(265 days)
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 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
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "bellavista 1000" ventilator. It is a letter confirming the device's substantial equivalence to legally marketed predicate devices.
Crucially, this document does NOT describe the acceptance criteria and study that proves the device meets the acceptance criteria in the way you are asking.
The 510(k) process for substantial equivalence (SE) reviews a new device against a predicate device. It demonstrates that the new device is as safe and effective as a legally marketed device, not that it independently "meets acceptance criteria" through clinical trials for novel devices.
Therefore, many of the specific points you requested (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this type of regulatory submission because clinical performance studies, as you've outlined, are generally not required for a 510(k) unless significant differences or new questions of safety/effectiveness arise.
The document states:
- "No clinical testing was conducted or required in support of this premarket notification." (Page 17)
- The comparison is primarily against a predicate device (HAMILTON-C2, K121225) and some reference devices (HAMILTON-G5, COVIDIEN-PB 840, DRAEGER-Oxylog 3000 plus).
Instead of clinical study data, the document relies on:
- Performance 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.
- Reliability testing as described in ASTM F1100-90.
- Validation testing with "wide range of System Acceptance Tests (SAT)".
- Biocompatibility testing according to ISO 10993-1, with certain scientific methodologies within ISO 18562-3.
- Comparison of Technical Specifications: Detailed tables comparing settings, alarms, monitoring parameters, and accuracy controls with the predicate device.
- Usability: Summative usability tests performed with a user group of respiratory therapists.
Given this, I will answer the applicable parts of your request based on the provided document and clarify why other points are not present.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
The "acceptance criteria" in this context are primarily demonstrating equivalence to the predicate device (HAMILTON-C2, K121225) and compliance with relevant performance standards. The "reported device performance" is presented through detailed comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Demonstrated Equivalence / Standard Compliance) | Reported bellavista 1000 Performance (vs. Predicate/Reference) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate HAMILTON-C2 (K121225). | "Intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg)." (Similar to predicate) |
| Patient Population | Substantially equivalent to predicate. | "Adults and pediatrics (IBW greater than 6 kg)." (Predicate has broader population including infants and neonates, but this "does not change the intended use.") |
| Environment of Use | Substantially equivalent to predicate. | "Hospitals, sub-acute care facilities and intra-hospital transfer." (Same as predicate) |
| Technology / Design | Similar system architecture, gas source, flow measurement, power supply, exhalation method to predicate. Compliance with relevant standards. | System Architecture: 2 microprocessors + alarm controller (Predicate: 1 microprocessor + alarm controller) Gas Source: Blower + high pressure O2 (Similar) User Interface: Touch screen (Predicate: touchscreen + keys + press-and-turn knob) Flow Measurement: Proximal flow sensor (Similar) Power Supply: AC, DC or battery (Similar) Exhalation: Membrane valve towards ambient (Similar) |
| Ventilation Modes | Similar to predicate and reference devices. | Lists various modes for adults and pediatrics (e.g., CPAP, PCV, VCV). Most are similar to the predicate or specific reference devices. PSV and S/T not available for pediatrics. |
| Setting Ranges | Bellavista setting is a maximum of 10% outside the range of the predicate device's setting (for ventilation modes). | CPAP: 4-30 mbar (Predicate: 0-35 mbar – narrower range, but acceptable) Exp Trig: 5-90% (Predicate: 5-80% – higher available range) FiO2: 21-100% (Similar) PEEP: 0-40 mbar (Predicate: 0-35 mbar – similar to reference G5) VtInsp/Vt: 40-2500 mL (Predicate: 20-2000 ml – similar to reference PB840) |
| Alarm Limits | Bellavista setting is a maximum of 10% outside the range of the predicate device's setting. Compliance with ISO 60601-1-8. | Apnea Time: 2-60s (Predicate: 15-60s) FiO2: Upper 24-100%, Lower 18-80% (Similar) MVInsp: 0.1-60 L/min (Similar) PPeak: Upper 7-65 mbar, Lower 1-55 mbar (Similar) Rate: 1-130 bpm (Similar) VtExp: 40-3000 mL (Similar) Leak%: 5-95%, Off (Predicate: n/a - new feature, informative only) |
