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.

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.

AI/ML Overview

The provided text describes the New Aera Tidal Assist™ Ventilator (TAV™) System and its substantial equivalence to a predicate device, the Breathe Technologies – NIOV Ventilator (BT-V2S).

Here's the breakdown of the acceptance criteria and the study information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for performance metrics with specific numerical targets. Instead, it compares the proposed device's features and performance to a predicate device (BT-V2S) and a reference device (Chad Evolution Model OM-900) to demonstrate substantial equivalence. The "acceptance criteria" are implied by the similarity to the predicate device and meeting general performance specifications and standards.

Feature	Predicate (BT-V2S)	Proposed Device (TAV System)	Status (Implicit Acceptance)
Device Classification	Class II/ONZ	Class II/ONZ	Met (Identical)
Prescription Device	Yes	Yes	Met (Identical)
Indications for Use	Similar to proposed device (volume assist for spontaneously breathing adults with respiratory insufficiency, continuous applications in institutional/home care, trained personnel/caregivers under physician)	Similar to predicate device	Met (Similar)
Patient Population	Spontaneously breathing adults (minimum tidal volume 3.5cc/kg PBW)	Spontaneously breathing adults (minimum tidal volume 3.5cc/kg PBW)	Met (Similar)
Environments of Use	Home and institutional settings	Home and institutional settings	Met (Similar)
Technical Method	Light-weight, portable, electronically timed/controlled volume assist ventilator; delivers bolus 50-250ml blended with ambient air; two components: ventilator & patient interface	Light-weight, portable, electronically timed/controlled volume assist ventilator; delivers bolus 50-250ml blended with ambient air; three components: regulator adapter, ventilator & patient interface	Met (Similar)
Method of Flow Control	Electronically controlled proportional valve	Electronically controlled proportional valve	Met (Identical)
Delivered Gas	Oxygen or air	Oxygen or air	Met (Identical)
Gas Supply Compatibility	DISS 1240 connection	DISS 1240 connection and other compatible regulated oxygen or air sources	Met (Compatible/Broader)
Patient Interface	Interface with large opening(s) for spontaneous breathing, pressurized nozzles for entrainment	Interface with large opening(s) for spontaneous breathing, pressurized nozzles for entrainment	Met (Similar mechanism)
Trigger Sensitivity	User adjustable fixed pressure setting	Preset relative flow trigger setting with signal artifact correction	Met (Equivalent performance demonstrated by testing)
Initiation of Bolus	At onset of inhalation	At onset of inhalation	Met (Identical)
Bolus Delivery Phase	During inhalation	During inhalation	Met (Identical)
Oxygen Bolus Size	50 to 250ml	50 to 250ml	Met (Identical)
Breath Rate	Up to 40 breaths/minute, patient triggered	Up to 40 breaths/minute, patient triggered	Met (Identical)
Additional Delivery Modes	Not offered	Capable of delivering pulsed-dose oxygen (Conserve Mode) & continuous flow oxygen (Constant Mode)	Exceeds (Improved functionality not raising new concerns)
Total Delivered Volume	Up to 1,150 ml (max 18 cmH2O)	Up to 1,150 ml (max 18 cmH2O)	Met (Identical)
Backup Mode	Yes	Yes	Met (Identical)
Backup Rate	3 LPM or 12 breaths/min	3 LPM or 12 breaths/min	Met (Identical)
Alarms	High/Low Source Pressure, High/Low Delivery Pressure, High Circuit Pressure, High PEEP, High Temp, System Fault, Breath Time Out, Low/High Breath Rate, Low Battery	Pressure regulation system, High/Low Flow Alarm, System Fault, Breath Time Out, Low/High Breath Rate, Low Battery	Met (Similar and adequate)
Battery Alarm	Low Battery (< 25%, or ~1 hour remaining)	Low Battery (~2 days remaining)	Met (Adequate and improved duration)
Battery Type	Internal, rechargeable	AA Alkaline, user replaceable	Met (Different but acceptable)
Battery Duration	4 hours, nominal use	14 days, nominal use	Exceeds (Improved duration)
Weight	1lb	3.8 oz	Exceeds (Improved)
Length	7.5"	4.8"	Exceeds (Improved)
Width	3.1"	2.4"	Exceeds (Improved)
Thickness	1.3"	0.9"	Exceeds (Improved)
Pillows Interface size options	Multiple sizes	Universal size	Met (Different but acceptable)
Standards	IEC 60601-1, IEC 60601-2-12, ASTM F1100-90, ASTM F1246-91	AAMI/ANSI ES60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-8, IEC 60601-1-11, ISO 10651-6	Met (Compliant)
Biocompatibility	ISO 10993-1	ISO 10993-1, Cytotoxicity, Sensitization, Irritation, Leachable/Extractables, Risk Based Assessment, VOC, PM2.5	Met (Compliant)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "Non-clinical Performance Testing" which includes:

