(265 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The testing described focuses on standard medical device performance and safety standards.
Yes.
Explanation: The device is a ventilator intended to provide "positive pressure ventilator support", which is a medical intervention to treat respiratory issues, thus qualifying it as a therapeutic device.
No
A ventilator provides respiratory support and does not diagnose medical conditions. Its use is for treatment rather than diagnosis.
No
The device description explicitly states it is a positive pressure ventilator with an internal turbine for pneumatic power and relies on an auxiliary oxygen source, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The bellavista 1000 ventilator is a life support device that provides mechanical ventilation to patients. It directly interacts with the patient's respiratory system to assist with breathing.
- Intended Use: The intended use clearly states it provides "positive pressure ventilator support" to patients. This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the mechanical aspects of ventilation, modes of operation, and power source. There is no mention of analyzing biological samples.
The information provided clearly indicates that the bellavista 1000 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatrics (IBW greater than 6 kg)
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bellavista was subjected to performance tests including: reliability testing, alarm tests, design control verification, software verification, and electromagnetic compliance, electrical safety, packaging verification, environmental testing, waveform testing and biocompatibility testing:
- Tests according to IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, ISO 80601-2-● 12:2011, IEC 60601-1-8:2006+A1:2012, ISO 80601-2-55:2011 was performed.
- Reliability testing was performed as described in ASTM F1100-90. ●
- Validation testing was performed with wide range of System Acceptance Tests (SAT) to ensure the ventilation performance
The non-clinical performance testing included testing of a set of ventilation modes as described above. The data demonstrates that the technological characteristics of the bellavista ventilator are substantially equivalent with the predicate device.
The results of the testing demonstrated that the bellavista complies with the applicable requirement of both standards as well as performed within performance specifications that are substantially equivalent to the predicate - Hamilton C2 -K121225.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HAMILTON-C2 (K121225)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
HAMILTON-G5 (K131774), COVIDIEN-PB 840 (K151252), DRAEGER-Oxylog 3000 plus (K103625)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, with flowing lines connecting them. Above the graphic, the text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. Below the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is also arranged in a circular fashion.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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 |
| Gewerbestrasse 8 | |
| 9470 Buchs SG | |
| Switzerland | |
| Name of contact: | Mr. Beat Keller |
| Phone: +41 81 750 66 99 | |
| FAX: +41 81 750 06 45 | |
| E-mail: keller@imt.ch | |
| Regulation Number: | 21 CFR 868.5895 |
| Class: | II |
| Product Code: | CBK |
| Predicate: | HAMILTON-C2 (K121225) |
| Reference devices: | HAMILTON-G5 (K131774) |
| COVIDIEN-PB 840 (K151252) | |
| 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
3
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 | ||
| (60 Lpm) | ≤ 26 mbar/L/s | |
| (30 Lpm) | ||
| Expiratory resistance | Adult | Pediatric |
| ≤ 20 mbar/L/s | ||
| (60 Lpm) | ≤ 20 mbar/L/s | |
| (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
Bellavista 1000 | Predicate
Hamilton C2
K121225 | Comments |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Product Code | CBK | CBK | The same classification |
| 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. | The HAMILTON-C2 ventilator is
intended to provide positive
pressure ventilator support to
adults, pediatrics, infants and
neonates.
Intended areas of use:
- In the intensive care ward or
in the recovery room - During transfer of ventilated
patients within the hospital
The HAMILTON-C2 ventilator is | Both devices have similar
indications for use. |
4
| imtmedical | bellavista | ||
|---|---|---|---|
| ------------ | ------------ | -- | -- |
| | | use by qualified, trained
personnel under the direction
of a physician and within the
limits of its stated technical
specifications. | |
|--------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Patient population | adults and pediatrics
(IBW greater than 6 kg) | adults, pediatrics, infants and
neonates. | The predicate has broader
population but that does not
change the intended use. |
| Environment of use | Hospitals, sub-acute care
facilities and intra-hospital
transfer | In the intensive care ward or in
the recovery room
During transfer of ventilated
patients within the hospital | The same environment of use |
| MRI suite | No | No | Both are not for use in the MRI
environment |
Technological Characteristics
| | Subject
Bellavista 1000 | Predicate
HAMILTON-C2
(K121225) | Remarks, Substantial
equivalence |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System architecture: | 2 microprocessors + alarm
controller | 1 microprocessor + alarm
controller | The technological
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
Technology | Subject
Bellavista 1000 | Predicate
HAMILTON-C2
(K121225) | Remarks, Substantial
equivalence |
| Picture | Image: Bellavista 1000 | Image: HAMILTON-C2 (K121225) | |
| System
architecture | bellavista's pneumatics deliver gas,
and its electrical systems control
pneumatics, monitor alarms, and
distribute power. | The HAMILTON-C2's pneumatics
deliver gas, and its electrical
systems control pneumatics,
monitor alarms, and distribute
power. | Both device have similar system
architecture |
| Gas source and
delivery | bellavista is an electronically
controlled pneumatic ventilation
system with an integrated air
compressing system.
