(451 days)
No
The description focuses on microprocessor control, sensors, and standard ventilation modes, with no mention of AI or ML.
Yes.
The device's intended use is to provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, which directly addresses a medical condition or aims to maintain health, thus qualifying it as a therapeutic device.
No.
The device is primarily a ventilator providing mechanical ventilation. While it does measure SpO2 and CO2, these are parameters to support the primary function of ventilation, not to diagnose a new condition. Therefore, it's not a diagnostic device.
No
The device description clearly indicates it is a physical ventilator with hardware components like sensors, buttons, an LCD screen, and a turbine. While it is microprocessor-controlled and has software, it is not solely software.
Based on the provided information, the Vivo 45 LS ventilator is not primarily an In Vitro Diagnostic (IVD) device.
Here's why:
- Core Function: The primary intended use of the Vivo 45 LS is to provide mechanical ventilation, which is a life support function involving the delivery of air to a patient's lungs. This is a direct interaction with the patient's body, not the analysis of samples taken from the body.
- IVD Definition: In Vitro Diagnostics are defined as medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Sensors: While the device can be equipped with SpO2 and CO2 sensors, these are used for monitoring physiological parameters in real-time during ventilation. They are measuring gases and oxygen saturation within the patient's respiratory system, not analyzing samples taken from the body in a laboratory setting. These sensors are accessories that enhance the functionality of the ventilator, but they don't change the fundamental nature of the device as a ventilator.
Therefore, the Vivo 45 LS is classified as a ventilator, which is a type of life support medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Vivo 45 LS ventilator (without the SpO2 and CO2 sensors) is intended to provide continuous or internittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.
The Vivo 45 LS with the SpO2 sensor is intended to measure function of arterial hemoglobin (% SpO2) and pulse rate.
The Vivo 45 LS 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 applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.
Product codes (comma separated list FDA assigned to the subject device)
CBK, NOU, BTT, CCK, DQA
Device Description
The Viyo 45 LS 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.
Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.
Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.
The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.
The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.
The Vivo 45 LS can be operated in the following combinations of ventilation and breath 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+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
- PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
- PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
- . VCV-Volume Controlled Ventilation
- VCV(A)-Assisted Volume Controlled Ventilation
- VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric through adult patients weighing more than 5 kg (11 lbs.)
Intended User / Care Setting
Home, institution, hospitals applications such as wheelchairs and gurneys.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify conformance with all requirements specifications and applicable standards, including comparative testing with the predicate device (Vivo 45 LS cleared in K193586).
Studies included:
- Electrical Safety: Conformance to ANSI/AAMI ES60601-1:2005.
- Electromagnetic Compatibility: Conformance to IEC 60601-1-2: 2014.
- Usability: Conformance to IEC 60601-1-6: 2010+A1:2013.
- Alarm Systems: Conformance to IEC 60601-1-8: 2006 (Second edition) + Am. 1: 2012.
- Medical equipment used in home healthcare environment: Conformance to IEC 60601-1-11: 2015.
- Critical care ventilators: Conformance to ISO 80601-2-12:2020.
- Respiratory gas monitors: Conformance to ISO 80601-2-55: 2018.
- Pulse oximeter equipment: Conformance to ISO 80601-2-61:2017.
- Home healthcare environment ventilators for ventilator-dependent patients: Conformance to ISO 80601-2-72:2015.
- Battery testing: Conformance to IEC 62133: 2012 (2nd Ed) and IEC 62133-2 Edition 1.0 2017.
- Humidifier testing: Conformance to ISO 80601-2-74: 2017.
Biocompatibility Testing of Gas Pathway and Humidified Gas Pathway:
- VOC: Tested per ISO 18562-3:2017. No VOC compounds observed in toxicologically significant quantities.
- Particulate matter: Tested per ISO 18562-2:2017. Particulate quantities well below acceptable limits.
- Carbon monoxide, Carbon dioxide, Ozone: Tested per ISO 18562-1:2017 recommendations. Emissions well below acceptable limits.
- Aldehydes: Tested using newly manufactured device. No risk for aldehyde exposure to adult or pediatric subjects under worst-case conditions.
- Extractable compounds: Humidified gas pathway tested per ISO 18562-4:2017 and ISO 10993-18:2020. No significant toxicological or biocompatibility risk for adult subjects.
- Cytotoxicity: Humidified gas pathway tested per ISO 10993-5:2009. Non-cytotoxic.
- Sensitization: Humidified gas pathway tested per ISO 10993-10:2010. Non-sensitizing.
- Irritation / Intracutaneous Reactivity: Humidified gas pathway tested per ISO 10993-10:2010. Non-irritating.
- Acute Systemic Toxicity: Humidified gas pathway tested per ISO 10993-11:2017. Non-toxic.
