
| Acute systemic toxicity (0.038 Double-Ended Guidewire) | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | conducted according to ISO 10993-11:2017 | from the SC test article extract injected into mice by the IP route. | |
| **14 FR Dilator** | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. 14 FR Dilator shall be non-cytotoxic. | Passed. |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). 14 FR Dilator shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. 14 Fr Dilator shall be non-sensitizing. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | 14 Fr Dilator shall be non-pyrogenic. | Passed. |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | 14 Fr Dilator shall be non-pyrogenic. | Passed. |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| 18 Fr Peel-Away Introducer Sheath | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. 18 Fr Peel-Away Introducer Sheath shall be non-cytotoxic. | Passed. |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). 18 Fr Peel-Away Introducer Sheath shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. 18 Fr Peel-Away Introducer Sheath shall be non-sensitizing. | Passed. |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract | 18 Fr Peel-Away Introducer Sheath | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | shall be non-pyrogenic. | |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | 18 Fr Peel-Away Introducer Sheath shall be non-pyrogenic. | Passed. |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
| **18 Gauge Puncture Needle** | | | |
| Cytotoxicity | The purpose of this GLP study was to | The full strength EMEM10 test article | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. 18 Gauge Puncture Needle shall be non-cytotoxic. | |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). 18 Gauge Puncture Needle shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. 18 Gauge Puncture Needle shall be non-sensitizing. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | 18 Gauge Puncture Needle shall be non-pyrogenic. | Passed. |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | 18 Gauge Puncture Needle shall be non-pyrogenic. | Passed. |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Tunneling Rod | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. Tunneling Rod shall be non-cytotoxic. | Passed. |
| Irritation | The purpose of this non-clinical GLP study was to evaluate the potential of test article extracts to induce local dermal irritation following intracutaneous injection in rabbits. This study was conducted according to the ISO 10993-23:2021. | The difference between each test extract overall mean score and corresponding control blank overall mean score shall be lower than 1.0 (0.0 for the SC and SO test extracts). Tunneling Rod shall be non-irritating. | Passed. |
| Sensitization | The purpose of this non-clinical GLP study was to evaluate the potential of the test article extracts to cause delayed dermal contact sensitization in the guinea pig. This study was conducted according to the ISO 10993-10:2021. | The topical application of the SC extract shall not induce delayed sensitization in the guinea pig. The topical application of the SO extract shall not induce delayed sensitization in the guinea pig. Tunneling Rod shall be non-sensitizing. | Passed. |
| Pyrogenicity (EP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract | Tunneling Rod shall be non-pyrogenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the European Pharmacopoeia. | | |
| Pyrogenicity (USP) | The purpose of this non-clinical GLP study was to evaluate if a test article extract induced a pyrogenic response following intravenous injection in rabbits. This study was conducted according to the requirements of the United States Pharmacopoeia, General chapter <151>. | Tunneling Rod shall be non-pyrogenic. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Acute systemic toxicity | The purpose of this non-clinical GLP study was to evaluate the acute systemic toxicity of the sodium chloride (SC) test article extract following intravenous (IV) and intraperitoneal (IP) injection in mice. This study was conducted according to ISO 10993-11:2017 | There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IV route.
