(312 days)
The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures.
The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.
The device is a single use, disposable, EtO sterilized device consisting of an Introducer Sheath (IS) with integrated electrodes, Compatible Dilator, and User Interface Device (UID) with associated hardware and firmware.
The Saranas Early Bird Bleed Monitoring System (Early Bird) is designed to detect extravascular fluid accumulation due to Internal Bleeding Complications (IBC) in realtime. without altering existing endovascular procedural workflows or protocols. The system allows for seamless integration by the clinician while placing the bioimpedance sensing electrodes in proximity to the site of a potential bleeding complication.
When using the Saranas sheath, the clinician will insert the sheath into the vasculature via Seldinger's technique, and power up the system per the Instructions for Use. Upon power up, the system performs a series of self-tests to ensure proper functionality, followed by initiation of the bleed monitoring algorithm.
Bleed monitoring is accomplished via a proprietary algorithm, which monitors and interrogates changes in regional bioimpedance. Bioimpedance measurements are obtained through a series of electrodes, which provide a means of electrical contact with body fluids and are located on the sheath cannula. The two outer electrodes drive a 250 uAp-p, 10k Hz, fixed frequency, alternating current to establish an electrical field, which is measured by the two inner electrodes. The limit is frequency dependent, and at 10kHz, the limit in normal condition is 100 uA RMS or 282 uAp-p. Extraneous signals are filtered out through a series of high and low pass filters integrated on the PCBA and digital filters employed in the firmware.
The Early Bird Bleed Monitoring System is designed to detect extravascular fluid accumulation due to Internal Bleeding Complications (IBC) by monitoring changes in regional bioimpedance. The device's performance was evaluated through a prospective, self-controlled acute animal investigation to establish its acceptance criteria and prove its capabilities.
1. Table of Acceptance Criteria and Reported Device Performance
The core performance acceptance criteria for the Early Bird system, specifically for bleed detection, and its reported performance are summarized in the table below, derived from the animal study results:
| Acceptance Criteria (Performance) | Reported Device Performance |
|---|---|
| Level 1 Bleed Detection Sensitivity | 100% Sensitivity |
| Level 1 Bleed Detection Specificity | 100% Specificity |
| Bleed Progression Performance | Statistically significant increase in volume detected at each bleed indicator level (Wilcoxon Signed Rank Test P |
§ 870.1345 Intravascular bleed monitor.
(a)
Identification. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
(i) Device performance characteristics;
(ii) Adverse effects, including gross necropsy and histopathology; and
(iii) Device usability, including device preparation, device handling, and user interface.
(2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Tensile testing of joints and materials;
(ii) Mechanical integrity testing;
(iii) Friction testing;
(iv) Flush testing;
(v) Air leakage and liquid leakage testing;
(vi) Latching and unlatching testing;
(vii) Kink and bend testing;
(viii) Insertion force testing;
(ix) Torque testing;
(x) Corrosion testing; and
(xi) Dimensional tolerance testing.
(3) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(5) The patient contacting components of the device must be demonstrated to be biocompatible.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Performance data must demonstrate electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety.
(8) Human factors performance evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use.
(9) Labeling must include:
(i) Instructions for use;
(ii) A shelf life and storage conditions;
(iii) Compatible procedures;
(iv) A sizing table; and
(v) Quantification of blood detected.