(312 days)
Not Found
Not Found
No
The description mentions a "proprietary algorithm" for monitoring bioimpedance changes, but there is no mention of AI, ML, or any learning-based approach. The algorithm appears to be based on fixed bioimpedance measurements and filtering.
No.
The device is indicated for the introduction of catheters and other devices, and for the detection and monitoring of extravascular fluid accumulation (bleeding), which are diagnostic and procedural support functions, not therapeutic.
Yes
The device provides an "early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation" and "is designed to detect extravascular fluid accumulation due to Internal Bleeding Complications (IBC) in real-time." This detection and monitoring of a medical condition aligns with the definition of a diagnostic device.
No
The device description explicitly states it consists of an Introducer Sheath with integrated electrodes, a Compatible Dilator, and a User Interface Device with associated hardware and firmware. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Early Bird device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, or other bodily fluids outside of the body.
- Early Bird's Function: The Early Bird device operates in vivo (within the living body). It is an introducer sheath with integrated electrodes that are inserted into the femoral vein. It monitors changes in bioimpedance within the body to detect extravascular fluid accumulation (internal bleeding).
The device's function is to provide real-time monitoring of a physiological condition within the patient, not to analyze a specimen taken from the patient. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
QFJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a prescription use setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A prospective, self-controlled acute animal investigation was conducted to evaluate the safety and efficacy of the Early Bird in detecting extravascular fluid accumulation via simulated IBC.
Sample Size: Twenty (20) female Yorkshire Cross swine.
The primary endpoint was sensitivity of Level 1 bleed detection, and the secondary endpoint was bleed progression performance.
Level 1 bleed detection resulted in 100% sensitivity and 100% specificity.
The Early Bird successfully identified bleed progression with a 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.
0
DE NOVO CLASSIFICATION REQUEST FOR EARLY BIRD BLEED MONITORING SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Intravascular bleed monitor. 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 bleed complications.
NEW REGULATION NUMBER: 21 CFR 870.1345
CLASSIFICATION: II
PRODUCT CODE: QFJ
BACKGROUND
DEVICE NAME: Early Bird Bleed Monitoring System
SUBMISSION NUMBER: DEN180021
DATE DE NOVO RECEIVED: April 23, 2018
SPONSOR INFORMATION:
Saranas, Inc. 2450 Holcombe Blvd. Suite X Houston, Texas 77021
INDICATIONS FOR USE
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.
LIMITATIONS
The sale, distribution, and use of the Early Bird are restricted to prescription use in accordance with 21 CFR 801.109.
1
Insertion of more than one Early Bird device in the same vessel or in the adjoining vessel is not recommended due to potential interaction between the two bioimpedance measurement signals. If more than one introducer sheath is required simultaneously to perform a procedure, use a standard introducer sheath in the secondary position.
The Early Bird may not detect an internal bleeding complication if internal bleeding has already occurred prior to insertion of the introducer sheath or prior to initial bioimpedance measurement.
Do not attempt to place a guidewire with a maximum diameter greater than 0.035" (0.89 mm) through the dilator.
Do not attempt to insert a catheter or interventional device having a diameter larger than the Early Bird introducer sheath size (Table 1). Device damage or breakage may result.
Do not attempt to insert multiple catheters or devices when the combined diameter is larger than the Early Bird introducer sheath size (Table 1). Device damage or breakage may result.
Difficulties with sheath insertion at the insertion site may result in kinking of the device. If the Early Bird is kinked, remove the device and replace with a new one.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
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.
2
Image /page/2/Figure/0 description: The image shows a medical device with several labeled components. The components include a user interface display, a flush line, a dilator, an introducer sheath with embedded electrodes, a battery pull tab, and a sheath hub with an internal hemostasis valve. The device appears to be designed for insertion into the body, with the dilator likely used to create an initial opening.
Figure 1: Early Bird Bleed Monitoring System
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.
3
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The patient contacting materials of the Early Bird Bleed Monitoring System include Pebax®, stainless steel, liquid silicone rubber, acrylonitrile butadiene styrene, ethylene propylene diene monomer rubber, polycarbonate, and cyanoacrylate. Therefore, per the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"", the device is considered an externally communicating device in contact with blood for limited contact ( Sterility Tests | Passed |
| Packaging and Shelf Life Validation
- ISO 11607-1:2016 Packaging for Terminally Sterilized Medical Devices – Part 1:
Requirements for Material, Sterile Barrier Systems and Packaging. - ASTM D4332-14, Standard Practice for Conditioning Containers, Packages, or
Packaging Components for Testing - ASTM D4169-14, Standard Practice for Performance Testing of Shipping Containers
and Systems - ASTM F2096-11, standard test method for detecting gross leaks in packaging by
internal pressurization - ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems
for Medical Devices - Functional Testing | Passed |
ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY
The Early Bird Bleed Monitoring System conforms with FDA-recognized standards for basic safety and essential performance of Medical Electrical Equipment. Acceptable justifications and rationale were provided when not conforming to specific clauses.
