📋 FDA Reference
Jms AV Fistula Needles
Jms
Summary: The JMS AV Fistula Needles are used for vascular access in hemodialysis patients. They are typically utilized by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K911199 ↗
Decision Date ?
August 28, 1991
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The JMS AV Fistula Needles were cleared through the FDA 510(k) pathway on August 28, 1991. Manufactured by Jms, they are classified as Class 2 medical devices under product code FIE.
What It Is
JMS AV Fistula Needles are specialized needles designed for use in hemodialysis, providing access to arteriovenous fistulas. These needles are crucial for ensuring adequate blood flow rates during dialysis, typically exceeding 300 ml/min. They are designed to minimize trauma to the blood vessels and ensure patient comfort during repeated use.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Access to a native arteriovenous fistula.
- Access to a synthetic arteriovenous graft.
Clinical Applications
- Cannulation of an arteriovenous fistula for hemodialysis.
- Cannulation of a synthetic arteriovenous graft for hemodialysis.
- Withdrawal of blood from dialysis access for extracorporeal filtration.
- Return of dialyzed blood through the vascular access during a hemodialysis session.
Practical Considerations
- Available gauge and needle configurations depend on the specific product and its labeling; 15G is commonly used for adult hemodialysis access.
- The needle must be compatible with the dialysis blood tubing and equipment in use.
- Cannulation should be performed by trained dialysis personnel using appropriate aseptic technique.
- Potential complications include infiltration, hematoma, bleeding, infection, thrombosis, and injury to the access.
- These are needles rather than implantable devices; MRI considerations generally relate to any metallic components and the product labeling. They should be removed before MRI unless the specific labeling states otherwise.
Related Literature
The linked study evaluated hemolysis and blood trauma in different vascular access systems for hemodialysis. It highlighted issues such as insufficient blood flow and blood trauma associated with current technologies. The study introduced the LifeSite System as an alternative, noting its subcutaneous valve and 12F cannula accessed by a 14G needle. Limitations include its focus on in vitro conditions, which may not fully represent clinical scenarios.
Frequently Asked Questions
What is JMS AV Fistula Needles used for?
They are used for vascular access in hemodialysis, allowing for efficient blood flow during treatment.
What specialties typically use this device?
Nephrologists and dialysis nurses in dialysis centers and hospitals typically use these needles.
What are the FDA-cleared indications?
The needles are indicated for vascular access in patients requiring hemodialysis, suitable for use with both native fistulas and synthetic grafts.
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.