Breathe Technologies Life2000™ Ventilation System

K170037 · Breathe Technologies · CBK · Aug 11, 2017 · Anesthesiology

Device Facts

• Record ID: K170037
• Device Name: Breathe Technologies Life2000™ Ventilation System
• Applicant: Breathe Technologies
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Breathe Technologies Life2000™ Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor. The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System is applicable for adult patients who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control mode of ventilation. The System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

Device Story

Life2000 Ventilation System provides mechanical ventilatory support; consists of Life2000 Ventilator and Life2000 Compressor. Ventilator delivers physician-prescribed volume via Universal Connector to ET tube or non-invasive mask (e.g., Breathe Pillows Entrainment Interface). Compressor provides dedicated source of compressed air; supplements facility in-wall gas or tanks. System operates in Assist/Control mode. Used in home and institutional settings by trained personnel under physician direction. Ventilator uses venturi effect to augment flow. Output monitored via PIP alarms. Benefits include portable continuous ventilatory support. Compressor includes battery backup, motor stall/pressure alarms, and membrane air dryer. Healthcare providers use system to manage adult patients requiring respiratory support.

Clinical Evidence

Bench testing only. Compliance with ISO 10993-1, ASTM F1246-91, AAMI/ANSI 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-72, IEC 62133, and IEC 62366. Human Factors Validation (HFV) testing conducted with over 100 participants across 4 user groups (patients, caregivers, respiratory therapists, physicians/nurses) in simulated home and clinical environments demonstrated safe and effective use without critical use errors.

Technological Characteristics

Portable battery-powered ventilator and compressor system. Materials: Polycarbonate (mask body), Silicone (nose pillows). Compressor features membrane air dryer, mist separator, and fixed-speed motor. Connectivity: Standalone. Power: Mains and battery. Alarms: High motor/electronics temperature, motor stall, low/high pressure. Sterilization: Non-sterile. Software: Embedded firmware.

Indications for Use

Indicated for adult patients requiring continuous or intermittent mechanical ventilatory support via invasive (ET tube) or non-invasive (mask) positive pressure ventilation in home and institutional settings. Contraindicated for ambulance or air transportation.

Regulatory Classification

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.

Predicate Devices

• Life2000 Ventilation System (K141943)
• Hybrid NE Mask (K062019)

Reference Devices

• Compressor Mini (K023354)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, with a stylized design resembling a bird or wing above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

August 11, 2017

Breathe Technologies % Craig Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman St. Alameda, California 94501

Re: K170037

Trade/Device Name: Breathe Technologies Life2000™ Ventilation System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, NOU Dated: July 3, 2017 Received: July 5, 2017

Dear Craig Coombs:

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 Actinclude 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.

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

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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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

# Michael J. Ryan -S

for Lori Wiggins, MPT, CLT 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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#### Indications for Use

510(k) Number (if known) K170037

Device Name

Breathe Technologies Life2000™ Ventilation System

Indications for Use (Describe)

The Breathe Technologies Life2000™ Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

The Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor.

The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System is applicable for adult patients who require the following types of ventilatory support:

- · Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- · Assist/Control mode of ventilation.

The System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| Category | Comments |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Breathe Technologies<br>175 Technology Drive, Suite 100<br>Irvine, CA 92618<br>Tel: [phone]<br>Contact: Samir Ahmad, Ph.D. |
| Correspondent Contact<br>Information: | Craig Coombs<br>President<br>Coombs Medical Device Consulting, Inc<br>1193 Sherman St.<br>Alameda, CA 94501<br>Office: 510.337.0140<br>Fax: [phone] |
| Device Common Name: | Mechanical Ventilator |
| Device Classification & Name: | 21 CFR 868.5895 Continuous Ventilator |
| Device Classification &<br>Product Code: | Class II<br>Primary: CBK; Secondary: NOU |
| Device Proprietary Name: | Breathe Technologies Life2000™ Ventilation System |

