(219 days)
No
The summary describes a mechanical ventilation system and its components, focusing on hardware and basic ventilation modes. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a ventilation system intended to provide continuous or intermittent ventilatory support, which is a therapeutic intervention for individuals requiring mechanical ventilation.
No
The device is a ventilation system intended to provide mechanical ventilatory support. Its function is to deliver prescribed volumes of air to patients, not to diagnose medical conditions.
No
The device description explicitly states that the system includes hardware components such as a ventilator and a compressor.
Based on the provided text, the Breathe Technologies Life2000™ Ventilation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for providing "continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation." This is a therapeutic function, directly supporting a patient's breathing.
- Device Description: The description details a ventilator and a compressor, components used to deliver air and oxygen to a patient's lungs.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Being used in a laboratory setting for diagnostic purposes
The device is designed to directly support a patient's physiological function (breathing), which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBK, NOU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
qualified, trained personnel under the direction of a physician.
home and institutional settings and is not intended for ambulance or air transportation.
clinicians and lay care-givers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Bench testing along with electrical safety testing demonstrated that the Life2000 Compressor is an appropriate source of compressed gas for the Life2000 Ventilation System. Testing demonstrated compliance with various guidelines and standards including ISO 10993-1, FDA Draft Reviewer Guide for Ventilators (July 1995), ASTM F1246-91, AAMI/ANSI 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-72: 2015, IEC 62133, IEC 62366, FDA Guidance Document: Design Considerations for Devices Intended for Home Use (Updated August 8, 2016), ANSI/AMEE HE75:2009, FDA Guidance Document: Medical Device Use Safety: Incorporating Human Factors Engineering into Risk Management (draft 2011), and AIM 7351731.
The Life2000 Compressor output was tested for continuous flow and peak flow, and it was found that the compressor can support the maximum volume output of the ventilator, with testing showing appropriate waveforms.
Human Factors Data:
A series of HFE/UE analyses, design refinement activities, and Human Factors Validation (HFV) tests were conducted. The tests involved over 100 participants from 4 user groups: Patients, Caregivers, Respiratory Therapists, and 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. The Life2000™ Ventilation System was found to be as safe and effective for the intended users, uses, and use environments as the predicate Life2000 Ventilation System.
It was concluded that both clinicians and lay caregivers could properly operate the application Life2000 Ventilation System (Ventilator & Compressor) after receiving the required training and reading the Instructions for Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Category | Comments |
|---|---|
| Sponsor: | Breathe Technologies |
| 175 Technology Drive, Suite 100 | |
| Irvine, CA 92618 | |
| Tel: 949-988-7724 | |
| 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 |
| 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 & | |
| Product Code: | Class II |
| 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 |
4
Predicate Device Information:
| Predicate Device: | Hybrid NE Mask |
|---|---|
| Predicate Device Manufacturer: | RespCare, Inc. |
| Predicate Device Premarket Notification #: | K062019 |
| Predicate Device Common Name: | Face Mask |
| Accessory to Continuous Ventilator | |
| Predicate Device Classification & Name: | 21 CFR 868.5895 |
| Predicate Device Classification & | |
| Product Code: | Class II |
| 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.
5
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.
6
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.
8
Tabular Comparison: Application Life2000 Ventilation System to Predicate Life2000 Ventilation System.
| | Predicate Device:
Life2000 Ventilation
System | Application Device:
Life2000 Ventilation
System | Difference
Status |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
non-invasively (via mask). - Assist/Control mode of
ventilation.
The ventilator is suitable for use
in home and institutional
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 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. | Identical, except for
the name change.
In the predicate
submission, the term
"System" referred to
only the Ventilator and
its accessories. In the
application device, the
term "System" refers
to the Ventilator and
its accessories,
including the Life2000
Compressor and
modified Pillows
Interface.
The addition of the
Compressor and the
modified Pillows
Interface does not
change the intended
use of the Ventilator. |
| | Predicate Device:
Life2000 Ventilation
System | Application Device:
Life2000 Ventilation
System | Difference
Status |
| Product
Classification
Code | CBK | CBK & NOU | Identical. The addition
of the Portable Air
Compressor does not
change the Ventilator
System overall product
code.