| Monitoring Parameters | Bellavista measuring range maximum 20% outside predicate; compliance with ASTM F 1100-90 (indicators within 10%, freq. within 1 bpm or 10%). | %Spont: 0-100% (Similar) AutoPEEP: 0-100 mbar (Similar) CStat: 0-1000 mL/mbar (Predicate: 0-200 mL/mbar – higher range, but minor difference) FiO2: 18-100 Vol% (Similar) MVExp: 0-250 L/min (Predicate: 0-99.9 L/min – higher range, related to higher peak flows) PEEP/PMean/PPeak/PPlateau: Similar ranges and accuracies. |
| Accuracy of Controls | Bellavista setting within 10% of predicate range. | Volume: ± (5 mL + 6%) (Predicate: ±10% or ±10 ml) (Similar)Inspiratory pressure: ± (0.8 mbar + 4%) (Predicate: ± (1.6 mbar + 4%)) (Similar)PEEP: ± (0.5 mbar + 1%) (Predicate: ± (1.6 mbar + 4%)) (Similar)Oxygen: ± (3.5% FiO2 + 5% of actual reading) (Similar to reference Dräger Oxylog 3000) |
| Biocompatibility | Materials in gas pathway evaluated per ISO 10993-1 and ISO 18562-3, acceptable for intended use. | VOC (gas emission), CO, CO2, Ozone and PM25 testing performed. Materials found acceptable. |
| Electrical Safety/EMC | Compliance with IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007. | Performed and demonstrated compliance. |
| Reliability | Performed as described in ASTM F1100-90. | Testing performed. |
| Software Validation | System Acceptance Tests (SAT). | Testing performed. |
| Usability | Summative usability tests performed with representative user group. | Performed with a user group of respiratory therapists. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a 510(k) premarket notification relying on technical specifications and performance testing against standards and a predicate device, not a clinical study with patient samples.
- Data Provenance: The document does not specify the country of origin for the internal testing data, but the submitter is IMTMEDICAL AG, Switzerland. The testing is non-clinical (laboratory/bench testing) rather than retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of clinical expert consensus would be relevant for devices involving image interpretation or diagnosis. For a ventilator, "ground truth" for performance is established through internationally recognized performance standards (e.g., ISO, IEC, ASTM) and physical measurements using test lungs and calibrated sensors.
- The usability testing was conducted with a user group reported as "respiratory therapists," but no number or detailed qualifications are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. This is a method used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs consensus. It does not apply to the technical performance testing of a ventilator.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is a type of clinical study for diagnostic devices, especially those using AI, to assess the impact of AI on human reader performance. This document concerns a ventilator, which is a therapeutic device, and explicitly states "No clinical testing was conducted or required."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in spirit, for certain aspects. The performance testing (e.g., accuracy of controls, alarm limits, monitoring parameters) represents the "standalone" or "algorithm only" performance of the ventilator's internal systems against engineering specifications and international standards. This is not "AI algorithm only" but "device functionality only." The document does not detail specific "algorithms" for AI, as this is a traditional ventilator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's technical performance is the relevant international performance standards (e.g., IEC, ISO, ASTM) and the measured performance of the legally marketed predicate device. These standards define acceptable ranges for parameters like accuracy, flow, pressure, etc.
8. The sample size for the training set
- Not Applicable. This is a traditional medical device (ventilator). The document does not describe the use of machine learning or AI models requiring a "training set" of data. Its design and validation rely on engineering principles, known predicate device performance, and adherence to established standards.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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
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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 (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
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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 AGGewerbestrasse 89470 Buchs SGSwitzerland |
| Name of contact: | Mr. Beat KellerPhone: +41 81 750 66 99FAX: +41 81 750 06 45E-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