bellavista uses room air and high-
pressure oxygen. Air enters through
a fresh gas intake port and is
compressed together with the
oxygen by the blower. Oxygen
enters through a high pressure inlet.
An electronic mixer valve provides
for the operator-set concentration.
Gas is supplied to the patient via the
microprocessor controlled
inspiratory valve. | The HAMILTON-C2 is an
electronically controlled pneumatic
ventilation system with an
integrated air compressing system.
The HAMILTON-C2 uses room air
and low- or high-pressure oxygen.
Air enters through a fresh gas intake
port and is compressed together
with the oxygen by the blower.
Oxygen enters through a high - or
low-pressure inlet.
A mixer valve provides for the
operator-set concentration when
using the high-pressure oxygen inlet.
Gas is supplied to the patient via the
inspiratory valve. | The gas sources and delivery are
similar. Both entrain room air
which is compressed by a blower.
The gas mixture is controlled by a
mixer prior to delivery to a
patient.
The bellavista does not offer the
option of a low pressure oxygen
source, which is needed in a
home use environment. The
bellavista is not intended for the
home setting. |
| Exhalation | Gas exhaled by the patient passes
through the flow sensor and exits
through the expiratory exhalation
valve with a membrane. The
exhalation valve is part of the circuit
thus ensuring that no exhaled gas
comes into contact with any internal
part of bellavista. | Gas exhaled by the patient passes
through the expiratory limb
breathing circuit parts, including flex
tubes, the Flow Sensor, the Y-piece,
a water trap, and an expiratory
valve cover and membrane. Gas is
vented through the expiratory valve
cover such that no exhaled gas
comes into contact with any internal
components of the HAMILTON-C2. | The exhalation pathway is similar. |
| User Interface | The user provides inputs to
bellavista microprocessor system
through a touchscreen. | The user provides inputs to the
HAMILTON-C2 microprocessor
system through a touchscreen, keys,
and a press-and-turn knob. | The user interface of Hamilton
features a press-and-turn knob
through plus keys through which
the entire user interface can be
operated. Touch screen operation
is optional. Bellavista is operated
with touch screen only. |
| Power supply | It is powered by AC, DC or battery. | It is powered by AC or DC with
battery backup to protect against
power failure or unstable power and
to facilitate intra-hospital transport. | Similar |
| Ventilator
Technology | Subject
Bellavista 1000 | Predicate
HAMILTON-C2
(K121225) | Remarks, Substantial
equivalence |
| Control
architecture | These [the user's] inputs become
instructions for the bellavista's
pneumatics to deliver a precisely
controlled gas mixture to the
patient. | The HAMILTON-C2's microprocessor
system controls gas delivery and
monitors the patient. [The user's]
inputs become instructions for the
HAMILTON-C2's pneumatics to
deliver a precisely controlled gas
mixture to the patient. | Control architecture is similar |
| Sensors and
Monitoring | bellavista receives inputs from the
proximal Flow Sensor and other
sensors within the ventilator.
Monitored data is also displayed by
the graphic user interface.
A galvanic oxygen sensor (oxygen
cell) monitors the oxygen
concentration of the gas to be
delivered to the patient. | The HAMILTON-C2 receives inputs
from the proximal Flow Sensor and
other sensors within the ventilator.
Based on this monitored data, the
HAMILTON-C2 adjusts gas delivery
to the patient. Monitored data is
also displayed by the graphic user
interface.