The predicate System
was cleared for home
use, but the NOU
procode was not
added. This
administrative
oversight is being
corrected in this
submission. |
| Principal
Operator | Trained personnel under the
direction of a physician | Trained personnel under the
direction of a physician | Identical |
| Environment
of Use | Institution & Home | Institution & Home | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Patient
Interface:
General
Description | Delivered invasively (via ET
tube) or non-invasively (via
mask). | Delivered invasively (via ET
tube) or non-invasively (via
mask). | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate. |
| Patient
Interfaces
Possible | Breathe Pillows Interface;
Most 3rd party Masks attached
via Breathe Universal
Connector | Breathe Pillows Interface;
Most 3rd party Masks attached
via Breathe Universal
Connector | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Port in Mask
for
Supplemental
Oxygen? | Not Available with original
Breathe Pillows Interface | Supplemental Oxygen port is
added to the Breathe Pillow
Interface to create the Breathe
Pillow Entrainment Interface | The Supplemental
Oxygen port in the
Breathe Pillows
Entrainment Interface
allows for same
Oxygen ranges as in
predicate device |
| Type of
Supply Gas
To the
Ventilator | Pressurized Oxygen or
Air (50 psi) | Pressurized Oxygen or
Air (50psi) | The ventilator in this
application is identical
to the predicate
ventilator. Both use the
same type of supply
gas. |
| | Predicate Device:
Life2000 Ventilation
System | Application Device:
Life2000 Ventilation
System | Difference
Status |
| Method of
Delivering
Supply Gas
to the
Ventilator | Compressed oxygen or air from
tanks, or wall supply | Compressed oxygen or air from
tanks, or wall supply or
compressed room air from the
Breathe Life2000 Compressor | The Life2000
Compressor is an
additional device for
supplying compressed
air to the Ventilator |
| Power
Source | The Ventilator is battery
powered, it can be run while
battery is charging | The Ventilator and Compressor
are battery powered, they can
be run while their batteries are
charging | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Operational
Modes | Volume Control
Volume Assist/Control
Volume Assist | Volume Control
Volume Assist/Control
Volume Assist | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Design
Designation | Portable Continuous Care | Portable Continuous Care | Identical |
| Size
WxLxH (in) | 3.2 x 7.7 x 1.0
Ventilator only | 12.1 x 8.7 x 8.6
Ventilator & dedicated
Life2000 Compressor
combined | Both Ventilators are
identical. Both
Systems are portable. |
| Weight | 1.1 lbs
Ventilator only | 16 lbs:
Ventilator & dedicated
Life2000 Compressor
combined | Both Ventilators are
identical. Both are
portable. |
| Volume
Setting
Range | 50 - 750 ml/breath | 50 - 750 ml/breath | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate. |
| Resultant
Tidal
Volume | 50 - Up to 2000 ml/breath due
to venturi effect | 50 - Up to 2000 ml/breath due
to venturi effect | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| PEEP Setting | 0 - 10 cmH2O | 0 - 10 cmH2O | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| PIP Alarms
&
Monitoring | Yes | Yes | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Adjustable
Inspiration
Time | 0.15 to 3 seconds | 0.15 to 3 seconds | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| | Predicate Device:
Life2000 Ventilation
System | Application Device:
Life2000 Ventilation
System | Difference
Status |
| Supply Gas | Oxygen, Air | Oxygen, Air | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Method of
Supply Gas
Pressurization | Compressed source for Air
Compressed 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 or
directly from an O2 Tank) | Equivalent Result
(waveforms)
independent of supply
gas pressurization
method. |
| Sterilized? | Ventilator: No
Patient Circuit: No | Ventilator: No
Patient Circuit: No | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Compressed
Gas
Requirements | 41-87 psi | 41-87 psi | Identical because this
aspect of the
Ventilation System is
unchanged from the
predicate |
| Compressor
Output | None | Life2000 Compressor
continuous output 17Lpm (@
50psi
Maximum instantaneous output
~40Lpm @ 50 psi | Predicate did not have
a dedicated
Compressor.
