(113 days)
Not Found
No
The summary describes a standard pressure-supported and pressure-controlled ventilator with CPAP function. There is no mention of AI, ML, or any features that would typically utilize these technologies. The performance studies focus on standard ventilator metrics like pressure stability and waveform performance.
Yes
Explanation: The device is an assist ventilator intended to augment the breathing of patients suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea, which are conditions that require therapeutic intervention. It delivers pressure-controlled ventilation, pressure support ventilation, or CPAP to assure sufficient gas exchange, clearly indicating a direct therapeutic action.
No
Explanation: The device is described as an assist ventilator that provides therapy (pressure-supported and pressure-controlled ventilation) to augment breathing, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a housing, power supply, and an airflow outlet tube, indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Vivo 40 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Vivo 40 is an "assist ventilator intended to augment the breathing of spontaneously breathing adult patients... suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea." This describes a device that directly interacts with the patient's respiratory system to provide therapy.
- Device Description: The description details a "pressure-supported and pressure-controlled ventilator with a CPAP function." It describes how airflow is delivered to the patient via a tube and interface.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Vivo 40 does not perform any such analysis of bodily specimens.
The Vivo 40 is a therapeutic medical device used to support breathing, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.
The Vivo 40 is intended to be used for both invasive and non-invasive applications.
The Vivo 40 is intended to be operated by qualified and trained personnel.
The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.
The Vivo 40 must always be prescribed by a licensed physician.
Product codes (comma separated list FDA assigned to the subject device)
MNT
Device Description
The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneously breathing patients to augment the breathing.
In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.
The therapy delivered by the Breas Vivo 40 System can be either:
-
- Pressure Controlled Ventilation (PCV) or
-
- Pressure Support Ventilation (PSV) or
-
- Constant Positive Airway Pressure (CPAP)
The Vivo 40 airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive and invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.
The Vivo 40 has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.
The outer dimensions of the Vivo 40 housine are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.
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 patients >66 lbs (>30 kg)
Intended User / Care Setting
Qualified and trained personnel.
Clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.
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)
Bench testing was performed. This testing includes Pressure stability, Dynamic pressure regulation, Waveform performance and Target volume feature.
Bench testing has confirmed that the new device Breas Vivo 40 is substantial equivalent with regards to Wave-form performance as well as Work of Breathing, Pressure Dynamic regulation and Target Volume feature.
No clinical testing has been performed by Breas Medical. Rather, one clinical article supporting the use of volume controlled ventilation in combination with pressure controlled has been attached.
In conclusion, pressure controlled ventilation with Target Volume feature is as safe and effective as that of therapy without Target Volume feature.
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.
Breas Vivo 40 (current device (K071702), Respironics BiPAP® AVAPS (K070328)
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.
Not Found
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).
0
Breas Medical AB
Image /page/0/Picture/3 description: The image shows a handwritten number "K090113" in black ink. The number is written in a simple, slightly irregular style, with some variations in the thickness of the lines. The background of the image is white, with some scattered black spots or noise, particularly in the lower-left corner.
510(k) SUMMARY
MAY 14 2009
Submitter
Contact Person
Summary Date
Name of Device
Common Name
Classification Name
Product Code
Predicate Devices
Breas Medical AB Foretagsvagen 1 SE 435 33 Molnlycke Sweden Birgitta Bolander Quality & Regulatory Affairs Director Phone: +46 31 868830 Fax: +46 31 868810 2008-12-09
Breas Vivo 40 System
Vivo 40 Target Volume
Non- continuous ventilator (21 CFR 868.5895) .
MNT
Breas Vivo 40 (current device (K071702) Respironics BiPAP® AVAPS (K070328)
1
Device Description:
The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneously breathing patients to augment the breathing.
In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.
The therapy delivered by the Breas Vivo 40 System can be either:
-
- Pressure Controlled Ventilation (PCV) or
-
- Pressure Support Ventilation (PSV) or
-
- Constant Positive Airway Pressure (CPAP)
The Vivo 40 airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive and invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.
The Vivo 40 has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.
The outer dimensions of the Vivo 40 housine are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.
Intended Use:
The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.
The Vivo 40 is intended to be used for both invasive and non-invasive applications.
The Vivo 40 is intended to be operated by qualified and trained personnel.
The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.
The Vivo 40 must always be prescribed by a licensed physician.
2
Device modification
The modification is to add the feature Target Volume.
Comparison of Technological Characteristics
Compared to main predicate device Breas Vivo 40 (current version without Target Volume) the new device Breas Vivo 40 Target Volume has:
- Same Technology (software based pressure-, flow- and time- regulation) .
- Same Design (microprocessor-controlled blower as air source) .
- Same Environments of use �
- Same Intended use ●
Compared to predicate device Respironics BiPAP AVAPS the new device Breas Vivo 40 Target Volume has
- Same Technology (software based pressure-, flow- and time- regulation) .
- Same Target Volume Technology (Automatic pressure adjustments between the . chosen IPAPmax and IPAPmin in order to reach and keep the desired tidal volume.
- Similar design (microprocessor-controlled blower as air source) .
- Same environments of use .
- Same Intended use (apart from Invasive use included for Breas Vivo 40 Target . Volume)
Non-clinical performance data
To determine equivalence between the Breas Vivo 40 without Target Volume, Breas Vivo 40 Target Volume and Respironics BiPAP AVAPS bench testing was performed. This testing includes Pressure stability, Dynamic pressure regulation, Waveform performance and Target volume feature.
Conclusions drawn from the nonclinical tests
Bench testing has confirmed that the new device Breas Vivo 40 is substantial equivalent with regards to Wave-form performance as well as Work of Breathing, Pressure Dynamic regulation and Target Volume feature.
Clinical performance data
No clinical testing has been performed by Breas Medical.
Rather, one clinical article supporting the use of volume controlled ventilation in combination with pressure controlled has been attached. See appendix 12.
In conclusion, pressure controlled ventilation with Target Volume feature is as safe and effective as that of therapy without Target Volume feature.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
14 2009 MAY
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Birgitta Bolander Ouality & Regulatory Affairs Director Breas Medical AB Foretagsvagen 1 SE 435 33 Molnlycke SWEDEN
Re: K090113
Trade/Device Name: Breas Vivo 40 Target Volume Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: April 15, 2009 Received: April 22, 2009
Dear Ms. Bolander:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
4
Page 2- Ms. Bolander
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Sumner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
5
Image /page/5/Picture/3 description: The image shows the phrase "STATEMENT OF INDICATIONS FOR USE" in bold, uppercase letters. The text is black and stands out against a white background. The image appears to be a cropped section of a larger document, focusing specifically on the statement of indications for use.
510(k) Number (if known):
Device Name: Breas Vivo 40 Target Volume
Indications for Use:
The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.
The Vivo 40 is intended to be used for both invasive and non-invasive applications.
The Vivo 40 is intended to be operated by qualified and trained personnel.
The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.
The Vivo 40 must always be prescribed by a licensed physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) the land on
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K990113
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