- Materials Mediated Pyrogenicity: Humidified gas pathway tested per ISO 10993-11:2017. Non-pyrogenic.
- Genotoxicity – Reverse Mutation: Humidified gas pathway tested per ISO 10993-3:2014. Non-mutagenic.
Functional Performance Testing:
- HFNT function: Verified to meet all specifications.
- Alarm pre-silence function: Verified to meet all specifications.
- Humidifier and heated wire functions: Tested for humidity output, normal operation, fault detection, safe power cutoff, alarms, max water temperature, heated circuit temperature accuracy, cleaning, and gas leakage. Met all specifications. Comparative pressure, flow, and volume waveforms testing demonstrated equivalence to the cleared predicate device.
- Supplemental oxygen: Tested for safety and performance at 30 liters per minute. All tests passed.
- Accuracy of controls and monitored values: Confirmed to meet specifications.
- Alarms testing: Confirmed proper operation of physiologic and technical alarms.
- Cybersecurity testing: Confirmed conformance with all cybersecurity specifications.
- Software verification and validation: Performed at unit, integration, and system level. All tests passed.
Summative Human Factors Testing:
- Study participants: 15 healthcare professionals (HCP) who are respiratory therapists (RT), 15 HCP who are registered nurses (RN), and 15 lay caregiver (LCG) users.
- Key Results:
- The intended user populations can safely and successfully use the Vivo 45 LS.
- The training was understood and successfully applied by the users.
- Performance of critical tasks did not result in any patterns of use errors or difficulties that would lead to patient harm (including compromised medical care).
- No new hazards, hazardous situations, or hazard-related use-scenarios were identified.
- Use-related hazards have been reasonably mitigated and residual risks are considered acceptable.
- In addition to summative human factors study, multiple formative HF studies, prior summative HF studies, design reviews, assessment of known use problems and field data review, and use-related risk management activities were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
January 13, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Breas Medical AB % Maureen O'Connell Regulatory Consultant O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K233452
Trade/Device Name: Vivo 45 LS Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, NOU, BTT, CCK, DQA Dated: December 20, 2024 Received: December 20, 2024
Dear Maureen O'Connell:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233452
Device Name Vivo 45 LS
Indications for Use (Describe)
The Vivo 45 LS ventilator (without the SpO2 and CO2 sensors) is intended to provide continuous or internittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.
The Vivo 45 LS with the SpO2 sensor is intended to measure function of arterial hemoglobin (% SpO2) and pulse rate.
The Vivo 45 LS 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 applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY-K233452
Breas Medical Vivo 45 LS
510(k) Owner
Breas Medical AB Foretagsvagen 1 Molnlycke, Vastra Gotalands Lan (Se-14) SWEDEN 435 33
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180 Phone: 978-207-1245
Date Prepared: January 9, 2025
Trade Names of Device Vivo 45 LS
Common or Usual Name
Continuous ventilators, home use
Classification Name
Continuous ventilators; 21 C.F.R. §868.5895 Class II Product Code: NOU
Primary Predicate Device(s) Breas Medical AB Vivo 45 LS cleared in K193586
Reference Device(s)
Fisher & Paykel Healthcare, LTD. MR810Respiratory Humidifier cleared in K131957 Newport Medical Instruments, Inc. Newport HTS50 Ventilator With Dual Pac Battery System cleared in K082724 Fisher & Paykel Healthcare, LTD. myAIRVO 2 Humidifier cleared in K131895
Indications for Use
The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) 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 more than 5 kg (11 lbs.), however, the mouthpiece ventilation modes are for adult patients only.
5
The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.
The Vivo 45 LS 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 45 LS is not intended to be used as an emergency transport or critical care ventilator.
Device Description
The Viyo 45 LS 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.
Flow and pressure are read using flow and pressure sensors. Essential parameters such as pressure, flow and volume are presented on the ventilator screen, both in the form as graphs and numbers.
Operator actions are performed via the front panel where the buttons and an LCD screen are located (and two dedicated buttons on the top of the ventilator control starting/stopping treatment and pausing the alarm audio). There are dedicated LEDs and buttons for managing alarm conditions and an Information button which provides integrated user support.
The Vivo 45 LS can be operated by external AC or DC power supply and contains an integrated battery as well as an optional click in battery.
The Vivo 45 LS can be used with two types of patient circuits: single limb patient circuits including an active exhalation valve and single limb patient circuits including a passive leakage port.
