The Breas Vivo 30 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day.

The Breas Vivo 30 shall only be used by patients with spontaneous breathing.

The Breas Vivo 30 is not intended for life-sustaining applications or for transport of critical care patients.

The Breas Vivo 30 is intended for non-invasive use.

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

Device Description

The Vivo 30 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.

The Vivo 30 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 30 System can be either:

1. Pressure Controlled Ventilation (PCV) or
1. Pressure Support Ventilation (PSV) or
1. Constant Positive Airway Pressure (CPAP)

The Vivo 30 airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks.

The Vivo 30 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 30 housing are 7.2 × 8.9 inches, and the device weighs 7.3 pounds.

AI/ML Overview

The provided document K060546 describes the Breas Vivo 30 System, a bilevel ventilator. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical performance studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it outlines a series of tests performed to demonstrate that the device meets its stated performance specifications and is substantially equivalent to a predicate device. The general acceptance criterion implied is the successful completion of all specified tests.

Acceptance Criteria Category	Reported Device Performance
Non-clinical Testing	Device passed all tests, meeting stated performance specifications and addressing Risk Analysis issues.
Comparative Testing	Bench-testing confirmed substantial equivalence to predicate devices regarding Wave-form performance, Work of Breathing, and Pressure Dynamic regulation.
Regulatory Compliance	Passed all tests against: - IEC 601-1 (Electrical Safety) - ISO 10651-6 (Safety and Essential Performance) - ISO 17510-1 (Safety and Performance) - Electromagnetic Compatibility (EMC) - Mechanical Safety - Environmental Testing - Functional Testing - Particle matter testing - FDA's "Reviewer Guidance for Premarket Notification Submissions" (Nov 1993 draft) - FDA's "Draft Reviewer Guidance for Ventilators" (July 1995)
Software Validation	All device software (embedded and Calendar Analysis PC software) documented and tested in accordance with FDA's May 11, 2005 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". Device passed all tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document focuses on non-clinical bench testing. Therefore, there is no patient-based test set or associated sample size in the traditional sense of human subjects. The testing involved the device itself and potentially various scenarios, simulations, and measurement equipment.

Data provenance: The testing was conducted by Breas Medical AB, a Swedish company, but the specific location of the tests is not detailed beyond "non-clinical testing was conducted." The submission is to the FDA in the United States.

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 is not applicable as the submission did not involve a clinical study with a patient test set requiring expert ground truth establishment. The "ground truth" for non-clinical tests would be defined by engineering specifications, regulatory standards, and the performance of the predicate device.

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

This is not applicable due to the absence of a patient-based test set requiring expert adjudication.

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 done. The device is a ventilator, not an AI-assisted diagnostic tool for human readers.

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

The device itself is a standalone medical device (ventilator). The "performance" discussed is its mechanical and functional operation as specified by its engineering and regulatory standards, not the performance of an algorithm in a diagnostic context. The document specifies that clinical studies were not required to support substantial equivalence. The standalone performance was evaluated through the non-clinical and comparative bench testing described.

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

For the non-clinical tests, the "ground truth" was established by engineering specifications, recognized regulatory standards (IEC, ISO), and the performance characteristics of the predicate device. For instance, electrical safety compliance is determined by meeting the specified limits in IEC 601-1, which serves as the ground truth for that test.

8. The sample size for the training set

This is not applicable. The device is a hardware system with embedded software for control; it is not a machine learning or AI-based device that undergoes "training" with a dataset in the conventional sense. The software was "documented and tested," which refers to software validation practices, not machine learning model training.

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

This is not applicable as there was no training set for a machine learning model.

Summary

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K060546

510(k) Premarket Notification_________________________________________________________________________________________________________________________________________________

MAY 2 6 2006

Breas Vivo™ 30 System

Breas Medical AB

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	February 13, 2006
Name of Device	Breas Vivo 30 System
Common Name	Bilevel system
Classification Name	Non- continuous ventilator (21 CFR 868.5895)
Product Code	MNS
Predicate Device	ResMed VPAP II ST-A (K974417)

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Device Description:

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 30 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 30 System can be either:

1. Pressure Controlled Ventilation (PCV) or
1. Pressure Support Ventilation (PSV) or
1. Constant Positive Airway Pressure (CPAP)

The Vivo 30 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 outer dimensions of the Vivo 30 housing are 7.2 × 8.9 inches, and the device weighs 7.3 pounds.

Intended Use:

The Breas Vivo 30 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day.

The Breas Vivo 30 shall only be used by patients with spontaneous breathing.

The Breas Vivo 30 is not intended for life-sustaining applications or for transport of critical care patients.

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The Breas Vivo 30 is intended for non-invasive use.

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

The Breas Vivo 30 is intended to be operated by qualified and trained personnel.

Comparison of Use and Technological Characteristics:

The Vivo 30 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 device, the Breas Vivo 30 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 30 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 30 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 30 System is substantial equivalent with regards to Wave-form performance as well as Work of Breathing and Pressure Dynamic regulation.
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,

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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 30 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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-like figure with three horizontal lines forming the body and head. Below the bird are curved lines representing water or waves. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2006

Mr. Karl-Johan Holm Quality Assurance & Regulatory Affairs Mananger Breas Medical AB Företagsvagen 1 Molnlycke, Vastra Gotaland SWEDEN 'SE 435 33

Re: K060546

Trade/Device Name: Breas Vivo 30 System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: February 22, 2006 Received: March 1, 2006

Dear Mr. 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 – Mr. 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 (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.

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 vour 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) 276-0120. 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): K060546

Device Name:

Breas Vivo 30 System

Indications For Use:

The Breas Vivo 30 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

of Anesthesiology, General Hospital,
on Control, Dental Devices
	K060546

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).