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.

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:

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 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.

AI/ML Overview

This document describes the Breas Vivo 40 ventilator with a new "Target Volume" feature, seeking 510(k) clearance from the FDA. The submission largely relies on predicate device comparison and bench testing rather than extensive clinical studies.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Devilce(Breas Vivo 40 without Target Volume and Respironics BiPAP AVAPS)	Substantial equivalence in: - Pressure stability - Dynamic pressure regulation - Waveform performance - Target volume feature	Bench testing confirmed substantial equivalence for: - Wave-form performance - Work of Breathing - Pressure Dynamic regulation - Target Volume feature
Safety and Effectiveness	As safe and effective as therapy without the Target Volume feature.	Clinical article attached (Appendix 12) supporting the use of volume-controlled ventilation in combination with pressure-controlled ventilation.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. The primary evidence presented is bench testing and a single clinical article, not a clinical study with a defined patient test set for the device itself.
Data Provenance:
- Bench Testing: Performed by Breas Medical AB (Sweden). This is retrospective as it's testing a modification to an existing device.
- Clinical Article: Referencing "one clinical article" provided in Appendix 12. The provenance (country of origin, retrospective/prospective) of this article's data is not specified in the provided text.

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

Not applicable. As no clinical study with a patient test set for the device was performed by Breas Medical, there were no experts used to establish ground truth for such a test set. The bench testing relies on engineering standards and measurements, not expert human assessment. The cited clinical article would have its own ground truth establishment methods, but these are not for the device's specific performance in this submission.

4. Adjudication Method for the Test Set

Not applicable. No human-involved test set requiring adjudication was conducted by Breas Medical for this submission.

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

No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing has been performed by Breas Medical."

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

Yes, in a sense, standalone performance testing was done in the form of "bench testing." The "Target Volume" feature is a software-based algorithm that adjusts pressure. The bench tests evaluated the performance of this algorithm (and the integrated device) in a controlled environment, without human intervention in the device's operation during the tests.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for bench testing is established by engineering specifications, physical principles, and measurement standards for ventilator performance (e.g., precise pressure and flow measurements, waveform analysis, tidal volume delivery).
Clinical Article: The ground truth for the cited clinical article (not part of Breas Medical's direct testing) would depend on the study's design, but typically in clinical ventilation studies, it could involve physiological measurements (e.g., blood gas analysis, lung mechanics), patient outcomes, or expert clinical assessment.

8. The Sample Size for the Training Set

Not applicable. The Vivo 40 with the Target Volume feature is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. Its "training" or development would involve engineering design, simulation, and iterative hardware/software development and testing, not a labeled training dataset.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The development of the device's control algorithms would be based on established physiological models, control theory, and engineering principles, with validation through simulations and bench testing.

Summary

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Breas Medical AB

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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)

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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.

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 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 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.

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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.

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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

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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

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510(k) Number (if known):

Device Name: Breas Vivo 40 Target Volume

Indications for Use:

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

Page 4.1

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).