bellavista 1000

K163127 · Imtmedical AG · CBK · Jul 31, 2017 · Anesthesiology

Device Facts

• Record ID: K163127
• Device Name: bellavista 1000
• Applicant: Imtmedical AG
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The bellavista 1000 ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg). Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer. It is intended for use by qualified, trained personnel under the direction of a physician.

Device Story

The bellavista 1000 is a turbine-powered, positive pressure ventilator for intubated or mask-ventilated adult and pediatric patients. It utilizes room air and high-pressure oxygen, mixed via an electronic valve and delivered through a microprocessor-controlled inspiratory valve. The device features a proximal flow sensor and galvanic oxygen cell for monitoring. Operated by clinicians via a touchscreen interface, it provides various ventilation modes (e.g., CPAP, PCV, VCV, APRV). The system includes dual microprocessors and an alarm controller to manage gas delivery, monitor patient parameters, and trigger visual/audible alarms for physiological or technical failures. It supports intra-hospital transport via internal lithium-ion battery power. Output data is displayed on the GUI to assist clinicians in adjusting ventilation settings, thereby supporting patient respiratory function.

Clinical Evidence

No clinical testing was conducted or required. Substantial equivalence is supported by non-clinical performance testing, including reliability testing (ASTM F1100-90), design control verification, software verification, electromagnetic compliance (IEC 60601-1-2), electrical safety (IEC 60601-1), and biocompatibility (ISO 10993-1).

Technological Characteristics

Turbine-based, electronically controlled pneumatic ventilator. Materials evaluated per ISO 10993-1 and ISO 18562-3. Features proximal flow sensor, galvanic oxygen cell, and dual microprocessor architecture with alarm controller. Power: 100–240VAC, 24VDC, and dual Li-ion batteries. Connectivity: touchscreen interface. Sterilization: disposable exhalation valve/circuit. Software: multi-processor control system.

Indications for Use

Indicated for positive pressure ventilator support for adult and pediatric patients with an ideal body weight (IBW) greater than 6 kg in hospital, sub-acute care, and intra-hospital transfer settings.

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

• HAMILTON-C2 (K121225)

Reference Devices

• HAMILTON-G5 (K131774)
• COVIDIEN-PB 840 (K151252)
• DRAEGER-Oxylog 3000 plus (K103625)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2017

Imtmedical Ag % Paul Dryden Manager Promedic, LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134-2958

Re: K163127

Trade/Device Name: bellavista 1000 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: June 27, 2017 Received: June 28, 2017

Dear Paul Dryden:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely,

for CDR Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### A. General Company Information

| Date: | 31-Jul-17 |
|----------------------|----------------------------------------------------------------------------------------------|
| Trade Name: | bellavista 1000 |
| Common Name: | Continuous ventilator, facility use |
| Classification Name: | Ventilator, continuous, facility use |
| Submitter: | IMTMEDICAL AG<br>Gewerbestrasse 8<br>9470 Buchs SG<br>Switzerland |
| Name of contact: | Mr. Beat Keller<br>Phone: [phone]<br>FAX: [phone]<br>E-mail: [e-mail] |
| Regulation Number: | 21 CFR 868.5895 |
| Class: | II |
| Product Code: | CBK |
| Predicate: | HAMILTON-C2 (K121225) |
| Reference devices: | HAMILTON-G5 (K131774)<br>COVIDIEN-PB 840 (K151252)<br>DRAEGER-Oxylog 3000 plus (K103625) |

#### Device Description and Accessories B.

The bellavista 1000 ventilator (hereafter referred to as "bellavista") is designed for continuous ventilation of adult and pediatric patients.

The bellavista ventilator is a positive pressure ventilator for intubated patients and patients with mask ventilation. Its pneumatic power is provided by an internal turbine. Supplemental oxygen is provided by an auxiliary oxygen source.

The following modes of ventilation are available

- Adults: CPAP, PCV, P-A/C, PC-SIMV, PSV, S, S/T, T, beLevel, APRV, VCV, ● V-A/C, VC-SIMV.
- Pediatrics the following modes of ventilation are available: CPAP, PCV, P-A/C, ● PC-SIMV, S, T, beLevel, APRV, VCV, V-A/C, VC-SIMV

## Accessories

Flow Sensor Provided -Disposable Exhalation Valve

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Compatibility accessories specifications -

The bellavista may be used with standard single or dual limb disposable ventilator circuits. In addition a heated humidifier and its compatible circuit, heated single or dual limb, can be connected to the bellavista.