An oxygen cell (sensor) monitors the
oxygen concentration of the gas to
be delivered to the patient. This
galvanic cell generates a voltage
proportional to the partial pressure
of oxygen in the delivered gas. | Both devices incorporate a flow
sensor, oxygen sensor, and
monitor data |
| Alarming | A comprehensive system of visual
and audible alarms helps ensure the
patient is monitored. Clinical alarms
can indicate an abnormal
physiological condition. Technical
alarms, triggered by the ventilator's
self-tests, including ongoing
background checks, can indicate a
hard-ware or software failure. | A comprehensive system of visual
and audible alarms helps ensure the
patient is monitored. Clinical alarms
can indicate an abnormal
physiological condition. Technical
alarms, triggered by the ventilator's
self-tests, including ongoing
background checks, can indicate a
hardware or software failure. | Both device have similar alarms
and comply with ISO 60601-1-8. |
| Patient safety | bellavista has several means to help
ensure that patient or respiratory
pressures are maintained. The
maximum working pressure is
ensured by the high pressure alarm
limit. If the set high pressure limit is
reached, the ventilator cycles into
exhalation.
bellavista has two microprocessor
systems, one which controls the
ventilation, the other one which
controls the user interface. An
additional alarm controller
(watchdog) alarms in the unlikely
event of a complete failure. The two
processor systems crosscheck each
other and are able to alarm
independently. This helps to prevent
simultaneous failure of the main
functions. | The HAMILTON-C2 has several
means to help ensure that patient or
respiratory pressures are
maintained. The maximum working
pressure is ensured by the high
pressure alarm limit. If the set high
pressure limit is reached, the
ventilator cycles into exhalation. The
ventilator pressure cannot exceed
60 cmH20
The gas delivery and monitoring
functions are cross-checked by an
alarm controller. This cross-
checking helps prevent simultaneous
failure of these two main functions
and minimizes the possible hazards
of software failure. | Both devices have similar patient
safety features. |
| | Subject
Bellavista 1000 | Predicate
HAMILTON-C2
(K121225) | Remarks, Substantial equivalence |
| Picture |
|
| Both device use a disposable exhalation
valve of similar design |
| Opening Diameter | 18 mm | 22 mm | Different opening but this does not
affect performance |
| Technology | Membrane Valve towards ambient | Membrane Valve towards ambient | Similar technology |
| PEEP Regulation
Accuracy | -0.1 – 0.6 mbar | -0.3 - 1.9 mbar | Bellavista shows better PEEP
accuracy under various conditions
than the predicate, but we are
making no claims |
| Expiratory
Resistance | 13.7 ±3.6 mbar/L/s
42.1 ±9.5 mbar/L/s | 12.3 ±3.2 mbar/L/s
47.3 ±7.1 mbar/L/s | The difference in resistance means
less work for the patient. |
5
6
bellavista
7
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
bellavista 1000 | Primary Predicate device:
HAMILTON-C2 (K121225) | Remarks, Substantial equivalence |
|---------------------------------|-----------------------------------------|----------------------------------------------------|-----------------------------------------------------|
| O2 Sensor
Original | Envitec | Envitec | Both device incorporate an in-line
oxygen sensor |
| manufacturer
Type
Picture | OOM102-HS
Image: OOM102 | OOM202-1
Image: OOM202-1 | |
| Sensor technology | galvanic oxygen sensor (oxygen
cell) | galvanic oxygen sensor (oxygen
cell) | Similar technology |
| Range | 0 - 100% O2 | 0 – 100% O2 | Similar range |
| Accuracy at 100% |
0 | 0 – 1000
mL/mbar | n.a. | 0 – 200
