The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

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

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

Device Description

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply.

The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (ventilator). It describes the device, its intended use, a comparison to predicate devices, and the basis for substantial equivalence.

However, it does not include details about acceptance criteria, specific device performance numerical results, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, as these are typically part of a clinical validation study and not usually found in a 510(k) summary for a ventilator.

The document discusses the ventilatory support capabilities and patient populations for which the device is intended, but not the kind of detailed performance metrics usually required for AI/algorithm-based diagnostic devices.

Summary

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September 13, 2019

Imtmedical AG Colleen Watson Director, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa, IL 60045 USA

Re: K183364

Trade/Device Name: bellavista 1000 and bellavista 1000e Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: August 13, 2019 Received: August 15, 2019

Dear Colleen Watson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James Lee Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183364

Device Name

bellavista 1000 and bellavista 1000e

Indications for Use (Describe)

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

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92

The assigned 510(k) number is:

Submitted by:	imtmedical AGGewerbestrasse 89470 Buchs SG Switzerland
Establishment RegistrationNumber:	3004553423
Contact Person:	Colleen WatsonDirector, Regulatory AffairsPhone: (872) 757-0070e-mail: colleen.okeeffe@vyaire.com
Date Summary Prepared:	August 12, 2019
Reason for PremarketNotification:	New Device
Trade Name:	bellavista 1000 and bellavista 1000e
Common/Usual Name:	Ventilator, continuous, facility use
Product Code:	CBK
Regulatory Class:	Class II
Predicate Device:	bellavista 1000 (K163127)

vyaire.com

Vyaire Medical, Inc.
26125 N. Riverwoods Blvd. Mettawa, IL 60045 USA

Vyaire Medical, Inc. 22745 Savi Ranch Pkwy Yorba Linda, CA 92887 USA

Vyaire Medical Oy Kuortaneenkatu 2 FI-00510 Helsinki Finland

Vyaire Medical GmbH Leibnizstrasse 7 97204 Hoechberg Germany

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Reference devices:

Multiple reference devices have been used for the modifications to support substantial equivalence.

Manufacturer / Tradename	510(k) Number	Product Code
Hamilton C3	K161450	CBK, DQA
Dräger V500	K093633	CBK
CareFusion Avea	K103211	CBK
Pulmonetic Systems PalmtopVentilator PTV-10	K070594	CBK
Vyaire SiPAP	K031745	CBK
Maquet Servo-u	K151814	CBK
Puritan Bennett 840	K151252	CBK

Device Description:

Indications for Use:

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

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

Comparison of bellavista 1000/1000e to the predicate:

We present in the following tables a comparison of the subject device compared to the predicate and reference devices.

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	Subject bellavista1000 / bellavista1000e	Predicate bellavista1000 (K163127)	Remarks, Substantial equivalence
Product code	CBK	CBK	The same classification
Intended use	The bellavista1000/1000e ventilatoris intended to providepositive pressureventilatory support toadult and pediatricpatients andoptionally infant andneonatal patients.	The bellavista 1000ventilator is intendedto provide positivepressure ventilatorsupport to adults andpediatrics (IBWgreater than 6 kg).	Neonates are included in theintended patient population ofthe reference device Hamilton C3(K161450)
Environment of use	Environment of use:hospitals, sub-acutecare facilities andintra-hospital transferWhen used onneonatal patients: theenvironment of use isthe NICU	Environment of use:hospitals, sub-acutecare facilities andintra-hospital transfer	Both devices aresubstantially equivalent forenvironment of use for adult andpediatric patient population.The environment of use for neonataland infant patients is substantiallyequivalent to the environment of useof the reference device, Hamilton C3(K161450).
Intended users	It is intended for useby qualified, trainedpersonnel under thedirection of aphysician.	It is intended for useby qualified, trainedpersonnel under thedirection of aphysician.	Both devices aresubstantially equivalent
Patient population	Adults, pediatrics,infants and neonates	Adults and pediatrics(IBW greater than 6kg)	Neonates and infants are included inthe intended patient population ofthe reference device Hamilton C3(K161450)

Table 1: Comparison of Indications for Use

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Comparison of Technological Characteristics

We have added SpO2 and EtCO2 monitoring to the device.

Discussion of the Differences:

Indications for Use

Indications for use are to provide positive pressure ventilator support to adults, pediatrics and neonates.

Technology

The technology of a turbine based portable ventilator is identical to the predicate.

Environment of Use

The environment of use – hospital and intra-hospital transport is equal to the predicate.

Patient Population

The patient population of adults and pediatrics is equal to the predicate. .
. The patient population of neonates is similar to the reference device Hamilton C3 (K161450)

Ventilation Modes

Adult/Pediatric Ventilation Modes

Ventilation modes that are equivalent and not changed between subject and predicate device bellavista 1000 are:

The following ventilation modes have been cleared in the predicate device (K163127):

СРАР ●
PCV
P-A/C
PC-SIMV
bsv
ഗ
S/T ●
T
beLevel
APRV VCV
V-A/C
VC-SIMV

The following modes were not available in the predicate device bellavista 1000 (K163127) but are part of the subject device. We have utilized reference devices where applicable.

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Neonatal ventilation modes (modes in K163127 but not for neonates)

As neonatal ventilation had not been cleared in predicate device bellavista 1000 (K163127), all neonatal modes are compared to reference devices.

Summary of Ventilation Mode Comparison

Ventilation modes are either equivalent to the predicate – bellavista 1000 (K163127) or are similar to one of the reference devices as identified. 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.

Substantial Equivalence Conclusion

We have compared the subject device bellavista 1000/1000e to the predicate device bellavista 1000 and where needed provided reference devices. The testing performed has demonstrated that the bellavista can be found to be substantially equivalent.

Regulation Number and Section

§ 868.5895 Continuous ventilator.

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