The specifications for determining compatibility are:

| Circuits | Connections | 15 mm / 22 mm |
|------------------------|---------------------------|-------------------------------|
| Tubing | Adults - 22 mm ID | Pediatric - 15 mm or 22 mm ID |
| Inspiratory resistance | Adult | Pediatric |
| | ≤ 15 mbar/L/s<br>(60 Lpm) | ≤ 26 mbar/L/s<br>(30 Lpm) |
| Expiratory resistance | Adult | Pediatric |
| | ≤ 20 mbar/L/s<br>(60 Lpm) | ≤ 20 mbar/L/s<br>(30 Lpm) |
| Leakage | ≤ 0.36 L/min at 30 cmH2O | |
| Compliance | ≤ 3.5 mL/cm H2O | |

Only use breathing circuits which meet the above specifications and which have the indications for use with mechanical ventilators.

#### ﻥ Indications for Use

The bellavista 1000 ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg).

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

It is intended for use by qualified, trained personnel under the direction of a physician.

#### Tables of Comparison D.

| Attribute | Subject<br>Bellavista 1000 | Predicate<br>Hamilton C2<br>K121225 | Comments |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Product Code | CBK | CBK | The same classification |
| Indications for Use | The bellavista 1000 ventilator is<br>intended to provide positive<br>pressure ventilator support to<br>adults and pediatrics (IBW<br>greater than 6 kg).<br><br>Environment of use: hospitals,<br>sub-acute care facilities and<br>intra-hospital transfer<br><br>It is intended for use by<br>qualified, trained personnel<br>under the direction of a<br>physician. | The HAMILTON-C2 ventilator is<br>intended to provide positive<br>pressure ventilator support to<br>adults, pediatrics, infants and<br>neonates.<br><br>Intended areas of use:<br>- In the intensive care ward or<br>in the recovery room<br>- During transfer of ventilated<br>patients within the hospital<br><br>The HAMILTON-C2 ventilator is | Both devices have similar<br>indications for use. |

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| imtmedical | bellavista | | |
|------------|------------|--|--|
|------------|------------|--|--|

| | | use by qualified, trained<br>personnel under the direction<br>of a physician and within the<br>limits of its stated technical<br>specifications. | |
|--------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Patient population | adults and pediatrics<br>(IBW greater than 6 kg) | adults, pediatrics, infants and<br>neonates. | The predicate has broader<br>population but that does not<br>change the intended use. |
| Environment of use | Hospitals, sub-acute care<br>facilities and intra-hospital<br>transfer | In the intensive care ward or in<br>the recovery room<br>During transfer of ventilated<br>patients within the hospital | The same environment of use |
| MRI suite | No | No | Both are not for use in the MRI<br>environment |

