Who is the manufacturer of Vivo 45 LS?

Breas Medical AB filed the 510(k) submission for Vivo 45 LS (K233452).

What is the FDA product code for Vivo 45 LS?

NOU. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Vivo 45 LS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Vivo 45 LS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Vivo 45 LS

K233452 · Breas Medical AB · NOU · Jan 13, 2025 · Anesthesiology

Device Facts

Record ID	K233452
Device Name	Vivo 45 LS
Applicant	Breas Medical AB
Product Code	NOU · Anesthesiology
Decision Date	Jan 13, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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.

Device Story

Portable, microprocessor-controlled, turbine-based ventilator; provides pressure support, pressure control, or volume-controlled ventilation. Inputs: flow/pressure sensors; user settings via front panel/LCD. Outputs: ventilatory support; real-time graphs/numeric parameters on screen. Used in home, hospital, and portable settings (wheelchairs/gurneys) by clinicians or patients/caregivers. Features integrated humidifier and heated wire circuit (non-invasive only); High Flow Nasal Therapy (HFNT) mode; alarm pre-silence function. Healthcare providers use output to adjust therapy settings; device benefits patients by providing respiratory support and monitoring physiological parameters.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical safety, EMC, usability, alarm systems, gas monitoring, battery, humidifier performance), biocompatibility (ISO 18562, ISO 10993), and summative human factors validation (n=45: 15 RTs, 15 RNs, 15 lay caregivers).

Technological Characteristics

Turbine-based gas delivery; microprocessor-controlled. Integrated humidifier (metal heater plate) and heated wire circuit (spiraled wire, patient-end temp sensor). Connectivity: AC/DC power, internal/external battery. Software-controlled. Biocompatible materials per ISO 18562/10993. Dimensions/form factor: portable ventilator.

Indications for Use

Indicated for pediatric through adult patients (>5 kg) requiring continuous or intermittent mechanical ventilation (invasive or non-invasive). Mouthpiece ventilation modes for adult patients only. Optional SpO2 and CO2 monitoring. Not for emergency transport or critical care.

Regulatory Classification

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.

Predicate Devices

Vivo 45 LS (K193586)

Reference Devices

MR810 Respiratory Humidifier (K131957)
Newport HTS50 Ventilator With Dual Pac Battery System (K082724)
myAIRVO 2 Humidifier (K131895)

