Saranas Early Bird Bleed Monitoring System

K230273 · Saranas, Inc. · QFJ · May 25, 2023 · Cardiovascular

Device Facts

• Record ID: K230273
• Device Name: Saranas Early Bird Bleed Monitoring System
• Applicant: Saranas, Inc.
• Product Code: QFJ · Cardiovascular
• Decision Date: May 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1345
• Device Class: Class 2

Indications for Use

The Early Bird is intended: • to be inserted into the femoral artery or femoral vein to provide a conduit for the insertion of diagnostic and interventional endovascular devices. • to provide physicians with an early indication of extravascular fluid accumulation, which may be due to a potential internal bleeding complication. • to detect and monitor changes in bioimpedance due to extravascular fluid accumulation, and to provide physicians with indications that a potential internal bleeding complication is progressing. The Early Bird is intended to provide physicians and other healthcare providers with additional information to aid in their clinical assessment of the patient during and after endovascular procedures. As such, it is not intended to diagnose or replace clinical judgment of healthcare professionals.

Device Story

Single-use, sterile, disposable introducer sheath with four embedded electrodes; used in femoral artery/vein during endovascular procedures. Electrodes connect to battery-powered User Interface Display (UID). Device monitors bioimpedance changes indicating extravascular fluid accumulation (potential internal bleeding). Firmware update adds detection scheme: triggers Level 1 alert based on impedance drop threshold from baseline or bioimpedance drop rate (slope threshold). Physician observes visual/audible indicators on UID to assess patient status. Reset functionality allows re-establishing baseline if device dislodged or during active bleeding. Provides supplemental information for clinical decision-making; does not replace professional judgment.

Clinical Evidence

Bench testing only. Design verification and validation activities utilized existing data sets from the predicate device's animal validation study. Software verification and regression testing confirmed the enhanced algorithm reliably triggers Level 1 detection via impedance drop threshold.

Technological Characteristics

Single-use introducer sheath with 4 embedded electrodes; radiopaque dilator. Powered by 1.5V AAA alkaline battery. Bioimpedance sensing principle. Connectivity: standalone UID with visual/audible indicators. Sterilization: Ethylene Oxide (SAL 10^-6). Software: firmware-based detection algorithm (threshold and slope-based). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for introduction of catheters, catheter balloons, and other diagnostic and interventional devices into femoral artery or vein while maintaining hemostasis during endovascular procedures; provides early indication of potential internal bleeding complications via detection/monitoring of extravascular fluid accumulation.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the intravascular bleed monitor is subject to the following special controls: - (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; - Adverse effects, including gross necropsy and histopathology; and (ii) - (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; - Mechanical integrity testing: (ii) - (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; - Torque testing; (ix) - Corrosion testing; and (x) - (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: - Instructions for use: (i) - (ii) A shelf life and storage conditions: - (iii) Compatible procedures: - (iv) A sizing table; and - Quantification of blood detected. (v)

*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.

Predicate Devices

• Saranas Early Bird Bleed Monitoring System (DEN180021)

Submission Summary (Full Text)

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May 25, 2023

Saranas Inc. % Allison Komiyama Consultant RQM+ 2251 San Diego Ave. Suite B-257 San Diego, California 92110

Re: K230273

Trade/Device Name: Saranas Early Bird Bleed Monitoring System Regulation Number: 21 CFR 870.1345 Regulation Name: Intravascular bleed monitor Regulatory Class: Class II Product Code: QFJ Dated: January 31, 2023 Received: January 31, 2023

Dear Allison Komiyama:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

Device Name

Saranas Early Bird Bleed Monitoring System

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "saranas." The word "saranas" is written in a light gray, sans-serif font. To the right of the word is a stylized image of a bird. The bird is red with a yellow beak and a purple wing.

### 510(k) Summary for the Saranas® Early Bird® Bleed Monitoring System

| Contact Information | |
|---------------------|-----------------------------------------------------------------------------------------------|
| Manufacturer Name | Saranas, Inc.<br>2450 Holcombe Boulevard<br>Suite X<br>Houston, Texas 77021,<br>United States |
| Telephone: | [phone] |
| Official Contact | Odell Roberts<br>Quality Director |
| Consultant | Allison Komiyama, PhD, RAC<br>RQM+<br>[e-mail] |
| Telephone: | [phone] |

510(k) Summary prepared on April 21, 2023

#### 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.

Regulation Number: 21 CFR 870.1345

Classification: II

Product Code: QFJ

Device Trade/Proprietary Name: Saranas® Early Bird® Bleed Monitoring System

#### Claim of Equivalence

Traditional 510(k) claiming equivalence to legally marketed device of same name:

Saranas® Early Bird® Bleed Monitoring System DE NOVO Submission Number: DEN180021

Date DE NOVO Classification Granted: March 1, 2019

#### Device Description

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.

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Image /page/4/Picture/0 description: The image shows the logo for "Saranas". The text "saranas" is written in a light gray, lowercase font. To the right of the text is a stylized image of a bird. The bird is red with a yellow beak and a dark red wing.