## Section 5: 510(k) Summary

#### Predicate Device Information:

| Predicate Device: | Life2000 Ventilation System |
|----------------------------------------------------|-----------------------------|
| Predicate Device Manufacturer: | Breathe Technologies, Inc. |
| Predicate Device Premarket Notification #: | K141943 |
| Predicate Device Common Name: | Continuous Ventilator |
| Predicate Device Classification & Name: | 21 CFR 868.5895 |
| Predicate Device Classification &<br>Product Code: | Class II<br>CBK |

## Reference Device Information:

| Reference Device: | Compressor Mini |
|-------------------------------------------|-------------------------|
| Reference Device Manufacturer: | Siemens |
| Reference Device Premarket Notification # | K023354 |
| Reference Device Common Name: | Portable Air Compressor |
| Reference Device Classification & Name: | 21 CFR 868.6250 |
| Reference Device Classification & | Class II |
| Product Code: | BTI |

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#### Predicate Device Information:

| Predicate Device: | Hybrid NE Mask |
|----------------------------------------------------|-------------------------------------------------|
| Predicate Device Manufacturer: | RespCare, Inc. |
| Predicate Device Premarket Notification #: | K062019 |
| Predicate Device Common Name: | Face Mask<br>Accessory to Continuous Ventilator |
| Predicate Device Classification & Name: | 21 CFR 868.5895 |
| Predicate Device Classification &<br>Product Code: | Class II<br>CBK |

## b. Date Summary Prepared

#### 2 August 2017

#### c. Description of Device

The Breathe Technologies Life2000 Ventilation System includes a portable, battery powered, continuous ventilator that was cleared in K141943 along with the Breathe Pillows Interface, Universal Connector and various other dedicated accessories.

In this submission, the Life2000 Ventilation System is expanding with the inclusion of additional components, including the Life2000 Compressor, a portable air compressor. This Life2000 Compressor provides a primary source of compressed air for the Life2000 Ventilator, in addition to the previously cleared gas sources of facility in-wall compressed gas (air & oxygen) and tanks of compressed medical gas. The Life2000 Compressor provides a dedicated docking station for the Life2000 Ventilator.

The Ventilator administers the physician-prescribed volume to the patient via the previously cleared Breathe Technologies Universal Connector which connects into the patient's tracheostomy tube, endotracheal tube, or any off the shelf non-invasive mask. It can also be used with the previously cleared Breathe Technologies Pillows Interface (K141943), a type of nasal mask.

This submission includes new versions of the Pillows Interface, labeled as the Breathe Pillows Entrainment Interface, that have an inlet for supplemental oxygen. It also includes labeling for the use of third party supplemental Oxygen Adapters for use with the Universal Connector. These inlets or Adapters allow the physician to administer supplemental oxygen into the patient circuit or interface.

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#### d. Intended Use

The Breathe Technologies Life2000™ Ventilation System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

The Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor.

The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System is applicable for adult patients who require the following types of ventilatory support:

- · Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- · Assist/Control mode of ventilation.

The System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.

#### e. Comparison to Predicate Device

The Life2000 Ventilation System (Life2000 Ventilator + Accessories + Life2000 Compressor) is identical in Intended Use, Indications for Use, technology, performance, and environment of use to the Life2000 Ventilation System (Life2000 Ventilator + Accessories) that was cleared under K141943.

The Life2000 Ventilator, a component of the Life2000 Ventilation System, is fundamentally unchanged between the predicate and application Systems.

The Life2000 Compressor is included in this Life2000 Ventilation System 510(k) because it is a dedicated accessory for the Life2000 Ventilation System. The addition of the Life2000 Compressor as a source of compressed air for the Life2000 Ventilator raises no new questions of safety or efficacy. The Life2000 Compressor is referenced to the Siemens Compressor Mini (K023354) in regards to technology, technology application and use risk. This submission includes testing to support the conclusion that the Life2000 Compressor provides an adequate level of compressed air to the Life2000 Ventilator.

The oxygen inlets added to the previously cleared Breathe Pillows Interface are substantially equivalent in Intended Use. Indications for Use, technology and design as the oxygen inlet ports in the RespCare Hybrid NE Mask (K062019).

