The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

Device Description

The Viyo 45 LS Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The Vivo 45 LS can be operated in the following combinations of ventilation and breath modes:

PSV-Pressure Support Ventilation
PSV(TgV)-Pressure Support Ventilation with Target Volume ●
PCV-Pressure Controlled Ventilation
PCV(TgV)-Pressure Controlled Ventilation with Target Volume ●
PCV(A)-Assisted Pressure Controlled Ventilation
PCV(A+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
. VCV-Volume Controlled Ventilation
VCV(A)-Assisted Volume Controlled Ventilation
VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation
VCV-MPV- Volume Controlled Ventilation with MouthPiece Ventilation ●
CPAP-Continuous Positive Airway Pressure, with optional features for HFNT-High Flow ● Nasal Therapy

High flow nasal therapy (HFNT) may be prescribed for spontaneously breathing patients undergoing non-invasive ventilatory therapy using a small, medium or large nasal cannula interface. The user may prescribe a flow rate setting in the range of 4 to 60 liters per minute. It is recommended to use an external humidifier, the Fisher & Paykel MR 850, during HFNT, due to possibly higher humidification output requirements of the patient. The Vivo 45 LS automatically disables the internal humidifier when the HFNT feature is being used.

Conditioning of the breathing air's temperature and humidity level may be prescribed for noninvasively ventilated patients using the integrated humidifier and heated wire patient circuit of the Vivo 45 LS at the clinician's discretion to enhance patient comfort and compliance. The humidification function is enabled by the Vivo 45 LS only when the device is powered by AC Mains and is automatically disabled including power to the heating plate when the device is powered by battery. The humidifier heating level can be selected by the user by setting the heating level (1-5) on the device user interface.

The Vivo 45 LS provides the user with available settings that determine the power delivered to the heater wire. This setting is in terms of a patient-end temperature in the range of 16 to 30° C. The heated wire patient circuit contains a temperature sensor located at the patient connection port, and the firmware of the Vivo 45 LS continuously monitors the temperature and automatically adjusts the power delivered to the heater wire to maintain the temperature at the user set point.

AI/ML Overview

The provided text is a 510(k) summary for the Breas Medical AB Vivo 45 LS ventilator. It details the device's characteristics, comparisons to predicate devices, and performance data to demonstrate substantial equivalence to legally marketed devices.

However, the document does not contain the kind of information requested in your prompt regarding acceptance criteria and a study proving a device meets a specific acceptance criteria table. Instead, it discusses:

Substantial Equivalence: The primary goal of this submission is to demonstrate that the modified Vivo 45 LS is substantially equivalent to a previously cleared predicate device (K193586) and reference devices. This is done by showing similar intended use, technological characteristics, and performance data.
Performance Testing: It lists various performance tests conducted according to relevant standards (e.g., electrical safety, EMC, usability, alarm systems, biocompatibility, accuracy of controls and monitored values, cybersecurity, software verification/validation, human factors). The text states that "all tests passed" or "met all specifications," implying that the device did meet internal acceptance criteria for these tests, but these specific criteria are not explicitly detailed in a table for most categories.
Human Factors Study: A summative human factors study was performed to assess user safety and effectiveness, including specific findings related to critical tasks and risk mitigation.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or MRMC studies in the manner you've outlined, as that level of detail is not present for quantitative performance metrics tied to specific acceptance thresholds.

Based on the provided text, here's what can be extracted regarding the types of studies and the nature of the performance assessment:

The document focuses on demonstrating substantial equivalence for a modified medical device. This is a regulatory pathway where the new device is shown to be as safe and effective as a legally marketed predicate device. The "proof" is largely comparative and based on meeting recognized standards and internal specifications, rather than a standalone clinical trial proving a specific performance target against a pre-defined acceptance criterion.

