(442 days)
K103392 - Chad Evolution Model OM-900
No
The description focuses on basic ventilation modes, flow control, and a simple user interface. There is no mention of adaptive algorithms, learning from patient data, or any terms associated with AI/ML.
Yes
This device is a ventilator, which is used to aid adult patients with respiratory insufficiency and assist breathing, fitting the definition of a therapeutic device.
No
Explanation: The provided text explicitly states that the device is a "volume assist ventilator intended to aid adult patients with respiratory insufficiency." Its functions are described as delivering gas to assist breathing and conserving oxygen. There is no mention of the device performing any diagnostic functions such as identifying or monitoring disease conditions.
No
The device description clearly outlines hardware components including a wearable ventilator, nasal pillow interface, battery, pneumatic ports, and a bypass valve. It is a physical medical device with integrated software for control and user interface.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The New Aera Tidal Assist™ Ventilator is a medical device that assists breathing by delivering air or oxygen to the patient's lungs. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it is a "volume assist ventilator intended to aid adult patients with respiratory insufficiency." This describes a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the mechanical and pneumatic aspects of delivering gas to the patient, not on analyzing biological samples.
Therefore, the device described is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.
Product codes
ONZ
Device Description
The New Aera Tidal Assist Ventilation (TAV) system comprises a small, lightweight, wearable, battery-powered ventilator, TAV-C100, and a nasal pillow interface, TAV-NP10. The system is intended to connect to an air or oxygen source and supports three modes of delivery:
- Tidal Assist mode, a breath-activated ventilation assist mode in which the delivered gas from the source entrains additional room air at the nasal pillows interface, delivering it under positive pressure during the patient's inhalation to assist breathing;
- Conserve mode, a breath-activated delivery mode used to conserve oxygen consumption when using a cylinder with regulator; and
- Constant mode, presenting a continuous 1 – 5 LPM flow of oxygen to the patient.
For the Tidal Assist mode, the user may select one of five flow delivery settings, corresponding to a delivered minute volume of approximately 1 - 5 LPM.
For the Conserve mode, the user may select one of five pulse delivery settings, corresponding to an equivalent gas flow rate of approximately 1 - 5 LPM.
For the Constant mode, the user may select one of five flow delivery settings, corresponding to a delivered gas flow rate of approximately 1 - 5 LPM.
The TAV system is battery operated, running from a single AA alkaline battery. Under typical usage, battery life is ~ 14 days; a low battery alert activates when battery life is less than 2 days under typical usage.
The system has a simple user interface, comprising:
- a mode selection button;
- buttons to increase or decrease the delivered flow rate;
- a button to turn the device on and off, and to temporarily silence any alarms;
- LED indicators for the current delivery mode, flow setting, and low battery and alarm conditions; and
- an audible buzzer used to alert the user to an alarm condition.
The device has two pneumatic ports:
- an inlet port, used to connect the regulated gas source to the device, and
- an outlet port, used to connect the device to the patient interface.
Lastly, the device has a bypass valve, used to deliver a constant 2 LPM gas flow rate to the patient in the event of a system failure.
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
intended for operation by trained personnel, patients or caregivers under the direction of a physician.
institutional or home care environment.
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
Non-clinical Performance Testing:
Biocompatibility of Materials: Tested materials in patient contact, including Controller VOC and PM25, and Patient interface (ISO 10993-1 Cytotoxicity, Sensitization, Irritation, Leachable and Extractable with a risk based assessment). The information supports the materials as biocompatible for their intended use.
Electrical, EMC, EMI testing: Evaluated per ANSI/AAMI/ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11. The device performed as intended and met the requirements.
Bench testing:
Comparison of Total Delivered Volume between the proposed device and the predicate.
Comparison of Delivered Volume of the proposed device using oxygen versus air as a gas source.
Comparison of waveforms.
Additional testing included: Battery life and run-time, Alarms, Trigger Sensitivity, Back-up rate, Delivered volume in the different modes, Shelf-life and Oxygen and Fire hazard testing, Accelerated Aging, Cleaning pre- and post- performance. The proposed device was tested to assure that it meets its performance specifications and was found to meet its performance requirements.