The Vivo 45 LS can be operated in the following combinations of ventilation and breath 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+TgV)-Assisted Pressure Controlled Ventilation with Target Volume ●
- PCV-SIMV-Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation
- PCV-MPV-Pressure Controlled Ventilation with MouthPiece Ventilation ●
- . VCV-Volume Controlled Ventilation
- VCV(A)-Assisted Volume Controlled Ventilation
- VCV-SIMV-Volume Controlled Ventilation with Synchronized Intermittent Mandatory ● Ventilation
6
- VCV-MPV- Volume Controlled Ventilation with MouthPiece Ventilation ●
- CPAP-Continuous Positive Airway Pressure, with optional features for HFNT-High Flow ● Nasal Therapy
High flow nasal therapy (HFNT) may be prescribed for spontaneously breathing patients undergoing non-invasive ventilatory therapy using a small, medium or large nasal cannula interface. The user may prescribe a flow rate setting in the range of 4 to 60 liters per minute. It is recommended to use an external humidifier, the Fisher & Paykel MR 850, during HFNT, due to possibly higher humidification output requirements of the patient. The Vivo 45 LS automatically disables the internal humidifier when the HFNT feature is being used.
Conditioning of the breathing air's temperature and humidity level may be prescribed for noninvasively ventilated patients using the integrated humidifier and heated wire patient circuit of the Vivo 45 LS at the clinician's discretion to enhance patient comfort and compliance. The humidification function is enabled by the Vivo 45 LS only when the device is powered by AC Mains and is automatically disabled including power to the heating plate when the device is powered by battery. The humidifier heating level can be selected by the user by setting the heating level (1-5) on the device user interface.
The Vivo 45 LS provides the user with available settings that determine the power delivered to the heater wire. This setting is in terms of a patient-end temperature in the range of 16 to 30° C. The heated wire patient circuit contains a temperature sensor located at the patient connection port, and the firmware of the Vivo 45 LS continuously monitors the temperature and automatically adjusts the power delivered to the heater wire to maintain the temperature at the user set point.
Technological Characteristics Compared to Predicate
Breas Medical's Vivo 45 LS is a modification to Breas Medical's previously cleared Vivo 45 LS (K193586) which is the primary predicate device. Three reference devices were used to support substantial equivalence of the humidifier and heated wire breathing circuit. Specifically, the Newport HTS50 Ventilator cleared in K082724 was used as a reference device to support an integrated humidifier, the MR810Respiratory Humidifier cleared in K131957 was used to support the humidifier and heated breathing circuit, and the myAIRVO 2 Humidifier cleared in K131895 was used to support substantial equivalence of the High Flow Humidification (HFNT).
The Breas Vivo 45 LS has the same intended use and similar technological characteristics to the predicate and reference devices. Breas Medical believes that the Vivo 45 LS described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to legally marketed predicate and reference devices that are also Class II medical devices. Table 1 compares the Vivo 45 LS with the primary predicate Vivo 45 LS.
7
| Table 1 |
|---|
| Substantial Equivalence; Vivo 45 LS |
| Primary Predicate Device |
| Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of
Differences |
|--------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | Vivo 45 LS (subject device) | Vivo 45 LS (predicate device) | |
| 510(k) Number | - | K193586 | - |
| Software
Controlled | Yes | Yes | Same |
| Gas Delivery
System | Turbine | Turbine | Same |
| Air | Ambient air | Ambient air | Same |
| Oxygen Supply | Connection for low O2 pressure
supply with bleed rate of 30 l/min | Connection for low O2 pressure
supply with bleed rate of 15 l/min | Substantially
equivalent: The design
of the Vivo 45 LS
remains unchanged.
The oxygen flow is
provided and controlled
by an external oxygen
supply. |
| Patient Type
Settings | Adult - Invasive, Adult – NIV,
Pediatric - Invasive, Pediatric -
NIV | Adult, Pediatric | Substantially
equivalent: Both
devices provide Adult
and Pediatric settings
and both devices are
indicated for invasive
and non-invasive (NIV)
ventilation. |
| Patient Circuit
Types | Single Limb with Leak,