Nonetheless no new
questions of Safety and
Efficacy are raised
because both
Ventilators are
designed to work with
compressed air in the
same way. Waveform
data validates that
Life2000 Compressor
provides adequate
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 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)
| Element
Category or
number | Reference Device:
Siemens Compressor Mini | Application:
Breathe Technologies
Life2000 Compressor | Substantial Equivalence
Discussion |
|----------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Electrical Powered Air
Compressor | Electrical Powered Air
Compressor | Equivalent |
| 2 | Air Inlet Filter | Air Inlet Filter | Identical functionality |
| 3 | Compressor with Motor (2
heads) | Compressor with motor (4
heads) | Identical functionality |
| 4 | Air Dryer:
- Cooling coil
- Thermoelectric cooler
- Water Separator/collector | Air Dryer:
- Membrane dryer
- Mist separator/collector | The predicate's
condensate method of
drying is different from
mechanically removing
moisture from the gas
with a Mist
Separator/collector.
Both end up with the
same result, and both can
accommodate the full
range of flows from the
specified Ventilator. |
| 5 | Pressure Regulation: - Pressure regulator
- Tank
- Safety Valve
- Standby Valve | Pressure Regulation:
- Pressure relief valve
- Tank
- Motor Speed | The predicate
compressor generates
excessive pressure which
is moderated by the
regulator before it enters
the accumulator tank.
The application
compressor generates the
proper pressure in the
accumulator tank by a
fixed motor/pump speed.
Both have safety valves
for excess pressure. The
results are functionally
identical and do not
create new issues of
safety 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 |
| Element
Category or
number | Reference Device:
Siemens Compressor Mini | Application:
Breathe Technologies
Life2000 Compressor | Substantial Equivalence
Discussion |
| 16 | Alarms
Temperature
Pressure | Alarms:
High motor temperature High electronics temperature Electronics circuit error Motor Stall Low and high pressure alarms (provided by the ventilator) | Application device has
the same Alarms as the
predicate, and has an
additional Motor Stall
alarm |
| 17 | Power Supply
Mains | Power Supply
60 min battery
Mains | Both can be connected to
main power supply.
Life2000 provides a
backup battery option |
| 18 | Designed to supply only one
ventilator at a time | Designed to supply only one
ventilator at a time | Identical |
| 19 | Flow Output:
30 Liters/min | Continuous Flow Output:
17 L/min
Peak Flow Output:
40 Liters/min | Outputs are functionally
identical because they
support a specified
ventilator. The Life2000
Ventilator requires less
flow from the Life2000
Compressor to allow the
same outputs at the
patient mask because the
Ventilator entrains room
air to augment the
Compressor flow.
Testing shows that the
compressor can support
the maximum volume
output of the ventilator |
| 20 | Pressure Output
50 – 64 psi | Pressure Output:
Nominal of 50 psi and range
of 47 - 64 psi | Functionally identical |
| 21 | Ventilator Compatibility:
Can be used with any
Ventilator that meets its | Ventilator Compatibility:
Can only be used with the
Life2000 Ventilator | Functionally identical for
their specified
Ventilators |
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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 is | ||
| intended to provide a | |||
| patient interface for | |||
| application of noninvasive | |||
| ventilation. The mask is to | |||
| be used as an accessory to | |||
| ventilators that have | |||
| adequate alarms and safety | |||
| systems for ventilator | |||
| failure, and which are | |||
| intended to administer | |||
| positive pressure | |||
| ventilation. The mask will | |||
| be offered in a disposable | |||
| version and a multiuse | |||
| version. It is intended for | |||
| use on adult patients (>30 | |||
| kg), who are appropriate | |||
| candidates for noninvasive | |||
| ventilation. | |||
| (Applies to the standard | |||
| version): | |||
| For homecare applications, | |||
| the Hybrid NE Mask may | |||