Here's a breakdown of the information that is available or implicitly stated, addressing your points where possible, and noting what is missing:

A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the document for the overall device.
- The document presents tables comparing the subject device's features and performance specifications (e.g., accuracy of controls, accuracy of monitored values, alarm settings) to the predicate device. It then broadly states that "testing confirmed that the Vivo 45 LS meets its accuracy specifications," implying acceptance criteria were met but not detailing them in a distinct "acceptance criteria vs. reported performance" table.
- For example, under "Accuracy of Controls," it lists "Inspiratory Pressure: max of ±0.5cmH2O, ±5%" for both subject and predicate device, and notes "Same." This implies this was an acceptance criterion, and performance matched it. However, actual reported device performance (e.g., "The device demonstrated an inspiratory pressure accuracy of ±0.3cmH2O, ±4%") is not provided.
Sample sized used for the test set and the data provenance:
- Human Factors Testing: The only specific sample size mentioned is for the summative human factors study:
  - Sample Size: 15 Respiratory Therapists (RTs), 15 Registered Nurses (RNs), and 15 Lay Caregivers (LCGs). Total = 45 participants.
  - Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It's a "summative human factors testing" which is typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable directly in the context of setting "ground truth" for diagnostic accuracy, as this is a ventilator, not a diagnostic imaging device.
- For Human Factors: The experts involved would be the human factors professionals designing and performing the study, and potentially clinicians involved in scenario review. Their number and specific qualifications are not detailed.
Adjudication method for the test set:
- Not applicable directly for diagnostic accuracy.
- For Human Factors: Errors and difficulties observed during the human factors study were subject to "root cause analysis." The method of adjudication for identifying these errors or classifying them (e.g., by multiple observers) is not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not addressed. This type of study (MRMC for AI assistance) is relevant for AI-powered diagnostic aids, not for the core function of a mechanical ventilator.
- The "human factors testing" evaluated user interaction and safety with the device, not the device's diagnostic performance in assisting human "readers."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not detailed for the AI (if any). The device is a ventilator, a mechanical and software-controlled device. Its "standalone performance" refers to its ability to meet specifications for delivering ventilation, controlling parameters, and managing alarms.
- The document states: "Performance testing included testing to the standards and procedures listed below:" and then lists many standards, followed by "The Vivo 45 LS with humidifier and heated wire patient circuit met all specifications, and the comparative waveforms testing demonstrated equivalence to the cleared Vivo 45 LS device." and "Testing of the Vivo 45 LS was performed to confirm accuracy of controls and monitored values. The testing confirmed that the Vivo 45 LS meets its accuracy specifications." This implies rigorous standalone testing.
The type of ground truth used:
- For ventilator performance (pressure, flow, volume, etc.): "Ground truth" would be established by reference measurement devices/standards in a laboratory setting. The specific reference standards used are implied to be those within the listed IEC and ISO standards that the device was tested against.
- For Biocompatibility: "Ground truth" is established by laboratory analyses against specified chemical and biological endpoints (e.g., absence of VOCs above threshold, non-cytotoxic results, non-sensitizing results), based on ISO standards.
- For Human Factors: "Ground truth" for safe and effective use is established by the pre-defined critical tasks that users must perform successfully without errors that lead to harm. "Root cause analysis" was performed on observed errors.
The sample size for the training set:
- Not applicable. This document describes the testing and regulatory submission for a physical medical device (ventilator) with integrated software, not an AI/ML algorithm that undergoes "training."
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

In summary, while the document confirms rigorous testing against various standards and specifications, it does not present the specific acceptance criteria and detailed reported performance in a structured comparative table as requested for an AI/ML driven diagnostic device. The focus is on demonstrating compliance with regulatory standards and substantial equivalence to a predicate device, rather than proving a statistical performance metric against clinical ground truth for a novel AI indication.

Summary

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January 13, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Breas Medical AB % Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180

Re: K233452

Trade/Device Name: Vivo 45 LS Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, NOU, BTT, CCK, DQA Dated: December 20, 2024 Received: December 20, 2024

Dear Maureen O'Connell:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233452

Device Name Vivo 45 LS

Indications for Use (Describe)

The Vivo 45 LS ventilator (without the SpO2 and CO2 sensors) is intended to provide continuous or internittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.

The Vivo 45 LS with the SpO2 sensor is intended to measure function of arterial hemoglobin (% SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.

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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510(k) SUMMARY-K233452

Breas Medical Vivo 45 LS

510(k) Owner

Breas Medical AB Foretagsvagen 1 Molnlycke, Vastra Gotalands Lan (Se-14) SWEDEN 435 33

Submission Correspondent

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: 978-207-1245

Date Prepared: January 9, 2025

Trade Names of Device Vivo 45 LS

Common or Usual Name

Continuous ventilators, home use

Classification Name

Continuous ventilators; 21 C.F.R. §868.5895 Class II Product Code: NOU

Primary Predicate Device(s) Breas Medical AB Vivo 45 LS cleared in K193586

Reference Device(s)

Fisher & Paykel Healthcare, LTD. MR810Respiratory Humidifier cleared in K131957 Newport Medical Instruments, Inc. Newport HTS50 Ventilator With Dual Pac Battery System cleared in K082724 Fisher & Paykel Healthcare, LTD. myAIRVO 2 Humidifier cleared in K131895

Indications for Use

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The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

Device Description

Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.