Single Limb with Active
Exhalation Valve | Single Limb with Leak,
Single Limb with Active
Exhalation Valve | Same |
| Circuit
Compensation | Yes, Pre-use test | Yes, Pre-use test | Same |
8
| Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences |
|---|---|---|---|
| Model | Vivo 45 LS (subject | ||
| device) | Vivo 45 LS (predicate device) | - | |
| Ventilation Modes | |||
| PSV, PSV(TgV) | Yes | Yes | Same |
| PCV, PCV(TgV), | |||
| PCV(A), | |||
| PCV(A+TgV), | |||
| PCV-SIMV, PCV- | |||
| MPV | Yes | Yes | Same |
| VCV, VCV(A), | |||
| VCV-SIMV, | |||
| VCV-MPV | Yes | Yes | Same |
| CPAP with | |||
| optional features | |||
| for HFNT | Yes | CPAP only | Substantially equivalent: High |
| flow mode is analogous to | |||
| CPAP mode except instead of | |||
| a fixed pressure, the flow is | |||
| fixed at the user-specified | |||
| setting. |
| Ventilation Parameter Settings | |||
|---|---|---|---|
| Inspiratory | |||
| Pressure | Adult: 4 – 50 cmH2O | Adult: 4 – 50 cmH2O | Same |
| Pediatric: 4 – 50 | |||
| cmH2O | |||
| (Limited to 30 cmH2O above PEEP) | Pediatric: 4 – 50 cmH20 | ||
| (Limited to 30 cmH2O above PEEP) | |||
| CPAP Pressure | 4 to 20 cmH2O | 4 to 20 cmH2O | Same |
| PEEP | 0 to 20 cmH2O | ||
| (circuit with | |||
| exhalation valve) | |||
| 2 to 20 cmH2O | |||
| (circuit with leakage | |||
| port) | 0 to 20 cmH2O | ||
| (circuit with exhalation valve) | |||
| 2 to 20 cmH2O | |||
| (circuit with leakage port) | Same | ||
| Breath Rate | 4 to 40 BPM (Adult) | ||
| 6 to 60 BPM | |||
| (Pediatric) | 4 to 40 BPM (Adult) | ||
| 6 to 60 BPM (Pediatric) | Same | ||
| Inspiratory Time | 0.3 to 5 sec (Adult) | ||
| 0.3 to 2 sec (Pediatric) | 0.3 to 5 sec (Adult) | ||
| 0.3 to 2 sec (Pediatric) | Same | ||
| Trigger Type | eSync | ||
| (circuit with | |||
| exhalation valve) | |||
| eSync | |||
| (circuit with leakage | |||
| port) | eSync | ||
| (circuit with exhalation valve) | |||
| eSync | |||
| (circuit with leakage port) | Same |
9
| Manufacturer | Breas Medical AB | Discussion of Differences | |
|---|---|---|---|
| Model | Vivo 45 LS (subject device) | Vivo 45 LS (predicate device) | - |
| Rise Time | Rise Time – Pressure: | ||
| 1 to 9 | |||
| (PSV & PCV, PCV-SIMV, VCV-SIMV, PCV-MPV) |
Rise Time – Volume:
50% to 90% of insp. time, Off
(VCV, VCV-SIMV, VCV-MPV) | Rise Time – Pressure:
1 to 9
(PSV & PCV, PCV-SIMV, VCV-SIMV, PCV-MPV)
Rise Time – Volume:
50% to 90% of insp. time, Off
(VCV, VCV-SIMV, VCV-MPV) | Same |
| Tidal Volume | 300 to 2000 ml
(Adult)
50 to 400 ml
(Pediatric) | 300 to 2000 ml (Adult)
50 to 400 ml (Pediatric) | Same |
| Sigh | Off, every 10 to 250 breaths
(sigh interval)
125% to 200% of actual set pressure or volume within pressure/volume limits | Off, every 10 to 250 breaths
(sigh interval)
125% to 200% of actual set pressure or volume within pressure/volume limits | Same |
| Flow Pattern | Square, Decelerating | Square, Decelerating | Same |
Alarm Settings
Note that the subject device includes HFNT. When HFNT is used, only the Disconnection, High/Low FiO2 and High/Low SpO2 alarms are available. This is consistent with other HFNT devices. The information presented below applies to all other ventilation modes.
| Low Pressure
Alarm | Pediatric:
1 to 50 cmH2O
Adult:
1 to 50 cmH2O | Pediatric:
1 to 50 cmH2O
Adult:
1 to 50 cmH2O | Same |
|------------------------|--------------------------------------------------------------------|--------------------------------------------------------------|------|
| High Pressure
Alarm | 5 to 70 cmH2O | 5 to 70 cmH2O | Same |
| Low Vt Alarm | Off, 100 to 2000 ml
(Adult)
Off, 20 to 500 ml
(Pediatric) | Off, 100 to 2000 ml (Adult)
Off, 20 to 500 ml (Pediatric) | Same |
10
| Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences |
|---|---|---|---|
| Model | Vivo 45 LS (subject | ||
| device) | Vivo 45 LS (predicate device) | - | |
| Low Minute | |||
| Volume Alarm | Off, 1 to 30 liters | ||
| (Adult) | |||
| Off, 0.1 to 10 liters | |||
| (Pediatric) | Off, 1 to 30 liters (Adult) | ||
| Off, 0.1 to 10 liters (Pediatric) | Same | ||
| High Minute | |||
| Volume Alarm | 1 to 40 liters, Off | ||
| (Adult) | |||
| 1 to 20 liters, Off | |||
| (Pediatric) | 1 to 40 liters, Off (Adult) | ||
| 1 to 20 liters, Off (Pediatric) | Same | ||
| Low PEEP Alarm | On, Off | On, Off | Same |
| High PEEP | |||
| Alarm | On, Off | On, Off | Same |
| Disconnection | |||
| (high leakage) | |||
| Alarm | On, Off | On, Off | Same |
| Obstruction | |||
