(330 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard ventilation technology.
Yes.
This device provides ventilatory support to individuals requiring mechanical ventilation, which directly treats a medical condition.
No
Explanation: The device is a ventilator that provides ventilatory support, which is a therapeutic function, not a diagnostic one. Its purpose is to administer air/oxygen, not to identify or monitor medical conditions.
No
The device description explicitly states it is a "portable, battery powered, critical care ventilator" and describes physical components like the Patient Universal Connector and NIOV Pillows Interface, indicating it is a hardware device with integrated software.
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 is to provide mechanical ventilation to individuals requiring respiratory support. This is a direct intervention on the patient's body, not a test performed on samples taken from the body.
- Device Description: The device description details a ventilator that delivers air to the patient via tubes or masks. This is consistent with a life support device, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is clearly a therapeutic medical device used for respiratory support.
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 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.
Product codes
CBK
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.
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.
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)
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.
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 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)
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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
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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.