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 ventilator is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator 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 ventilator is suitable for use in home and institutional settings.

Device Description

The Breathe Technologies Life2000 Ventilation System is a portable, battery powered, critical care ventilator. The Ventilator administers the physician-prescribed volume to the patient via the attached Breathe Technologies Patient 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 Breath Technologies NIOV Pillows Interface, a type of nasal mask. The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, gas supply. The Ventilator is intended for Institutional or Home Use. It is not intended for use during emergency/medical transportation.

AI/ML Overview

The Breathe Technologies Life2000 Ventilation System is a portable, battery-powered critical care ventilator for adult patients requiring continuous or intermittent ventilatory support.

Here's an analysis of its acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Predicate Device (LTV-1200, K060647) Acceptance Criteria	Application Device (Life2000 Ventilation System) Performance	Evaluation / Difference Status
Indications for Use	Continuous/intermittent ventilatory support, adult & pediatric (>5kg), invasive/non-invasive, A/C, SIMV, CPAP, NPPV modes, institutional, home & transport settings	Continuous/intermittent ventilatory support, adult patients only, invasive/non-invasive, Assist/Control mode, institutional & home settings	Difference: Application device's indications are a subset of the predicate (adults only, fewer modes, no transport). This is considered acceptable as it's a narrower use case.
Product Classification Code	CBK	CBK	Identical
CFR Citation	21 CFR 868.5895	21 CFR 868.5895	Identical
Principal Operator	Trained personnel under direction of a physician	Trained personnel under direction of a physician	Identical
Environment of Use	Institution, Home, and Transport	Institution & Home	Difference: Application device not validated for transport. This is an accepted difference as it narrows the intended use.
Patient Interface	Invasive (ET tube) or non-invasive (mask)	Invasive (ET tube) or non-invasive (mask)	Identical
Power Source	Battery Powered, run while charging	Battery Powered, run while charging	Identical
Operational Modes	Volume Control, Volume Assist/Control, Volume Assist, Pressure Control, Pressure Support, SIMV, CPAP, NPPV	Volume Control, Volume Assist/Control, Volume Assist	Difference: Application device modes are a subset of the predicate. This is an accepted difference as fewer documented modes are presented.
Active Exhalation Valve?	Yes, Mechanical	Yes, Mechanical/Pneumatic	Clinically Equivalent
Design Designation	Portable Critical Care	Portable Critical Care	Identical
Size WxLxH (in)	3 x 10 x 12	3.2 x 7.7 x 1.0	Difference: Application device is much smaller. Considered an improvement potentially making it easier for patients to handle, with no new safety/effectiveness issues raised.
Weight	13.4 lbs	1.1 lbs	Difference: Application device is much lighter. Considered an improvement potentially making it easier for patients to handle, with no new safety/effectiveness issues raised.
Volume Setting Range	50 - 2000 ml/breath	50 - 750 ml/breath	Difference: Application device range is a subset of the predicate. This is an accepted difference as it's a narrower range.
Resultant Tidal Volume	50 - 2000 ml/breath	50 - Up to 2000 ml/breath due to venturi effect	Identical
PEEP Setting	0 – 20 cmH2O	0 - 10 cmH2O	Difference: Application device range is a subset of the predicate. This is an accepted difference as it's a narrower range.
PIP Alarms & Monitoring	Yes	Yes	Identical
Adjustable Inspiration Time	0.3 - 9.9 seconds	0.15 to 3 seconds	Difference: I-time of application device is a subset of predicate. Only clinically relevant times are used. This is an accepted difference.
Supply Gas	Oxygen, Air	Oxygen, Air	Identical
Method of supply gas pressurization	Internal turbine for Air, Compressed Source for O2	Compressed source for Air, Compressed source for O2	Clinically Equivalent
Sterilized?	Ventilator: No, Patient Circuit: No	Ventilator: No, Patient Circuit: No	Identical

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for specific performance tests (e.g., comparative waveform testing, human factors).
- The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond general statements of compliance with international and US standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document identifies general "qualified, trained personnel under the direction of a physician" as the intended operators for the device. However, it does not specify the number or qualifications of experts used to establish ground truth or conduct specific performance assessments for the testing mentioned (e.g., comparative waveform testing, human factors).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any adjudication methods for the test sets.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study is mentioned, as this device is a mechanical ventilator, not an AI-assisted diagnostic tool. The "comparative effectiveness" studies mentioned are related to device performance compared to a predicate, not human reader performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable to a mechanical ventilator device. The device's performance is inherently standalone in its function, but its operation always involves a human user (qualified personnel under a physician's direction).
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Summary of Supporting Data," the ground truth for device performance is established through compliance with recognized standards such as ISO 10993-1, FDA Draft Reviewer Guide for Ventilators, ASTM F1246-91, IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-12. This implies engineering and clinical performance metrics defined by these standards serve as the "ground truth" for the device's functional and safety capabilities.
- Specific tests mentioned like "Ventilator Cleaning validation," "Risk characterization of VOC's," "Static Analysis Tool verification of software," "Comparative Waveform Testing," and "Human Factors and Usability Testing" would have their own defined ground truths based on established protocols for those types of evaluations (e.g., cleanliness standards, toxicology limits, software quality metrics, physiological waveform accuracy, human-computer interaction success rates).
The sample size for the training set
- This is not applicable for a mechanical ventilator. Training sets are typically associated with machine learning or AI models, which are not described as integral to this device's function.
How the ground truth for the training set was established
- This is not applicable for a mechanical ventilator.