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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(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 | SubjectBellavista 1000 | PredicateHamilton C2K121225 | Comments |
|---|---|---|---|
| Product Code | CBK | CBK | The same classification |
| Indications for Use | The bellavista 1000 ventilator isintended to provide positivepressure ventilator support toadults and pediatrics (IBWgreater than 6 kg).Environment of use: hospitals,sub-acute care facilities andintra-hospital transferIt is intended for use byqualified, trained personnelunder the direction of aphysician. | The HAMILTON-C2 ventilator isintended to provide positivepressure ventilator support toadults, pediatrics, infants andneonates.Intended areas of use:- In the intensive care ward orin the recovery room- During transfer of ventilatedpatients within the hospitalThe HAMILTON-C2 ventilator is | Both devices have similarindications for use. |
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| imtmedical | bellavista | ||
|---|---|---|---|
| ------------ | ------------ | -- | -- |
| use by qualified, trainedpersonnel under the directionof a physician and within thelimits of its stated technicalspecifications. | |||
|---|---|---|---|
| Patient population | adults and pediatrics(IBW greater than 6 kg) | adults, pediatrics, infants andneonates. | The predicate has broaderpopulation but that does notchange the intended use. |
| Environment of use | Hospitals, sub-acute carefacilities and intra-hospitaltransfer | In the intensive care ward or inthe recovery roomDuring transfer of ventilatedpatients within the hospital | The same environment of use |
| MRI suite | No | No | Both are not for use in the MRIenvironment |
Technological Characteristics
| SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantialequivalence | |
|---|---|---|---|
| System architecture: | 2 microprocessors + alarmcontroller | 1 microprocessor + alarmcontroller | The technologicalcharacteristics 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 | |
| VentilatorTechnology | SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantialequivalence |
| Picture | Image: Bellavista 1000 | Image: HAMILTON-C2 (K121225) | |
| Systemarchitecture | bellavista's pneumatics deliver gas,and its electrical systems controlpneumatics, monitor alarms, anddistribute power. | The HAMILTON-C2's pneumaticsdeliver gas, and its electricalsystems control pneumatics,monitor alarms, and distributepower. | Both device have similar systemarchitecture |
| Gas source anddelivery | bellavista is an electronicallycontrolled pneumatic ventilationsystem with an integrated aircompressing system.bellavista uses room air and high-pressure oxygen. Air enters througha fresh gas intake port and iscompressed together with theoxygen by the blower. Oxygenenters through a high pressure inlet.An electronic mixer valve providesfor the operator-set concentration.Gas is supplied to the patient via themicroprocessor controlledinspiratory valve. | The HAMILTON-C2 is anelectronically controlled pneumaticventilation system with anintegrated air compressing system.The HAMILTON-C2 uses room airand low- or high-pressure oxygen.Air enters through a fresh gas intakeport and is compressed togetherwith the oxygen by the blower.Oxygen enters through a high - orlow-pressure inlet.A mixer valve provides for theoperator-set concentration whenusing the high-pressure oxygen inlet.Gas is supplied to the patient via theinspiratory valve. | The gas sources and delivery aresimilar. Both entrain room airwhich is compressed by a blower.The gas mixture is controlled by amixer prior to delivery to apatient.The bellavista does not offer theoption of a low pressure oxygensource, which is needed in ahome use environment. Thebellavista is not intended for thehome setting. |
| Exhalation | Gas exhaled by the patient passesthrough the flow sensor and exitsthrough the expiratory exhalationvalve with a membrane. Theexhalation valve is part of the circuitthus ensuring that no exhaled gascomes into contact with any internalpart of bellavista. | Gas exhaled by the patient passesthrough the expiratory limbbreathing circuit parts, including flextubes, the Flow Sensor, the Y-piece,a water trap, and an expiratoryvalve cover and membrane. Gas isvented through the expiratory valvecover such that no exhaled gascomes into contact with any internalcomponents of the HAMILTON-C2. | The exhalation pathway is similar. |
| User Interface | The user provides inputs tobellavista microprocessor systemthrough a touchscreen. | The user provides inputs to theHAMILTON-C2 microprocessorsystem through a touchscreen, keys,and a press-and-turn knob. | The user interface of Hamiltonfeatures a press-and-turn knobthrough plus keys through whichthe entire user interface can beoperated. Touch screen operationis optional. Bellavista is operatedwith touch screen only. |