#### Technological Characteristics

| | Subject<br>Bellavista 1000 | Predicate<br>HAMILTON-C2<br>(K121225) | Remarks, Substantial<br>equivalence |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System architecture: | 2 microprocessors + alarm<br>controller | 1 microprocessor + alarm<br>controller | The technological<br>characteristics are similar. |
| Gas source: | Blower + high pressure O2 | Blower + high pressure O2 | |
| User Interface: | Touch screen | Touch screen + keys + press-and-turn knob | |
| Flow measurement: | Proximal flow sensor | Proximal flow sensor | |
| Power supply: | 100 – 240VAC, 24VDC | 100 - 240VAC, 12 - 24 VDC | |
| Battery: | 2x Lithium Ion batteries | 2x Lithium Ion batteries | |
| Ventilator<br>Technology | Subject<br>Bellavista 1000 | Predicate<br>HAMILTON-C2<br>(K121225) | Remarks, Substantial<br>equivalence |
| Picture | Image: Bellavista 1000 | Image: HAMILTON-C2 (K121225) | |
| System<br>architecture | bellavista's pneumatics deliver gas,<br>and its electrical systems control<br>pneumatics, monitor alarms, and<br>distribute power. | The HAMILTON-C2's pneumatics<br>deliver gas, and its electrical<br>systems control pneumatics,<br>monitor alarms, and distribute<br>power. | Both device have similar system<br>architecture |
| Gas source and<br>delivery | bellavista is an electronically<br>controlled pneumatic ventilation<br>system with an integrated air<br>compressing system.<br>bellavista uses room air and high-<br>pressure oxygen. Air enters through<br>a fresh gas intake port and is<br>compressed together with the<br>oxygen by the blower. Oxygen<br>enters through a high pressure inlet.<br>An electronic mixer valve provides<br>for the operator-set concentration.<br>Gas is supplied to the patient via the<br>microprocessor controlled<br>inspiratory valve. | The HAMILTON-C2 is an<br>electronically controlled pneumatic<br>ventilation system with an<br>integrated air compressing system.<br>The HAMILTON-C2 uses room air<br>and low- or high-pressure oxygen.<br>Air enters through a fresh gas intake<br>port and is compressed together<br>with the oxygen by the blower.<br>Oxygen enters through a high - or<br>low-pressure inlet.<br>A mixer valve provides for the<br>operator-set concentration when<br>using the high-pressure oxygen inlet.<br>Gas is supplied to the patient via the<br>inspiratory valve. | The gas sources and delivery are<br>similar. Both entrain room air<br>which is compressed by a blower.<br>The gas mixture is controlled by a<br>mixer prior to delivery to a<br>patient.<br>The bellavista does not offer the<br>option of a low pressure oxygen<br>source, which is needed in a<br>home use environment. The<br>bellavista is not intended for the<br>home setting. |
| Exhalation | Gas exhaled by the patient passes<br>through the flow sensor and exits<br>through the expiratory exhalation<br>valve with a membrane. The<br>exhalation valve is part of the circuit<br>thus ensuring that no exhaled gas<br>comes into contact with any internal<br>part of bellavista. | Gas exhaled by the patient passes<br>through the expiratory limb<br>breathing circuit parts, including flex<br>tubes, the Flow Sensor, the Y-piece,<br>a water trap, and an expiratory<br>valve cover and membrane. Gas is<br>vented through the expiratory valve<br>cover such that no exhaled gas<br>comes into contact with any internal<br>components of the HAMILTON-C2. | The exhalation pathway is similar. |
| User Interface | The user provides inputs to<br>bellavista microprocessor system<br>through a touchscreen. | The user provides inputs to the<br>HAMILTON-C2 microprocessor<br>system through a touchscreen, keys,<br>and a press-and-turn knob. | The user interface of Hamilton<br>features a press-and-turn knob<br>through plus keys through which<br>the entire user interface can be<br>operated. Touch screen operation<br>is optional. Bellavista is operated<br>with touch screen only. |
| Power supply | It is powered by AC, DC or battery. | It is powered by AC or DC with<br>battery backup to protect against<br>power failure or unstable power and<br>to facilitate intra-hospital transport. | Similar |
| Ventilator<br>Technology | Subject<br>Bellavista 1000 | Predicate<br>HAMILTON-C2<br>(K121225) | Remarks, Substantial<br>equivalence |
| Control<br>architecture | These [the user's] inputs become<br>instructions for the bellavista's<br>pneumatics to deliver a precisely<br>controlled gas mixture to the<br>patient. | The HAMILTON-C2's microprocessor<br>system controls gas delivery and<br>monitors the patient. [The user's]<br>inputs become instructions for the<br>HAMILTON-C2's pneumatics to<br>deliver a precisely controlled gas<br>mixture to the patient. | Control architecture is similar |
| Sensors and<br>Monitoring | bellavista receives inputs from the<br>proximal Flow Sensor and other<br>sensors within the ventilator.<br>Monitored data is also displayed by<br>the graphic user interface.<br>A galvanic oxygen sensor (oxygen<br>cell) monitors the oxygen<br>concentration of the gas to be<br>delivered to the patient. | The HAMILTON-C2 receives inputs<br>from the proximal Flow Sensor and<br>other sensors within the ventilator.<br>Based on this monitored data, the<br>HAMILTON-C2 adjusts gas delivery<br>to the patient. Monitored data is<br>also displayed by the graphic user<br>interface.<br>An oxygen cell (sensor) monitors the<br>oxygen concentration of the gas to<br>be delivered to the patient. This<br>galvanic cell generates a voltage<br>proportional to the partial pressure<br>of oxygen in the delivered gas. | Both devices incorporate a flow<br>sensor, oxygen sensor, and<br>monitor data |
| Alarming | A comprehensive system of visual<br>and audible alarms helps ensure the<br>patient is monitored. Clinical alarms<br>can indicate an abnormal<br>physiological condition. Technical<br>alarms, triggered by the ventilator's<br>self-tests, including ongoing<br>background checks, can indicate a<br>hard-ware or software failure. | A comprehensive system of visual<br>and audible alarms helps ensure the<br>patient is monitored. Clinical alarms<br>can indicate an abnormal<br>physiological condition. Technical<br>alarms, triggered by the ventilator's<br>self-tests, including ongoing<br>background checks, can indicate a<br>hardware or software failure. | Both device have similar alarms<br>and comply with ISO 60601-1-8. |
| Patient safety | bellavista has several means to help<br>ensure that patient or respiratory<br>pressures are maintained. The<br>maximum working pressure is<br>ensured by the high pressure alarm<br>limit. If the set high pressure limit is<br>reached, the ventilator cycles into<br>exhalation.<br>bellavista has two microprocessor<br>systems, one which controls the<br>ventilation, the other one which<br>controls the user interface. An<br>additional alarm controller<br>(watchdog) alarms in the unlikely<br>event of a complete failure. The two<br>processor systems crosscheck each<br>other and are able to alarm<br>independently. This helps to prevent<br>simultaneous failure of the main<br>functions. | The HAMILTON-C2 has several<br>means to help ensure that patient or<br>respiratory pressures are<br>maintained. The maximum working<br>pressure is ensured by the high<br>pressure alarm limit. If the set high<br>pressure limit is reached, the<br>ventilator cycles into exhalation. The<br>ventilator pressure cannot exceed<br>60 cmH20<br>The gas delivery and monitoring<br>functions are cross-checked by an<br>alarm controller. This cross-<br>checking helps prevent simultaneous<br>failure of these two main functions<br>and minimizes the possible hazards<br>of software failure. | Both devices have similar patient<br>safety features. |
| | Subject<br>Bellavista 1000 | Predicate<br>HAMILTON-C2<br>(K121225) | Remarks, Substantial equivalence |
| Picture | <br> | <br> | Both device use a disposable exhalation<br>valve of similar design |
| Opening Diameter | 18 mm | 22 mm | Different opening but this does not<br>affect performance |
| Technology | Membrane Valve towards ambient | Membrane Valve towards ambient | Similar technology |
| PEEP Regulation<br>Accuracy | -0.1 – 0.6 mbar | -0.3 - 1.9 mbar | Bellavista shows better PEEP<br>accuracy under various conditions<br>than the predicate, but we are<br>making no claims |
| Expiratory<br>Resistance | 13.7 ±3.6 mbar/L/s<br>42.1 ±9.5 mbar/L/s | 12.3 ±3.2 mbar/L/s<br>47.3 ±7.1 mbar/L/s | The difference in resistance means<br>less work for the patient. |

