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 Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes a Breathe Technologies Life2000™ Ventilation System seeking 510(k) clearance, intending to demonstrate substantial equivalence to its predicate device (the previous version of the Life2000 Ventilation System, K141943) and a reference device (Siemens Compressor Mini, K023354). The acceptance criteria are largely implied by compliance with various medical device standards and through bench testing and human factors validation. The "device performance" is primarily assessed against the predicate and reference devices, demonstrating functional equivalence and safety.

Since specific quantitative acceptance criteria with numerical targets and direct performance comparisons are not explicitly laid out in a table in the provided text, I will infer them from the comparisons made to the predicate and reference devices, and the standards listed.

Inferred Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Inferred from Predicate/Standard)	Reported Device Performance (Application Device)
Intended Use	Provide continuous or intermittent ventilatory support for adults requiring mechanical ventilation (invasive/non-invasive, Assist/Control mode) in home/institutional settings.	Identical to predicate, with the addition of the Life2000 Compressor and modified Pillows Interface. The addition does not change the intended use of the Ventilator.
Technology	Similar fundamental technology as predicate (Vaporizer) and reference device (Compressor).	Ventilator is fundamentally unchanged from predicate. Compressor technology (electrical powered air compressor, air inlet filter, compressor with motor (4 heads vs 2 heads in reference device), air dryer (membrane dryer vs cooling coil/thermoelectric cooler in reference), pressure regulation (motor speed vs regulator/tank in reference), room air inlet, compressed air outlet, drainage, dust filter, cooling fans, power inlet, ON/OFF switch, user interface, alarms (additional motor stall alarm), power supply (60 min battery option added to mains)). All differences are stated to not raise new questions of safety or efficacy.
Performance (Ventilator)	Volume Setting Range: 50 - 750 ml/breath Resultant Tidal Volume: 50 - up to 2000 ml/breath due to venturi effect PEEP Setting: 0 - 10 cmH2O PIP Alarms & Monitoring: Yes Adjustable Inspiration Time: 0.15 to 3 seconds	Identical to predicate Life2000 Ventilator for all these parameters.
Performance (Compressor)	Flow Output: Sufficient to support the specified ventilator (Reference device: 30 L/min) Pressure Output: ~50 psi (Reference device: 50 – 64 psi)	Continuous Flow Output: 17 L/min; Peak Flow Output: ~40 L/min. Testing shows that the compressor can support the maximum volume output of the ventilator. The Life2000 Ventilator requires less flow from the Compressor to allow the same outputs because it entrains room air. Nominal Pressure Output: 50 psi (range 47-64 psi). Functionally identical.
Biocompatibility	Compliance with ISO 10993-1.	Materials identical to previously cleared systems. New particulate and volatile organic compound (VOC) testing conducted for the Life2000 Compressor.
Electrical Safety	Compliance with AAMI/ANSI 60601-1, IEC 60601-1-2.	Bench testing, along with electrical safety testing, along with EMC home level testing performed and found compliant.
Mechanical Safety	Compliance with ASTM F1246-91, ISO 80601-2-12, ISO 80601-2-72.	Bench testing demonstrated complaint with these standards.
Human Factors/Usability	Safe and effective use by intended user populations in intended use environments without use errors leading to negative clinical outcomes.	A series of HFE/UE analyses, design refinement, and Human Factors Validation (HFV) tests were conducted. Results revealed representative participants were able to use the system without use errors that could result in negative clinical outcomes. Concluded to be as safe and effective as the predicate system. Clinicians and lay care-givers could properly operate the device after required training and IFU.
Mask Performance	Provides noninvasive interface, allows oxygen supplementation, functionally equivalent despite differences in facial interface (nasal vs. mouth & nose) and entrainment method.	Breathe Pillows Entrainment Interface: Provides noninvasive interface, allows oxygen supplementation. Utilizes entrainment (similar to K141943) while predicate (K062019) does not. Facial interface is nose only (vs. mouth & nose). Offered in 4 sizes (S,M,L,XL vs S,M,L). Materials (Polycarbonate, Silicone) are the same. No headgear needed (vs. Nylon, Neoprene, Velcro). All differences concluded to not raise new questions of safety or efficacy; functionally equivalent output.

