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510(k) Data Aggregation
(114 days)
Re: K230273
Trade/Device Name: Saranas Early Bird Bleed Monitoring System Regulation Number: 21 CFR 870.1345
Regulation Number: 21 CFR 870.1345
Classification: II
Product Code: QFJ
Device Trade/Proprietary Name
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| Device
Regulation /
Classification
Name | 21 CFR 870.1345
| 21 CFR 870.1345
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.
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 Saranas Early Bird Bleed Monitoring System (Early Bird) is a single use, disposable, Ethylene Oxide sterilized medical device. The Early Bird now claims a 2-year shelf life.
The Early Bird consists of the following: introducer sheath, user interface display (UID), for the early detection and monitoring of potential internal bleeding complications (IBCs), and a compatible dilator as shown in Figure 1.
The Early Bird introducer sheath contains four embedded electrodes on the cannula and a hemostasis valve located within the sheath hub. The distal end of the sheath has a tapered leading edge which transitions smoothly to the tapered dilator, forming an atraumatic device. The dilator is radiopaque to aid in visibility under fluoroscopy during insertion.
The Early Bird electrodes are connected via conductors, which transverse an independent lumen in the flush line, to a battery powered impedance analyzer, which resides in the User Interface Display (UID), depicted in Figure 2. The Early Bird is designed to monitor changes in bioimpedance due to extravascular fluid accumulation in the region where the device is inserted into the body during a percutaneous endovascular procedure.
The document K230273 describes the Saranas Early Bird Bleed Monitoring System, an intravascular bleed monitor, and its modifications. Here's a summary of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantifiable "acceptance criteria" in a table format for its modified algorithm's performance on human data. Instead, it describes the modifications to the algorithm and the verification that these modifications function as intended. The "reported device performance" is indicated by the overarching statement that "Verification results all passed, indicating that the enhanced algorithm provides an alternate Level 1 bleed detection which triggers upon an impedance drop threshold from a baseline impedance value." This implies that the new detection mechanism was successfully implemented and demonstrated to trigger under the specified conditions.
However, based on the description of the device's function, we can infer some implied performance goals:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance of Enhanced Algorithm: | |
| - Level 1 bleed detection upon an impedance drop threshold from a baseline impedance value. | "Verification results all passed, indicating that the enhanced algorithm provides an alternate Level 1 bleed detection which triggers upon an impedance drop threshold from a baseline impedance value." |
| - Level 1 bleed detection upon a bioimpedance drop rate exceeding a slope threshold (identical to predicate). | The document states this criterion is "identical to the predicate device trigger criterion" and implies continued functional performance, as the new algorithm "augments" rather than replaces the existing one. "Verification results all passed" supports this. |
| - Level 3 detections function the same as in the predicate version of the firmware. | "Once the Level 1 bleed is activated by either detection scheme, the Level 3 detections function the same as in the predicate version of the firmware." This implies successful verification of this unchanged functionality. |
| Improved Power On Self-Test: | |
| - Reduced erroneous faults after activation due to widened upper limit of calibration self-check. | "The modified device has an improved power on self-test upon activation, which allows for confirming the functional health of the device with a reduction of false error indications. Specifically, the upper limit of the calibration self-check was widened to reduce erroneous faults after activation." |
| Reset Functionality: | |
| - Ability for users to reset the EBBMS detection algorithm. | "The enhanced firmware also provides an opportunity for users to reset the EBBMS detection algorithm at their discretion." The instructions for use (IFU) changes explicitly detail the reset procedure: "Briefly, at the physician's discretion, pressing the power button for seven (7) seconds, anytime five (5) minutes after activation, initiates the reset action as indicated by all three Bleed Monitoring Indicators (red LEDs) flashing once per second. A successful reset is confirmed by all indicators flashing once and a brief audible tone identical to the power on sequence of the predicate and modified device (i.e., power on sequence unchanged)." |
| No New Concerns for Safety or Effectiveness: | "The subject device does not introduce any new concerns for safety or effectiveness with the firmware changes." "Risk analysis and assessment were conducted... In summary, there were no unacceptable risks due to device operation because of the algorithm changes." "The software design verification and validation activities and regression testing provide a high degree of assurance for safety and effectiveness that the device performs as intended. These design controls demonstrate reliable results and risk controls that form the basis for substantial equivalence between the designs of the modified Early Bird and the cleared Early Bird (DEN180021)." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "design validation activities centered around existing data sets from the Early Bird animal validation study."
- Sample Size: The exact sample size for this "test set" (existing data sets from the animal validation study) is not specified in the provided text.
- Data Provenance: The data is from an "Early Bird animal validation study." The country of origin and whether it was retrospective or prospective are not specified, but it was an animal study, not human.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. Given that the validation was based on "existing data sets from the Early Bird animal validation study," the ground truth likely refers to the actual presence or absence of bleeds in the animal models, perhaps determined by direct observation, imaging, or post-mortem examination. The role or number of experts involved in establishing this ground truth for the animal study is not mentioned.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not discussed or indicated in the provided text. The evaluation focused on technical verification and validation of the algorithm's functional changes against existing animal study data.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone evaluation of the algorithm's performance was done. The "design verification activities centered around existing Early Bird software and electrical verification test protocols and acceptance criteria" and "design validation activities centered around existing data sets from the Early Bird animal validation study." This indicates that the algorithm's direct output was assessed against known outcomes in an animal model without human intervention as part of the primary evaluation of the firmware update.
7. The Type of Ground Truth Used:
The ground truth used was from an "Early Bird animal validation study." For an internal bleed monitor, the ground truth in such a study would typically be direct observation of extravascular fluid accumulation (bleeding) in the animal model, possibly through invasive surgical inspection, imaging techniques (e.g., ultrasound, CT), or post-mortem examination during the animal study. The document doesn't specify the exact method, but it is not pathology or human outcomes data for this firmware update validation.
8. The Sample Size for the Training Set:
The document focuses on a firmware update to an already cleared device (DEN180021). It does not provide information about the sample size of any training set used for the original algorithm development or for this specific modification. The validation for this update used "existing data sets from the Early Bird animal validation study" as the test set, implying the update itself might have been developed based on analysis of such data, but explicit training set size is not given.
9. How the Ground Truth for the Training Set Was Established:
As the document does not specify a training set or its size for this update, it does not describe how the ground truth for any training set was established.
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(312 days)
NEW REGULATION NUMBER: 21 CFR 870.1345
CLASSIFICATION: II
PRODUCT CODE: QFJ
BACKGROUND
DEVICE
classified as follows:
Product Code: OFJ Device Type: Intravascular bleed monitor Regulation Number: 21 CFR 870.1345
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 |
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