| Alarm | On, Off | On, Off | Same |
| Low Breath Rate | |||
| Alarm | Off, 4 to 30 BPM | ||
| (Adult) | |||
| Off, 1 to 30 BPM | |||
| (Adult - MPV) | |||
| Off, 6 to 50 BPM | |||
| (Pediatric) | Off, 4 to 30 BPM (Adult) | ||
| Off, 1 to 30 BPM (Adult - MPV) | |||
| Off, 6 to 50 BPM (Pediatric) | Same | ||
| High Breath Rate | |||
| Alarm | 10 to 70 BPM, Off | ||
| (Adult) | |||
| 10 to 99 BPM, Off | |||
| (Pediatric) | 10 to 70 BPM, Off (Adult) | ||
| 10 to 99 BPM, Off (Pediatric) | Same | ||
| Low Pulse Rate | |||
| Alarm | Off, 30 to 230 | Off, 20 to 250 | Substantially equivalent: The |
| subject device is within the | |||
| specification of the predicate | |||
| and within the accurate pulse | |||
| rate reporting range of the | |||
| pulse oximeter. | |||
| High Pulse Rate | |||
| Alarm | 30 to 230, Off | 20 to 250, Off | Substantially equivalent: The |
| subject device is within the | |||
| specification of the predicate | |||
| and within the accurate pulse | |||
| rate reporting range of the | |||
| pulse oximeter. | |||
| Low FiO2 Alarm | Off, 21 to 100% | Off, 21 to 100% | Same |
| High FiO2 Alarm | 21 to 100%, Off | 21 to 100%, Off | Same |
| Low SpO2 Alarm | Off, 85 to 100% | Off, 85 to 100% | Same |
| Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences |
| Model | Vivo 45 LS (subject | ||
| device) | Vivo 45 LS (predicate device) | - | |
| Low EtCO2 | |||
| Alarm | Off, 1 to 99 mmHg | Off, 1 to 99 mmHg | Same |
| High EtCO2 | |||
| Alarm | 1 to 99 mmHg, Off | 1 to 99 mmHg, Off | Same |
| High Insp CO2 | |||
| Alarm | 1 to 99 mmHg, Off | 1 to 99 mmHg, Off | Same |
| Re-Breathing (low | |||
| leakage) Alarm | On, Off | On, Off | Same |
| High Patient Air | |||
| Temp Alarm | Yes | Yes | Same |
| Low Last Power | |||
| Source Alarm | Yes | Yes | Same |
| Power Fail Alarm | Yes | Yes | Same |
| Low Alarm | |||
| Battery Alarm | Yes | Yes | Same |
| Function Failure | |||
| Alarms | Yes | Yes | Same |
| Alarm Pre-Silence | Yes | No | Substantially equivalent: Both |
| devices share the same | |||
| physical buttons, including the | |||
| Audio Pause button which | |||
| mutes active alarms in both | |||
| devices. The subject device | |||
| includes the additional alarm | |||
| pre-silence function (pre- | |||
| silencing of alarms for the | |||
| coming 2 minutes). The | |||
| existing Audio Pause hardware | |||
| button is used for the pre- | |||
| silence function by the user | |||
| pressing and holding it down | |||
| for three seconds. The pre- | |||
| silence function is | |||
| recommended in IEC 60601-1- | |||
| 8 Edition 2.1 Annex A | |||
| Subclause 681 (FDA | |||
| Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences |
| Model | Vivo 45 LS (subject device) | Vivo 45 LS (predicate device) | - |
| Accuracy of Controls | |||
| Inspiratory | |||
| Pressure | max of ±0.5cmH2O, ±5% | max of ±0.5cmH2O, ±5% | Same |
| PEEP | max of ±0.5cmH2O, ±5% | max of ±0.5cmH2O, ±5% | Same |
| Tidal Volume | max of ±12ml, ±10% | max of ±12ml, ±10% | Same |
| Breath Rate | ±2% | ±2% | Same |
| Inspiratory Time | Minimum of: | ||
| ±(20 msec + 5% of setting), and | |||
| ±0.1sec | Minimum of: | ||
| ±(20 msec + 5% of setting), and | |||
| ±0.1sec | Same | ||
| Accuracy of Monitored Values | |||
| Ppeak | max of ±0.5cmH2O, ±10% | max of ±0.5cmH2O, ±10% | Same |
| PEEP | max of ±0.5cmH2O, ±10% | max of ±0.5cmH2O, ±10% | Same |
| Pmean | max of ±0.5cmH2O, ±10% | max of ±0.5cmH2O, ±10% | Same |
| Leakage | ±10% | ±10% | Same |
| Tidal Volume | max of ±10ml, ±10% | max of ±10ml, ±10% | Same |
| FiO2 | ±2% | ±2% | Same |
| % in TgV | ±1% | ±1% | Same |
| Total Rate | ±1bpm | ±1bpm | Same |
| Spont Rate | ±1bpm | ±1bpm | Same |
| SpO2 | ±2% | ±2% | Same |
| Pulse Rate | ±1% | ±1% | Same |
| I:E | ±0.1 unit | ±0.1 unit | Same |
| Manufacturer | Breas Medical AB | Breas Medical AB | Discussion of Differences |
| Model | Vivo 45 LS (subject device) | Vivo 45 LS (predicate device) | - |
| Rise Time | Max of ±10%, 0.1 sec | Max of ±10%, 0.1 sec | Same |
| EtCO2 | ±(0.3 vol% + 4% of reading) within 0-15% range | ±(0.3 vol% + 4% of reading) within 0-15% range | Same |
| InspCO2 | ±(0.3 vol% + 4% of reading) within 0-15% range | ±(0.3 vol% + 4% of reading) within 0-15% range | Same |
| Apnea-Hypopnea Index (AHI) | No | No | Same |
11
12
13
The Vivo 45 LS is a modification to the Vivo 45 LS ventilator cleared in K193586. The devices share the same mechanical parts, electronics, and software, except for the differences described below.
