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Astroid Planning App
.Decimal
Summary: The Astroid Planning App by .Decimal is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to plan and optimize dialysis access for patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K173940 ↗
Decision Date ?
May 15, 2018
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Astroid Planning App was cleared through the FDA 510(k) pathway on May 15, 2018. Manufactured by .Decimal, it is classified as a Class 2 device under product code MUJ.
What It Is
The Astroid Planning App is a software tool designed to assist clinicians in planning dialysis access procedures. It provides detailed visualizations and simulations to optimize the placement and function of dialysis access devices. The app aims to improve procedural outcomes by allowing for precise pre-procedural planning.
FDA-Cleared Indications
- Planning vascular access procedures for patients who require hemodialysis.
- Supporting pre-procedural planning for creation of an arteriovenous fistula or vascular graft.
- Using patient-specific imaging and anatomical information to assist selection of a dialysis-access site and approach.
Clinical Applications
- Preoperative planning for hemodialysis arteriovenous fistula creation.
- Planning placement or creation of an arteriovenous graft for dialysis access.
- Reviewing patient-specific vascular anatomy before dialysis-access surgery or intervention.
- Supporting selection of the access location and procedural approach in patients with chronic kidney disease who need hemodialysis access.
Practical Considerations
- The software depends on accurate, current patient imaging and appropriate image quality.
- It should be used as a planning aid and does not replace clinical assessment, vascular examination, or the treating clinician's judgment.
- The record describes compatibility with standard imaging modalities; users should verify supported image formats, acquisition requirements, and software compatibility before use.
- This is planning software rather than an implanted device, so it has no patient-applied physical size, implant duration, or MRI labeling in the supplied record.
- The FDA record and supplied text do not establish that the software is independently diagnostic or that it replaces intraoperative imaging or procedural confirmation.
Frequently Asked Questions
What is the Astroid Planning App used for?
The Astroid Planning App is used for planning dialysis access procedures, helping clinicians optimize the placement and function of vascular access devices.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for planning dialysis access in patients requiring vascular access for hemodialysis, such as those with end-stage renal disease.
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.