The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.

The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.

The Vivo 45 LS can be operated in the following combinations of ventilation and breath modes:

PSV-Pressure Support Ventilation
PSV(TgV)-Pressure Support Ventilation with Target Volume ●
PCV-Pressure Controlled Ventilation
PCV(TgV)-Pressure Controlled Ventilation with Target Volume ●
PCV(A)-Assisted Pressure Controlled Ventilation
PCV(A+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
. VCV-Volume Controlled Ventilation
VCV(A)-Assisted Volume Controlled Ventilation
VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation

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VCV-MPV- Volume Controlled Ventilation with MouthPiece Ventilation ●
CPAP-Continuous Positive Airway Pressure, with optional features for HFNT-High Flow ● Nasal Therapy

Technological Characteristics Compared to Predicate

Breas Medical's Vivo 45 LS is a modification to Breas Medical's previously cleared Vivo 45 LS (K193586) which is the primary predicate device. Three reference devices were used to support substantial equivalence of the humidifier and heated wire breathing circuit. Specifically, the Newport HTS50 Ventilator cleared in K082724 was used as a reference device to support an integrated humidifier, the MR810Respiratory Humidifier cleared in K131957 was used to support the humidifier and heated breathing circuit, and the myAIRVO 2 Humidifier cleared in K131895 was used to support substantial equivalence of the High Flow Humidification (HFNT).

The Breas Vivo 45 LS has the same intended use and similar technological characteristics to the predicate and reference devices. Breas Medical believes that the Vivo 45 LS described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to legally marketed predicate and reference devices that are also Class II medical devices. Table 1 compares the Vivo 45 LS with the primary predicate Vivo 45 LS.

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Table 1
Substantial Equivalence; Vivo 45 LS
Primary Predicate Device

Manufacturer	Breas Medical AB	Breas Medical AB	Discussion ofDifferences
Model	Vivo 45 LS (subject device)	Vivo 45 LS (predicate device)
510(k) Number	-	K193586	-
SoftwareControlled	Yes	Yes	Same
Gas DeliverySystem	Turbine	Turbine	Same
Air	Ambient air	Ambient air	Same
Oxygen Supply	Connection for low O2 pressuresupply with bleed rate of 30 l/min	Connection for low O2 pressuresupply with bleed rate of 15 l/min	Substantiallyequivalent: The designof the Vivo 45 LSremains unchanged.The oxygen flow isprovided and controlledby an external oxygensupply.
Patient TypeSettings	Adult - Invasive, Adult – NIV,Pediatric - Invasive, Pediatric -NIV	Adult, Pediatric	Substantiallyequivalent: Bothdevices provide Adultand Pediatric settingsand both devices areindicated for invasiveand non-invasive (NIV)ventilation.
Patient CircuitTypes	Single Limb with Leak,Single Limb with ActiveExhalation Valve	Single Limb with Leak,Single Limb with ActiveExhalation Valve	Same
CircuitCompensation	Yes, Pre-use test	Yes, Pre-use test	Same

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Manufacturer	Breas Medical AB	Breas Medical AB	Discussion of Differences
Model	Vivo 45 LS (subjectdevice)	Vivo 45 LS (predicate device)	-
Ventilation Modes
PSV, PSV(TgV)	Yes	Yes	Same
PCV, PCV(TgV),PCV(A),PCV(A+TgV),PCV-SIMV, PCV-MPV	Yes	Yes	Same
VCV, VCV(A),VCV-SIMV,VCV-MPV	Yes	Yes	Same
CPAP withoptional featuresfor HFNT	Yes	CPAP only	Substantially equivalent: Highflow mode is analogous toCPAP mode except instead ofa fixed pressure, the flow isfixed at the user-specifiedsetting.

