The Vivo 50 ventilator (with or without the iOxy and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing at least 10 kg (22 lbs.).

The Vivo 50 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 50 with the CO2 sensor is intended to measure CO2. in the inspiratory and expiratory gas.

The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 50 is not intended to be used as a transport and critical care ventilator.

Device Description

The Vivo 50 Ventilator is a portable, microprocessor controlled turbine based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation.

Internal flow and pressure are read through flow/ pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.

All the operator actions are performed via the front panel where clear buttons and screen are located. There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.

The Vivo 50 can be operated by external AC or DC power supply and contains an integroted battery as well as an additional click on battery.

The Vivo 50 can be used with both single limb patient circuits including an active exhalation valve and single limb patient circuits including a leakage port.

The Vivo 50 can be operated in 9 different ventilation modes:

. PSV - Pressure Support Ventilation
PSV(TgV) Pressure Support Ventilation with Target Volume .
PCV Pressure Controlled Ventilation
PCV(TgV) Pressure Controlled Ventilation with Target Volume
PCV(A) Assisted Pressure Controlled Ventilation
PCV(A+TaV) Assisted Pressure Controlled Ventilation with Taraet Volume ●
VCV Volume Controlled Ventilation
VCV(A) Assisted Volume Controlled Ventilation ●
CPAP Continuous Positive Airwav Pressure ●

The internal memory data of the Vivo 50 can be downloaded to a PC, printed out, and analysed via the Vivo 50 PC Software. The Vivo 50 PC Software is the support software for follow-up on patient treatment. The PC Software can communicate with the ventilator in two ways, either using an USB cable or a Compact Flash memory card.

The Vivo 50 PC Software provides presentation features of logged data by 24 hours, 30 days and 365 days resolution. The Vivo 50 PC Software presents treatment parameters such as pressure, volume, flow, leakage but also events such as alarms and change of settings. Further, the hours of usage is presented.

The Vivo 50 with the iOxy kit , consisting of an SpO2 (blood oxygen saturation) Nonin sensor, an electronic unit and cable, is intended to be connected to ventilator for logging SpO2 and pulse rate data and, when applicable, for real time monitoring. The SpO2 and pulse rate measurements are stored in the Vivo 50 internal memory log which can be downloaded to a PC and viewed in the Vivo 50 PC software. The SpO2 sensors are manufactured by Nonin Medical Inc.

The Vivo 50 with the CO2 sensor can be connected with the purpose to measure and display End Tidal CO2 (EtCO2) as well as Inspired CO2 (InspCO2). The EtCO2 displays the end-tidal carbon dioxide, measured on the last portion of the exhaled volume. The InspCO2 displays the inspired carbon dioxide.

The CO2 sensor can be connected to the patient breathing circuit and to the Vivo 50 in order to monitor and store CO2 measurements. The CO2 measurements will be stored in the Vivo 50 data memory which can be downloaded to a PC and viewed in the Vivo 50 PC software.

The CO2 sensor used with the Vivo 50 is manufactured by PHASEIN AB and is in used with PHASIEN AB carbon dioxide gas analyser cleared device under K081601 & K123043.

The Vivo 50 Remote Alarm Unit enables care providers and clinical personnel to monitor the Vivo 50 alarms remotely. The Remote Alarm unit is connected to the ventilator via a 10. 25 or 50 meter cable and powered by the ventilator. The Remote Alarm repeats alarms from the Vivo 50. The alarm signal sound level may be adjusted by the user. The actions or adjustments on the Remote Alarm unit do not, in any way, affect the alarm indications, alarm sound level, or audio pause on the Vivo 50.

AI/ML Overview

This device is a ventilator, and the provided document is a 510(k) summary for its clearance. For ventilators, acceptance criteria and associated "studies" typically refer to compliance with recognized standards and internal verification/validation testing rather than clinical performance studies measuring accuracy metrics like sensitivity/specificity against ground truth. The document explicitly states that no clinical studies were required or performed to support substantial equivalence for the Vivo 50.

Therefore, the "acceptance criteria" for this device are its compliance with various medical device standards and the internal non-clinical testing performed by the manufacturer.