| Power supply | It is powered by AC, DC or battery. | It is powered by AC or DC withbattery backup to protect againstpower failure or unstable power andto facilitate intra-hospital transport. | Similar |
| VentilatorTechnology | SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantialequivalence |
| Controlarchitecture | These [the user's] inputs becomeinstructions for the bellavista'spneumatics to deliver a preciselycontrolled gas mixture to thepatient. | The HAMILTON-C2's microprocessorsystem controls gas delivery andmonitors the patient. [The user's]inputs become instructions for theHAMILTON-C2's pneumatics todeliver a precisely controlled gasmixture to the patient. | Control architecture is similar |
| Sensors andMonitoring | bellavista receives inputs from theproximal Flow Sensor and othersensors within the ventilator.Monitored data is also displayed bythe graphic user interface.A galvanic oxygen sensor (oxygencell) monitors the oxygenconcentration of the gas to bedelivered to the patient. | The HAMILTON-C2 receives inputsfrom the proximal Flow Sensor andother sensors within the ventilator.Based on this monitored data, theHAMILTON-C2 adjusts gas deliveryto the patient. Monitored data isalso displayed by the graphic userinterface.An oxygen cell (sensor) monitors theoxygen concentration of the gas tobe delivered to the patient. Thisgalvanic cell generates a voltageproportional to the partial pressureof oxygen in the delivered gas. | Both devices incorporate a flowsensor, oxygen sensor, andmonitor data |
| Alarming | A comprehensive system of visualand audible alarms helps ensure thepatient is monitored. Clinical alarmscan indicate an abnormalphysiological condition. Technicalalarms, triggered by the ventilator'sself-tests, including ongoingbackground checks, can indicate ahard-ware or software failure. | A comprehensive system of visualand audible alarms helps ensure thepatient is monitored. Clinical alarmscan indicate an abnormalphysiological condition. Technicalalarms, triggered by the ventilator'sself-tests, including ongoingbackground checks, can indicate ahardware or software failure. | Both device have similar alarmsand comply with ISO 60601-1-8. |
| Patient safety | bellavista has several means to helpensure that patient or respiratorypressures are maintained. Themaximum working pressure isensured by the high pressure alarmlimit. If the set high pressure limit isreached, the ventilator cycles intoexhalation.bellavista has two microprocessorsystems, one which controls theventilation, the other one whichcontrols the user interface. Anadditional alarm controller(watchdog) alarms in the unlikelyevent of a complete failure. The twoprocessor systems crosscheck eachother and are able to alarmindependently. This helps to preventsimultaneous failure of the mainfunctions. | The HAMILTON-C2 has severalmeans to help ensure that patient orrespiratory pressures aremaintained. The maximum workingpressure is ensured by the highpressure alarm limit. If the set highpressure limit is reached, theventilator cycles into exhalation. Theventilator pressure cannot exceed60 cmH20The gas delivery and monitoringfunctions are cross-checked by analarm controller. This cross-checking helps prevent simultaneousfailure of these two main functionsand minimizes the possible hazardsof software failure. | Both devices have similar patientsafety features. |
| SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantial equivalence | |
| Picture | Both device use a disposable exhalationvalve of similar design | ||
| Opening Diameter | 18 mm | 22 mm | Different opening but this does notaffect performance |
| Technology | Membrane Valve towards ambient | Membrane Valve towards ambient | Similar technology |
| PEEP RegulationAccuracy | -0.1 – 0.6 mbar | -0.3 - 1.9 mbar | Bellavista shows better PEEPaccuracy under various conditionsthan the predicate, but we aremaking no claims |
| ExpiratoryResistance | 13.7 ±3.6 mbar/L/s42.1 ±9.5 mbar/L/s | 12.3 ±3.2 mbar/L/s47.3 ±7.1 mbar/L/s | The difference in resistance meansless 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
| Subjectbellavista 1000 | Primary Predicate device:HAMILTON-C2 (K121225) | Remarks, Substantial equivalence | |
|---|---|---|---|
| O2 SensorOriginal | Envitec | Envitec | Both device incorporate an in-lineoxygen sensor |
| manufacturerTypePicture | OOM102-HSImage: OOM102 | OOM202-1Image: OOM202-1 | |
| Sensor technology | galvanic oxygen sensor (oxygencell) | galvanic oxygen sensor (oxygencell) | 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 |