Bench testing: Comparison of Total Delivered Volume, comparison of Delivered Volume with oxygen vs. air, comparison of waveforms, Battery life and run-time, Alarms, Trigger Sensitivity, Back-up rate, Delivered volume in different modes, Shelf-life, Oxygen and Fire hazard testing, Accelerated Aging, Cleaning pre- and post- performance.
Biocompatibility testing
Electrical, EMC, EMI testing
Usability study

The document does not specify sample sizes (e.g., number of devices, number of test runs) for these non-clinical tests.
It also does not provide any information on data provenance such as country of origin or whether the data was retrospective or prospective, as these are non-clinical bench and usability studies, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes non-clinical performance and usability testing. "Ground truth" in the context of expert review for medical image analysis or similar diagnostic tasks is not relevant here. The "ground truth" for performance would be established by validated test methods and reference standards.

For the usability study, two user groups were involved:

Healthcare Professionals (HCPs)
Lay Users (patients and caregivers)
The number of participants in each group is not specified, nor are their specific qualifications beyond being an HCP, patient, or caregiver.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to the described non-clinical performance and usability testing. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation of data by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a ventilator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is implicitly addressed by the extensive non-clinical bench testing. The performance specifications like bolus size, breath rate, trigger sensitivity, alarms, and delivered volume in different modes were tested directly on the device itself, without human intervention for performance interpretation. The device's technological functions, such as its trigger sensitivity algorithm with signal artifact correction, were tested for consistent performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be established by:

Reference standards and validated measurement equipment: For physical performance metrics like delivered volume, flow rate, pressure, and battery life.
Compliance with recognized industry standards: Such as those listed (e.g., IEC 60601-1, ISO 10993-1) for electrical safety, EMC, and biocompatibility.
Pre-defined acceptance criteria for functional performance: For features like alarm activation, backup modes, and shelf-life, which are evaluated against specified parameters.
Observation against pre-defined critical tasks: For the usability study, where observed performance of users on critical tasks indicated successful usability.

8. The sample size for the training set

This information is not provided. The document describes a 510(k) submission focused on demonstrating substantial equivalence through non-clinical testing, not the development or training of an AI algorithm. If internal algorithms are present (e.g., for trigger sensitivity), details about their training would typically not be included in this type of submission summary.

9. How the ground truth for the training set was established

This information is not provided and is not applicable in the context of this 510(k) submission summary for a ventilator device.

Summary

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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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152664

Device Name

Tidal Assist™ Ventilator (TAV) System

Indications for Use (Describe)

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.

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510(k) Summary Page 1 of 7 12/1/2016

Official Contact:	New Aera, Inc.2400 Camino Ramon, Suite 365San Ramon, CA 94583
	Todd Allum - Vice President of EngineeringTel - 925-322-0145
Proprietary or Trade Name:	Tidal AssistTM Ventilator (TAVTM) System
Common/Usual Name:	Continuous ventilator
Classification Name/Code:	ONZ - continuous ventilator21 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:

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; ●

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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:

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	PredicateBreathe Ventilator, BT-V2SK131562	Proposed TAV Systems
Device Classification& Product code:	Class II/ONZ	Class II/ONZ
Prescription Device:	Yes	Yes
Device Description:	The Predicate Ventilator, withaccessories is a small, wearable,ventilator that interfaces withproprietary nasal and tracheostomybreathing circuits.	The New Aera Tidal AssistTMVentilation (TAV) system, withaccessories is a small, wearable,ventilator that interfaces withproprietary nasal breathing circuits.
Indications for Use:	The Breathe Technologies Ventilator,with accessories, is a volume assistventilator intended to aid adultpatients with respiratoryinsufficiency. It is designed forpatients who are capable ofspontaneously breathing a minimumtidal volume of 3.5cc/kg of predictedbody weight. The device is designedfor continuous applications such aspatient ambulation, physical therapy,occupational therapy, respiratorytherapy, and other rehabilitationefforts in an institutional or homecare environment. The device isintended for operation by trainedpersonnel, patients or caregiversunder the direction of a physician.	The New Aera Tidal AssistTMVentilator, with accessories, is avolume assist ventilator intended toaid adult patients with respiratoryinsufficiency. It is designed forpatients who are capable ofspontaneously breathing a minimumtidal volume of 3.5cc/kg of predictedbody weight. The device is designedfor continuous applications such aspatient ambulation, physical therapy,occupational therapy, respiratorytherapy, and other rehabilitationefforts in an institutional or homecare environment. The device isintended for operation by trainedpersonnel, patients or caregiversunder the direction of a physician.
Technical Method:	The device consists of twocomponents: a ventilator and apatient interface. The device is alight-weight, portable, electronicallytimed and controlled volume assistventilator. The device delivers bolusvolumes of 50-250ml. The devicedelivers augmented volumes that areblended in the interface, patient'sairway and lung with ambient airprovided by the patient's spontaneousbreath	The device consists of threecomponents: a regulator adapter,ventilator and a patient interface. Thedevice is a light-weight, portable,electronically timed and controlledvolume assist ventilator. The devicedelivers bolus volumes of 50-250ml.The device delivers augmentedvolumes that are blended in theinterface, patient's airway and lungwith ambient air provided by thepatient's spontaneous breath
Method of FlowControl:	Electronically controlled proportionalvalve	Electronically controlled proportionalvalve
Delivered Gas:	Oxygen or air	Oxygen or air
Gas SupplyCompatibility:	DISS 1240 connection	DISS 1240 connection and othercompatible regulated oxygen or airsources
Attribute	PredicateBreathe Ventilator, BT-V2SK131562	Proposed TAV Systems
Patient Interface andDelivery Method:	An interface with relatively largeopening(s) through which the user canspontaneously breathe through.Pressurized nozzles are located withinthe interface to entrain ambient airthrough these openings during oxygendelivery in order to augment thedelivered volume.	An interface with relatively largeopening(s) through which the user canspontaneously breathe through.Pressurized nozzles are located within theinterface to entrain ambient air throughthese openings during oxygen delivery inorder to augment the delivered volume.
Trigger Sensitivity:	User adjustable fixed pressure setting	Preset relative flow trigger setting withsignal 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 DeliveryModes:	Not offered	Capable of delivering pulsed-dose oxygen(Conserve Mode), as well as continuousflow oxygen (Constant Mode).
Total DeliveredVolume (oxygen andentrained ambientair):	The NIOV System delivers tidalvolumes of up to 1,150 ml by providingpositive inspiratory pressure with amaximum pressure up to 18 cmH2O(Breathe Technologies PM-00-0057-A)	The TAV System delivers tidal volumesof up to 1,150 ml by providing positiveinspiratory pressure with a maximumpressure 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 systemandHigh Flow Alarm
	High Delivery Pressure	High Flow Alarm
	High Circuit Pressure	Low Flow Alarm
	High PEEP Pressure	System Fault Alarm
	Low Source Pressure (< 41 PSIG)	High Flow AlarmLow Flow Alarm
	Low Delivery Pressure	Low Flow Alarm
	High Temperature	None
	System Fault	System Fault
	Breath Time Out:	Breath Time Out:
	20 or 60 seconds	20 seconds
	Low Breath Rate:	Low Breath Rate:
	4 breaths/min	4 breaths/min
	High Breath Rate:	High Breath Rate:
	5 to 120 breaths/min	21 to 120 breaths/min
Attribute	Predicate	Proposed TAV Systems
	Breathe Ventilator, BT-V2SK131562
Battery Alarm:	Low Battery (< 25%, or ~1 hourremaining)	Low Battery (~2 days remaining)
Battery:	Internal, rechargeable	AA Alkaline, user replaceable
Battery duration:	4 hours, nominal use	14 days, nominal use
Weight:	1lb	3.8 oz
Length:	7.5"	4.8"
Width:	3.1"	2.4"
Thickness:	1.3"	0.9"
Pillows Interface sizeoptions	Multiple sizes	Universal size
Standards:	IEC 60601-1IEC 60601 - 2- 12ASTM F1100-90ASTM F1246-91	AAMI / ANSI ES60601-1:2005IEC 60601-1-2: 2007IEC 60601-1-8IEC 60601-1-11ISO 10651-6
Biocompatibility:	ISO 10993-1	ISO 10993-1CytotoxicitySensitizationIrritationLeachable / ExtractablesRisk Based AssessmentVOCPM2.5