Ventilation Parameter Settings

InspiratoryPressure	Adult: 4 – 50 cmH2O	Adult: 4 – 50 cmH2O	Same
	Pediatric: 4 – 50cmH2O(Limited to 30 cmH2O above PEEP)	Pediatric: 4 – 50 cmH20(Limited to 30 cmH2O above PEEP)
CPAP Pressure	4 to 20 cmH2O	4 to 20 cmH2O	Same
PEEP	0 to 20 cmH2O(circuit withexhalation valve)2 to 20 cmH2O(circuit with leakageport)	0 to 20 cmH2O(circuit with exhalation valve)2 to 20 cmH2O(circuit with leakage port)	Same
Breath Rate	4 to 40 BPM (Adult)6 to 60 BPM(Pediatric)	4 to 40 BPM (Adult)6 to 60 BPM (Pediatric)	Same
Inspiratory Time	0.3 to 5 sec (Adult)0.3 to 2 sec (Pediatric)	0.3 to 5 sec (Adult)0.3 to 2 sec (Pediatric)	Same
Trigger Type	eSync(circuit withexhalation valve)eSync(circuit with leakageport)	eSync(circuit with exhalation valve)eSync(circuit with leakage port)	Same

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Manufacturer	Breas Medical AB		Discussion of Differences
Model	Vivo 45 LS (subject device)	Vivo 45 LS (predicate device)	-
Rise Time	Rise Time – Pressure:1 to 9(PSV & PCV, PCV-SIMV, VCV-SIMV, PCV-MPV)Rise Time – Volume:50% to 90% of insp. time, Off(VCV, VCV-SIMV, VCV-MPV)	Rise Time – Pressure:1 to 9(PSV & PCV, PCV-SIMV, VCV-SIMV, PCV-MPV)Rise Time – Volume:50% to 90% of insp. time, Off(VCV, VCV-SIMV, VCV-MPV)	Same
Tidal Volume	300 to 2000 ml(Adult)50 to 400 ml(Pediatric)	300 to 2000 ml (Adult)50 to 400 ml (Pediatric)	Same
Sigh	Off, every 10 to 250 breaths(sigh interval)125% to 200% of actual set pressure or volume within pressure/volume limits	Off, every 10 to 250 breaths(sigh interval)125% to 200% of actual set pressure or volume within pressure/volume limits	Same
Flow Pattern	Square, Decelerating	Square, Decelerating	Same

Alarm Settings

Note that the subject device includes HFNT. When HFNT is used, only the Disconnection, High/Low FiO2 and High/Low SpO2 alarms are available. This is consistent with other HFNT devices. The information presented below applies to all other ventilation modes.

Low PressureAlarm	Pediatric:1 to 50 cmH2OAdult:1 to 50 cmH2O	Pediatric:1 to 50 cmH2OAdult:1 to 50 cmH2O	Same
High PressureAlarm	5 to 70 cmH2O	5 to 70 cmH2O	Same
Low Vt Alarm	Off, 100 to 2000 ml(Adult)Off, 20 to 500 ml(Pediatric)	Off, 100 to 2000 ml (Adult)Off, 20 to 500 ml (Pediatric)	Same

