Who is the manufacturer of BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM?

Breathe Technologies filed the 510(k) submission for BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM (K141943).

What is the FDA product code for BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM

K141943 · Breathe Technologies · CBK · Jun 12, 2015 · Anesthesiology

Device Facts

Record ID	K141943
Device Name	BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
Applicant	Breathe Technologies
Product Code	CBK · Anesthesiology
Decision Date	Jun 12, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic

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 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 Story

Portable, battery-powered critical care ventilator; provides positive pressure ventilation via tracheostomy, endotracheal tube, or nasal mask. Input: external compressed gas supply (air/oxygen). Operation: delivers physician-prescribed volume using pneumatic active exhalation valve; supports Assist/Control mode. Output: mechanical ventilation to patient. Used in home/institutional settings by trained personnel/physicians. Small/lightweight (1.1 lbs) for belt/shoulder wear. Benefits: provides portable ventilatory support for adult patients; enables mobility compared to larger stationary ventilators.

Clinical Evidence

Bench testing only. Compliance demonstrated with ISO 10993-1, IEC 60601-1, IEC 60601-1-2, ISO 80601-2-12, and ASTM F1246-91. Additional testing included ventilator cleaning validation, VOC risk characterization, static software analysis, comparative waveform testing, and human factors/usability testing.

Technological Characteristics

Portable critical care ventilator; battery-powered; pneumatic active exhalation valve. Dimensions: 3.2 x 7.7 x 1.0 inches; Weight: 1.1 lbs. Gas supply: external compressed air/oxygen. Materials: polycarbonate (Universal Connector). Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2, ISO 80601-2-12, ASTM F1246-91.

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 or institutional settings. Requires qualified, trained personnel under physician direction.

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

LTV-1200 (K060647)

Reference Devices

Breathe Technologies NIOV Ventilator (K103345)
ResMed Ultra Mirage II Nasal Mask (K050359)

Related Devices

K131562 — BREATHE NIOV VENTILATION SYSTEM · Breathe Technologies · Mar 6, 2014
K981668 — SMARTVENT 201 PORTABLE VENTILATOR · Versamed , Ltd. · Apr 7, 1999
K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) · Draeger Medical B.V. · Nov 26, 2008
K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR · Impact Instrumentation, Inc. · Apr 7, 2011
K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV · Impact Instrumentation, Inc. · Dec 10, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Device Information: | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Category | Comments | | Sponsor: | Breathe Technologies 175 Technology Drive, Suite 100 Irvine, CA 92618 Tel: 949-988-7700 Contact: Samir Ahmad, Ph.D. | | Correspondent Contact Information: | Craig Coombs President Coombs Medical Device Consulting, Inc 1193 Sherman St. Alameda, CA 94501 Office: 510.337.0140 Fax: 510.337.0416 | | Device Common Name: | Mechanical Ventilator | | Device Classification & Name: | 21 CFR 868.5895 Continuous Ventilator | | Device Classification & Product Code: | Class II CBK | | 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Breathe Technologies. The word "Breathe" is in a large, light blue font, with the word "TECHNOLOGIES" in a smaller font below it. There is a blue wave design below the word "TECHNOLOGIES". The Ventilator is intended for Institutional or Home Use. It is not intended for use during emergency/medical transportation. ### d. 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 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 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. {5}------------------------------------------------ | | Predicate Device: LTV-1200 K060647 | Application Device: Life2000 Ventilation System | Difference Status | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: - Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). - Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home and transport settings. | 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. | The Indications for Use for the application device is a subset of the Indications for Use of the predicate. In particular, the application device treats only adult patients, rather than the predicate's >5kg limit. The application device does not have all the ventilation modes that the predicate device possesses. Finally, the application device is not indicated for use in emergency/medical transport settings. | | Product Classification Code | CBK | CBK | Identical | | CFR Citation | 21 CFR 868.5895 | 21 CFR 868.5895 | Identical | | Principal Operator | Trained personnel under the direction of a physician | Trained personnel under the direction of a physician | Identical | | Environment of Use | Institution, Home, and Transport | Institution & Home | Application device is not validated to work in an emergency/medical transport environment. | | Patient Interface | 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 run while battery is charging | Battery Powered, can be run while battery is 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 | The operational modes of the application device are a subset of the predicate. | | | Predicate Device: LTV-1200 K060647 | Application Device: Life2000 Ventilation System | Difference Status | | 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 | The application device is much smaller than predicate device. Potentially easier for patient to handle. No new issues of S&E are raised by the size reduction | | Weight | 13.4 lbs | 1.1 lbs | The application device is much smaller than predicate device. Potentially easier for patient to handle. No new issues of S&E are raised by the weight reduction. | | Volume Setting Range | 50 - 2000 ml/breath | 50 - 750 ml/breath | The volume range of the application device is a subset of the predicate device | | 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 | The PEEP range of the application device is a subset of the predicate device | | PIP Alarms & Monitoring | Yes | Yes | Identical | | Adjustable Inspiration Time | 0.3 - 9.9 seconds | 0.15 to 3 seconds | I-time of application device is a subset of predicate. Only clinically relevant times are used | | 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 Result from Ventilator | | Sterilized? | Ventilator: No Patient Circuit: No | Ventilator: No Patient Circuit: No | Identical | # Tabular Comparison to Predicate Device {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Breathe Technologies. The word "Breathe" is written in a large, light blue font. Below that, the word "TECHNOLOGIES" is written in a smaller, light blue font. There is a curved, light blue line below the word "TECHNOLOGIES". {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Breathe Technologies. The word "Breathe" is written in a large, sans-serif font in blue. Below "Breathe" is the word "TECHNOLOGIES" in a smaller, sans-serif font, also in blue. Underneath the words is a blue wave design. ## 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.