(283 days)
No
The document describes a standard electronically controlled pneumatic ventilator and does not mention any AI or ML capabilities.
Yes
The device is a ventilator, which provides respiratory support, directly treating a medical condition (respiratory insufficiency).
No
The text describes the device as a ventilator intended to provide positive pressure ventilatory support, not to diagnose a condition.
No
The device description explicitly states it is an "electronically controlled pneumatic ventilation system" with a "pneumatic system" and "electrical systems," indicating it includes significant hardware components beyond just software.
Based on the provided information, 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 1000/1000e is a ventilator. Its function is to provide positive pressure ventilatory support to patients by controlling the delivery of respiratory gas. It interacts directly with the patient's respiratory system, not with specimens taken from the body.
- Intended Use: The intended use clearly states providing "positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients". This is a life support function, not a diagnostic test performed on a sample.
Therefore, the bellavista 1000/1000e falls under the category of a therapeutic device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
CBK
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.
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
adult and pediatric patients and optionally infant and neonatal patients
Intended User / Care Setting
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).
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)
Not Found
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.
bellavista 1000 (K163127)
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.
K161450, K093633, K103211, K070594, K031745, K151814, K151252
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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
1
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
2
Indications for Use
510(k) Number (if known) K183364
Device Name
bellavista 1000 and bellavista 1000e
Indications for Use (Describe)
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).
| 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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Image /page/3/Picture/0 description: The image shows the logo for Vyaire Medical. The word "Vyaire" is in a dark blue color, with the "V" and "y" connected. The word "MEDICAL" is in a light blue color and is located below the word "Vyaire".
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 AG
Gewerbestrasse 8
9470 Buchs SG Switzerland |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 3004553423 |
| Contact Person: | Colleen Watson
Director, Regulatory Affairs
Phone: (872) 757-0070
e-mail: colleen.okeeffe@vyaire.com |
| Date Summary Prepared: | August 12, 2019 |
| Reason for Premarket
Notification: | 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
4
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 Palmtop | ||
| Ventilator PTV-10 | K070594 | CBK |
| Vyaire SiPAP | K031745 | CBK |
| Maquet Servo-u | K151814 | CBK |
| Puritan Bennett 840 | K151252 | CBK |
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.
Indications for Use:
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).
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.
5
| | Subject bellavista
1000 / bellavista
1000e | Predicate bellavista
1000 (K163127) | Remarks, Substantial equivalence |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | CBK | CBK | The same classification |
| Intended use | The bellavista
1000/1000e ventilator
is intended to provide
positive pressure
ventilatory support to
adult and pediatric
patients and
optionally infant and
neonatal patients. | The bellavista 1000
ventilator is intended
to provide positive
pressure ventilator
support to adults and
pediatrics (IBW
greater than 6 kg). | Neonates are included in the
intended patient population of
the reference device Hamilton C3
(K161450) |
| Environment of use | Environment of use:
hospitals, sub-acute
care facilities and
intra-hospital transfer
When used on
neonatal patients: the
environment of use is
the NICU | Environment of use:
hospitals, sub-acute
care facilities and
intra-hospital transfer | Both devices are
substantially equivalent for
environment of use for adult and
pediatric patient population.
The environment of use for neonatal
and infant patients is substantially
equivalent to the environment of use
of the reference device, Hamilton C3
(K161450). |
| Intended users | It is intended for use
by qualified, trained
personnel under the
direction of a
physician. | It is intended for use
by qualified, trained
personnel under the
direction of a
physician. | Both devices are
substantially equivalent |
| Patient population | Adults, pediatrics,
infants and neonates | Adults and pediatrics
(IBW greater than 6
kg) | Neonates and infants are included in
the intended patient population of
the reference device Hamilton C3
(K161450) |
Table 1: Comparison of Indications for Use
6
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.
7
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.