The Breas Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non- invasive applications. The Breas Vivo 40 is intended to be operated by qualified and trained personnel. The Breas Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. The Breas Vivo 40 must always be prescribed by a licensed physician.

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 invasive and 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

Here's an analysis of the provided text regarding the Breas Vivo 40 System, focusing on acceptance criteria and the study proving it meets those criteria:

Device: Breas Vivo 40 System (Bilevel system, Ventilator)
Intended Use: For spontaneous breathing adult patients (>30 kg) requiring long-term support by mechanical ventilation (night and part-day), and for CPAP therapy for obstructive sleep apnea. Not for life support or transport of critical care patients.

1. Acceptance Criteria and Reported Device Performance

The provided document describes the device's adherence to various regulatory and performance standards rather than specific quantitative acceptance criteria with numerical targets. The "reported device performance" is essentially a statement of compliance or "passed all tests."

Acceptance Criteria Category	Specific Standard/Test Referenc	Reported Device Performance
General Performance	Stated performance specifications	Device passed all tests.
Risk Management	All Risk Analysis issues	Appropriately addressed.
Comparative Testing	Wave-form performance	Substantially equivalent to predicate.
	Work of Breathing	Substantially equivalent to predicate.
	Pressure Dynamic regulation	Substantially equivalent to predicate.
Electrical Safety	IEC 601-1	Device passed all tests.
Safety & Essential Performance	ISO 10651-6	Device passed all tests.
Safety & Performance CPAP	ISO 17510-1	Device passed all tests.
Electromagnetic Compatibility (EMC)	EMC testing	Device passed all tests.
Mechanical Safety	Mechanical Safety testing	Device passed all tests.
Environmental	Environmental testing	Device passed all tests.
Functional	Functional testing	Device passed all tests.
Particle Matter	Particle matter testing	Device passed all tests.
Software Documentation & Testing	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 Data Provenance

The document explicitly states that "Non-clinical testing was conducted" and "Comparative testing... was performed." These refer to bench-testing and device-level verification.

Sample Size for Test Set: Not specified in the provided text, but it pertains to physical units of the ventilator and possibly components, not patient data.
Data Provenance: The tests were conducted on the device itself, likely within a laboratory or manufacturing setting. No patient data (e.g., country of origin, retrospective/prospective) is associated with this testing as it was non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of the provided information. The testing was non-clinical bench-testing, comparing the device to pre-established standards and a predicate device. "Ground truth" in this context would be the performance characteristics of the standards or the predicate device, not established by human experts for a test set of medical cases.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) typically refer to expert review processes for clinical data or imaging, which were not part of this submission's testing. The "adjudication" for the bench-tests would be whether the device passed the specified criteria, which is a binary outcome based on measurement, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

The document explicitly states: "Clinical studies were not required to support a substantial equivalence determination."

Therefore, there is no information on:

Effect size of how human readers improve with AI vs without AI assistance. (This is an AI-specific question, and this device is a ventilator, not an AI diagnostic tool.)

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of this device. The Breas Vivo 40 is a mechanical ventilator, not an AI algorithm or a diagnostic software. Its performance is inherent to its hardware and controlling software, which directly delivers therapy. There isn't a separate "algorithm only" performance to be evaluated outside of the device's functional operation. The software testing mentioned was for compliance with FDA guidance, not for standalone diagnostic performance.

7. The Type of Ground Truth Used

For the non-clinical and comparative bench testing, the "ground truth" was established by:

Engineering Specifications / Pre-defined Measurement Criteria: For meeting its own "stated performance specifications" (e.g., pressure delivery accuracy, flow rates).
International Standards: Compliance with standards like IEC 601-1, ISO 10651-6, ISO 17510-1 for safety and performance.
Predicate Device Performance: For the comparative testing (Wave-form performance, Work of Breathing, Pressure Dynamic regulation), the performance of the legally marketed predicate devices (Respironics Vision, Breas Vivo 40 (K053607)) served as the benchmark for substantial equivalence.

No pathology, expert consensus on clinical cases, or outcomes data were used as ground truth for this submission, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable. The Breas Vivo 40 System is a mechanical ventilator, not a machine learning or AI-driven device that requires a "training set" of data in the typical sense for algorithm development. The software testing mentioned refers to verification and validation of the embedded control software, not training a predictive model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there was no "training set" for an AI algorithm.

Summary

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Breas Medical AB

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter	Breas Medical AB	FEB 15
	Företagsvagen 1
	SE 435 33 Molnlycke
	Sweden
Contact Person	Ibb Jessen
	Quality Assurance and Regulatory Affairs Manager
	Phone: +46 31 868848
	Fax: +46 31 868810
Summary Date	June 14:th, 2007
Name of Device	Breas Vivo 40 System
Common Name	Bilevel system
Classification Name	Non- continuous ventilator (21 CFR 868.5895)
Product Code	MNT
Predicate Device	Respironics Vision (K982545)
	Breas Vivo 40 (current device (K053607))

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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 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 invasive and 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 Viyo 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.

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Breas Medical AB

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 or invasive use with appropriate patients.

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 device, the Breas Vivo 40 System has:

Same intended use (Respironic Vision)

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, including testing of work of breathing for invasive use, 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 in the original application 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 software 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 & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.

Public Health Service

FEB 15 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ibb Jessen Quality Assurance & Regulatory Affairs Manager Breas Medical AB Företagsvagen 1 435 33 Molnlycke SWEDEN

Re: K071702

Trade/Device Name: Breas Vivo 40 Invasive Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: January 31, 2008 Received: February 4, 2008

Dear Mr. Jessen:

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. Jessen

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.

Sadote Y. Michioms.

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): K071702

Device Name: Breas Vivo 40 Invasive

Indications for Use:

It is not intended to provide the total ventilatory requirements of the patient.

It is intended to be used for both invasive and non- invasive applications.

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

The Breas Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.

The Breas Vivo 40 must always be prescribed by a licensed physician.

Prescription Use > (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)

Ming Thinh

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K071702 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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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).