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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:

(Note: Other acceptance criteria related to biocompatibility, mechanical performance, electrical safety, software, and usability were also met, but the specific performance metrics for the bleed detection algorithm are highlighted above.)

2. Sample Size and Data Provenance

• Test Set Sample Size: 20 female Yorkshire Cross swine.
• Data Provenance: Prospective, self-controlled acute animal investigation conducted within a controlled laboratory setting (likely within the United States, given the FDA submission context, though not explicitly stated). The data is prospective as it was collected during a designed experiment.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish the ground truth for the animal study. However, the ground truth establishment involved:

• Veterinary or Scientific Personnel: Presumably, qualified personnel (veterinarians, researchers) collected and measured bleed volumes and performed fluoroscopic imaging.
• Pathologist: A histopathology expert would have been involved in the systemic gross necropsy to study end-organ effects and confirm no vessel trauma related to the device.

The qualifications of these individuals are not detailed, but it can be inferred that they were experienced professionals in veterinary science, experimental surgery, and pathology.

4. Adjudication Method for the Test Set

The document does not describe an explicit "adjudication method" in the context of multiple human readers for the test set, as the primary endpoint was measured mechanically (device detection triggering) and then correlated with measured bleed volumes and confirmed by gross necropsy. The ground truth itself was established by controlled bleed simulations and subsequent measurements/examinations, rather than by human interpretation of images requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study focuses on the device's ability to detect bleeds in an animal model, not on human readers' performance with and without AI assistance. The device acts as an automated detection system.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance study was conducted. The sensitivity and specificity results (100% for Level 1 bleed detection) were derived from the automated detection capabilities of the Early Bird system in the animal model, without human intervention in the real-time detection process by the device itself. Human observation confirmed the ground truth of the simulated bleeds.

7. Type of Ground Truth Used

The ground truth used was based on:

• Simulated Bleeds / Measured Volumes: 500 ml of blood solution infused at 10 ml/min in the subcutaneous tissue near the access site in an animal model. Blood volumes were measured upon triggering of the Early Bird bleed indicators.
• Fluoroscopic Images: Collected upon triggering of the Early Bird bleed indicators to confirm extravasation.
• Gross Necropsy and Histopathology: Systemic gross necropsy was performed to study end-organ effects, and histopathology confirmed no vessel trauma related to the device.

This combination of controlled experimental simulation, direct measurement, and pathological confirmation ensured a robust ground truth for the presence and volume of bleeding.

8. Sample Size for the Training Set

The document explicitly states: "A clinical study was not completed to support this De Novo classification request." This implies that there were no human clinical studies for training or testing reported in this submission. The "training" of the proprietary algorithm is not explicitly detailed but would have occurred internally by the manufacturer using internal data or potentially data from previous bench or animal studies not specifically described as a "training set" in this regulatory document. The performance study described (20 swine) is the test set that validates the already developed device.

9. How Ground Truth for the Training Set Was Established

As no specific "training set" (in terms of a distinct, reported dataset used for algorithm development) is described in the provided text, the method for establishing its ground truth is not detailed. It is assumed that the proprietary algorithm was developed and refined using internal data and validation processes by Saranas, Inc. prior to the formal animal study presented for regulatory submission.

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