2. Sample Sizes and Data Provenance

Test Set (Human Factors Validation - HFV): "over 100 participants"
- Data Provenance: Not explicitly stated, but the context of an FDA submission for a US company (Breathe Technologies, Irvine, CA) suggests the data is likely from the USA and would be prospective as it involves active testing with participants for validation.
- Test Set (Bench Testing): Not explicitly stated, but typically involves a number of units sufficient to demonstrate design validation and compliance with standards.
Training Set: Not mentioned in the provided text. The document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device through testing and comparison, rather than developing a new algorithm/AI from a training set.

3. Number of Experts and their Qualifications (for Ground Truth)

Human Factors Validation: No explicit mention of experts establishing a "ground truth" for the test set in the traditional sense (e.g., radiologists interpreting images). The HFV tests evaluated user performance against usability objectives (safe and effective use).
- The study involved diverse user groups: Patients, Caregivers, Respiratory Therapists, and Physicians and Critical Care Nurses. Their performance in using the device constituted the primary evaluation in the HFV. Their "qualifications" are implied by their roles as end-users of the device.

4. Adjudication Method (for Test Set)

The document does not describe an adjudication method in the context of expert consensus, as it is not an interpretative study. The Human Factors Validation (HFV) tests assessed user performance directly.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document describes a substantial equivalence submission for a physical medical device (ventilator system), not an AI/software device requiring human reader interpretation or assistance. Therefore, there is no discussion of AI assistance or its effect size on human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a hardware medical device (ventilator system and accessories), not an algorithm or AI. Standalone performance for this device would refer to its functional performance as a ventilator (volume, pressure, alarms, etc.), which was tested through bench testing and compliance with various standards, as listed. The "algorithm" in this context would be the device's control software, which is implicitly validated through the functional and performance testing.

7. Type of Ground Truth Used

For Human Factors Validation: The ground truth was implicitly the observed safe and effective use of the device by representative users (patients, caregivers, respiratory therapists, physicians, and critical care nurses) in simulated environments, as evaluated against predefined usability goals and error detection.
For Bench Testing and Compliance: The ground truth was established by approved engineering specifications, international/national standards, and regulatory guidelines (e.g., ISO 10993-1, FDA Draft Reviewer Guide for Ventilators, ASTM F1246-91, AAMI/ANSI 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-72, IEC 62133, IEC 62366, FDA Guidance Documents). The device's performance was measured against these objective criteria.

8. Sample Size for the Training Set

Not applicable / Not mentioned. The document does not describe a machine learning algorithm or AI component that would require a distinct training set. The submission focuses on validating hardware components and their integrated system.

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

Not applicable. As no training set for an AI/algorithm is mentioned, the method for establishing its ground truth is not discussed.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.

· 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Category	Comments
Sponsor:	Breathe Technologies175 Technology Drive, Suite 100Irvine, CA 92618Tel: 949-988-7724Contact: Samir Ahmad, Ph.D.
Correspondent ContactInformation:	Craig CoombsPresidentCoombs Medical Device Consulting, Inc1193 Sherman St.Alameda, CA 94501Office: 510.337.0140Fax: 510.337.0416
Device Common Name:	Mechanical Ventilator
Device Classification & Name:	21 CFR 868.5895 Continuous Ventilator
Device Classification &Product Code:	Class IIPrimary: 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 &Product Code:	Class IICBK

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 MaskAccessory to Continuous Ventilator
Predicate Device Classification & Name:	21 CFR 868.5895
Predicate Device Classification &Product Code:	Class IICBK

b. Date Summary Prepared

2 August 2017

c. Description of Device

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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.