mL/mbar | n.a. | Bellavista has a slightly
higher measuring range. This
can be considered a minor
difference and substantially
equivalent. |
| CStat/kg | Compliance per kg body
weight | 0 – 99
mL/mbar/kg | n.a. | n.a. | n.a. | Calculating this parameter
does not affect safety or
effectiveness but is provided
for the clinicians use. |
| FiO2 | Inspiratory oxygen
concentration | 18 – 100
Vol% | ±(2.5%O2 + 2.5%)d) | 18 – 105 Vol% | ±(2.5%O2 + 2.5%)d) | Similar to predicate |
| FlowExp Peak | Expiratory peak flow | 0 – 180
L/min | ±0.5 L/min; ±10%e) | 0 – 210 L/min | ±1.2 L/min; ±10%e) | Similar to predicate |
| FlowInsp Peak | Inspiratory peak flow | 0 – 180
L/min | ±0.5 L/min; ±10%e) | 0 – 210 L/min | ±1.2 L/min; ±10%e) | Similar to predicate |
| I:E | Ratio inspiration time
versus expiration time | 1:99 –
100:1 | 10%c) | 1:99 – 9.9:1 | n.a. | Similar to predicate |
| Leak % | Leak flow in % of the
totally delivered volume | 0 – 100 % | n.a. | 0 – 100 % | 10%c) | Similar to predicate |
| Leak Flow | Average leak flow | 0 – 200
L/min | ±15%c) | n.a. | n.a. | Bellavista has a higher
measuring range. This is
necessary for the higher
peak flows which the device
is able to deliver. The
monitoring parameter can be
considered substantially
equivalent. |
| MVExp | Expiratory volume per
minute | 0 – 250
L/min | ±0.5 L/min; ±10%e) | 0 – 99.9 L/min | ±0.3 L/min; ±10%e) | Bellavista has a higher
measuring range. This is
related to the higher peak
flows which the device is
able to deliver. The
monitoring parameter can be
considered substantially
equivalent. |
| Monitoring
parameter | Description of
monitoring parameter | Subject
Bellavista 1000 | | Predicate
HAMILTON-C2 (K121225) | | Remarks, Substantial
equivalence |
| | | Range | Accuracy 2) | Range | Accuracy e) | |
| MVExp Spont | Expiratory minute
volume of triggered
breaths | 0 – 250
L/min | ±0.5 L/min; ±10% e) | 0 - 99.9 L/min | ±0.3 L/min; ±10% e) | Bellavista has a higher
measuring range. This is
related to the higher peak
flows which the device is
able to deliver. The
monitoring parameter can be
considered substantially
equivalent. |
| MVInsp | Inspiration volume of all
breaths per minute | 0 – 250
L/min | ±0.5 L/min; ±10% e) | 0 - 99.9 L/min | ±0.3 L/min; ±10% e) | Bellavista has a higher
measuring range. This is
related to the higher peak
flows which the device is
able to deliver. The
monitoring parameter can be
considered substantially
equivalent. |
| MVInsp Spont | Inspiratory minute
volume of triggered
breaths | 0 - 250
L/min | ±0.5 L/min; ±10% e) | 0 – 99.9 L/min | ±0.3 L/min; ±10% e) | Bellavista has a higher
measuring range. This is
related to the higher peak
flows which the device is
able to deliver. The
monitoring parameter can be
considered substantially
equivalent. |
| MVInsp/kg
MVExp/kg | Volume per minute per
kg body weight | 0 - 9999
mL/min/kg | | n.a. | n.a. | Calculating this parameter
does not affect safety or
effectiveness but is provided
for the clinicians use. |
| PEEP | Measured positive end-
expiratory pressure | 0 - 100
mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PMean | Mean pressure during
cycle | 0 - 100
mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PPeak | Peak pressure during the
inspiration | 0 - 100
mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PPlateau | Plateau pressure (only
available if plateau > 0) | 0 – 100
mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PTP | Pressure Time Product,
pressure/time Integral
during triggering, closely
related to WOBImp | 0 - 100
mbars | n.a. | 0 - 100
mbars | n.a. | Similar to predicate |
| P0.1 | Occlusion pressure
100ms after the trigger.
The monitoring value is
calculated online using
an extrapolation method.