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Manufacturer	Breas Medical AB	Breas Medical AB	Discussion of Differences
Model	Vivo 45 LS (subjectdevice)	Vivo 45 LS (predicate device)	-
Low MinuteVolume Alarm	Off, 1 to 30 liters(Adult)Off, 0.1 to 10 liters(Pediatric)	Off, 1 to 30 liters (Adult)Off, 0.1 to 10 liters (Pediatric)	Same
High MinuteVolume Alarm	1 to 40 liters, Off(Adult)1 to 20 liters, Off(Pediatric)	1 to 40 liters, Off (Adult)1 to 20 liters, Off (Pediatric)	Same
Low PEEP Alarm	On, Off	On, Off	Same
High PEEPAlarm	On, Off	On, Off	Same
Disconnection(high leakage)Alarm	On, Off	On, Off	Same
ObstructionAlarm	On, Off	On, Off	Same
Low Breath RateAlarm	Off, 4 to 30 BPM(Adult)Off, 1 to 30 BPM(Adult - MPV)Off, 6 to 50 BPM(Pediatric)	Off, 4 to 30 BPM (Adult)Off, 1 to 30 BPM (Adult - MPV)Off, 6 to 50 BPM (Pediatric)	Same
High Breath RateAlarm	10 to 70 BPM, Off(Adult)10 to 99 BPM, Off(Pediatric)	10 to 70 BPM, Off (Adult)10 to 99 BPM, Off (Pediatric)	Same
Low Pulse RateAlarm	Off, 30 to 230	Off, 20 to 250	Substantially equivalent: Thesubject device is within thespecification of the predicateand within the accurate pulserate reporting range of thepulse oximeter.
High Pulse RateAlarm	30 to 230, Off	20 to 250, Off	Substantially equivalent: Thesubject device is within thespecification of the predicateand within the accurate pulserate reporting range of thepulse oximeter.
Low FiO2 Alarm	Off, 21 to 100%	Off, 21 to 100%	Same
High FiO2 Alarm	21 to 100%, Off	21 to 100%, Off	Same
Low SpO2 Alarm	Off, 85 to 100%	Off, 85 to 100%	Same
Manufacturer	Breas Medical AB	Breas Medical AB	Discussion of Differences
Model	Vivo 45 LS (subjectdevice)	Vivo 45 LS (predicate device)	-
Low EtCO2Alarm	Off, 1 to 99 mmHg	Off, 1 to 99 mmHg	Same
High EtCO2Alarm	1 to 99 mmHg, Off	1 to 99 mmHg, Off	Same
High Insp CO2Alarm	1 to 99 mmHg, Off	1 to 99 mmHg, Off	Same
Re-Breathing (lowleakage) Alarm	On, Off	On, Off	Same
High Patient AirTemp Alarm	Yes	Yes	Same
Low Last PowerSource Alarm	Yes	Yes	Same
Power Fail Alarm	Yes	Yes	Same
Low AlarmBattery Alarm	Yes	Yes	Same
Function FailureAlarms	Yes	Yes	Same
Alarm Pre-Silence	Yes	No	Substantially equivalent: Bothdevices share the samephysical buttons, including theAudio Pause button whichmutes active alarms in bothdevices. The subject deviceincludes the additional alarmpre-silence function (pre-silencing of alarms for thecoming 2 minutes). Theexisting Audio Pause hardwarebutton is used for the pre-silence function by the userpressing and holding it downfor three seconds. The pre-silence function isrecommended in IEC 60601-1-8 Edition 2.1 Annex ASubclause 681 (FDA
Manufacturer	Breas Medical AB	Breas Medical AB	Discussion of Differences
Model	Vivo 45 LS (subject device)	Vivo 45 LS (predicate device)	-
Accuracy of Controls
InspiratoryPressure	max of ±0.5cmH2O, ±5%	max of ±0.5cmH2O, ±5%	Same
PEEP	max of ±0.5cmH2O, ±5%	max of ±0.5cmH2O, ±5%	Same
Tidal Volume	max of ±12ml, ±10%	max of ±12ml, ±10%	Same
Breath Rate	±2%	±2%	Same
Inspiratory Time	Minimum of:±(20 msec + 5% of setting), and±0.1sec	Minimum of:±(20 msec + 5% of setting), and±0.1sec	Same
Accuracy of Monitored Values
Ppeak	max of ±0.5cmH2O, ±10%	max of ±0.5cmH2O, ±10%	Same
PEEP	max of ±0.5cmH2O, ±10%	max of ±0.5cmH2O, ±10%	Same
Pmean	max of ±0.5cmH2O, ±10%	max of ±0.5cmH2O, ±10%	Same
Leakage	±10%	±10%	Same
Tidal Volume	max of ±10ml, ±10%	max of ±10ml, ±10%	Same
FiO2	±2%	±2%	Same
% in TgV	±1%	±1%	Same
Total Rate	±1bpm	±1bpm	Same
Spont Rate	±1bpm	±1bpm	Same
SpO2	±2%	±2%	Same
Pulse Rate	±1%	±1%	Same
I:E	±0.1 unit	±0.1 unit	Same
Manufacturer	Breas Medical AB	Breas Medical AB	Discussion of Differences
Model	Vivo 45 LS (subject device)	Vivo 45 LS (predicate device)	-
Rise Time	Max of ±10%, 0.1 sec	Max of ±10%, 0.1 sec	Same
EtCO2	±(0.3 vol% + 4% of reading) within 0-15% range	±(0.3 vol% + 4% of reading) within 0-15% range	Same
InspCO2	±(0.3 vol% + 4% of reading) within 0-15% range	±(0.3 vol% + 4% of reading) within 0-15% range	Same
Apnea-Hypopnea Index (AHI)	No	No	Same

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The Vivo 45 LS is a modification to the Vivo 45 LS ventilator cleared in K193586. The devices share the same mechanical parts, electronics, and software, except for the differences described below.