| Operatingtemperature | 0 – 50 °C | 0 – 50 °C | Similar operating temperature |
| Operating humidity | 0 - 99 %RH non-condensing | 0 – 99 %RH non-condensing | Similar operating humidity |
| Temperaturecompensation | 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 ventilationsetting | SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantialequivalence |
|---|---|---|---|---|
| CPAP | Continuous Positive AirwayPressure | 4 - 30 mbar | 0 – 35 mbar | Bellavista has a narrower CPAPrange which does not raise newsafety and effectivenessconcerns as the clinician isdetermining the CPAP settingsas needed. |
| Exp Trig | Expiration trigger, criterion forswitching from inspiration toexpiration in pressure supportedbreaths in % of inspiratory peakflow | 5 - 90 % | 5 – 80% | Similar to predicate, just a higheravailable range for adjustment |
| FiO2 | Oxygen concentration of therespiration air | 21 - 100% | 21 - 100% | Similar to predicate |
| Pattern | Pattern of inspiratory flow withvolume controlled ventilation | Sqa (Square)Dec (Decelerating)Dec50 (Decelerating to50%) | n.a. | Similar to reference deviceHamilton G5 (K131774) |
| PEEP,EPAP | Positive End-Expiratory Pressure | 0 – 40 mbar | 0 – 35 mbar | Similar to reference deviceHamilton G5 (K131774) |
| PHigh | upper level pressure withbeLevel and APRV (absolute) | 2 - 60 mbar | 0 - 60 mbar | Similar to predicate |
| PLow | lower level pressure with APRV(absolute) | 0 – 40 mbar | 0 – 35 mbar | Similar to reference deviceCovidien PB840 (K151252) |
| PInspIPAP | Inspiration pressure (relativeabove PEEP)Inspiration pressure (absolutepressure) | 2 - 60 mbar | 5 - 60 mbar | Similar to predicate (upper limit)and reference device DrägerOxylog 3000 (K103625) |
| Plateau | Plateau time, betweeninspiration and expiration withvolume controlled ventilation | 0 – 70% | n.a. | Similar to reference deviceHamilton G5 (K131774) |
| PSupport | Support pressure of pressuresupported breaths (relativeabove PEEP) | 0 – 60 mbar | 0 – 60 mbar | Similar to predicate |
| Rate | Breathing frequency | 1 – 100 bpm | 1 – 80 bpm | Similar to reference deviceHamilton G5 (K131774) |
| Rise Time | Slope of inspiratory pressureincrease | 0 – 2000 ms | 0 – 2000 ms | Similar to predicate |
| TInsp | Inspiration time of controlledbreaths | 0.1 - 10 s | 0.1 - 12 s | Similar to reference deviceHamilton G5 (K131774) |
| TInsp MaxI-TimeMax | Maximum inspiration time ofpressure supported breaths | 0.3 – 3 s | 1 – 3 s | Similar to reference deviceHamilton G5 (K131774) |
| THigh | Time on upper level | 0.1 – 59.8 s | 0.1 – 40 s | Similar to reference deviceCovidien PB840 (K151252) |
| TLow | Time on lower level | 0.2 – 10 s | 0.2 – 40 s | Similar to predicate |
| Trigger | Criterion to trigger inspirationspontaneously by the patient | Off / pressure / flow | Off / pressure | Similar to predicate |
| PressureTrigger | Pressure below PEEP fortriggering | 0.1 – 15 mbar | n.a. | Similar to reference deviceCovidien PB840 (K151252) |
| FlowTrigger | Inspirational flow for triggering | 0.1 – 20 L/min | 1.0 - 20 L/min | Similar to predicate |
| VtInsp,Vt | Tidal volume | 40 – 2500 mL | 20 – 2000 mL | Similar to reference deviceCovidien PB840 (K151252) |
| Setting | Description of ventilationsetting | SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantialequivalence |
| Sighamplitude | Increase of inspiratory pressureor tidal volume for sigh breaths | 5 – 50 % | 10 mbar | Sigh is configurable in bellavistaversus fixed in the predicate |
| Sighinterval | Number of regular breaths afterwhich sigh breaths are delivered | 10 – 200 breaths | 50 breaths | device. The maximumconfigurable amplitude is 50% or |
| Sigh | Number of consecutive sighbreaths | 1 – 5 breaths | 1 breath | 10 mbar respectively andtherefore can be consideredwithin the range of the predicatedevice.Sigh is not available in pediatricventilation |
| Height | Patient Height | 50 - 250 cm | 30 – 250 cm | Similar to reference deviceCovidien PB840 (K151252) |
| ATC | Automatic Tube Compensation,Tube resistance compensation | Off, ET, Trachd 5 – 12 mm10 – 100% | Off, ET, Trachd 3 – 10 mm0 – 100% | Similar to reference deviceHamilton G5 (K131774) Tubediameter is the dominantparameter of tube resistancecompensation. Smaller diametersmake for a higher compensation.Bellavista supports up to 12 mmtubes which results in acompensation of 1.0 mbar versus2.4 mbar for a 10 mm tubeduring a typical peak flow of 50L/min. Considering the smallresulting difference of 1.4 mbar,bellavista and the predicatedevice can therefore beconsidered sufficiently |
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bellavista
Ventilation Modes and Performance settings
- Bellavista setting is a maximum of 10% outside the range of the predicate device's setting.