High Flow Nasal Therapy (HFNT): The device software has been modified to provide an option for high flow nasal therapy in which the airflow is controlled according to a user setting.
Alarm Pre-Silence: The device software has been modified to provide the user the ability to pre-silence alarms for the coming two minutes. The existing Audio Pause hardware button for silencing active alarms is used for the pre-silence function by the user pressing and holding it down for three seconds.
Humidifier: Humidification can now be provided via a metal heater plate and associated electronics integrated into the base of the Vivo 45 LS device, combined with a click-in humidifier water chamber accessory which also has a metal plate that contacts the heater and transfers the heat to the water. The device software allows the user to set the heater temperature, controls the temperature, monitors for faults, and provides associated alarms. Use of the humidifier is limited to non-invasive ventilation only.
Heated Wire Patient Circuit: Heating of the patient circuit can now be provided via electronics integrated into the Vivo 45 LS device, combined with a heated wire patient circuit accessory which has a proprietary electrical connector that plugs into the back of the Vivo 45 LS device. The patient circuit accessory has a spiraled wire embedded in its wall to receive power the Vivo 45 LS and heat the wall, and a temperature sensor at the patient-end. The device software allows the user to set the temperature at the patient-end, controls the temperature, monitors for faults, and provides associated alarms. Use of the heated wire patient circuit is limited to non-invasive ventilation only.
Supplemental Oxygen Flow Rating: The rating for the maximum flow rate of oxygen introduced through the connector at the back of the Vivo 45 LS has been increased from 15 to 30 liters per minute. No changes to the Vivo 45 LS hardware or software were necessary to accommodate this change in rating. The change was made based on safety and performance
14
verification. The extended supplemental oxygen flow range can be useful for HFNT. The labeling of the Vivo 45 LS has been updated accordingly.
Performance Data
The Vivo 45 LS was subjected to performance testing which verified conformance with all requirements specifications and applicable standards, and which included comparative testing with the Vivo 45 LS predicate device which supported substantial equivalence.
| Performance Testing to Standards | |
|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 Medical electrical |
| equipment-Part 1: General requirements for basic safety and | |
| essential performance | |
| Electromagnetic | |
| compatibility | IEC 60601-1-2: 2014 Medical electrical equipment-Part 1-2: |
| General requirements for basic safety and essential | |
| performance-Collateral standard: Electromagnetic | |
| disturbances-Requirements and tests | |
| Usability | IEC 60601-1-6: 2010+A1:2013 Medical electrical |
| equipment-Part 1-6: General requirements for basic safety | |
| and essential performance-Collateral standard: Usability | |
| Alarms systems | IEC 60601-1-8: 2006 (Second edition) + Am. 1: 2012 |
| Medical electrical equipment-Part 1-8: General | |
| requirements for basic safety and essential performance- | |
| Collateral standard: General requirements, tests and | |
| guidance for alarm systems in medical electrical equipment | |
| and medical electrical systems | |
| Medical equipment used | |
| in home healthcare | |
| environment | IEC 60601-1-11: 2015 Medical electrical equipment-Part 1- |
| 11: General requirements for basic safety and essential | |
| performance-Collateral standard: Requirements for medical | |
| electrical equipment systems used in the home healthcare | |
| environment | |
| Critical care ventilators | ISO 80601-2-12:2020 Medical electrical equipment Part 2- |
| 12: Particular requirements for safety of lung ventilators- | |
| Critical care ventilators | |
| Respiratory gas monitors | ISO 80601-2-55: 2018 Medical electrical equipment Part 2- |
| 55: Particular requirements for the basic safety and essential | |
| performance of respiratory gas monitors | |
| Pulse oximeter | |
| equipment | ISO 80601-2-61:2017 Medical electrical equipment Part 2- |
| 61: Particular requirements for basic safety and essential | |
| performance of pulse oximeter equipment | |
| Home healthcare | |
| environment ventilators | |
| for ventilator-dependent | |
| patients | ISO 80601-2-72:2015 Medical electrical equipment Part 2- |
| 72: Particular requirements for basic safety and essential | |
| performance of home healthcare environment ventilators for | |
| ventilator-dependent patients | |
| Battery testing | IEC 62133: 2012 (2nd Ed) Secondary cells and batteries |
| requirements for portable sealed secondary cells, and for | |
| batteries made from them, for use in portable applications |
IEC 62133-2 Edition 1.0 2017 Secondary cells and batteries
containing alkaline or other non-acid electrolytes-Safety
requirements for portable sealed secondary cells, and for
batteries made from them. For use in portable applications –
Part 2: Lithium systems |
