(114 days)
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.
§ 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.