· 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:Life2000 VentilationSystem	Application Device:Life2000 VentilationSystem	DifferenceStatus
Indicationsfor Use	The Breathe TechnologiesLife2000 Ventilation System isintended to provide continuousor intermittent ventilatorysupport for the care ofindividuals who requiremechanical ventilation. Theventilator is intended for use byqualified, trained personnelunder the direction of aphysician.Specifically, the ventilator isapplicable for adult patients whorequire the following types ofventilatory support:- Positive PressureVentilation, deliveredinvasively (via ET tube) ornon-invasively (via mask).- Assist/Control mode ofventilation.The ventilator is suitable for usein home and institutionalsettings.	The Breathe TechnologiesLife2000™ Ventilation System isintended to provide continuousor intermittent ventilatorysupport for the care ofindividuals who requiremechanical ventilation.The Life2000 VentilationSystem consists of the Life2000Ventilator and the Life2000Compressor.The System is intended for useby qualified, trained personnelunder the direction of aphysician. Specifically, theSystem is applicable for adultpatients who require thefollowing types of ventilatorysupport:• Positive PressureVentilation, deliveredinvasively (via ET tube) ornon-invasively (via mask).• Assist/Control mode ofventilation.The System is suitable for use inhome and institutional settingsand is not intended forambulance or air transportation.	Identical, except forthe name change.In the predicatesubmission, the term"System" referred toonly the Ventilator andits accessories. In theapplication device, theterm "System" refersto the Ventilator andits accessories,including the Life2000Compressor andmodified PillowsInterface.The addition of theCompressor and themodified PillowsInterface does notchange the intendeduse of the Ventilator.
	Predicate Device:Life2000 VentilationSystem	Application Device:Life2000 VentilationSystem	DifferenceStatus
ProductClassificationCode	CBK	CBK & NOU	Identical. The additionof the Portable AirCompressor does notchange the VentilatorSystem overall productcode.The predicate Systemwas cleared for homeuse, but the NOUprocode was notadded. Thisadministrativeoversight is beingcorrected in thissubmission.
PrincipalOperator	Trained personnel under thedirection of a physician	Trained personnel under thedirection of a physician	Identical
Environmentof Use	Institution & Home	Institution & Home	Identical because thisaspect of theVentilation System isunchanged from thepredicate
PatientInterface:GeneralDescription	Delivered invasively (via ETtube) or non-invasively (viamask).	Delivered invasively (via ETtube) or non-invasively (viamask).	Identical because thisaspect of theVentilation System isunchanged from thepredicate.
PatientInterfacesPossible	Breathe Pillows Interface;Most 3rd party Masks attachedvia Breathe UniversalConnector	Breathe Pillows Interface;Most 3rd party Masks attachedvia Breathe UniversalConnector	Identical because thisaspect of theVentilation System isunchanged from thepredicate
Port in MaskforSupplementalOxygen?	Not Available with originalBreathe Pillows Interface	Supplemental Oxygen port isadded to the Breathe PillowInterface to create the BreathePillow Entrainment Interface	The SupplementalOxygen port in theBreathe PillowsEntrainment Interfaceallows for sameOxygen ranges as inpredicate device