Summary

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

June 12, 2015

Breathe Technologies C/O Mr. Craig Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman St. Alameda, CA 94501

Re: K141943/S003

Trade/Device Name: Breathe Technologies Life2000 Ventilation System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 8, 2015 Received: June 10, 2015

Dear Mr. 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 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.

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Page 2 - Mr. Coombs

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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 yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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) K141943

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 ventilator is intended for use by qualified, trained personnel under the direction of a physician.

Specifically, the ventilator 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 ventilator is suitable for use in home and institutional settings.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Device Information:
Category	Comments
Sponsor:	Breathe Technologies175 Technology Drive, Suite 100Irvine, CA 92618Tel: 949-988-7700Contact: 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 IICBK
Device Proprietary Name:	Breathe Technologies Life2000 Ventilation System

Section 5: 510(k) Summary

Predicate Device Information:

Predicate Device:	LTV-1200
Predicate Device Manufacturer:	Pulmonetic Systems, Inc.
Predicate Device Premarket Notification #	K060647
Predicate Device Common Name:	Mechanical Ventilator
Predicate Device Classification & Name:	21 CFR 868.5895
Predicate Device Classification &	Class II
Product Code:	CBK

b. Date Summary Prepared

12 June 2015

c. Description of Device

The Breathe Technologies Life2000 Ventilation System is a portable, battery powered, critical care ventilator.

The Ventilator administers the physician-prescribed volume to the patient via the attached Breathe Technologies Patient 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 Breath Technologies NIOV Pillows Interface, a type of nasal mask.

The ventilator is small and light enough to be worn on a patient's belt, or slung over their shoulder. It is connected to a separate, third party, gas supply.

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The Ventilator is intended for Institutional or Home Use. It is not intended for use during emergency/medical transportation.

d. Indications for Use

Specifically, the ventilator is applicable for adult patients who require the following types of ventilatory support:

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

The ventilator is suitable for use in home and institutional settings.

e. Comparison to Predicate Device

The Life2000 Ventilation System is substantially equivalent in Intended Use, Indications for Use, technology, and performance to the LTV-1200 that was cleared under K060647.

The Life2000 serves a subset of the cohort (adult) that are indicated for the LTV-1200 (patients >5kg).

The Life2000 has all the ventilation modes that are necessary for a critical care ventilator, whereas the LTV-1200 includes modes like SIMV and CPAP.

The Life2000 has a pneumatic active exhalation valve. whereas the LTV-1200 has a mechanical/pneumatic active exhalation valve.

Any technological differences between the Breathe Technologies Life2000 and the LTV-1200 can be determined to be clinically insignificant when compared to the reference device, the Breathe Technologies NIOV Ventilator, cleared under K103345.

The following table presents a comparison of the features of the predicate and applications devices, along with an analysis of why the resultant differences do not negatively impact a conclusion of substantial equivalence.