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## bellavista

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Image /page/7/Picture/0 description: The image shows the logo for imtmedical. The logo is written in lowercase letters. The first two letters, "im", are in a dark blue color, while the rest of the letters are in a teal color.

#### Exhalation valve

### Sensor Technology

| | Subject<br>bellavista 1000 | Primary Predicate device:<br>HAMILTON-C2 (K121225) | Remarks, Substantial equivalence |
|---------------------------------|-----------------------------------------|----------------------------------------------------|-----------------------------------------------------|
| O2 Sensor<br>Original | Envitec | Envitec | Both device incorporate an in-line<br>oxygen sensor |
| manufacturer<br>Type<br>Picture | OOM102-HS<br>Image: OOM102 | OOM202-1<br>Image: OOM202-1 | |
| Sensor technology | galvanic oxygen sensor (oxygen<br>cell) | galvanic oxygen sensor (oxygen<br>cell) | Similar technology |
| Range | 0 - 100% O2 | 0 – 100% O2 | Similar range |
| Accuracy at 100% | <1% | <1% | Similar accuracy |
| Linearity | <3% | <3% | Similar linearity |
| Response time 90% | <12 s | <12 s | Similar response time |
| Operating<br>temperature | 0 – 50 °C | 0 – 50 °C | Similar operating temperature |
| Operating humidity | 0 - 99 %RH non-condensing | 0 – 99 %RH non-condensing | Similar operating humidity |
| Temperature<br>compensation | Yes | Yes | Similar temperature compensation |
| Storage temperature | -20 - 50 °C | -20 - 50 °C | Similar storage conditions |