There shall be no mortality or evidence of systemic toxicity from the SC test article extract injected into mice by the IP route. | Passed. |
| Smart Charger / Docking Station | | | |
| Cytotoxicity | The purpose of this GLP study was to evaluate the potential cytotoxic effect of a test article extract using an in vitro mammalian cell culture. This study was conducted according to the ISO 10993-5:2009. | The full strength EMEM10 test article extract shall show no cytotoxic potential to L-929 mouse fibroblast cells. Smart Charger / Docking Station shall be non-cytotoxic. | Passed. |
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# A.5 Electrical Safety
Table 8 summarizes testing performed to verify that the applicable components of the alfapump® System meet its requirement to comply with the following standards:
Table 8 Electrical Safety testing
| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Legibility of Marking | To prove that the marking, labels and device labels of the alfapump® System components required by IEC 60601-1:2005/Amd2:2020 are clearly legible. | Testing per IEC 60601-1:2005/Amd2:2020, clause 7.1.2. | Passed. |
| Durability of marking test | To prove that the marking, labels and device labels of the alfapump® System components required by IEC 60601-1:2005/Amd2:2020 are sufficiently durable to remain clearly legible during the expected service life of the me equipment. | Testing per IEC 60601-1:2005/Amd2:2020, clause 7.1.3. | Passed. |
| Leakage current | To measure the leakage currents and patient auxiliary currents and to prove that the limits defined by IEC 60601-1:2005/Amd2:2020, clause 8 are not exceed. Measurement of Touch Current (TC), Patient Leakage Current (P), Patient leakage current with mains on the F-type | Testing per IEC 60601-1:2005/Amd2:2020, clause 8.7. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | applied parts. Other tests for leakage currents defined by IEC 60601-1:2005/Amd2:2020 are not applicable for the components of the alfapump System. | | |
| Dielectric strength test | To evaluate through a dielectric strength test the capability of solid electrical insulation of the alfapump® System components to withstand the test voltages as specified in Table 6 of IEC 60601-1:2005/Amd2:2020. | Testing per IEC 60601-1:2005/Amd2:2020, clause 8.8.3. | Passed. |
| Mechanical strength and resistance to heat - Ball pressure test of thermoplastic parts | To evaluate the resistance to heat that shall be retained by all types of insulation during the expected service life of the alfapump® System components. | Testing per IEC 60601-1:2005/Amd2:2020, clause 8.8.4.1. | Passed. |
| Instability - overbalance in transport position | To prove that the alfapump® System components do not overbalance when placed in any transport position of normal use on a plane inclined at an angle of 10° from the horizontal plane. | Testing per IEC 60601-1:2005/Amd2:2020, clause 9.4.2.1. | Passed. |
| Instability - overbalance excluding transport position | To prove that the alfapump® System components do not overbalance when placed in any | Testing per IEC 60601-1:2005/Amd2:2020, clause 9.4.2.2. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| | position of normal use, excluding any transport positions, on a plane inclined at an angle of 5° from the horizontal plane. | | |
| Excessive temperatures | To verify that maximum temperatures do not exceed limits defined by IEC 60601-1:2005/Amd2:2020, clause 11 (Table 22, 23, 24 and RMF for AP). | Testing per IEC 60601-1:2005/Amd2:2020, clause 11.1.1. | Passed. |
| Spillage, leakage, ingress of water, cleaning, disinfection | To prove that the alfapump® System components ensure a sufficient degree of protection against spillage, leakage, ingress of water or particulate matter, cleaning and disinfection. | Testing per IEC 60601-1:2005/Amd2:2020, clause 11.6.1. | Passed. |
| Single fault conditions | To prove that the alfapump® System components are designed so that they remain single fault safe. | Testing per IEC 60601-1:2005/Amd2:2020, in accordance with clauses 13.2.2, 13.2.3 and 13.2.12 (other SFCs listed in 13.2 are not applicable). | Passed. |
| Push Test | To prove that the alfapump® System components are designed to have adequate mechanical strength when subjected to mechanical stress caused by pushing. | Testing per IEC 60601-1:2005/Amd2:2020, clause 15.3.2. | Passed. |
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| Test | Purpose | Acceptance Criteria | Results |
| --- | --- | --- | --- |
| Impact Test | To prove that the alfapump® System components are designed to have adequate mechanical strength when subjected to mechanical stress caused by impact. | Testing per IEC 60601-1:2005/Amd2:2020, clause 15.3.3. | Passed. |
| Drop Test (hand-held and portable) | To prove that the alfapump® System components are designed to have adequate mechanical strength when subjected to mechanical stress caused by dropping. | Testing per IEC 60601-1:2005/Amd2:2020, clauses 15.3.4.1 and 15.3.4.2. | Passed. |
| Mould Stress Relief | To prove that the alfapump® System components are designed to have adequate mechanical strength when subjected to mechanical stress caused by molding stress relief. | Testing per IEC 60601-1:2005/Amd2:2020, clause 15.3.6. | Passed. |
| Shock test | To prove that the Smart Charger and Docking Station are designed to have adequate mechanical stren…