Here's the information extracted and formatted as requested, with explanations where direct answers are not applicable due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Reference Standard/Test)	Reported Device Performance (Summary)
Non-Clinical Testing:
Risk Analysis	Performed as part of Quality Assurance measures.
Requirements Reviews	Performed as part of Quality Assurance measures.
Design Reviews	Performed as part of Quality Assurance measures.
Integration Testing	Performed as part of Quality Assurance measures.
Performance Testing	Thoroughly tested through verification of specifications and validation. Concludes substantial equivalence to predicate devices.
Safety Testing	Performed, including Standards compliance testing.
Simulated Use Testing	Performed as part of Quality Assurance measures.
Software Validation	Thoroughly tested through verification of specifications and validation.
Electrical Safety (IEC 60601-1)	Compliance ensured.
Electromagnetic Compatibility (IEC 60601-1-2)	Compliance ensured.
Alarm Systems (IEC 60601-1-8)	Compliance ensured.
Software Life Cycle (IEC 62304)	Compliance ensured.
Usability (IEC 60601-1-6, IEC 62366)	Compliance ensured.
Programmable Electrical Medical Systems (IEC 60601-1-4)	Compliance ensured.
Pulse Oximeter Equipment (ISO 9919)	Compliance ensured (for iOxy kit).
Respiratory Gas Monitors (ISO 21647)	Compliance ensured (for CO2 sensor).
Home Care Ventilators (EN ISO 10651-2, EN ISO 10651-6)	Compliance ensured.
Electrically Powered Home Care Ventilators (ASTM F1246-91)	Compliance ensured.
Ventilators for Critical Care (ASTM F1100)	Used for waveform standard analysis between Vivo 50 and predicate devices.
Clinical Testing:	No clinical studies were required or performed.

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

Test Set Sample Size: Not applicable. The submission explicitly states "The subject of this premarket submission, Vivo 50 did not require clinical studies to support substantial equivalence." The testing described is non-clinical (verification and validation against specifications and standards), not a clinical 'test set' with patient data.
Data Provenance: Not applicable, as there was no clinical test set using patient data. All testing mentioned is internal, non-clinical lab/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical test set requiring ground truth established by experts.

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

Not applicable. There was no clinical test set requiring 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:

Not applicable. No MRMC study was mentioned or performed. This device is a standalone ventilator, not an AI-assisted diagnostic tool that would involve human readers.

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

The performance testing and standards compliance outlined in "Summary of Non-Clinical Tests" represent the standalone performance of the device against its specifications and relevant standards. This is not a specific "algorithm-only" study in the sense of a diagnostic AI, but rather the integrated system's performance. The device's functionality (e.g., controlling ventilation modes, displaying parameters, managing alarms) is intrinsically "standalone" in its operation.

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

Not applicable. For non-clinical verification and validation of a medical device like a ventilator, the "ground truth" equates to the established engineering specifications for the device, and the requirements outlined in the applicable medical device standards (e.g., IEC 60601 series, ISO 9919, ISO 21647, ASTM F1246-91, ASTM F1100). Performance is measured against these objective, predefined criteria.

8. The sample size for the training set:

Not applicable. This document describes a medical device (ventilator) that underwent traditional engineering verification and validation, not a machine learning or AI algorithm development process that typically involves a "training set."

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

Not applicable. As there was no training set (see point 8), no ground truth was established for it.

Summary

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K123144

Page 1 of 6

510(k) Summary

JUN 1 8 2013

In accordance with 21 CFR 807.92 the following summary of information is provided:

Dote:

June 17, 2013

9617566

Establishment Number

Submitter:

GE Healthcare, BREAS MEDICAL AB Företagsvagen 1 Mölnlycke, SWEDEN 435 33

Primary Contact Person:

Shlomi Deler - Regulatory Affairs Manager

GE Healthcare, GE medical Systems Israel Ltd. Tel : +972 98915407 Fax: +972 98997776

Secondary Contact Person:

Ajrulla Zuta - Regulatory Affairs Leader

GE Healthcare , BREAS MEDICAL AB

Tel: +46 (0)31 86 88 19 Fax: +46 31 86 88 10

US Agent:

Pam Schaub GE Healthcare 9900 w. innovation drrp2138 Wauwatosa, WI 53226 Phone: 414 7212584 ext Fax: 262 9971160 Email: pam.schaub@ge.com

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Page 2 of 6

Device Trade Name:

Vivo 50

Common/Usual Name:

Portable Ventilator

Classification Names and

Product Code[s]:

CBK 21 CFR 868.5895, Continuous Ventilator

NOU 21 CFR 868.5895, Continuous Ventilator, Home Use

DQA 21 CFR 870.2700, Oximeter

CCK 21 CFR 868.1400, Analyzer, gas, carbon-dioxide, gaseous-phase

Predicate Device(s):

iVent101 Trilogy100 [cleared under K112754] [cleared under K111610]

VEO Multigas Monitor {cleared under K081601 & K123043]

Device Description:

Internal flow and pressure are read through flow/ pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both as graphs and numbers.

The Vivo 50 can be operated by external AC or DC power supply and contains an integroted battery as well as an additional click on battery.

The Vivo 50 can be used with both single limb patient circuits including an active exhalation valve and single limb patient circuits including a leakage port.

The Vivo 50 can be operated in 9 different ventilation modes:

. PSV - Pressure Support Ventilation
PSV(TgV) Pressure Support Ventilation with Target Volume .