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	Predicate Device:LTV-1200K060647	Application Device:Life2000 VentilationSystem	DifferenceStatus
Indicationsfor Use	The LTV 1200 ventilator isintended to providecontinuous or intermittentventilatory support forthe care of individuals whorequire mechanical ventilation.The ventilator is a restrictedmedical device intended for useby qualified, trained personnelunder the direction of aphysician.Specifically, the ventilator isapplicable for adult and pediatricpatients weighingat least 5 kg (11 lbs.), whorequire the following types ofventilatory support:- Positive Pressure Ventilation,delivered invasively (via ETtube) or non-invasively (viamask).- Assist/Control, SIMV, CPAP,or NPPV modes of ventilation.The ventilator is suitable for usein institutional, home andtransport settings.	The Breathe TechnologiesLife2000 Ventilation System isintended to provide continuousor intermittent ventilatorysupport for the care ofindividuals who requiremechanical ventilation.The ventilator is intended for useby qualified, trained personnelunder the direction of aphysician.Specifically, the ventilator isapplicable for adult patientswho require the following typesof ventilatory support:- Positive Pressure Ventilation,delivered invasively (via ETtube) or non-invasively (viamask).- Assist/Control mode ofventilation.The ventilator is suitable for usein home and institutionalsettings.	The Indications forUse for the applicationdevice is a subset ofthe Indications for Useof the predicate.In particular, theapplication devicetreats only adultpatients, rather thanthe predicate's >5kglimit. The applicationdevice does not haveall the ventilationmodes that thepredicate devicepossesses. Finally, theapplication device isnot indicated for use inemergency/medicaltransport settings.
ProductClassificationCode	CBK	CBK	Identical
CFR Citation	21 CFR 868.5895	21 CFR 868.5895	Identical
PrincipalOperator	Trained personnel under thedirection of a physician	Trained personnel under thedirection of a physician	Identical
Environmentof Use	Institution, Home, andTransport	Institution & Home	Application device is notvalidated to work in anemergency/medicaltransport environment.
PatientInterface	Delivered invasively (via ET tube)or non-invasively (via mask).	Delivered invasively (via ET tube)or non-invasively (via mask).	Identical
Power Source	Battery Powered, can be runwhile battery is charging	Battery Powered, can be runwhile battery is charging	Identical
OperationalModes	Volume ControlVolume Assist/ControlVolume AssistPressure ControlPressure SupportSIMVCPAPNPPV	Volume ControlVolume Assist/ControlVolume Assist	The operational modesof the applicationdevice are a subset ofthe predicate.
	Predicate Device:LTV-1200K060647	Application Device:Life2000 VentilationSystem	DifferenceStatus
ActiveExhalationValve?	Yes, Mechanical	Yes, Mechanical/Pneumatic	Clinically Equivalent
DesignDesignation	Portable Critical Care	Portable Critical Care	Identical
SizeWxLxH (in)	3 x 10 x 12	3.2 x 7.7 x 1.0	The application deviceis much smaller thanpredicate device.Potentially easier forpatient to handle. Nonew issues of S&E areraised by the sizereduction
Weight	13.4 lbs	1.1 lbs	The application deviceis much smaller thanpredicate device.Potentially easier forpatient to handle. Nonew issues of S&E areraised by the weightreduction.
VolumeSettingRange	50 - 2000 ml/breath	50 - 750 ml/breath	The volume range ofthe application deviceis a subset of thepredicate device
ResultantTidal Volume	50 - 2000 ml/breath	50 - Up to 2000 ml/breath dueto venturi effect	Identical
PEEP Setting	0 – 20 cmH2O	0 - 10 cmH2O	The PEEP range of theapplication device is asubset of the predicatedevice
PIP Alarms &Monitoring	Yes	Yes	Identical
AdjustableInspirationTime	0.3 - 9.9 seconds	0.15 to 3 seconds	I-time of applicationdevice is a subset ofpredicate. Onlyclinically relevanttimes are used
Supply Gas	Oxygen, Air	Oxygen, Air	Identical
Method ofsupply gaspressurization	Internal turbine for AirCompressed Source for O2	Compressed source for AirCompressed source for O2	Clinically EquivalentResult from Ventilator
Sterilized?	Ventilator: NoPatient Circuit: No	Ventilator: NoPatient Circuit: No	Identical

Tabular Comparison to Predicate Device

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f. Summary of Supporting Data

The Software Design and Validation process along with the bench testing of the device demonstrated that the Breathe Technologies Life2000 Ventilation System operates as intended.

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

ISO 10993-1 (2009): Biological evaluation of medical devices -- Part 1: Evaluation and Testing
. 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
. IEC 60601 - 1 (2005): Medical electrical equipment - General Requirements for Safety
. IEC 60601-1-2:2007 3rd Edition Medical Electrical Equipment- Part 1-2: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
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

The following additional testing was requested by the FDA to demonstrate Substantial Equivalence.

Ventilator Cleaning validation .
. Risk characterization of VOC's for most vulnerable patient population
. Static Analysis Tool verification of software
. Comparative Waveform Testing
Human Factors and Usability Testing with all intended cohorts and users.

Breathe Technologies concludes from this comparison and the supporting data that the Breathe Technologies Life2000 Ventilation System is substantially equivalent to to the predicate Pulmonetic Systems LTV-1200 (K060647).

1 Per Annex B.3, it was determined that all of the materials (and material processes) used in Life2000 are identical those in a reference device, the NIOV Ventilator and Accessories (K103345), except the polycarbonate material in the Universal Connector, which was shown to be identical to the polycarbonate used in the ResMed Ultra Mirage II Nasal Mask (K050359). This analysis was adopted for the Volatile Organic Compound and Particulate Matter testing.

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).