FIGURE 1: Early Bird Bleed Monitoring System

Image /page/4/Figure/4 description: The image shows a medical device with several labeled components. The device includes a fully functional introducer sheath, a sheath hub with an internal hemostasis valve, and a bleed detection array with embedded electrodes. Additionally, the image identifies a standard flush line with a stopcock, a user interface display with visual and audible indicators, and a dilator.

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.

## FIGURE 2: Early Bird User Interface Display

Image /page/4/Figure/8 description: The image shows a Saranas Early Bird Bleed Monitoring System device. The device has several buttons and LED indicators, including a power button, power indicator, silence button, device error LED, and low battery LED. There are also three level indicators for bleed detection and progression.

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Image /page/5/Picture/0 description: The image shows the logo for "saranas". The word "saranas" is written in a light gray, lowercase font. To the right of the word is a stylized image of a red bird with a yellow beak. The bird is facing to the right.

#### Indications for Use

The Early Bird is indicated for the introduction of 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.

#### Summary of Device Instructions for Use (IFU) Changes

- . A clarification was added to one device warning because of firmware changes.
- Sheath preparation directions for use included additional information: ●
- o The device is activated by pulling on the battery isolation pull tab before it is inserted into a patient for use and turned off after confirming a blinking green light.
- The device is reactivated by pressing the power button after the device is inserted into O the patient.
- Early Bird bioimpedance measurement reset functionality directions for use were added: .
- Briefly, at the physician's discretion, pressing the power button for seven (7) seconds, o 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 o identical to the power on sequence of the predicate and modified device (i.e., power on sequence unchanged).

#### Technological Characteristics of Modified Device Versus Predicate Device

Some internal bleeding complications may progress slowly resulting in a rate of change of bioimpedance lower than the existing Early Bird Bleed Monitoring System (EBBMS) device's slope threshold. As a result, these slower bleeds may go undetected. This software release augments the detection algorithm by integrating an additional detection scheme based on an impedance drop threshold to supplement the current detection algorithm. The enhanced algorithm triggers a Level 1 bleed detection upon either an impedance drop threshold from a baseline impedance value or a bioimpedance drop rate that exceeds a slope threshold: the later trigger criterion being identical to the predicate device trigger criterion. 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.

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. The enhanced firmware also provides an opportunity for users to reset the EBBMS detection algorithm at their discretion. Resetting the device is equivalent to activating a new device, reestablishing the bioimpedance baseline and enables further bleed detection and monitoring. The physical Early Bird device is unchanged from the firmware update. There are no changes to device materials or dimensions. There are no hardware changes to the Early Bird device related to the update of the firmware.

Below is a table that summarizes the technological characteristics of the device in this K230273 submission and compares these technological characteristics to the legally marketed Early Bird Bleed Monitoring System (DEN180021).

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Image /page/6/Picture/0 description: The image shows the logo for "saranas.". The word "saranas" is written in a light gray, sans-serif font. To the right of the word is a stylized image of a bird in red and pink with a yellow beak.

| Doc Number: | Re |
|--------------------|----|
| Traditional 510(k) | |
| Submission | Pa |

| | Subject Device<br>(K230273) | Predicate Device<br>(DEN180021) | Rationale for Substantial<br>Equivalence (SE) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Saranas, Inc. | Saranas, Inc. | No change |
| Device Name | Saranas® Early Bird® Bleed<br>Monitoring System | Saranas® Early Bird® Bleed<br>Monitoring System | No change |
| Device<br>Regulation /<br>Classification<br>Name | 21 CFR 870.1345 Intravascular<br>Bleed Monitor | 21 CFR 870.1345 Intravascular<br>Bleed Monitor | No change |
| Product Code /<br>Class | QFJ / Class II | QFJ / Class II | No change |
| Indications for<br>Use | The Early Bird is indicated for the<br>introduction of catheters, catheter<br>balloons, and other diagnostic and<br>interventional devices into the<br>femoral artery or femoral vein while<br>maintaining hemostasis during<br>diagnostic and interventional<br>endovascular procedures.<br>The Early Bird provides physicians<br>with an early indication of a potential<br>internal bleeding complication by<br>initial detection and monitoring of | The Early Bird is indicated for the<br>introduction of catheters, catheter<br>balloons, and other diagnostic and<br>interventional devices into the<br>femoral artery or femoral vein while<br>maintaining hemostasis during<br>diagnostic and interventional<br>endovascular procedures.<br>The Early Bird provides physicians<br>with an early indication of a potential<br>internal bleeding complication by<br>initial detection and monitoring of | No change |
| | extravascular fluid accumulation. | extravascular fluid accumulation. | |
| Intended Use | The Early Bird is intended:<br>• to be inserted into the femoral<br>artery or femoral vein to provide a<br>conduit for the insertion of<br>diagnostic and interventional<br>endovascular devices.<br>• to provide physicians with an early<br>indication of extravascular fluid<br>accumulation, which may be due to<br>a potential internal bleeding<br>complication.<br>• to detect and monitor changes in<br>bioimpedance due to extravascular<br>fluid accumulation, and to provide<br>physicians with indications that a<br>potential internal bleeding<br>complication is progressing.<br>The Early Bird is intended to provide<br>physicians and other healthcare<br>providers with additional information<br>to aid in their clinical assessment of<br>the patient during and after<br>endovascular procedures. As such,<br>it is not intended to diagnose or<br>replace clinical judgment of<br>healthcare professionals. | The Early Bird is intended:<br>• to be inserted into the femoral<br>artery or femoral vein to provide a<br>conduit for the insertion of diagnostic<br>and interventional endovascular<br>devices.<br>• to provide physicians with an early<br>indication of extravascular fluid<br>accumulation, which may be due to a<br>potential internal bleeding<br>complication.<br>• to detect and monitor changes in<br>bioimpedance due to extravascular<br>fluid accumulation, and to provide<br>physicians with indications that a<br>potential internal bleeding<br>complication is progressing.<br>The Early Bird is intended to provide<br>physicians and other healthcare<br>providers with additional information<br>to aid in their clinical assessment of<br>the patient during and after<br>endovascular procedures. As such, it<br>is not intended to diagnose or<br>replace clinical judgment of<br>healthcare professionals. | No change |
| Shelf Life | 2 years | 1 year | Two-year real time aging and<br>two-year accelerated aging<br>validation studies, conducted<br>in compliance with applicable<br>ISO and ASTM standards,<br>verified that packaging and<br>sterile barrier requirements,<br>electrical performance<br>requirements, and mechanical<br>performance requirements<br>were all met, demonstrating<br>equivalent performance to the<br>predicate device. |