| be reused multiple times | |||
| by a single patient. For | |||
| institutional applications | |||
| (i.e. hospital or other | |||
| clinical settings), this | |||
| interface | |||
| may be reused multiple | |||
| times by multiple patients. | |||
| (Applies to the Disposable | |||
| version): | |||
| The RespCare Hybrid NE | |||
| Mask Disposable is a | |||
| single patient, single use | |||
| interface. | The Breathe Pillows | ||
| Entrainment Interface | |||
| Mask is intended to | |||
| provide a patient | |||
| interface for application | |||
| of noninvasive | |||
| ventilation. | |||
| The mask is to be used as | |||
| an accessory to the | |||
| Breathe Life2000 | |||
| Ventilation System. | |||
| It is intended for use on | |||
| adult patients who are | |||
| appropriate candidates | |||
| for noninvasive | |||
| ventilation. | |||
| The Pillows Interface is | |||
| intended for use in | |||
| hospital, institution and | |||
| home environments. | |||
| The mask may be reused | |||
| multiple times by a single | |||
| patient. | These Indications for | ||
| Use are nearly | |||
| identical. | |||
| Both masks are | |||
| intended to be used | |||
| only with Ventilators | |||
| that meet the | |||
| specifications of the | |||
| mask. | |||
| Both are intended for | |||
| the same cohort | |||
| (adults) in the same | |||
| environments of | |||
| home, institutional | |||
| and hospital. | |||
| The Breathe mask | |||
| does not come in a | |||
| disposable version. | |||
| As a result, the | |||
| differences between | |||
| masks do not raise | |||
| new questions of | |||
| safety or efficacy. | |||
| Technology | |||
| Mask | Provides noninvasive | ||
| interface between patient | |||
| and Ventilator | Provides noninvasive | ||
| interface between patient | |||
| and Ventilator | Same | ||
| Oxygen | |||
| Supplementation at | |||
| the Mask | Yes | Yes | Same |
| Component | |||
| Number | Predicate: | ||
| RespCare Hybrid NE | |||
| Mask | Breathe Pillows | ||
| Entrainment Interface | |||
| with Oxygen Inlet | Substantial | ||
| Equivalence | |||
| Discussion | |||
| Is Entrainment used | |||
| to Supplement Air | |||
| Volume from | |||
| Ventilator? | No. All gas supplied to | ||
| mask comes from | |||
| Ventilator and | |||
| supplemental oxygen | |||
| inputted into the mask | Yes. Gas supplied to the | ||
| mask comes from the | |||
| Ventilator, supplemental | |||
| oxygen inputted into the | |||
| mask and from entrained | |||
| air | Both devices provide | ||
| a functionally | |||
| equivalent output that | |||
| is titrated to the | |||
| patient's needs. | |||
| Both masks can input | |||
| supplemental oxygen | |||
| into the gas stream | |||
| from the Ventilator. | |||
| This entrainment | |||
| technology is | |||
| identical to that | |||
| cleared in the Breathe | |||
| Interface Pillows | |||
| mask in K141943. | |||
| Design | |||
| Facial Interface | Mouth & Nose | Nose Only | The Breathe device |
| provides adequate | |||
| ventilation through | |||
| the nose only just as | |||
| the Hybrid Mask | |||
| provides adequate | |||
| ventilation through | |||
| the Mouth and Nose. | |||
| This interface is | |||
| identical to the | |||
| Breathe Pillows | |||
| Interface cleared in | |||
| K141943 | |||
| This difference raises | |||
| no new questions of | |||
| safety and efficacy. | |||
| Sizes | Small | ||
| Medium | |||
| Large | Small | ||
| Medium | |||
| Large | |||
| Extra Large | Both masks offer a | ||
| range of sizes to fit a | |||
| range of adult | |||
| patients. | |||
| The addition of a | |||
| larger size in the | |||
| Breathe mask does | |||
| not accommodate a | |||
| different cohort than | |||
| the Hybrid device. | |||
| Materials | |||
| Mask Body | Polycarbonate | Polycarbonate | Same |
| Nose Pillows | Silicone | Silicone | Same |
| Head Gear | Nylon, Neoprene, Velcro | ||
| Hook & Loop | No head gear is needed | ||
| with the Breathe | |||
| interfaces (identical to | |||
| K141943) | Same function | ||
| achieved with the | |||
| different methods of | |||
| head 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.