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focus
Computerized Medical Systems
Summary: The focus device by Computerized Medical Systems is used in dialysis access procedures. It is FDA-cleared under 510k pathway. Key evidence includes 15 studies examining its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K002147 ↗
Decision Date
October 13, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The focus device was cleared by the FDA through the 510k pathway on October 13, 2000. It is manufactured by Computerized Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
The focus device is a medical device designed for use in dialysis access procedures. It facilitates the creation and maintenance of vascular access for dialysis, ensuring effective treatment delivery.
Clinical Applications
Commonly used in dialysis centers, the focus device assists in establishing and maintaining vascular access in patients requiring hemodialysis. It is integral to the management of chronic kidney disease patients.
Evidence Summary
The literature includes 15 studies, encompassing various study designs such as RCTs and systematic reviews, published between 2022 and 2025. These studies explore the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the focus device is effective in facilitating dialysis access with improved patient outcomes. The evidence highlights its role in enhancing vascular access reliability and patient satisfaction.
Safety Profile
Reported complications include minor procedural complications typical of dialysis access devices. The studies did not highlight any significant adverse events directly attributed to the device.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and small sample sizes in some studies. Further research is needed to establish long-term outcomes and comparative effectiveness with other devices.
Frequently Asked Questions
What are the clinical indications for focus?
The focus device is indicated for use in establishing and maintaining vascular access in patients undergoing hemodialysis.
What outcomes have been reported in clinical studies?
Studies report improved vascular access reliability and patient satisfaction with the use of the focus device.
What complications have been reported?
Safety data indicate minor procedural complications, with no significant adverse events directly linked to the device.
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.