High Flow Nasal Therapy (HFNT): The device software has been modified to provide an option for high flow nasal therapy in which the airflow is controlled according to a user setting.

Alarm Pre-Silence: The device software has been modified to provide the user the ability to pre-silence alarms for the coming two minutes. The existing Audio Pause hardware button for silencing active alarms is used for the pre-silence function by the user pressing and holding it down for three seconds.

Humidifier: Humidification can now be provided via a metal heater plate and associated electronics integrated into the base of the Vivo 45 LS device, combined with a click-in humidifier water chamber accessory which also has a metal plate that contacts the heater and transfers the heat to the water. The device software allows the user to set the heater temperature, controls the temperature, monitors for faults, and provides associated alarms. Use of the humidifier is limited to non-invasive ventilation only.

Heated Wire Patient Circuit: Heating of the patient circuit can now be provided via electronics integrated into the Vivo 45 LS device, combined with a heated wire patient circuit accessory which has a proprietary electrical connector that plugs into the back of the Vivo 45 LS device. The patient circuit accessory has a spiraled wire embedded in its wall to receive power the Vivo 45 LS and heat the wall, and a temperature sensor at the patient-end. The device software allows the user to set the temperature at the patient-end, controls the temperature, monitors for faults, and provides associated alarms. Use of the heated wire patient circuit is limited to non-invasive ventilation only.

Supplemental Oxygen Flow Rating: The rating for the maximum flow rate of oxygen introduced through the connector at the back of the Vivo 45 LS has been increased from 15 to 30 liters per minute. No changes to the Vivo 45 LS hardware or software were necessary to accommodate this change in rating. The change was made based on safety and performance

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verification. The extended supplemental oxygen flow range can be useful for HFNT. The labeling of the Vivo 45 LS has been updated accordingly.

Performance Data

The Vivo 45 LS was subjected to performance testing which verified conformance with all requirements specifications and applicable standards, and which included comparative testing with the Vivo 45 LS predicate device which supported substantial equivalence.

Performance Testing to Standards
Electrical Safety	ANSI/AAMI ES60601-1:2005 Medical electricalequipment-Part 1: General requirements for basic safety andessential performance
Electromagneticcompatibility	IEC 60601-1-2: 2014 Medical electrical equipment-Part 1-2:General requirements for basic safety and essentialperformance-Collateral standard: Electromagneticdisturbances-Requirements and tests
Usability	IEC 60601-1-6: 2010+A1:2013 Medical electricalequipment-Part 1-6: General requirements for basic safetyand essential performance-Collateral standard: Usability
Alarms systems	IEC 60601-1-8: 2006 (Second edition) + Am. 1: 2012Medical electrical equipment-Part 1-8: Generalrequirements for basic safety and essential performance-Collateral standard: General requirements, tests andguidance for alarm systems in medical electrical equipmentand medical electrical systems
Medical equipment usedin home healthcareenvironment	IEC 60601-1-11: 2015 Medical electrical equipment-Part 1-11: General requirements for basic safety and essentialperformance-Collateral standard: Requirements for medicalelectrical equipment systems used in the home healthcareenvironment
Critical care ventilators	ISO 80601-2-12:2020 Medical electrical equipment Part 2-12: Particular requirements for safety of lung ventilators-Critical care ventilators
Respiratory gas monitors	ISO 80601-2-55: 2018 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essentialperformance of respiratory gas monitors
Pulse oximeterequipment	ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essentialperformance of pulse oximeter equipment
Home healthcareenvironment ventilatorsfor ventilator-dependentpatients	ISO 80601-2-72:2015 Medical electrical equipment Part 2-72: Particular requirements for basic safety and essentialperformance of home healthcare environment ventilators forventilator-dependent patients
Battery testing	IEC 62133: 2012 (2nd Ed) Secondary cells and batteries
	requirements for portable sealed secondary cells, and forbatteries made from them, for use in portable applicationsIEC 62133-2 Edition 1.0 2017 Secondary cells and batteriescontaining alkaline or other non-acid electrolytes-Safetyrequirements for portable sealed secondary cells, and forbatteries made from them. For use in portable applications –Part 2: Lithium systems
Humidifier testing	ISO 80601-2-74: 2017 Medical electrical equipment Part 2-74 : Particular requirements for basic safety and essentialperformance of respiratory humidifying equipment