All supporting data demonstrate that the Life2000 Compressor is appropriate for its intended use within the Life2000 Ventilation System. All supporting data demonstrate the Breathe Pillows Entrainment Interface, and the use of third-party Oxygen Adapters in-line with the Universal Circuit Connector, are appropriate for their intended use within the Life2000 Ventilation System.

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#### f. Summary of Supporting Data

The bench testing along with the electrical safety testing demonstrate that the Life2000 Compressor is an appropriate source of compressed gas for the Life2000 Ventilation System.

In particular, testing demonstrated that Life2000 Ventilation System is compliant with the following Guidelines and Standards:

- ISO 10993-1 (2009): Biological evaluation of medical devices -- Part 1: Evaluation and testing
- o Materials were identical to those used in an identical manner in previously cleared Breathe Technologies Ventilation Systems.
- New particulate and volatile organic compound (VOC) testing was conducted for о the Life2000 Compressor as a component of the Life2000 Ventilation System.
- . FDA Draft Reviewer Guide for Ventilators (July 1995)
- ASTM F1246-91 (1991, Reapproved 2005); Standard Specification for Electrically ● Powered Home Care Ventilators, Part 1 - Positive Pressure Ventilators and Ventilator Circuits
- AAMI/ANSI 60601 1 (2005): Medical electrical equipment General Requirements ● for Safety and Essential Performance
- . IEC 60601-1-2 (2007) Medical Electrical Equipment, General Requirements for Basic Safety & Essential Performance: Electromagnetic Compatibility - Requirements & Test.
- ISO 80601-2-12 (2011), First Edition 2011-04-15, Medical electrical equipment -Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators.
- ISO 80601-2-72: 2015 Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients.
- IEC 62133 Edition 2.0 2012: 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.
- IEC 62366: 2007: Medical devices - Application of usability engineering to medical devices.
- FDA Guidance Document: Design Considerations for Devices Intended for Home Use. ● Updated August 8, 2016. Additional EMC home level testing was performed per guidance.
- ANSI/AMEE HE75:2009: Human Factors Engineering-Design of Medical Devices. ●

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Image /page/7/Picture/0 description: The image shows the logo for Breathe Technologies. The word "Breathe" is written in a large, light blue font. Below it, the word "TECHNOLOGIES" is written in a smaller, light blue font. There is a light blue swoosh design below the word "TECHNOLOGIES".

- FDA Guidance Document: Medical Device Use Safety: Incorporating Human Factors . Engineering into Risk Management, draft 2011.
- AIM 7351731: Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers

#### g. Summary of Human Factors Data

A series of HFE/UE analyses, design refinement activities and Human Factors Validation (HFV) tests were conducted to evaluate the safe and effective use of the Life2000™ Ventilation System by its intended user populations in its intended use environments. The results of the HFV tests, included the testing of over 100 participants from 4 user groups:

- Patients
- . Caregivers
- Respiratory Therapists ●
- Physicians and Critical Care Nurses .

The test participants were evaluated under home and clinical simulated environments.

Human Factors validation revealed that representative participants were able to use the Life2000™ Ventilation System without use errors that could result in negative clinical outcomes. As a result of these HFE/UE studies, the Life2000™ Ventilation System has been found to be as safe and effective for the intended users, uses and use environments as the predicate Life2000 Ventilation System.

Breathe Technologies concludes that both clinicians and lay care-givers could properly operate the application Life2000 Ventilation System (Ventilator & Compressor) after receiving the required training and reading the Instructions for Use, just as was demonstrated with the predicate Life2000 Ventilation System.