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510(k) Summary

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510(k) Summary Page 5 of 7 12/1/2016

In the table above we offer an explanation of the similarities and differences, if any, between the proposed device and the predicate. In summary,

Indications -

The TAV System is indicated as 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.
Discussion This is similar to the predicate K131562 Breathe Technologies Ventilator ● BT-V2S.

Patient Population -

It is intended for spontaneously breathing adults.
Discussion The patient population is similar to the predicate K131562 Breathe ● Technologies - Ventilator BT-V2S.

Environment of Use -

For use in home and institutional settings ●
Discussion The environments of use and personnel are similar to the predicate K131562 -. Breathe Technologies – Ventilator BT-V2S.

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510(k) Summary Page 6 of 7 12/1/2016

Technology -

The TAV is an electronically controlled proportional valve which has a breath detection sensor that triggers oxygen flow. In connects to an oxygen or air source and the patient interface is a nasal interface. It includes a conserver feature which delivers a bolus upon inhalation. The TAV has a pulsed dose mode and a constant flow mode which the predicate does not.
Discussion As outlined in the table above the technology and device features are similar to ● the predicate - K131562 - Breathe Technologies - Ventilator BT-V2S.

Performance Specifications -

The performance specifications of the TAV are similar to the predicate regarding bolus size, ● breath rate, and trigger sensitivity. Both devices include backup modes and rates, and similar alarms.
. Discussion - Comparison of performance supports similarities to the predicate - K131562 -Breathe Technologies – Ventilator BT-V2S and the reference device – K103392 – Chad Evolution Model OM-900.

Differences

The differences between the proposed and predicate relate to:

Technology – TAV incorporates pulse-dose oxygen (conserve mode) and continuous flow oxygen (constant mode) which are not in the predicate, but are in the reference device. These additional modes are convenience features for the user.
Patient interface The TAV system only connects to the user via nasal pillows while the ● predicate can also be used with tracheostomy patients
Trigger sensitivity TAV incorporates a pre-set flow trigger setting with a signal artifact ● correction algorithm, whereas the predicate is user adjustable to a fixed threshold. Testing was performed which demonstrated that the TAV triggered consistently for all simulated patient conditions and provided equivalent volume support to that of the predicate device.
Battery - The TAV uses a standard alkaline battery which lasts 14 days where the predicate has an internal rechargeable battery with a single charge for the predicate lasting 4 hours vs. 14 days for the TAV system
Physical size - The TAV is smaller
. Discussion - as discussed in the above table, none of the differences raise new concerns when compared to the predicate for the intended use.

Non-clinical Performance Testing

We have performed a number of tests appropriate for the proposed device. These tests include:

Biocompatibility of Materials -

The materials in patient contact have been tested as follows: ●
- 0 Controller VOC and PM25
- o Patient interface
  - ISO 10993-1 Cytotoxicity, Sensitization, Irritation, Leachable and Extractable . with a risk based assessment.
Discussion The information supports the materials as biocompatible for their intended use. ●

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510(k) Summary Page 7 of 7 12/1/2016

Electrical, EMC, EMI testing -

We have evaluated the proposed device per ANSI/AAMI/ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11 the device performed as intended meeting the requirements.
. Discussion - The proposed device met the requirements of the standards.

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 ●
Discussion The proposed device was tested to assure that it meets its performance ● specifications. Upon completion of the tests, it was found to meet its performance requirements.

Usability -

We 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.

Substantial Equivalence Conclusion

The sponsor demonstrated through performance testing and non-clinical testing that the proposed device is substantially equivalent to the predicate.

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).