No maneuver is
necessary. | 0 - 100
mbar | ±(2 mbar ±4%) | 0 – 99 mbar | n.a. | Similar to predicate |
| Rate | Measured breathing rate
(in the past 60s) | 0 - 200
bpm | ±1 bpm | 0 - 999 bpm | ±1 bpm | Similar to predicate |
| Ratespont | Rate of synchronized
(triggered) breaths (in
the past 60s) | 0 - 200
bpm | ±1 bpm | 0 – 999 bpm | ±1 bpm | Similar to predicate |
| Monitoring
parameter | Description of
monitoring parameter | Subject
Bellavista 1000 | | Predicate
HAMILTON-C2 (K121225) | | Remarks, Substantial
equivalence |
| | | Range | Accuracy 2) | Range | Accuracy | |
| RCExp | Expiratory time constant | 0.1 - 5 s | n.a. | 0 – 99.9 s | n.a. | Bellavista has a smaller
measuring range which does
not affect safety or
effectiveness.. This range is
adapted to the clinically
measured RCExp which is
typically not >2s. |
| RExp | Resistance (expiratory):
(PEnd Insp - PEEP) / Flow Exp mbar/L/s
Peak | 0 - 300 | n.a. | n.a. | n.a. | Calculating this parameter
does not affect safety or
effectiveness but is provided
for the clinicians use. |
| Rinsp | Resistance (inspiratory):
(PEnd Insufflation - PPlateau) /
Flow End Insufflation
(only available with
plateau > 0) | 0 – 300
mbar/L/s | n.a. | 0 - 999
mbar/L/s | n.a. | Similar to predicate |
| RSBI | Rapid Shallow Breathing
Index (Tobin Index): Rate bpm /L
/ Vtinsp
Parameter only makes
sense if for spontaneous
breathing with none or
minimal pressure
support. | 1 - 9999 | - | 10 - 400
bpm/L | n.a. | Bellavista has a higher
measuring range which does
not affect safety or
effectiveness. It allows a
larger range to be displayed
for the user.. |
| TExp | Expiration Time | 0 — 100 s | 10% c) | 0 - 60 | 0.1 s | Similar to predicate |
| TInsp | Inspiration Time | 0 — 100 s | 10% c) | 0 - 60 | 0.1 s | Similar to predicate |
| TInsp Support | Inspiration time of
supported breaths | 0 — 100 s | 10% c) | n.a. | n.a. | The parameter is not
available in the predicate
device, however since it is
based on the normal Tinsp it
can be considered
substantially equivalent. |
| Tinsp/TTot | Ratio of inspiration
versus cycle time: Tinsp /
(Tinsp + TExp) | 0 - 100% | 10% c) | n.a. | n.a. | The parameter is not
available in the predicate
device, however since it is
calculated on the normal Tinsp
and TExp it can be considered
substantially equivalent. |
| VtExp | Exp. tidal volume | 0 - 2500 mL | ±10 mL ; ±10% e) | 0 – 9000 mL | ±10 mL ; ±10% e) | Similar to predicate |
| VtInsp | Insp. tidal volume | 0 - 2500 mL | ±10 mL ; ±10% e) | 0 – 9000 mL | ±10 mL ; ±10% e) | Similar to predicate |
| Vtinsp/kg
VtExp/kg | Tidal volume per kg body
weight | 0 – 100
mL/kg | - | n.a. | n.a. | The parameter is not
available in the predicate
device, but this is just a
parameter for the user if
they want it. |
| WOBImp | The work of breathing
required for triggering.
Corresponds to the area
left of PEEP in the
pressure/flow diagram. | 0.00 - 9.99
J/L | - | n.a. | n.a. | The parameter is not
available in the predicate
device, but this is just a
parameter for the user if
they want it. |
| Pressure a) | Airway pressure
(measured internally) | -30 - 100
mbar | ±(2 mbar + 4%) | -10 – 80 mbar | n.a. | Similar to predicate |
| Flow a) | Flow | -300 -
300 L/min | ±10% c) | -300 - 300
L/min | n.a. | Similar to predicate |
| Volume a) | Volume | 0 - 2500 mL | ±10% c) | 0 - 3200 mL | n.a. | Similar to predicate |
| Monitoring
parameter | Description of
monitoring parameter | Subject
Bellavista 1000 | | Predicate
HAMILTON-C2 (K121225) | | Remarks, Substantial
equivalence |
| | | Range | Accuracy2) | Range | Accuracy | |
| Press./Volumeb) | Pressure versus volume loop | 0 – 100 mbar
0 – 2500 mL | ±(2 mbar + 4%)
±10%c) | -10 – 80 mbar
0 – 3200 mL | n.a. | Similar to predicate |
| Volume / Flowb) | Volume versus flow loop | 0 – 2500 mL
-300 – 300 L/min | ±10%c)
±10%c) | 0 – 3200 mL
-300 – 300 L/min | n.a. | Similar to predicate |
| Pressure/Flowb) | Pressure versus flow loop | 0 – 100 mbar
-300 – 300 L/min | ±(2 mbar + 4%)
±15%c) | -10 – 80 mbar
-300 – 300 L/min | n.a. | Similar to predicate |
12
13
14
imt
Monitoring Parameters
-
Bellavista measuring range is a maximum of 20% outside the measuring range of the predicate device's setting. Monitoring parameters often have different ranges between various ventilators. The smally related to clinical experience, whereas larger ranges represent the technically feasible.
