Saranas Early Bird Bleed Monitoring System
Saranas Inc.The Saranas Early Bird Bleed Monitoring System is a single-use medical device designed to be inserted into the femoral artery or vein during endovascular procedures. It detects and monitors internal bleeding by measuring changes in bioimpedance, providing early indications of potential bleeding complications to physicians. This helps clinicians maintain patient safety by enabling early intervention during or after vascular interventions.
Intended Use
The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures. It provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.
Technology
The device consists of an introducer sheath with embedded electrodes connected to a battery-powered impedance analyzer within a user interface display. It monitors bioimpedance changes caused by extravascular fluid accumulation. The updated firmware improves detection by using an algorithm combining an impedance drop threshold and a bioimpedance slope threshold to trigger bleed level alerts, with software allowing reset functionality. No hardware changes were made.
Performance
Design verification and validation activities, including software verification, electrical testing, and prior animal validation studies, demonstrated reliable performance and safety of the enhanced detection algorithm. Risk analyses confirmed no unacceptable risks from algorithm changes. Verification and validation activities support substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/31/2023
3 months - 2
FDA Approval
5/25/2023
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