{10}------------------------------------------------
| Alarm Limits | |||||
|---|---|---|---|---|---|
| Alarmlimit | Designation | Limit | Subject bellavista 1000 | Predicate HAMILTON-C2 (K121225) | Remarks, Substantialequivalence |
| Apneatime | Allowed timewithout a breath.bellavista switchesto Backup ifactivated | Upper | 2 – 60 s | 15 – 60 s | Similar to predicate |
| FiO2 | Oxygenconcentration of theventilation air. | UpperLower | 24 – 100%18 – 80% | 18 – 103%18 – 97% | Similar to predicate |
| MVInsp | Minute volumeinspiration | UpperLower | 0.1 – 60 L/min0.1 – 50 L/min, Off | 0.1 – 50 L/min0.1 – 50 L/min, Off | Similar to predicate |
| PPeak | Peak pressure | UpperLower | 7 – 65 mbar1 – 55 mbar | 15 – 79 mbar4 – 60 mbar | Similar to predicate |
| Rate | Breathing frequency | UpperLower | 1 – 130 bpm1 – 129 bpm | 0 – 99 bpm0 – 99 bpm | Similar to predicate |
| VtExp | Tidal volumeinspiration | UpperLower | 40 – 3000 mL10 – 2500 mL, Off | 10 – 3000 mL, Off10 – 3000 mL, Off | Similar to predicate |
| Leak% | Leak alarm in % ofthe deliveredminute volume | Upper | 5 – 95%, Off | n.a. | The Hamilton C2 has noleak alarm. This featureis informative for theuser only and does notraise new concerns ofsafety or effectiveness. |
Alarm Limits
- Bellavista setting is a maximum of 10% outside the range of the predicate device's setting.
Adjusting alarm limits see document: Substantial Equivalence Setting Alarms
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Monitoring Parameters
| Monitoringparameter | Description ofmonitoring parameter | SubjectBellavista 10002) | PredicateHAMILTON-C2 (K121225) | Remarks, Substantialequivalence | ||
|---|---|---|---|---|---|---|
| %Spont | % Synchronized(triggered) breaths perminute | 0 – 100% | ±1 | 0 – 100% | n.a. | Similar to predicate |
| %Spont 1h | % Synchronized(triggered) breaths overthe last hour | 0 – 100% | ±1 | n.a. | n.a. | Calculating this parameterdoes not affect safety oreffectiveness but is providedfor the clinicians use. |
| %Spont 8h | % Synchronized(triggered) breaths overthe last 8 hours | 0 – 100% | ±1 | n.a. | n.a. | Calculating this parameterdoes not affect safety oreffectiveness but is providedfor the clinicians use. |
| AutoPEEP | Intrinsic PEEP, absolutepressure measured atthe end of the HoldExpmaneuver. | 0 – 100mbar | ±(2 mbar ±4%) | 0 – 80 mbar | n.a. | Similar to predicate |
| CStat | Static compliance: CStat =$Vtinsp / (PEnd Plateau - PEEP)$only available if plateau >0 | 0 – 1000mL/mbar | n.a. | 0 – 200mL/mbar | n.a. | Bellavista has a slightlyhigher measuring range. Thiscan be considered a minordifference and substantiallyequivalent. |
| CStat/kg | Compliance per kg bodyweight | 0 – 99mL/mbar/kg | n.a. | n.a. | n.a. | Calculating this parameterdoes not affect safety oreffectiveness but is providedfor the clinicians use. |
| FiO2 | Inspiratory oxygenconcentration | 18 – 100Vol% | ±(2.5%O2 + 2.5%)d) | 18 – 105 Vol% | ±(2.5%O2 + 2.5%)d) | Similar to predicate |
| FlowExp Peak | Expiratory peak flow | 0 – 180L/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 – 180L/min | ±0.5 L/min; ±10%e) | 0 – 210 L/min | ±1.2 L/min; ±10%e) | Similar to predicate |
| I:E | Ratio inspiration timeversus expiration time | 1:99 –100:1 | 10%c) | 1:99 – 9.9:1 | n.a. | Similar to predicate |
| Leak % | Leak flow in % of thetotally delivered volume | 0 – 100 % | n.a. | 0 – 100 % | 10%c) | Similar to predicate |
| Leak Flow | Average leak flow | 0 – 200L/min | ±15%c) | n.a. | n.a. | Bellavista has a highermeasuring range. This isnecessary for the higherpeak flows which the deviceis able to deliver. Themonitoring parameter can beconsidered substantiallyequivalent. |