Performance testing included testing to the standards and procedures listed below:

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Biocompatibility: The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been evaluated for emission of volatile organic compounds (VOC), inorganic gases (CO, CO2, and Ozone) and particulate matter (PM2.5/PM10) in accordance with ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process. The humidified gas pathway comprised of the humidifier water chamber and heated wire patient circuit have been evaluated for solventextractable compounds and biocompatibility in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Additionally, the device was evaluated for emissions of aldehydes.

The Vivo 45 LS device and accessories were found to be biocompatible for the intended use, intended population and type of patient contact. Further details are provided below which support substantial equivalence.

VOC	The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been tested in accordance with ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 3: Tests for emissions of volatile organic compounds. No VOC compounds were observed in quantities that represent a toxicological risk to the intended patient population.
Particulate matter	The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been tested in accordance with ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 2: Tests for emissions of particulate matter. Particulate quantities were well below acceptable limits of exposure for all patient populations.
Carbon monoxide	The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been tested for generation of inorganic gases including carbon monoxide per the recommendations of ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in

	healthcare applications - Part 1: Evaluation and testingwithin a risk management process. Carbon monoxideemission was well below acceptable limits of exposure forall patient populations.
Carbon dioxide	The entire gas pathway including the Vivo 45 LS device,humidifier and heated wire patient circuit have been testedfor generation of inorganic gases including carbon dioxideper the recommendations of ISO 18562-1:2017Biocompatibility evaluation of breathing gas pathways inhealthcare applications - Part 1: Evaluation and testingwithin a risk management process. Carbon dioxideemission was well below acceptable limits of exposure forall patient populations.
Ozone	The entire gas pathway including the Vivo 45 LS device,humidifier and heated wire patient circuit have been testedfor generation of inorganic gases including ozone per therecommendations of ISO 18562-1:2017 Biocompatibilityevaluation of breathing gas pathways in healthcareapplications - Part 1: Evaluation and testing within a riskmanagement process. Ozone emission was well belowacceptable limits of exposure for all patient populations.
Aldehydes	Aldehyde testing was conducted using the final, finishedVivo 45 LS device (newly manufactured). Sampling foremission of aldehydes from the device at multiple time-points was conducted within a heated chamber atapproximately 40° C, with the device set to the minimalclinically relevant flow rate (i.e., worst-case conditions).Targeted analysis for Formaldehyde, Acetaldehyde,Acrolein, Propionaldehyde, Crotonaldehyde, Butyraldehyde,Benzaldehyde, Isovaleraldehyde, Valeraldehyde, Total-Tolualdehyde, Hexaldehyde, and 2,5-dimethylbenzaldehydewas performed. The conclusion was that the Vivo 45 LSdoes not pose a risk for aldehyde exposure to adult orpediatric subjects when operated under worst casetemperature and flow rate conditions.
Extractable compounds	The humidified gas pathway comprised of the humidifierwater chamber and heated wire patient circuit has beentested for extractable compounds per the recommendationsin ISO 18562-4:2017 and ISO 10993-18:2020 Biologicalevaluation of medical devices – Part 18: Chemicalcharacterization of medical device materials within a riskmanagement process, with the conclusion that use of theVivo 45 LS in adult subjects will not pose a significanttoxicological or biocompatibility risk.
Cytotoxicity	The humidified gas pathway comprised of the humidifier
	water chamber and heated wire patient circuit has beentested for cytotoxicity in accordance with ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests forin vitro cytotoxicity. The test article was found to be non-cytotoxic.
Sensitization	The humidified gas pathway comprised of the humidifierwater chamber and heated wire patient circuit has beentested for sensitization in accordance with ISO 10993-10:2010, Biological Evaluation of Medical Devices, Part 10:Tests for Irritation and Skin Sensitization. The test articlewas found to be non-sensitizing.
Irritation / IntracutaneousReactivity	The humidified gas pathway comprised of the humidifierwater chamber and heated wire patient circuit has beentested for irritation / intracutaneous reactivity in accordancewith ISO 10993-10:2010, Biological Evaluation of MedicalDevices, Part 10: Tests for Irritation and Skin SensitizationThe test article was found to be non-irritating.
Acute Systemic Toxicity	The humidified gas pathway comprised of the humidifierwater chamber and heated wire patient circuit has beentested for acute systemic toxicity in accordance with ISO10993-11:2017 Biological Evaluation of Medical Devices -Part 11: Tests for Systemic Toxicity. The test article wasfound to be non-toxic.
Materials MediatedPyrogenicity	The humidified gas pathway comprised of the humidifierwater chamber and heated wire patient circuit has beentested for materials mediated pyrogenicity in accordancewith ISO 10993-11:2017 Biological Evaluation of MedicalDevices - Part 11: Tests for Systemic Toxicity. The testarticle was found to be non-pyrogenic.
Genotoxicity – ReverseMutation	The humidified gas pathway comprised of the humidifierwater chamber and heated wire patient circuit has beentested for genotoxicity reverse mutation in accordance withISO 10993-3:2014, Biological Evaluation of MedicalDevices - Part 3: Tests for Genotoxicity, Carcinogenicity,and Reproductive Toxicity. The test article was found to benon-mutagenic.

