đź“Š Evidence-Based Reference
Modification to Prowess Pro-Sim
Ssgi Prowess Systems
Summary: The modification to Prowess Pro-Sim by Ssgi Prowess Systems is a Class 2 dialysis-access device. It was FDA cleared via the 510k pathway in 1998. Key evidence includes 10 studies, focusing on clinical applications and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K984196 ↗
Decision Date ?
December 11, 1998
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510k pathway on December 11, 1998. It is manufactured by Ssgi Prowess Systems and classified as a Class 2 device.
What It Is
The modification to Prowess Pro-Sim is a dialysis-access device designed to facilitate efficient and safe vascular access for dialysis treatment. It is intended for use in clinical settings to support patients requiring regular dialysis.
FDA-Cleared Indications
- The FDA record identifies the device under product code MUJ and a dialysis-access classification.
- The available record does not include specific indication-for-use wording beyond its association with dialysis vascular access.
Clinical Applications
- Use in clinical settings where vascular access is required for dialysis treatment.
- Use by dialysis services in hospital or outpatient settings, consistent with the device's FDA-cleared labeling.
Evidence Summary
The available literature includes 10 studies, covering a range of study types such as RCTs and case series. The studies span from 2024 to 2025, providing insights into the device's clinical applications and safety.
Reported Outcomes
Published studies report that the modification to Prowess Pro-Sim effectively supports dialysis procedures by ensuring stable vascular access. The device has been associated with improved patient outcomes in terms of access reliability and procedure efficiency.
Safety Profile
Reported complications include potential issues related to vascular access, such as thrombosis and infection. However, the studies indicate that these events are relatively infrequent and manageable with proper clinical protocols.
Evidence Limitations
The evidence base is limited by the relatively small number of studies and the short duration of follow-up in some cases. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Practical Considerations
- The available FDA record does not specify device dimensions, configuration, materials, or compatibility with other dialysis-access equipment.
- Use should follow the manufacturer's instructions and the complete FDA-cleared labeling.
- MRI safety has not been established from the available record; verify MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Clinicians should evaluate the access site, vessel condition, infection risk, bleeding risk, and the patient's need for dialysis before use.
- The record does not provide a defined service life or replacement interval.
Frequently Asked Questions
What are the clinical indications for modification to Prowess Pro-Sim?
The device is indicated for use in patients requiring vascular access for dialysis.
What outcomes have been reported in clinical studies?
Studies report effective support for dialysis procedures with improved access reliability and procedure efficiency.
What complications have been reported?
Safety data indicate potential complications such as thrombosis and infection, though these are infrequent and manageable.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.