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601 1:2005, MOD)60601-1-2
- IEC 60601-1-2 Edition 4.0 2014-02 ● Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-6 Edition 3.1 2013-10 ● Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8 Edition 2.1 2012-11 ● Medical electrical equipment - Part 1-8: General requirements for basic safety and
5
essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 62366-1 Edition 1.0 2015-02 ● Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
MAGNETIC RESONANCE (MR) COMPATIBILITY
The Early Bird Bleed Monitoring System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. Therefore, the device is MR Unsafe.
SOFTWARE
Software documentation was provided in accordance with the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued May 11, 2005) for a Moderate Level of Concern (LOC). A Moderate LOC is deemed appropriate as malfunction of the device software or a latent design flaw in the device software may lead to erroneous information or a delay in the delivery of appropriate medical care, which would likely result in minor injury but would likely not result in serious injury or death due to the current practice of medicine.
USABILITY TESTING
Usability testing was necessary to mitigate risks associated with delayed or incorrect treatment due to user misinterpretation or overreliance on the indicator. Test reports were provided in accordance with the FDA Guidance Document, "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff" (issued February 02, 2016). A total of 15 end-users participated in the study. Testing was performed in a simulated environment using a sequence of tasks that targeted the critical tasks identified by the sponsor. The results of the testing met the predetermined, quantitative and qualitative acceptance criteria.
PERFORMANCE TESTING - BENCH
A summary of the performance bench testing completed on the Early Bird Bleed Monitoring System can be found below in Table 3.
| Test | Purpose | Result |
|---|---|---|
| Dimensional | Demonstrate conformance of | |
| various device diameters and | ||
| lengths. | Passed | |
| Guidewire Compatibility | Demonstrate that a 0.035" | |
| guidewire can pass through the | ||
| dilator. | Passed |
| Table 3: Performance Bench Testing Overview of the Early Bird Bleed Monitoring System | |||
|---|---|---|---|
6
| Flush Test | Demonstrate that the dilator and sheath can allow fluid to pass through. | Passed |
|---|---|---|
| Leak Test | Demonstrate no formation of a falling drop. | Passed |
| Dilator Insertion Force | Demonstrate insertion force and that the hemostasis valve does not dislodge. | Passed |
| Dilator Latch/Unlatch Force | Demonstrate a 7.0 lbf max latch force and 3.0 – 8.0 lbf unlatch force. | Passed |
| Device and Component Tensile | Demonstrate tensile strength of the overall device and individual components. | Passed. |
| Sheath and Dilator Kink/Bend | Demonstrate device ability to withstand kinking/bending. | Observations reported. Data leveraged from non-clinical animal testing and warning added to labeling regarding risk of kinking/bending for acceptable result. |
| Sheath and Dilator 3-Point Bending | Demonstrate ability to bend within specifications. | Passed. |
| Sheath Torsional Stiffness | Demonstrate torsional stiffness conforms to specification. | Passed. |
| Device Torque | Demonstrate device ability to withstand torqueing. | Passed. |
| Device and Component Friction | Demonstrate device ability to operate within frictional requirements. | Passed. |
PERFORMANCE TESTING - ANIMAL AND/OR CADAVER
A prospective, self-controlled acute animal investigation was conducted to evaluate the safety and efficacy of the Early Bird in detecting extravascular fluid accumulation via simulated IBC. The primary endpoint was sensitivity of Level 1 bleed detection, and the secondary endpoint was bleed progression performance. Twenty (20) female Yorkshire Cross swine underwent femoral vessel cannulation with the Early Bird. After preparation of the access site, the Early Bird was introduced into the target vessel. To simulate a bleed, 500 ml of blood solution was infused at 10 ml/min in the subcutaneous tissue near the access site. Blood volumes and fluoroscopic images were collected upon triggering of the Early Bird bleed indicators. Systemic gross necropsy was performed to study the endorgan effects of the Early Bird. Level 1 bleed detection resulted in 100% sensitivity and 100% specificity.
| Table 4. Sensitivity and Specificity at Level 1 Detection | ||
|---|---|---|
| Early Bird Level 1 Bleed | ||
| Detection | Bleed Status | |
| Detection | Bleed Simulations or Access | |
| Site Bleeds | No Bleed Simulations or No | |
| Access Site Bleeds | ||
| Detection | 40 = True Positive* | 0 = False Positive |
7
| Non-Detection | 0 = False Negative | 30 = True Negative |
|---|---|---|
| Sensitivity/Specificity | Sensitivity = 100% | Specificity = 100% |
| * 10 true bleeds that occurred prior to bleed simulation and 30 bleeds that were detected during | ||
| bleed simulation (40 total). |
The Early Bird successfully identified bleed progression with a statistically significant increase in volume detected at each bleed indicator level (as described in Table 5, Wilcoxon Signed Rank Test P