| MVExp | Expiratory volume perminute | 0 – 250L/min | ±0.5 L/min; ±10%e) | 0 – 99.9 L/min | ±0.3 L/min; ±10%e) | Bellavista has a highermeasuring range. This isrelated to the higher peakflows which the device isable to deliver. Themonitoring parameter can beconsidered substantiallyequivalent. |
| Monitoringparameter | Description ofmonitoring parameter | SubjectBellavista 1000 | PredicateHAMILTON-C2 (K121225) | Remarks, Substantialequivalence | ||
| Range | Accuracy 2) | Range | Accuracy e) | |||
| MVExp Spont | Expiratory minutevolume of triggeredbreaths | 0 – 250L/min | ±0.5 L/min; ±10% e) | 0 - 99.9 L/min | ±0.3 L/min; ±10% e) | Bellavista has a highermeasuring range. This isrelated to the higher peakflows which the device isable to deliver. Themonitoring parameter can beconsidered substantiallyequivalent. |
| MVInsp | Inspiration volume of allbreaths per minute | 0 – 250L/min | ±0.5 L/min; ±10% e) | 0 - 99.9 L/min | ±0.3 L/min; ±10% e) | Bellavista has a highermeasuring range. This isrelated to the higher peakflows which the device isable to deliver. Themonitoring parameter can beconsidered substantiallyequivalent. |
| MVInsp Spont | Inspiratory minutevolume of triggeredbreaths | 0 - 250L/min | ±0.5 L/min; ±10% e) | 0 – 99.9 L/min | ±0.3 L/min; ±10% e) | Bellavista has a highermeasuring range. This isrelated to the higher peakflows which the device isable to deliver. Themonitoring parameter can beconsidered substantiallyequivalent. |
| MVInsp/kgMVExp/kg | Volume per minute perkg body weight | 0 - 9999mL/min/kg | n.a. | n.a. | Calculating this parameterdoes not affect safety oreffectiveness but is providedfor the clinicians use. | |
| PEEP | Measured positive end-expiratory pressure | 0 - 100mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PMean | Mean pressure duringcycle | 0 - 100mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PPeak | Peak pressure during theinspiration | 0 - 100mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PPlateau | Plateau pressure (onlyavailable if plateau > 0) | 0 – 100mbar | ±(2 mbar ±4%) | 0 – 80 mbar | ±(1.6 mbar ±4%) | Similar to predicate |
| PTP | Pressure Time Product,pressure/time Integralduring triggering, closelyrelated to WOBImp | 0 - 100mbar*s | n.a. | 0 - 100mbar*s | n.a. | Similar to predicate |
| P0.1 | Occlusion pressure100ms after the trigger.The monitoring value iscalculated online usingan extrapolation method.No maneuver isnecessary. | 0 - 100mbar | ±(2 mbar ±4%) | 0 – 99 mbar | n.a. | Similar to predicate |
| Rate | Measured breathing rate(in the past 60s) | 0 - 200bpm | ±1 bpm | 0 - 999 bpm | ±1 bpm | Similar to predicate |
| Ratespont | Rate of synchronized(triggered) breaths (inthe past 60s) | 0 - 200bpm | ±1 bpm | 0 – 999 bpm | ±1 bpm | Similar to predicate |
| Monitoringparameter | Description ofmonitoring parameter | SubjectBellavista 1000 | PredicateHAMILTON-C2 (K121225) | Remarks, Substantialequivalence | ||
| Range | Accuracy 2) | Range | Accuracy | |||
| RCExp | Expiratory time constant | 0.1 - 5 s | n.a. | 0 – 99.9 s | n.a. | Bellavista has a smallermeasuring range which doesnot affect safety oreffectiveness.. This range isadapted to the clinicallymeasured RCExp which istypically not >2s. |
| RExp | Resistance (expiratory):(PEnd Insp - PEEP) / Flow Exp mbar/L/sPeak | 0 - 300 | n.a. | n.a. | n.a. | Calculating this parameterdoes not affect safety oreffectiveness but is providedfor the clinicians use. |
| Rinsp | Resistance (inspiratory):(PEnd Insufflation - PPlateau) /Flow End Insufflation(only available withplateau > 0) | 0 – 300mbar/L/s | n.a. | 0 - 999mbar/L/s | n.a. | Similar to predicate |