Usability: Performed a usability study with two user groups - Healthcare Professionals (HCPs) and Lay Users (patients and caregivers). All participants, overall, were observed to perform critical tasks associated with the device and there were no instances of close calls or observed hazard-related use scenarios that could have resulted in significant patient or user harm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K131562 - Breathe Technologies – NIOV Ventilator (BT-V2S)
Reference Device(s)
K103392 - Chad Evolution Model OM-900
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2016
New Aera, Inc. % Mr. Paul Dryden Consultant 2400 Camino Ramon, Suite 365 Ramon, California 94583
Re: K152664
Trade/Device Name: Tidal Assist™ Ventilator (TAV™) System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: ONZ Dated: October 31, 2016 Received: November 2, 2016
Dear Mr. Paul Dryden:
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.
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.
1
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
Tina Kiang, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Tidal Assist™ Ventilator (TAV) System
Indications for Use (Describe)
The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE
ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13) 6740 BB
Page 1 of 2
PSC Publishing Services (301) 443
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
3
510(k) Summary Page 1 of 7 12/1/2016
| Official Contact: | New Aera, Inc.
2400 Camino Ramon, Suite 365
San Ramon, CA 94583 |
|----------------------------|-----------------------------------------------------------------------|
| | Todd Allum - Vice President of Engineering
Tel - 925-322-0145 |
| Proprietary or Trade Name: | Tidal AssistTM Ventilator (TAVTM) System |
| Common/Usual Name: | Continuous ventilator |
| Classification Name/Code: | ONZ - continuous ventilator
21 CFR 868.5895, Class II |
| Device: | Tidal AssistTM Ventilator (TAVTM) System |
| Predicate Device: | K131562 - Breathe Technologies – NIOV Ventilator (BT-V2S) |
| Reference Device: | K103392 - Chad Evolution Model OM-900 |
Device Description:
The New Aera Tidal Assist Ventilation (TAV) system comprises a small, lightweight, wearable, battery-powered ventilator, TAV-C100, and a nasal pillow interface, TAV-NP10. The system is intended to connect to an air or oxygen source and supports three modes of delivery:
- Tidal Assist mode, a breath-activated ventilation assist mode in which the delivered gas from ● the source entrains additional room air at the nasal pillows interface, delivering it under positive pressure during the patient's inhalation to assist breathing;
- Conserve mode, a breath-activated delivery mode used to conserve oxygen consumption when . using a cylinder with regulator; and
- . Constant mode, presenting a continuous 1 – 5 LPM flow of oxygen to the patient.
For the Tidal Assist mode, the user may select one of five flow delivery settings, corresponding to a delivered minute volume of approximately 1 - 5 LPM.
For the Conserve mode, the user may select one of five pulse delivery settings, corresponding to an equivalent gas flow rate of approximately 1 - 5 LPM.
For the Constant mode, the user may select one of five flow delivery settings, corresponding to a delivered gas flow rate of approximately 1 - 5 LPM.
The TAV system is battery operated, running from a single AA alkaline battery. Under typical usage, battery life is ~ 14 days; a low battery alert activates when battery life is less than 2 days under typical usage.
The system has a simple user interface, comprising:
- . a mode selection button;
- buttons to increase or decrease the delivered flow rate;
- a button to turn the device on and off, and to temporarily silence any alarms; ●
4
510(k) Summary Page 2 of 7 12/1/2016
- . LED indicators for the current delivery mode, flow setting, and low battery and alarm conditions; and
- an audible buzzer used to alert the user to an alarm condition.
The device has two pneumatic ports:
- an inlet port, used to connect the regulated gas source to the device, and ●
- an outlet port, used to connect the device to the patient interface. ●
Lastly, the device has a bypass valve, used to deliver a constant 2 LPM gas flow rate to the patient in the event of a system failure.
Indications for Use:
The New Aera Tidal Assist™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregivers under the direction of a physician.
Patient Population: Patients who are spontaneously breathing with a minimum tidal volume of 3.5cc/kg of body weight.
Environments of Use: Home and institutional settings
Contraindications
The TAV System is not designed for patients who cannot spontaneously breathe or who are fully dependent on mechanical ventilation.
Summary of substantial equivalence
The proposed TAV System has been compared to the predicate Breathe Technologies Ventilator (BT-V2S) (K131562), see Table 1.