Related Devices

K193586 — Vivo 45 LS · Breas Medical AB · Jan 27, 2021
K160481 — Vivo 60 · Breas Medical AB · Nov 9, 2016
K083526 — TRILOGY 100 VENTILATOR · Respironics Inc., Sleep & Home Respiratory Group · Mar 13, 2009
K193056 — Puritan Bennett 980 Series Ventilator System · Covidien, LLC · Nov 20, 2020
K981668 — SMARTVENT 201 PORTABLE VENTILATOR · Versamed , Ltd. · Apr 7, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ - 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. ## 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. {7}------------------------------------------------ | Table 1 | |-------------------------------------| | Substantial Equivalence; Vivo 45 LS | | Primary Predicate Device | | Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences | |--------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model | Vivo 45 LS (subject device) | Vivo 45 LS (predicate device) | | | 510(k) Number | - | K193586 | - | | Software Controlled | Yes | Yes | Same | | Gas Delivery System | Turbine | Turbine | Same | | Air | Ambient air | Ambient air | Same | | Oxygen Supply | Connection for low O2 pressure supply with bleed rate of 30 l/min | Connection for low O2 pressure supply with bleed rate of 15 l/min | Substantially equivalent: The design of the Vivo 45 LS remains unchanged. The oxygen flow is provided and controlled by an external oxygen supply. | | Patient Type Settings | Adult - Invasive, Adult – NIV, Pediatric - Invasive, Pediatric - NIV | Adult, Pediatric | Substantially equivalent: Both devices provide Adult and Pediatric settings and both devices are indicated for invasive and non-invasive (NIV) ventilation. | | Patient Circuit Types | Single Limb with Leak, Single Limb with Active Exhalation Valve | Single Limb with Leak, Single Limb with Active Exhalation Valve | Same | | Circuit Compensation | Yes, Pre-use test | Yes, Pre-use test | Same | {8}------------------------------------------------ | Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences | |-------------------------------------------------------------------|--------------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model | Vivo 45 LS (subject device) | 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 with optional features for HFNT | Yes | CPAP only | Substantially equivalent: High flow mode is analogous to CPAP mode except instead of a fixed pressure, the flow is fixed at the user-specified setting. | | Ventilation Parameter Settings | | | | |--------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------| | | | | | | Inspiratory Pressure | Adult: 4 – 50 cmH2O | Adult: 4 – 50 cmH2O | Same | | | Pediatric: 4 – 50 cmH2O (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 with exhalation valve) 2 to 20 cmH2O (circuit with leakage port) | 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 with exhalation valve) eSync (circuit with leakage port) | eSync (circuit with exhalation valve) eSync (circuit with leakage port) | Same | {9}------------------------------------------------ | 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 Pressure Alarm | Pediatric: 1 to 50 cmH2O Adult: 1 to 50 cmH2O | Pediatric: 1 to 50 cmH2O Adult: 1 to 50 cmH2O | Same | |------------------------|--------------------------------------------------------------------|--------------------------------------------------------------|------| | High Pressure Alarm | 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 | {10}------------------------------------------------ | Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences | |------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Model | Vivo 45 LS (subject device) | Vivo 45 LS (predicate device) | - | | Low Minute Volume 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 Minute Volume 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 PEEP Alarm | On, Off | On, Off | Same | | Disconnection (high leakage) Alarm | On, Off | On, Off | Same | | Obstruction Alarm | On, Off | On, Off | Same | | Low Breath Rate Alarm | 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 Rate Alarm | 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 Rate Alarm | Off, 30 to 230 | Off, 20 to 250 | Substantially equivalent: The subject device is within the specification of the predicate and within the accurate pulse rate reporting range of the pulse oximeter. | | High Pulse Rate Alarm | 30 to 230, Off | 20 to 250, Off | Substantially equivalent: The subject device is within the specification of the predicate and within the accurate pulse rate reporting range of the pulse 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 (subject device) | Vivo 45 LS (predicate device) | - | | Low EtCO2 Alarm | Off, 1 to 99 mmHg | Off, 1 to 99 mmHg | Same | | High EtCO2 Alarm | 1 to 99 mmHg, Off | 1 to 99 mmHg, Off | Same | | High Insp CO2 Alarm | 1 to 99 mmHg, Off | 1 to 99 mmHg, Off | Same | | Re-Breathing (low leakage) Alarm | On, Off | On, Off | Same | | High Patient Air Temp Alarm | Yes | Yes | Same | | Low Last Power Source Alarm | Yes | Yes | Same | | Power Fail Alarm | Yes | Yes | Same | | Low Alarm Battery Alarm | Yes | Yes | Same | | Function Failure Alarms | Yes | Yes | Same | | Alarm Pre-Silence | Yes | No | Substantially equivalent: Both devices share the same physical buttons, including the Audio Pause button which mutes active alarms in both devices. The subject device includes the additional alarm pre-silence function (pre- silencing of alarms for the coming 2 minutes). The existing Audio Pause hardware button is used for the pre- silence function by the user pressing and holding it down for three seconds. The pre- silence function is recommended in IEC 60601-1- 8 Edition 2.1 Annex A Subclause 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 | | | | | Inspiratory Pressure | 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 | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ 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 {14}------------------------------------------------ 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 electrical equipment-Part 1: General requirements for basic safety and essential performance | | Electromagnetic compatibility | IEC 60601-1-2: 2014 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic disturbances-Requirements and tests | | Usability | IEC 60601-1-6: 2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability | | Alarms systems | IEC 60601-1-8: 2006 (Second edition) + Am. 1: 2012 Medical electrical equipment-Part 1-8: General requirements for basic safety and essential performance- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | | Medical equipment used in home healthcare environment | IEC 60601-1-11: 2015 Medical electrical equipment-Part 1- 11: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment systems used in the home healthcare environment | | Critical care ventilators | ISO 80601-2-12:2020 Medical electrical equipment Part 2- 12: Particular requirements for safety of lung ventilators- Critical care ventilators…