Type ofSupply GasTo theVentilator	Pressurized Oxygen orAir (50 psi)	Pressurized Oxygen orAir (50psi)	The ventilator in thisapplication is identicalto the predicateventilator. Both use thesame type of supplygas.
	Predicate Device:Life2000 VentilationSystem	Application Device:Life2000 VentilationSystem	DifferenceStatus
Method ofDeliveringSupply Gasto theVentilator	Compressed oxygen or air fromtanks, or wall supply	Compressed oxygen or air fromtanks, or wall supply orcompressed room air from theBreathe Life2000 Compressor	The Life2000Compressor is anadditional device forsupplying compressedair to the Ventilator
PowerSource	The Ventilator is batterypowered, it can be run whilebattery is charging	The Ventilator and Compressorare battery powered, they canbe run while their batteries arecharging	Identical because thisaspect of theVentilation System isunchanged from thepredicate
OperationalModes	Volume ControlVolume Assist/ControlVolume Assist	Volume ControlVolume Assist/ControlVolume Assist	Identical because thisaspect of theVentilation System isunchanged from thepredicate
DesignDesignation	Portable Continuous Care	Portable Continuous Care	Identical
SizeWxLxH (in)	3.2 x 7.7 x 1.0Ventilator only	12.1 x 8.7 x 8.6Ventilator & dedicatedLife2000 Compressorcombined	Both Ventilators areidentical. BothSystems are portable.
Weight	1.1 lbsVentilator only	16 lbs:Ventilator & dedicatedLife2000 Compressorcombined	Both Ventilators areidentical. Both areportable.
VolumeSettingRange	50 - 750 ml/breath	50 - 750 ml/breath	Identical because thisaspect of theVentilation System isunchanged from thepredicate.
ResultantTidalVolume	50 - Up to 2000 ml/breath dueto venturi effect	50 - Up to 2000 ml/breath dueto venturi effect	Identical because thisaspect of theVentilation System isunchanged from thepredicate
PEEP Setting	0 - 10 cmH2O	0 - 10 cmH2O	Identical because thisaspect of theVentilation System isunchanged from thepredicate
PIP Alarms&Monitoring	Yes	Yes	Identical because thisaspect of theVentilation System isunchanged from thepredicate
AdjustableInspirationTime	0.15 to 3 seconds	0.15 to 3 seconds	Identical because thisaspect of theVentilation System isunchanged from thepredicate
	Predicate Device:Life2000 VentilationSystem	Application Device:Life2000 VentilationSystem	DifferenceStatus
Supply Gas	Oxygen, Air	Oxygen, Air	Identical because thisaspect of theVentilation System isunchanged from thepredicate
Method ofSupply GasPressurization	Compressed source for AirCompressed source for 02(both from Facility or tank)	Compressed source for Air(from Facility Compressor,Life2000 Compressor or tank);Compressed source for 02(From Facility Compressor ordirectly from an O2 Tank)	Equivalent Result(waveforms)independent of supplygas pressurizationmethod.
Sterilized?	Ventilator: NoPatient Circuit: No	Ventilator: NoPatient Circuit: No	Identical because thisaspect of theVentilation System isunchanged from thepredicate
CompressedGasRequirements	41-87 psi	41-87 psi	Identical because thisaspect of theVentilation System isunchanged from thepredicate
CompressorOutput	None	Life2000 Compressorcontinuous output 17Lpm (@50psiMaximum instantaneous output~40Lpm @ 50 psi	Predicate did not havea dedicatedCompressor.Nonetheless no newquestions of Safety andEfficacy are raisedbecause bothVentilators aredesigned to work withcompressed air in thesame way. Waveformdata validates thatLife2000 Compressorprovides adequateoutput.