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510(k) Summary Page 3 of 7 12/1/2016
| Attribute | Predicate
Breathe Ventilator, BT-V2S
K131562 | Proposed TAV Systems |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
& Product code: | Class II/ONZ | Class II/ONZ |
| Prescription Device: | Yes | Yes |
| Device Description: | The Predicate Ventilator, with
accessories is a small, wearable,
ventilator that interfaces with
proprietary nasal and tracheostomy
breathing circuits. | The New Aera Tidal AssistTM
Ventilation (TAV) system, with
accessories is a small, wearable,
ventilator that interfaces with
proprietary nasal breathing circuits. |
| Indications for Use: | The Breathe Technologies Ventilator,
with accessories, is a volume assist
ventilator intended to aid adult
patients with respiratory
insufficiency. It is designed for
patients who are capable of
spontaneously breathing a minimum
tidal volume of 3.5cc/kg of predicted
body weight. The device is designed
for continuous applications such as
patient ambulation, physical therapy,
occupational therapy, respiratory
therapy, and other rehabilitation
efforts in an institutional or home
care environment. The device is
intended for operation by trained
personnel, patients or caregivers
under the direction of a physician. | The New Aera Tidal AssistTM
Ventilator, with accessories, is a
volume assist ventilator intended to
aid adult patients with respiratory
insufficiency. It is designed for
patients who are capable of
spontaneously breathing a minimum
tidal volume of 3.5cc/kg of predicted
body weight. The device is designed
for continuous applications such as
patient ambulation, physical therapy,
occupational therapy, respiratory
therapy, and other rehabilitation
efforts in an institutional or home
care environment. The device is
intended for operation by trained
personnel, patients or caregivers
under the direction of a physician. |
| Technical Method: | The device consists of two
components: a ventilator and a
patient interface. The device is a
light-weight, portable, electronically
timed and controlled volume assist
ventilator. The device delivers bolus
volumes of 50-250ml. The device
delivers augmented volumes that are
blended in the interface, patient's
airway and lung with ambient air
provided by the patient's spontaneous
breath | The device consists of three
components: a regulator adapter,
ventilator and a patient interface. The
device is a light-weight, portable,
electronically timed and controlled
volume assist ventilator. The device
delivers bolus volumes of 50-250ml.
The device delivers augmented
volumes that are blended in the
interface, patient's airway and lung
with ambient air provided by the
patient's spontaneous breath |
| Method of Flow
Control: | Electronically controlled proportional
valve | Electronically controlled proportional
valve |
| Delivered Gas: | Oxygen or air | Oxygen or air |
| Gas Supply
Compatibility: | DISS 1240 connection | DISS 1240 connection and other
compatible regulated oxygen or air
sources |
| Attribute | Predicate
Breathe Ventilator, BT-V2S
K131562 | Proposed TAV Systems |
| Patient Interface and
Delivery Method: | An interface with relatively large
opening(s) through which the user can
spontaneously breathe through.
Pressurized nozzles are located within
the interface to entrain ambient air
through these openings during oxygen
delivery in order to augment the
delivered volume. | An interface with relatively large
opening(s) through which the user can
spontaneously breathe through.
Pressurized nozzles are located within the
interface to entrain ambient air through
these openings during oxygen delivery in
order to augment the delivered volume. |
| Trigger Sensitivity: | User adjustable fixed pressure setting | Preset relative flow trigger setting with
signal artifact correction |
| Initiation of Bolus: | At onset of inhalation | At onset of inhalation |
| Bolus Delivery Phase: | During inhalation | During inhalation |
| Oxygen Bolus Size: | 50 to 250ml | 50 to 250ml |
| Breath Rate: | Up to 40 breaths/minute,
patient triggered | Up to 40 breaths/minute,
patient triggered |
| Additional Delivery
Modes: | Not offered | Capable of delivering pulsed-dose oxygen
(Conserve Mode), as well as continuous
flow oxygen (Constant Mode). |
| Total Delivered
Volume (oxygen and
entrained ambient
air): | The NIOV System delivers tidal
volumes of up to 1,150 ml by providing
positive inspiratory pressure with a
maximum pressure up to 18 cmH2O
(Breathe Technologies PM-00-0057-A) | The TAV System delivers tidal volumes
of up to 1,150 ml by providing positive
inspiratory pressure with a maximum
pressure up to 18 cmH2O |
| Backup Mode: | Yes | Yes |
| Backup Rate: | 3 LPM or 12 breaths/min | 3LPM or 12 breaths/min |
| Alarms: | High Source Pressure (> 87 PSIG) | Pressure regulation system
and
High Flow Alarm |
| | High Delivery Pressure | High Flow Alarm |
| | High Circuit Pressure | Low Flow Alarm |
| | High PEEP Pressure | System Fault Alarm |
| | Low Source Pressure (