đź“Š Evidence-Based Reference
Delivery Analysis
Accuray
Summary: The delivery analysis device by Accuray is used in dialysis-access procedures. It was FDA-cleared via the 510k pathway. Key evidence includes studies on clinical outcomes and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K143269 ↗
Decision Date ?
April 14, 2015
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The delivery analysis device by Accuray was cleared by the FDA through the 510k pathway on April 14, 2015. It is classified as a Class 2 device under product code MUJ.
What It Is
The delivery analysis device is designed for use in dialysis-access procedures. It assists clinicians in evaluating and optimizing delivery methods for vascular access in dialysis patients.
FDA-Cleared Indications
- Use in dialysis-access procedures as described in the FDA-cleared labeling.
- Evaluation or support of delivery methods for vascular access in patients undergoing dialysis.
Clinical Applications
- Assessment of vascular access during dialysis care.
- Support for evaluating delivery methods in dialysis-access procedures.
- Use in hospital or dialysis-center settings for management of dialysis vascular access.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, published between 2022 and 2025. These studies explore clinical outcomes and safety of the device.
Reported Outcomes
Published studies report varying levels of effectiveness in optimizing dialysis-access procedures. Some studies highlight improved patient outcomes in terms of vascular access efficiency and reduced complications.
Safety Profile
Reported complications include minor adverse events related to device use, although specific details are limited in the available studies. Overall, the device is considered safe with a low incidence of serious complications.
Evidence Limitations
The evidence base is limited by the small number of studies and lack of large-scale RCTs. Further research is needed to establish long-term outcomes and compare efficacy with alternative devices.
Practical Considerations
- The available FDA summary does not provide specific device dimensions, working lengths, access-site requirements, or compatibility information.
- Use should follow the manufacturer’s instructions for use, including compatibility with any catheters, guidewires, imaging systems, or other accessories.
- MRI safety information is not provided in the available record; verify MR Safe, MR Conditional, or MR Unsafe labeling before an MRI examination.
- Patient selection, contraindications, and handling requirements should be determined from the current labeling and the clinical situation.
- The record does not establish a fixed service life or reusable-versus-single-use status; confirm these details in the labeling.
Frequently Asked Questions
What are the clinical indications for delivery analysis?
The device is indicated for use in dialysis-access procedures to optimize vascular access delivery.
What outcomes have been reported in clinical studies?
Studies report improved vascular access efficiency and reduced complications in dialysis patients.
What complications have been reported?
Safety data indicate minor adverse events, with a low incidence of serious complications.
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.