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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 a light blue. Below "Breathe" is the word "TECHNOLOGIES" in a smaller, sans-serif font, also in light blue. Underneath the word "TECHNOLOGIES" is a curved line that is also light blue.

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Tabular Comparison: Application Life2000 Compressor to Reference Device, the Compressor Mini (K023354)

ElementCategory ornumber	Reference Device:Siemens Compressor Mini	Application:Breathe TechnologiesLife2000 Compressor	Substantial EquivalenceDiscussion
1.	Electrical Powered AirCompressor	Electrical Powered AirCompressor	Equivalent
2	Air Inlet Filter	Air Inlet Filter	Identical functionality
3	Compressor with Motor (2heads)	Compressor with motor (4heads)	Identical functionality
4	Air Dryer:- Cooling coil- Thermoelectric cooler- Water Separator/collector	Air Dryer:- Membrane dryer- Mist separator/collector	The predicate'scondensate method ofdrying is different frommechanically removingmoisture from the gaswith a MistSeparator/collector.Both end up with thesame result, and both canaccommodate the fullrange of flows from thespecified Ventilator.
5	Pressure Regulation:- Pressure regulator- Tank- Safety Valve- Standby Valve	Pressure Regulation:- Pressure relief valve- Tank- Motor Speed	The predicatecompressor generatesexcessive pressure whichis moderated by theregulator before it entersthe accumulator tank.The applicationcompressor generates theproper pressure in theaccumulator tank by afixed motor/pump speed.Both have safety valvesfor excess pressure. Theresults are functionallyidentical and do notcreate new issues ofsafety or efficacy.
6	Room Air Inlet only	Room Air Inlet only	Identical functionality
7	Compressed Air outlet	Compressed Air Outlet	Identical functionality
8	Drainage Valve	Drainage valve	Identical functionality
9	Drainage bottle	Drainage bottle	Identical functionality
10	Dust Filter (for cooling)	Dust Filter (for cooling)	Identical functionality
11	Cooling Fans	Cooling fans	Identical functionality
12	Power Inlet connector	Power Inlet connector	Identical functionality
13	ON/OFF switch	ON/OFF switch	Identical functionality
14	User Interface	User Interface	Identical functionality
ElementCategory ornumber	Reference Device:Siemens Compressor Mini	Application:Breathe TechnologiesLife2000 Compressor	Substantial EquivalenceDiscussion
16	AlarmsTemperaturePressure	Alarms:High motor temperature High electronics temperature Electronics circuit error Motor Stall Low and high pressure alarms (provided by the ventilator)	Application device hasthe same Alarms as thepredicate, and has anadditional Motor Stallalarm
17	Power SupplyMains	Power Supply60 min batteryMains	Both can be connected tomain power supply.Life2000 provides abackup battery option
18	Designed to supply only oneventilator at a time	Designed to supply only oneventilator at a time	Identical
19	Flow Output:30 Liters/min	Continuous Flow Output:17 L/minPeak Flow Output:40 Liters/min	Outputs are functionallyidentical because theysupport a specifiedventilator. The Life2000Ventilator requires lessflow from the Life2000Compressor to allow thesame outputs at thepatient mask because theVentilator entrains roomair to augment theCompressor flow.Testing shows that thecompressor can supportthe maximum volumeoutput of the ventilator
20	Pressure Output50 – 64 psi	Pressure Output:Nominal of 50 psi and rangeof 47 - 64 psi	Functionally identical
21	Ventilator Compatibility:Can be used with anyVentilator that meets its	Ventilator Compatibility:Can only be used with theLife2000 Ventilator	Functionally identical fortheir specifiedVentilators

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Image /page/13/Picture/1 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 curved line below the word "TECHNOLOGIES".

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Image /page/14/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is written in a large, sans-serif font in a light blue color. Below "Breathe" is the word "TECHNOLOGIES" in a smaller, sans-serif font, also in light blue. A curved, light blue line appears below the word "TECHNOLOGIES".

