The Breas Vivo 40 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea. The Breas Vivo 40 shall only be used by patients with spontaneous breathing. The Breas Vivo 40 is not intended for life-sustaining applications or for transport of critical care patients. The Breas Vivo 40 is intended for non-invasive use.

Device Description

The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. 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 Vivo 40 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician. It is not intended for life support applications or for transport of critical care patients. The therapy delivered by the Breas Vivo 40 System can be either: 1) Pressure Controlled Ventilation (PCV) or 2) Pressure Support Ventilation (PSV) or 3) 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 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 housing are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.

AI/ML Overview

The Breas Vivo 40 System is a ventilator. The 510(k) summary does not include specific acceptance criteria values or detailed performance results in the format requested. Instead, it broadly states that the device passed various tests and met its stated performance specifications.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Specification	Acceptance Criteria	Reported Device Performance
Non-clinical Performance	Capable of meeting stated performance specifications; all Risk Analysis issues addressed.	"The device passed all tests."
Comparative Testing to Predicate Devices	Substantial equivalence with predicate devices regarding Wave-form performance, Work of Breathing, and Pressure Dynamic regulation.	"This bench-testing confirmed that the Breas Vivo 40 System is substantial equivalent with regards to Wave-form performance as well as Work of Breathing and Pressure Dynamic regulation."
Electrical Safety (per IEC 601-1)	Compliance with IEC 601-1 requirements.	"The device passed all tests."
Safety and Essential Performance (per ISO 10651-6)	Compliance with ISO 10651-6 requirements.	"The device passed all tests."
Safety and Performance (per ISO 17510-1)	Compliance with ISO 17510-1 requirements.	"The device passed all tests."
Electromagnetic Compatibility (EMC)	Compliance with EMC testing requirements.	"The device passed all tests."
Mechanical Safety	Compliance with mechanical safety testing requirements.	"The device passed all tests."
Environmental Testing	Compliance with environmental testing requirements.	"The device passed all tests."
Functional Testing	Compliance with functional testing requirements.	"The device passed all tests."
Particle Matter Testing	Compliance with particle matter testing requirements.	"The device passed all tests."
Software Documentation and Testing (per FDA Guidance)	Documented and tested in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."	"The device passed all tests."

2. Sample size used for the test set and the data provenance:

The document describes bench testing, meaning the tests were conducted in a laboratory setting, not on human subjects.
The sample size for the test set (number of devices tested for each category) is not specified in the provided summary.
The data provenance is not explicitly stated beyond being non-clinical testing performed by the manufacturer, Breas Medical AB, which is based in Sweden.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as the summary describes non-clinical, bench testing of the device's physical and functional performance against technical standards and predicate devices. No human experts were used to establish a "ground truth" for diagnostic or clinical evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable as the summary describes non-clinical, bench testing. Adjudication methods are typically used in clinical studies for human interpretation or diagnosis.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a ventilator, and the testing described is non-clinical bench testing, not a study involving human readers or AI assistance.
The document explicitly states: "Clinical studies were not required to support a substantial equivalence determination."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable in the context of this device. The Breas Vivo 40 System is a physical medical device (ventilator) with embedded software, not a standalone diagnostic algorithm. The software itself was documented and tested for compliance with FDA guidance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical bench testing, the "ground truth" was established by technical standards, engineering specifications, and the performance characteristics of legally marketed predicate devices. This is not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

This is not applicable. The device is a ventilator, not a machine learning model that requires a training set of data.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set for this device.

Summary

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K053607

Breas Vivo

40 System

Breas Medical AB

ูลค้า 1 6

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter	Breas Medical AB
	Företagsvagen 1
	SE 435 33 Molnlycke
	Sweden
Contact Person	Karl- Johan Holm
	Quality Assurance and Regulatory Affairs Manager
	Phone: +46 31 868830
	Fax: +46 31 868810
Summary Date	December 15, 2005
Name of Device	Breas Vivo 40 System
Common Name	Bilevel system
Classification Name	Non- continuous ventilator (21 CFR 868.5895)
Product Code	MNT
Predicate Devices	ResMed VPAP II (K974539)
	Respironics Vision (K982545)
	Mallinckrodt Knightstar 330 (K003075)
	ResMed VPAP III (K030843)
	Breas HA 50 Humidifier (K002454)

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Device Description:

The Vivo 40 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician.