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# Tabular Comparison: Application Life2000 Ventilation System to Predicate Life2000 Ventilation System.

| | Predicate Device:<br>Life2000 Ventilation<br>System | Application Device:<br>Life2000 Ventilation<br>System | Difference<br>Status |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Breathe Technologies<br>Life2000 Ventilation System is<br>intended to provide continuous<br>or intermittent ventilatory<br>support for the care of<br>individuals who require<br>mechanical ventilation. The<br>ventilator is intended for use by<br>qualified, trained personnel<br>under the direction of a<br>physician.<br>Specifically, the ventilator is<br>applicable for adult patients who<br>require the following types of<br>ventilatory support:<br>- Positive Pressure<br>Ventilation, delivered<br>invasively (via ET tube) or<br>non-invasively (via mask).<br>- Assist/Control mode of<br>ventilation.<br>The ventilator is suitable for use<br>in home and institutional<br>settings. | The Breathe Technologies<br>Life2000™ Ventilation System is<br>intended to provide continuous<br>or intermittent ventilatory<br>support for the care of<br>individuals who require<br>mechanical ventilation.<br>The Life2000 Ventilation<br>System consists of the Life2000<br>Ventilator and the Life2000<br>Compressor.<br>The System is intended for use<br>by qualified, trained personnel<br>under the direction of a<br>physician. Specifically, the<br>System is applicable for adult<br>patients who require the<br>following types of ventilatory<br>support:<br>• Positive Pressure<br>Ventilation, delivered<br>invasively (via ET tube) or<br>non-invasively (via mask).<br>• Assist/Control mode of<br>ventilation.<br>The System is suitable for use in<br>home and institutional settings<br>and is not intended for<br>ambulance or air transportation. | Identical, except for<br>the name change.<br>In the predicate<br>submission, the term<br>"System" referred to<br>only the Ventilator and<br>its accessories. In the<br>application device, the<br>term "System" refers<br>to the Ventilator and<br>its accessories,<br>including the Life2000<br>Compressor and<br>modified Pillows<br>Interface.<br>The addition of the<br>Compressor and the<br>modified Pillows<br>Interface does not<br>change the intended<br>use of the Ventilator. |
| | Predicate Device:<br>Life2000 Ventilation<br>System | Application Device:<br>Life2000 Ventilation<br>System | Difference<br>Status |
| Product<br>Classification<br>Code | CBK | CBK & NOU | Identical. The addition<br>of the Portable Air<br>Compressor does not<br>change the Ventilator<br>System overall product<br>code.<br><br>The predicate System<br>was cleared for home<br>use, but the NOU<br>procode was not<br>added. This<br>administrative<br>oversight is being<br>corrected in this<br>submission. |
| Principal<br>Operator | Trained personnel under the<br>direction of a physician | Trained personnel under the<br>direction of a physician | Identical |
| Environment<br>of Use | Institution & Home | Institution & Home | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Patient<br>Interface:<br>General<br>Description | Delivered invasively (via ET<br>tube) or non-invasively (via<br>mask). | Delivered invasively (via ET<br>tube) or non-invasively (via<br>mask). | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate. |
| Patient<br>Interfaces<br>Possible | Breathe Pillows Interface;<br>Most 3rd party Masks attached<br>via Breathe Universal<br>Connector | Breathe Pillows Interface;<br>Most 3rd party Masks attached<br>via Breathe Universal<br>Connector | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Port in Mask<br>for<br>Supplemental<br>Oxygen? | Not Available with original<br>Breathe Pillows Interface | Supplemental Oxygen port is<br>added to the Breathe Pillow<br>Interface to create the Breathe<br>Pillow Entrainment Interface | The Supplemental<br>Oxygen port in the<br>Breathe Pillows<br>Entrainment Interface<br>allows for same<br>Oxygen ranges as in<br>predicate device |
| Type of<br>Supply Gas<br>To the<br>Ventilator | Pressurized Oxygen or<br>Air (50 psi) | Pressurized Oxygen or<br>Air (50psi) | The ventilator in this<br>application is identical<br>to the predicate<br>ventilator. Both use the<br>same type of supply<br>gas. |