Component	Predicate:	Breathe Pillows	Substantial
Number	RespCare Hybrid NE	Entrainment Interface	Equivalence
	Mask	with Oxygen Inlet	Discussion
Indication for use:	The Hybrid NE Mask isintended to provide apatient interface forapplication of noninvasiveventilation. The mask is tobe used as an accessory toventilators that haveadequate alarms and safetysystems for ventilatorfailure, and which areintended to administerpositive pressureventilation. The mask willbe offered in a disposableversion and a multiuseversion. It is intended foruse on adult patients (>30kg), who are appropriatecandidates for noninvasiveventilation.(Applies to the standardversion):For homecare applications,the Hybrid NE Mask maybe reused multiple timesby a single patient. Forinstitutional applications(i.e. hospital or otherclinical settings), thisinterfacemay be reused multipletimes by multiple patients.(Applies to the Disposableversion):The RespCare Hybrid NEMask Disposable is asingle patient, single useinterface.	The Breathe PillowsEntrainment InterfaceMask is intended toprovide a patientinterface for applicationof noninvasiveventilation.The mask is to be used asan accessory to theBreathe Life2000Ventilation System.It is intended for use onadult patients who areappropriate candidatesfor noninvasiveventilation.The Pillows Interface isintended for use inhospital, institution andhome environments.The mask may be reusedmultiple times by a singlepatient.	These Indications forUse are nearlyidentical.Both masks areintended to be usedonly with Ventilatorsthat meet thespecifications of themask.Both are intended forthe same cohort(adults) in the sameenvironments ofhome, institutionaland hospital.The Breathe maskdoes not come in adisposable version.As a result, thedifferences betweenmasks do not raisenew questions ofsafety or efficacy.
Technology
Mask	Provides noninvasiveinterface between patientand Ventilator	Provides noninvasiveinterface between patientand Ventilator	Same
OxygenSupplementation atthe Mask	Yes	Yes	Same
ComponentNumber	Predicate:RespCare Hybrid NEMask	Breathe PillowsEntrainment Interfacewith Oxygen Inlet	SubstantialEquivalenceDiscussion
Is Entrainment usedto Supplement AirVolume fromVentilator?	No. All gas supplied tomask comes fromVentilator andsupplemental oxygeninputted into the mask	Yes. Gas supplied to themask comes from theVentilator, supplementaloxygen inputted into themask and from entrainedair	Both devices providea functionallyequivalent output thatis titrated to thepatient's needs.Both masks can inputsupplemental oxygeninto the gas streamfrom the Ventilator.This entrainmenttechnology isidentical to thatcleared in the BreatheInterface Pillowsmask in K141943.
Design
Facial Interface	Mouth & Nose	Nose Only	The Breathe deviceprovides adequateventilation throughthe nose only just asthe Hybrid Maskprovides adequateventilation throughthe Mouth and Nose.This interface isidentical to theBreathe PillowsInterface cleared inK141943This difference raisesno new questions ofsafety and efficacy.
Sizes	SmallMediumLarge	SmallMediumLargeExtra Large	Both masks offer arange of sizes to fit arange of adultpatients.The addition of alarger size in theBreathe mask doesnot accommodate adifferent cohort thanthe Hybrid device.
Materials
Mask Body	Polycarbonate	Polycarbonate	Same
Nose Pillows	Silicone	Silicone	Same
Head Gear	Nylon, Neoprene, VelcroHook & Loop	No head gear is neededwith the Breatheinterfaces (identical toK141943)	Same functionachieved with thedifferent methods ofhead attachment

Tabular Comparison: Application Breathe Pillows Entrainment Interface to Predicate Hybrid EV (K062019)

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Image /page/15/Picture/1 description: The image shows the logo for Breathe Technologies. The word "Breathe" is in a large, light blue font. Below that, the word "TECHNOLOGIES" is in a smaller, light blue font. There is a light blue swoosh below the word "TECHNOLOGIES".

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Image /page/16/Picture/0 description: The image contains 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. Underneath the text is a curved line that resembles a stylized breath or wave, also in light blue.

Conclusion

Breathe Technologies concludes that the nonclinical and human factors tests demonstrate that the application Life2000 Ventilation System (Life2000 Ventilator + Life2000 Compressor, with accessories) is as safe, as effective, and performs as well as the predicate Life2000 Ventilation System (K141943).

Additionally, Breathe Technologies concludes that the nonclinical and human factors tests demonstrate that the application Breathe Pillows Entrainment Interface with an oxygen inlet for supplemental oxygen is as safe, as effective, and performs as well as the predicate RespCare Hybrid NE mask (K062019) when used as part of the patient circuit of the Life2000 Ventilation System.

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).