-
Bellavista while it shows a difference in according to "DRAFT Reviewer Guidance for ventilators 1995" with reference made to the standard ASTM F 1100-90:
- All indicators shall be within 10% of the reading as described in paragraph 5.6.2 of the standard.
- Ventilatory frequency indicators and controllers shall be accurate to one breath per minute or 10% as described in section 5.6.4 of the standard.
- a) Curve
b) Loop
c) % of reading
d) Absolute value + % of reading
e) Larger value: specified value; % of reading
Accuracy of Controls
The accuracy listed in this table refers to the potential difference between the value applied by the ventilator.
| Parameter | Subject
bellavista 1000 | Predicate
HAMILTON-C2 (K121225) | Remarks, Substantial
equivalence |
|-------------------------|--------------------------------------|----------------------------------------|-------------------------------------------------------------|
| Volume | ± (5 mL + 6%) | ±10% or ±10 ml 2) | Similar to predicate |
| Inspiratory
pressure | ± (0.8 mbar + 4%) | ± (1.6 mbar + 4%) | Similar to predicate |
| PEEP | ± (0.5 mbar + 1%) | ± (1.6 mbar + 4%) | Similar to predicate |
| Oxygen | ± (3.5% FiO2 + 5% of actual reading) | ± (2.5% FiO2 + 2.5% of actual reading) | Similar to reference device
Dräger Oxylog 3000 (K103625) |
Accuracy of Controls
-
Bellavista setting is within 10% of the predicate range which is considered equivalent.
-
Whichever is greater
Default Settings
| Setting | Description of ventilation
setting | Subject
Bellavista 1000 | Predicate
HAMILTON-C2
(K121225) | Remarks, Substantial equivalence |
|---------|-----------------------------------------------|----------------------------|---------------------------------------|----------------------------------|
| | Patient | 174 cm male | 174 cm male | Similar to predicate |
| IBW | Ideal body weight | 70 kg | 70 kg | Similar to predicate |
| Mode | | P-A/C | ASV | See note 2) |
| Pinsp | Inspiration pressure (relative
above PEEP) | 15 mbar | 15 mbar | Similar to predicate 2) |
| PEEP | Positive End-Expiratory
Pressure | 4 mbar | 5 mbar | Similar to predicate 2) |
15
| Setting | Description of ventilation
setting | Subject
Bellavista 1000 | Predicate
HAMILTON-C2
(K121225) | Remarks, Substantial equivalence |
|-----------------|------------------------------------------------|----------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rate | Breathing frequency | 12 bpm | 10 bpm → 13 bpm | The lower initial rate of C2 and G5
after the test breaths quickly
adapts to 13 bpm for a normal
adult (C50, Rp5). This
demonstrates that the bellavista
default setting is substantially
equivalent. |
| TIinsp | Inspiration time of controlled
breaths | 1.7 s | 1 s → 2 s | The short initial inspiratory time
of C2 and G5 (I:E = 1:4) after the
test breaths quickly adapts to 1.8
– 2 s (I:E = 1:1.5) for a normal
adult (C50, Rp5). This
demonstrates that the bellavista
default setting is substantially
equivalent. |
| Flow
Trigger | Inspirational flow for
triggering | 2 L/min | 5 L/min | The bellavista has simailr settings
to the reference device, G5 and
PB 840 |
| Rise
Time | Slope of inspiratory pressure
increase | 50 ms | 50 ms | The default rise time is different
between bellavista and Hamilton. |
| FiO2 | Oxygen concentration of the
respiration air | 60 % | 50 % | Similar to predicate |
Default Settings
-
Bellavista setting is a maximum of 20% outside the range of the predicate device's setting.
-
Hamilton uses ASV as the default ventilation mode. ASV delivers three test breaths with the indicated setting to automatically modify the settings acording to the patient's lung mechanics. Bellavista default settings were compared to the three test breaths for substantial equivalence discussion.
Substantial Equivalence Discussion E.
The bellavista 1000 is viewed as substantially equivalent to the predicate device because:
Indications -
- Indications for use are to provide positive pressure ventilator support to adults and ● pediatrics (IBW greater than 6 kg),
Discussion - These are similar indications for use of the predicate - Hamilton C2 -K121225.
Technology -
The technology of a turbine based portable ventilator is identical to the predicate -Hamilton C2 - K121225.
Discussion - The technology and principle of operation for the proposed device is similar to the predicate - Hamilton C2 - K121225.