| Humidifier testing | ISO 80601-2-74: 2017 Medical electrical equipment Part 2-
74 : Particular requirements for basic safety and essential
performance of respiratory humidifying equipment |
Performance testing included testing to the standards and procedures listed below:
15
Biocompatibility: The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been evaluated for emission of volatile organic compounds (VOC), inorganic gases (CO, CO2, and Ozone) and particulate matter (PM2.5/PM10) in accordance with ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process. The humidified gas pathway comprised of the humidifier water chamber and heated wire patient circuit have been evaluated for solventextractable compounds and biocompatibility in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Additionally, the device was evaluated for emissions of aldehydes.
The Vivo 45 LS device and accessories were found to be biocompatible for the intended use, intended population and type of patient contact. Further details are provided below which support substantial equivalence.
| VOC | The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been tested in accordance with ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 3: Tests for emissions of volatile organic compounds. No VOC compounds were observed in quantities that represent a toxicological risk to the intended patient population. |
|---|---|
| Particulate matter | The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been tested in accordance with ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 2: Tests for emissions of particulate matter. Particulate quantities were well below acceptable limits of exposure for all patient populations. |
| Carbon monoxide | The entire gas pathway including the Vivo 45 LS device, humidifier and heated wire patient circuit have been tested for generation of inorganic gases including carbon monoxide per the recommendations of ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in |
| healthcare applications - Part 1: Evaluation and testing | |
| within a risk management process. Carbon monoxide | |
| emission was well below acceptable limits of exposure for | |
| all patient populations. | |
| Carbon dioxide | The entire gas pathway including the Vivo 45 LS device, |
| humidifier and heated wire patient circuit have been tested | |
| for generation of inorganic gases including carbon dioxide | |
| per the recommendations of ISO 18562-1:2017 | |
| Biocompatibility evaluation of breathing gas pathways in | |
| healthcare applications - Part 1: Evaluation and testing | |
| within a risk management process. Carbon dioxide | |
| emission was well below acceptable limits of exposure for | |
| all patient populations. | |
| Ozone | The entire gas pathway including the Vivo 45 LS device, |
| humidifier and heated wire patient circuit have been tested | |
| for generation of inorganic gases including ozone per the | |
| recommendations of ISO 18562-1:2017 Biocompatibility | |
| evaluation of breathing gas pathways in healthcare | |
| applications - Part 1: Evaluation and testing within a risk | |
| management process. Ozone emission was well below | |
| acceptable limits of exposure for all patient populations. | |
| Aldehydes | Aldehyde testing was conducted using the final, finished |
| Vivo 45 LS device (newly manufactured). Sampling for | |
| emission of aldehydes from the device at multiple time- | |
| points was conducted within a heated chamber at | |
| approximately 40° C, with the device set to the minimal | |
| clinically relevant flow rate (i.e., worst-case conditions). | |
| Targeted analysis for Formaldehyde, Acetaldehyde, | |
| Acrolein, Propionaldehyde, Crotonaldehyde, Butyraldehyde, | |
| Benzaldehyde, Isovaleraldehyde, Valeraldehyde, Total- | |
| Tolualdehyde, Hexaldehyde, and 2,5-dimethylbenzaldehyde | |
| was performed. The conclusion was that the Vivo 45 LS | |
| does not pose a risk for aldehyde exposure to adult or | |
| pediatric subjects when operated under worst case | |
| temperature and flow rate conditions. | |
| Extractable compounds | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for extractable compounds per the recommendations | |
| in ISO 18562-4:2017 and ISO 10993-18:2020 Biological | |
| evaluation of medical devices – Part 18: Chemical | |
| characterization of medical device materials within a risk | |
| management process, with the conclusion that use of the | |
| Vivo 45 LS in adult subjects will not pose a significant | |
| toxicological or biocompatibility risk. | |
| Cytotoxicity | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for cytotoxicity in accordance with ISO 10993-5:2009 | |
| Biological evaluation of medical devices - Part 5: Tests for | |
| in vitro cytotoxicity. The test article was found to be non- | |
| cytotoxic. | |
| Sensitization | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for sensitization in accordance with ISO 10993- | |
| 10:2010, Biological Evaluation of Medical Devices, Part 10: | |
| Tests for Irritation and Skin Sensitization. The test article | |
| was found to be non-sensitizing. | |
| Irritation / Intracutaneous | |