| | Predicate Device:<br>Life2000 Ventilation<br>System | Application Device:<br>Life2000 Ventilation<br>System | Difference<br>Status |
| Method of<br>Delivering<br>Supply Gas<br>to the<br>Ventilator | Compressed oxygen or air from<br>tanks, or wall supply | Compressed oxygen or air from<br>tanks, or wall supply or<br>compressed room air from the<br>Breathe Life2000 Compressor | The Life2000<br>Compressor is an<br>additional device for<br>supplying compressed<br>air to the Ventilator |
| Power<br>Source | The Ventilator is battery<br>powered, it can be run while<br>battery is charging | The Ventilator and Compressor<br>are battery powered, they can<br>be run while their batteries are<br>charging | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Operational<br>Modes | Volume Control<br>Volume Assist/Control<br>Volume Assist | Volume Control<br>Volume Assist/Control<br>Volume Assist | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Design<br>Designation | Portable Continuous Care | Portable Continuous Care | Identical |
| Size<br>WxLxH (in) | 3.2 x 7.7 x 1.0<br>Ventilator only | 12.1 x 8.7 x 8.6<br>Ventilator & dedicated<br>Life2000 Compressor<br>combined | Both Ventilators are<br>identical. Both<br>Systems are portable. |
| Weight | 1.1 lbs<br>Ventilator only | 16 lbs:<br>Ventilator & dedicated<br>Life2000 Compressor<br>combined | Both Ventilators are<br>identical. Both are<br>portable. |
| Volume<br>Setting<br>Range | 50 - 750 ml/breath | 50 - 750 ml/breath | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate. |
| Resultant<br>Tidal<br>Volume | 50 - Up to 2000 ml/breath due<br>to venturi effect | 50 - Up to 2000 ml/breath due<br>to venturi effect | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| PEEP Setting | 0 - 10 cmH2O | 0 - 10 cmH2O | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| PIP Alarms<br>&<br>Monitoring | Yes | Yes | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Adjustable<br>Inspiration<br>Time | 0.15 to 3 seconds | 0.15 to 3 seconds | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| | Predicate Device:<br>Life2000 Ventilation<br>System | Application Device:<br>Life2000 Ventilation<br>System | Difference<br>Status |
| Supply Gas | Oxygen, Air | Oxygen, Air | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Method of<br>Supply Gas<br>Pressurization | Compressed source for Air<br>Compressed source for 02<br>(both from Facility or tank) | Compressed source for Air<br>(from Facility Compressor,<br>Life2000 Compressor or tank);<br>Compressed source for 02<br>(From Facility Compressor or<br>directly from an O2 Tank) | Equivalent Result<br>(waveforms)<br>independent of supply<br>gas pressurization<br>method. |
| Sterilized? | Ventilator: No<br>Patient Circuit: No | Ventilator: No<br>Patient Circuit: No | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Compressed<br>Gas<br>Requirements | 41-87 psi | 41-87 psi | Identical because this<br>aspect of the<br>Ventilation System is<br>unchanged from the<br>predicate |
| Compressor<br>Output | None | Life2000 Compressor<br>continuous output 17Lpm (@<br>50psi<br>Maximum instantaneous output<br>~40Lpm @ 50 psi | Predicate did not have<br>a dedicated<br>Compressor.<br>Nonetheless no new<br>questions of Safety and<br>Efficacy are raised<br>because both<br>Ventilators are<br>designed to work with<br>compressed air in the<br>same way. Waveform<br>data validates that<br>Life2000 Compressor<br>provides adequate<br>output. |

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Image /page/9/Picture/1 description: The image contains the logo for Breathe Technologies. The word "Breathe" is in large, blue, sans-serif font. Below that, the word "TECHNOLOGIES" is in a smaller, sans-serif font, also in blue. A blue swoosh design is below the word "TECHNOLOGIES".

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Image /page/10/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is in a large, sans-serif font and is colored in a light blue. Below "Breathe" is the word "TECHNOLOGIES" in a smaller, sans-serif font, also in light blue. Below the text is a stylized graphic that appears to be a wave or a breath of air, also in light blue.

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Image /page/11/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is in a large, sans-serif font and is colored in…