| RSBI | Rapid Shallow BreathingIndex (Tobin Index): Rate bpm /L/ VtinspParameter only makessense if for spontaneousbreathing with none orminimal pressuresupport. | 1 - 9999 | - | 10 - 400bpm/L | n.a. | Bellavista has a highermeasuring range which doesnot affect safety oreffectiveness. It allows alarger range to be displayedfor 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 ofsupported breaths | 0 — 100 s | 10% c) | n.a. | n.a. | The parameter is notavailable in the predicatedevice, however since it isbased on the normal Tinsp itcan be consideredsubstantially equivalent. |
| Tinsp/TTot | Ratio of inspirationversus cycle time: Tinsp /(Tinsp + TExp) | 0 - 100% | 10% c) | n.a. | n.a. | The parameter is notavailable in the predicatedevice, however since it iscalculated on the normal Tinspand TExp it can be consideredsubstantially 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/kgVtExp/kg | Tidal volume per kg bodyweight | 0 – 100mL/kg | - | n.a. | n.a. | The parameter is notavailable in the predicatedevice, but this is just aparameter for the user ifthey want it. |
| WOBImp | The work of breathingrequired for triggering.Corresponds to the arealeft of PEEP in thepressure/flow diagram. | 0.00 - 9.99J/L | - | n.a. | n.a. | The parameter is notavailable in the predicatedevice, but this is just aparameter for the user ifthey want it. |
| Pressure a) | Airway pressure(measured internally) | -30 - 100mbar | ±(2 mbar + 4%) | -10 – 80 mbar | n.a. | Similar to predicate |
| Flow a) | Flow | -300 -300 L/min | ±10% c) | -300 - 300L/min | n.a. | Similar to predicate |
| Volume a) | Volume | 0 - 2500 mL | ±10% c) | 0 - 3200 mL | n.a. | Similar to predicate |
| Monitoringparameter | Description ofmonitoring parameter | SubjectBellavista 1000 | PredicateHAMILTON-C2 (K121225) | Remarks, Substantialequivalence | ||
| Range | Accuracy2) | Range | Accuracy | |||
| Press./Volumeb) | Pressure versus volume loop | 0 – 100 mbar0 – 2500 mL | ±(2 mbar + 4%)±10%c) | -10 – 80 mbar0 – 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 | Subjectbellavista 1000 | PredicateHAMILTON-C2 (K121225) | Remarks, Substantialequivalence |
|---|---|---|---|
| Volume | ± (5 mL + 6%) | ±10% or ±10 ml 2) | Similar to predicate |
| Inspiratorypressure | ± (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 deviceDräger 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 ventilationsetting | SubjectBellavista 1000 | PredicateHAMILTON-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 (relativeabove PEEP) | 15 mbar | 15 mbar | Similar to predicate 2) |
| PEEP | Positive End-ExpiratoryPressure | 4 mbar | 5 mbar | Similar to predicate 2) |
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| Setting | Description of ventilationsetting | SubjectBellavista 1000 | PredicateHAMILTON-C2(K121225) | Remarks, Substantial equivalence |
|---|---|---|---|---|
| Rate | Breathing frequency | 12 bpm | 10 bpm → 13 bpm | The lower initial rate of C2 and G5after the test breaths quicklyadapts to 13 bpm for a normaladult (C50, Rp5). Thisdemonstrates that the bellavistadefault setting is substantiallyequivalent. |
| TIinsp | Inspiration time of controlledbreaths | 1.7 s | 1 s → 2 s | The short initial inspiratory timeof C2 and G5 (I:E = 1:4) after thetest breaths quickly adapts to 1.8– 2 s (I:E = 1:1.5) for a normaladult (C50, Rp5). Thisdemonstrates that the bellavistadefault setting is substantiallyequivalent. |
| FlowTrigger | Inspirational flow fortriggering | 2 L/min | 5 L/min | The bellavista has simailr settingsto the reference device, G5 andPB 840 |
| RiseTime | Slope of inspiratory pressureincrease | 50 ms | 50 ms | The default rise time is differentbetween bellavista and Hamilton. |
| FiO2 | Oxygen concentration of therespiration 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.
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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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§ 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).