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Performance Testing

Verification testing of the HFNT function was conducted, demonstrating that the function met all specifications.

Verification testing of the alarm pre-silence function was conducted, demonstrating that the function met all specifications.

The humidifier and heated wire functions were tested for humidity output, normal operation functions, detection and response to fault conditions including safe power cutoff and alarms, maximum water temperature, heated circuit temperature accuracy, cleaning, and gas leakage. Further, the Vivo 45 LS with these accessories installed

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was subjected to comparative pressure, flow and volume waveforms testing versus the cleared Vivo 45 LS device. The Vivo 45 LS with humidifier and heated wire patient circuit met all specifications, and the comparative waveforms testing demonstrated equivalence to the cleared Vivo 45 LS device.

The Vivo 45 LS was tested with supplemental oxygen for safety and performance at the rated flow rate of 30 liters per minute. All tests passed.

Testing of the Vivo 45 LS was performed to confirm accuracy of controls and monitored values. The testing confirmed that the Vivo 45 LS meets its accuracy specifications.

Alarms testing of the Vivo 45 LS was performed which confirmed proper operation of physiologic and technical alarms.

Cybersecurity testing confirmed conformance with all cybersecurity specifications.

Software verification and validation were performed at the unit, integration, and system level according to plans and protocols with predetermined pass/fail criteria. All tests passed.

Summative human factors testing was performed which determined the Vivo 45 LS is safe and effective for the intended users, uses and use environments.

The study included 15 healthcare professionals (HCP) who are respiratory therapists (RT) and 15 HCP who are registered nurses (RN) performing the tasks necessary to use the device in a clinical setting and 15 lay caregiver (LCG) users performing the tasks necessary to use the device in a home setting.

The critical tasks for Vivo 45 LS use were tested with the intended users, for its intended use and in a representative use environment. Based on the performance of the test participants, their observed behaviors, subjective feedback, and a root cause analysis of all use errors, close calls and difficulties observed, use of the Vivo 45 LS was successfully validated.

The intended user populations can safely and successfully use the Vivo 45 ● ra
The training was understood and successfully applied by the users ●
Performance of critical tasks did not result in any patterns of use errors or . difficulties that would lead to patient harm (including compromised medical care)
No new hazards, hazardous situations, or hazard-related use-scenarios were identified in the study
. Use-related hazards have been reasonably mitigated and residual risks that cannot be further mitigated have been reduced as far as possible and are considered acceptable.

In addition to the summative human factors study, the following HFE/UE processes have been conducted and support the conclusion regarding safety and efficacy:

· Multiple formative HF studies

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Prior summative HF studies (and the present changes follow the same user interface paradigm as previously studied) • Design reviews with subject matter experts • Assessment of known use problems and review of field data • Use-related risk management activities • Discussion of residual use-related risk
The testing described confirms that the Vivo 45 LS meets all requirements specifications and complies with the relevant standards, and is therefore substantially equivalent to the predicate devices.

Conclusion:

The Vivo 45 LS is substantially equivalent to the predicate devices, as the devices share a common intended use and technological characteristics as demonstrated through performance testing.

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).