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PCV Pressure Controlled Ventilation
PCV(TgV) Pressure Controlled Ventilation with Target Volume
PCV(A) Assisted Pressure Controlled Ventilation
PCV(A+TaV) Assisted Pressure Controlled Ventilation with Taraet Volume ●
VCV Volume Controlled Ventilation
VCV(A) Assisted Volume Controlled Ventilation ●
CPAP Continuous Positive Airwav Pressure ●

The CO2 sensor used with the Vivo 50 is manufactured by PHASEIN AB and is in used with PHASIEN AB carbon dioxide gas analyser cleared device under K081601 & K123043.

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Indications for use :

The Vivo 50 with the iOxy is intended to measure functional oxygen saturation of arterial hemoqlobin (%SpO2) and pulse rate.

The Vivo 50 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.

Technological Characteristics:

The Vivo 50 employs the same fundamental scientific technology as the following predicate devices, including equivalent turbine ventilator technology and equivalent software algorithms to control ventilation modes and monitoring functionality:

. iVent101 [cleared under K112754]
Trilogy 100 [cleared under K111610] .
VEO Multigas Monitor [cleared under K081601& K123043] .

The Vivo 50 shares the same intended use, use environment and target patient population as its predicate devices.

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Page 5 of 6

Summary of Non-Clinical Tests:

The Vivo 50 ventilator has been thoroughly tested through verification of specifications and validation, including software validation. Verification of compliance with applicable standards has also been completed to ensure safe use of the device in its intended use environment, including electrical safety and electromagnetic compatibility testing. The following quality assurance measures were opplied during the development of the Vivo 50 ventilator system:

Risk Analysis ●
Requirements Reviews .
Design Reviews .
Integration testing .
Performance testing .
Safety testing / including Standards compliance testing
Simulated use testing

Summary of Clinical Tests:

The subject of this premarket submission, Vivo 50 did not require clinical studies to support substantial equivalence.

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the Vivo 50 complies with the following voluntary standards and quidance documents:

Draft Reviewer quidance for ventilators .
Draft Guidance for industry and FDA staff Pulse Oximeters- Premarket . notification submissions
Draft Guidance for Industry and FDA Staff Pulse Oximeters .
FDA Guidance for the content of Premarket submissions for software . contained in Medical Devices
ASTM F1246-91, Electrically Powered Home Care ventilators, Part 1: . Positive-Pressure Ventilators and Ventilator Circuits
ASTM F1100. Standard specification for ventilators intended for Use in . Critical Care (for waveform standard analysis between the Vivo 50 and the predicate devices]

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IEC 60601-1, Medical Electrical Equipment General requirements for . safety
IEC 60601-1-2, Medical electrical equipment Part 1-2: General . requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-8, General requirements for safety collateral standard: . General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 62304, Medical device software -- Software life cycle processes .
IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General . requirements for safety - collateral standard: Usability
. IEC 62366, Medical devices - Application of usability engineering to medical devices
IEC 60601-1-4, Medical electrical equipment: part 1-4: general . requirements for collateral standard: programmable electrical medical systems
. ISO 9919, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
. ISO 21647, Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
EN ISO 10651-2, Lung Ventilators for medical use Particular requirements . for basic safety and essential performance - Part 2: Home Care Ventilators for ventilator dependent patients
EN ISO 10651-6, Lung Ventilators for medical use Particular requirements . for basic safety and essential performance – Part 6: Home care ventilator support devices

Substantial Equivalence Conclusion:

Based on the performance testing, GE Healthcare considers the Vivo 50 to perform in a substantially equivalent manner, as compared to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 three curved lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2013

Mr. Shlomi Deler Regulatory Affairs Manager GE Healthcare, BREAS MEDICAL AB Foretagsvagen 1 Molnlycke, Sweden 43533

Re: K123144

Trade/Device Name: Vivo 50 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, NOU, DQA, CCK Dated: May 16, 2013 Received: May 21, 2013

Dear Mr. Deler:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Deler

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Kwame Ulmer, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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: Vivo 50

Indications for Use:

The Vivo 50 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The Vivo 50 with the CO2 sensor is intended to measure CO2. in the inspiratory and expiratory gas.

Prescription Use_XXX__________________________________________________________________________________________________________________________________________________________	Over-The-Counter -------
Use_
(Part 21 CFR 801 Subpart D)	(Part 21 CFR 801 Subpart
AND/OR
C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

James J.	1
----------	---

DN	c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=James J. Lee
	0.9.2342.19200300.100.1.1=2000954859
Date	2013.06.17 12:42:51 -04'00'

Acting BC for

Dr. Anya Harry

Page 1 of 1

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

510(k) Number:

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).