It is not intended for life support applications or for transport of critical care patients.

The therapy delivered by the Breas Vivo 40 System can be either:

1. Pressure Controlled Ventilation (PCV) or
1. Pressure Support Ventilation (PSV) or
1. 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 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 housing are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.

Intended Use:

The Breas Vivo 40 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day.

The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea.

The Breas Vivo 40 shall only be used by patients with spontancous breathing.

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The Breas Vivo 40 is not intended for life-sustaining applications or for transport of critical care patients.

The Breas Vivo 40 is intended for non-invasive use.

The Breas Vivo 40 is intended for treatment of adult (who weigh more than 30 kg) patients.

The Breas Vivo 40 is intended to be operated by qualified and trained personnel,

Comparison of Use and Technological Characteristics:

The Vivo 40 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician.

It is not intended for life support applications or for transport of critical care patients.

As compared with the cited predicate devices, the Breas Vivo 40 System has:

Same intended uses

Same environments of use

Similar design (microprocessor-controlled blower as air source

Same technology ( software based pressure-, flow- and time- regulation)

The differences that do exist are minimal and involve primarily user preference features. The Breas Vivo 40 System has additional display indicator and audible alarm features as well as lockout features (to provide clinicians with optional means to control the ability of patients to change pressure settings). These features are described in labeling for the device that includes an Operator Manual.

Summary of Performance Testing:

1. Non-clinical testing was conducted to verify that the Breas Vivo 40 System is capable of meeting its stated performance specifications and that all Risk Analysis issues have been appropriately addressed. The device passed all tests,
1. Comparative testing to predicate devices was performed. This bench- testing confirmed that the Breas Vivo 40 System is substantial equivalent with regards to Wave-form performance as well as Work of Breathing and Pressure Dynamic regulation.

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1. Testing was conducted to demonstrate compliance with applicable requirements in the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the FDA's Division of Cardiovascular, Respiratory, and Neurological Devices and the July 1995 "Draft Reviewer Guidance for Ventilators". The testing included but was not limited to:
Electrical Safety testing per IEC 601-1 .
Safety and Essential Performance testing per ISO 10651-6
Safety and Performance testing per ISO 17510-1 ◆
. Electromagnetic Compatibility testing (EMC testing)
. Mechanical Safety testing
. Environmental testing
. Functional testing
. Particle matter testing

The device passed all tests.

1. All device ( the embedded software and the Calendar Analysis PC software ) softwares was documented and tested in accordance with the FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". The device passed all tests.
1. Clinical studies were not required to support a substantial equivalence determination.

Conclusions:

The Breas Vivo 40 System meets its stated performance specifications and criteria outlined in the Reviewer Guidance publications referenced above. We conclude that the device is capable of operating safely in its intended environments and will be effective in fulfilling its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three horizontal lines forming its body and a curved line representing its tail. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2005

Ms. Karl-Johan Holm Quality Assurance/Regulatory Affairs Manager BREAS Medical AB Företagsvägen 1 SE- 435 33 Mölnlycke SWEDEN

Re: K053607

Trade/Device Name: Breas Vivo 40 System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: December 14, 2005 Received: December 28, 2005

Dear Ms. Holm:

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 such 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.

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Page 2 - Ms. Holm

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K053607
Device Name:	Breas Vivo 40 System
Indications For Use:	The Breas Vivo 40 is designed for spontaneousbreathing patients who require long-termsupport by mechanical ventilation during nightand part of the day.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K053607

Page 1 of 1_______________________________________________________________________________________________________________________________________________________________

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).