Environment of Use -
- . The environment of use – hospital and intra-hospital transport is similar to the predicate.
Discussion - The environments of use are similar to the predicate - Hamilton C2 -K121225.
16
Patient Population -
- The patient population of pediatric to adults is similar to the predicate. ● Discussion - The patient population is not defined in the predicate so we provided a comparison of Tidal Volume and IBW to the predicate to help define the population. It is substantially equivalent to the predicate - Hamilton C2 - K121225.
Modes of Ventilation and Specifications -
- The modes of ventilation are similar to the predicate and reference devices. In ● addition, a comparison of the specifications and operating ranges are similar as well.
- The modes for each populations are: ●
- Adults: CPAP, PCV, P-A/C, PC-SIMV, PSV, S, S/T, T, beLevel, APRV, VCV, o V-A/C, VC-SIMV.
- Pediatrics the following modes of ventilation are available: CPAP, PCV, P-A/C, o PC-SIMV, S, T, beLevel, APRV, VCV, V-A/C, VC-SIMV
Discussion - All ventilation modes, except volume controlled ventilation, are similar to the predicate – Hamilton C2 – K121225, while the reference – Hamilton G5 – K131774 includes volume controlled ventilation mode. We compared the ventilation modes which had similar features and their operating ranges as well as waveforms and they were found to be substantially equivalent. The following table presents the modes tested. We note that for pediatrics the modes of PSV and S/T are not available.
| Unique Mode Components | Mode Comparison Tests | bellavista 1000 | Predicate Hamilton C2 (K121225) |
|---|---|---|---|
| 1 PC-Mandatory-setpoint | P-A/C | P-CMV | |
| 2 PV-mandatory - | |||
| setpoint+servo | P-A/C + ATC | P-CMV (+TRC) | |
| 3 PC-mandatory- | |||
| setpoint+adaptive | PSV(backup on) | PSIMV+ | |
| 4 PC-spontaneous-setpoint | CPAP | Spontaneous | |
| 5 PC-spontaneous- | |||
| setpoint+servo | CPAP(+ATC) | Spontaneous (+TRC) | |
| 6 VC-mandatory-setpoint | V-A/C | (s)CMV | |
| Special Mode Varieties | |||
| 7 PC-IMVs,s | APRV | APRV |
Biocompatibility of Materials
- . We evaluated all materials in the gas pathway according to ISO 10993-1, with some scientific methodologies within ISO 18562-3. The patient contact is Externally communicating, Tissue, Permanent Duration. For ventilators the testing included VOC (gas emission test method), CO, CO2, Ozone and PM25 testing. We performed a risk based assessment for the results.
Discussion - The materials have been evaluated and found to be acceptable for the intended use, intended population and type of patient contact.
17
Performance Testing
The bellavista was subjected to performance tests including: reliability testing, alarm tests, design control verification, software verification, and electromagnetic compliance, electrical safety, packaging verification, environmental testing, waveform testing and biocompatibility testing:
- Tests according to IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, ISO 80601-2-● 12:2011, IEC 60601-1-8:2006+A1:2012, ISO 80601-2-55:2011 was performed.
- Reliability testing was performed as described in ASTM F1100-90. ●
- Validation testing was performed with wide range of System Acceptance Tests (SAT) to ensure the ventilation performance
The non-clinical performance testing included testing of a set of ventilation modes as described above. The data demonstrates that the technological characteristics of the bellavista ventilator are substantially equivalent with the predicate device.
Discussion - The results of the testing demonstrated that the bellavista complies with the applicable requirement of both standards as well as performed within performance specifications that are substantially equivalent to the predicate - Hamilton C2 -K121225.
Usability
- . Summative usability tests was performed with a user group of respiratory therapists.
Discussion of Differences
The basic design, indications for use, patient population, and environments of use, technological characteristics, ventilation modes, alarms, performance specifications and features of the bellavista are similar to the predicate - K121225 - Hamilton C2.
Any difference as discussed above upon evaluation and risk assessment do not raise any new risks or safety concerns as compared to the predicates.
F. Summary of clinical testing
No clinical testing was conducted or required in support of this premarket notification.
Substantial Equivalence Conclusion G.
We have compared the bellavista 1000 to the predicate and where needed provided reference devices. The testing performed has demonstrated that the bellavista can be found to be substantially equivalent.
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