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Title: 510(k) Summary (K230273)

| Doc Number: | Revision: 0 |
|----------------------------------|-------------|
| Traditional 510(k)<br>Submission | Page 5 of 6 |

| | Subject Device<br>(K230273) | Predicate Device<br>(DEN180021) | Rationale for Substantial<br>Equivalence (SE) |
|--------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Working<br>Length (with<br>dilator) | 20 cm (23 cm) | 20 cm (23 cm) | No change |
| Single-Use<br>Device? | Yes | Yes | No change |
| Sterilization<br>Method | Ethylene Oxide; SAL 10-6 | Ethylene Oxide; SAL 10-6 | No change |
| Power Source | 1 Alkaline 1.5V AAA battery | 1 Alkaline 1.5V AAA battery | No change |
| Battery Life | Up to 12 hours | Up to 12 hours | No change |
| Electrical<br>Safety | ME Equipment Class: Internally<br>Powered | ME Equipment Class: Internally<br>Powered | No change |
| | Patient Connection: Type BF | Patient Connection: Type BF | |
| Initial Device<br>Activation | User interface display battery pull<br>tab | User interface display battery pull tab | No change |
| Internal<br>Bleeding<br>Complication<br>(IBC) Indicators | Audible and Visual indicators (three<br>levels) | Audible and Visual indicators (three<br>levels) | No change |
| Software<br>Verification and<br>Validation<br>Requirements<br>Met? | Yes | Yes | The subject device does not<br>introduce any new concerns<br>for safety or effectiveness<br>with the firmware changes.<br>The subject device and the<br>predicate device<br>demonstrated to be<br>substantially equivalent. |
| Ability for<br>device to be<br>reset? | Yes | No | The reset allows the clinician<br>to initiate a new, real-time<br>bleed monitoring session to<br>account for situations<br>involving active bleeding, or<br>when the device becomes<br>accidentally dislodged. The<br>reset restores the device to<br>the original factory settings.<br>There is no change to the<br>impedance measurement<br>mechanism or the IBC<br>indicators, and therefore, the<br>subject device and the<br>predicate device demonstrate<br>to be substantially equivalent. |
| Direct Contact<br>Biocompatibility<br>Testing | Meets ISO 10993 | Meets ISO 10993 | No change |

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Image /page/8/Picture/0 description: The image shows the logo for "saranas." The word "saranas" is written in a light gray, sans-serif font. To the right of the word is a stylized image of a bird. The bird is red with a yellow beak and a purple wing.

#### Non-clinical Performance Data

Design controls were conducted in accordance with IEC 62304:2006, ISO 13485:2016, 21 CFR Part 820 and ISO 14971:2019. Design verification activities centered around existing Early Bird software and electrical verification test protocols and acceptance criteria (e.g., for the User Interface Display, Printed Circuit Board Assembly, and non-product tool data processor), and design validation activities centered around existing data sets from the Early Bird animal validation study. 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. These design control activities 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).

#### Conclusions

Risk analysis and assessment were conducted in accordance with ISO 13485:2016 and ISO 14971:2019. In summary, there were no unacceptable risks due to device operation because of the algorithm changes.

The device algorithm change does not change existing device precautions, potential adverse events, and the essential performance statement within the Device Instructions for Use. Early Bird risk management documentation (hazards, failure modes, and effects analyses) was updated accordingly.

Possible device failure risk hazards have been mitigated through design verification and validation activities, and therefore, the risk level of possible device failure did not change.

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).