| Reactivity | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for irritation / intracutaneous reactivity in accordance | |
| with ISO 10993-10:2010, Biological Evaluation of Medical | |
| Devices, Part 10: Tests for Irritation and Skin Sensitization | |
| The test article was found to be non-irritating. | |
| Acute Systemic Toxicity | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for acute systemic toxicity in accordance with ISO | |
| 10993-11:2017 Biological Evaluation of Medical Devices - | |
| Part 11: Tests for Systemic Toxicity. The test article was | |
| found to be non-toxic. | |
| Materials Mediated | |
| Pyrogenicity | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for materials mediated pyrogenicity in accordance | |
| with ISO 10993-11:2017 Biological Evaluation of Medical | |
| Devices - Part 11: Tests for Systemic Toxicity. The test | |
| article was found to be non-pyrogenic. | |
| Genotoxicity – Reverse | |
| Mutation | The humidified gas pathway comprised of the humidifier |
| water chamber and heated wire patient circuit has been | |
| tested for genotoxicity reverse mutation in accordance with | |
| ISO 10993-3:2014, Biological Evaluation of Medical | |
| Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, | |
| and Reproductive Toxicity. The test article was found to be | |
| non-mutagenic. |
16
17
Performance Testing
Verification testing of the HFNT function was conducted, demonstrating that the function met all specifications.
Verification testing of the alarm pre-silence function was conducted, demonstrating that the function met all specifications.
The humidifier and heated wire functions were tested for humidity output, normal operation functions, detection and response to fault conditions including safe power cutoff and alarms, maximum water temperature, heated circuit temperature accuracy, cleaning, and gas leakage. Further, the Vivo 45 LS with these accessories installed
18
was subjected to comparative pressure, flow and volume waveforms testing versus the cleared Vivo 45 LS device. The Vivo 45 LS with humidifier and heated wire patient circuit met all specifications, and the comparative waveforms testing demonstrated equivalence to the cleared Vivo 45 LS device.
The Vivo 45 LS was tested with supplemental oxygen for safety and performance at the rated flow rate of 30 liters per minute. All tests passed.
Testing of the Vivo 45 LS was performed to confirm accuracy of controls and monitored values. The testing confirmed that the Vivo 45 LS meets its accuracy specifications.
Alarms testing of the Vivo 45 LS was performed which confirmed proper operation of physiologic and technical alarms.
Cybersecurity testing confirmed conformance with all cybersecurity specifications.
Software verification and validation were performed at the unit, integration, and system level according to plans and protocols with predetermined pass/fail criteria. All tests passed.
Summative human factors testing was performed which determined the Vivo 45 LS is safe and effective for the intended users, uses and use environments.
The study included 15 healthcare professionals (HCP) who are respiratory therapists (RT) and 15 HCP who are registered nurses (RN) performing the tasks necessary to use the device in a clinical setting and 15 lay caregiver (LCG) users performing the tasks necessary to use the device in a home setting.
The critical tasks for Vivo 45 LS use were tested with the intended users, for its intended use and in a representative use environment. Based on the performance of the test participants, their observed behaviors, subjective feedback, and a root cause analysis of all use errors, close calls and difficulties observed, use of the Vivo 45 LS was successfully validated.
- The intended user populations can safely and successfully use the Vivo 45 ● ra
- The training was understood and successfully applied by the users ●
- Performance of critical tasks did not result in any patterns of use errors or . difficulties that would lead to patient harm (including compromised medical care)
- No new hazards, hazardous situations, or hazard-related use-scenarios were identified in the study
- . Use-related hazards have been reasonably mitigated and residual risks that cannot be further mitigated have been reduced as far as possible and are considered acceptable.
In addition to the summative human factors study, the following HFE/UE processes have been conducted and support the conclusion regarding safety and efficacy:
· Multiple formative HF studies
19
- Prior summative HF studies (and the present changes follow the same user interface paradigm as previously studied) • Design reviews with subject matter experts • Assessment of known use problems and review of field data • Use-related risk management activities • Discussion of residual use-related risk
The testing described confirms that the Vivo 45 LS meets all requirements specifications and complies with the relevant standards, and is therefore substantially equivalent to the predicate devices.
Conclusion:
The Vivo 45 LS is substantially equivalent to the predicate devices, as the devices share a common intended use and technological characteristics as demonstrated through performance testing.