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## Ventilation Modes and Performance settings

| Setting | Description of ventilation<br>setting | Subject<br>Bellavista 1000 | Predicate<br>HAMILTON-C2<br>(K121225) | Remarks, Substantial<br>equivalence |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CPAP | Continuous Positive Airway<br>Pressure | 4 - 30 mbar | 0 – 35 mbar | Bellavista has a narrower CPAP<br>range which does not raise new<br>safety and effectiveness<br>concerns as the clinician is<br>determining the CPAP settings<br>as needed. |
| Exp Trig | Expiration trigger, criterion for<br>switching from inspiration to<br>expiration in pressure supported<br>breaths in % of inspiratory peak<br>flow | 5 - 90 % | 5 – 80% | Similar to predicate, just a higher<br>available range for adjustment |
| FiO2 | Oxygen concentration of the<br>respiration air | 21 - 100% | 21 - 100% | Similar to predicate |
| Pattern | Pattern of inspiratory flow with<br>volume controlled ventilation | Sqa (Square)<br>Dec (Decelerating)<br>Dec50 (Decelerating to<br>50%) | n.a. | Similar to reference device<br>Hamilton G5 (K131774) |
| PEEP,<br>EPAP | Positive End-Expiratory Pressure | 0 – 40 mbar | 0 – 35 mbar | Similar to reference device<br>Hamilton G5 (K131774) |
| PHigh | upper level pressure with<br>beLevel and APRV (absolute) | 2 - 60 mbar | 0 - 60 mbar | Similar to predicate |
| PLow | lower level pressure with APRV<br>(absolute) | 0 – 40 mbar | 0 – 35 mbar | Similar to reference device<br>Covidien PB840 (K151252) |
| PInsp<br>IPAP | Inspiration pressure (relative<br>above PEEP)<br>Inspiration pressure (absolute<br>pressure) | 2 - 60 mbar | 5 - 60 mbar | Similar to predicate (upper limit)<br>and reference device Dräger<br>Oxylog 3000 (K103625) |
| Plateau | Plateau time, between<br>inspiration and expiration with<br>volume controlled ventilation | 0 – 70% | n.a. | Similar to reference device<br>Hamilton G5 (K131774) |
| PSupport | Support pressure of pressure<br>supported breaths (relative<br>above PEEP) | 0 – 60 mbar | 0 – 60 mbar | Similar to predicate |
| Rate | Breathing frequency | 1 – 100 bpm | 1 – 80 bpm | Similar to reference device<br>Hamilton G5 (K131774) |
| Rise Time | Slope of inspiratory pressure<br>increase | 0 – 2000 ms | 0 – 2000 ms | Similar to predicate |
| TInsp | Inspiration time of controlled<br>breaths | 0.1 - 10 s | 0.1 - 12 s | Similar to reference device<br>Hamilton G5 (K131774) |
| TInsp Max<br>I-TimeMax | Maximum inspiration time of<br>pressure supported breaths | 0.3 – 3 s | 1 – 3 s | Similar to reference device<br>Hamilton G5 (K131774) |
| THigh | Time on upper level | 0.1 – 59.8 s | 0.1 – 40 s | Similar to reference device<br>Covidien PB840 (K151252) |
| TLow | Time on lower level | 0.2 – 10 s | 0.2 – 40 s | Similar to predicate |
| Trigger | Criterion to trigger inspiration<br>spontaneously by the patient | Off / pressure / flow | Off / pressure | Similar to predicate |
| Pressure<br>Trigger | Pressure below PEEP for<br>triggering | 0.1 – 15 mbar | n.a. | Similar to reference device<br>Covidien PB840 (K151252) |
| Flow<br>Trigger | Inspirational flow for triggering | 0.1 – 20 L/min | 1.0 - 20 L/min | Similar to predicate |
| VtInsp,<br>Vt | Tidal volume | 40 – 2500 mL | 20 – 2000 mL | Similar to reference device<br>Covidien PB840 (K151252) |
| Setting | Description of ventilation<br>setting | Subject<br>Bellavista 1000 | Predicate<br>HAMILTON-C2<br>(K121225) | Remarks, Substantial<br>equivalence |
| Sigh<br>amplitude | Increase of inspiratory pressure<br>or tidal volume for sigh breaths | 5 – 50 % | 10 mbar | Sigh is configurable in bellavista<br>versus fixed in the predicate |
| Sigh<br>interval | Number of regular breaths after<br>which sigh breaths are delivered | 10 – 200 breaths | 50 breaths | device. The maximum<br>configurable amplitude is 50% or |
| Sigh | Number of consecutive sigh<br>breaths | 1 – 5 breaths | 1 breath…