TAV System

K152664 · New Aera, Inc. · ONZ · Dec 2, 2016 · Anesthesiology

Device Facts

• Record ID: K152664
• Device Name: TAV System
• Applicant: New Aera, Inc.
• Product Code: ONZ · Anesthesiology
• Decision Date: Dec 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

TAV System is a small, wearable, battery-powered volume assist ventilator; inputs include regulated air or oxygen source. Device uses electronically controlled proportional valve to deliver gas via nasal pillow interface. Three modes: Tidal Assist (breath-activated, entrains room air to augment volume), Conserve (pulse-dose oxygen), and Constant (continuous flow). Operated by patients, caregivers, or clinicians in home/institutional settings. Features include signal artifact correction for breath detection, LED indicators, and audible alarms. Device provides positive inspiratory pressure (up to 18 cmH2O) to assist spontaneous breathing; helps patients with ambulation and rehabilitation. Powered by single AA alkaline battery (~14-day life). Bypass valve provides 2 LPM constant flow during system failure. Output helps reduce work of breathing for patients with respiratory insufficiency.

Clinical Evidence

Bench testing only. Testing included comparison of total delivered volume, waveforms, trigger sensitivity, alarm functionality, battery life, and cleaning validation. Usability study conducted with healthcare professionals and lay users (patients/caregivers) confirmed ability to perform critical tasks without hazard-related use scenarios. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Wearable, battery-powered volume assist ventilator. Materials: ISO 10993-1 compliant. Sensing: Flow-based breath detection. Energy: Single AA alkaline battery. Dimensions: 4.8" x 2.4" x 0.9". Connectivity: None. Sterilization: Not specified. Standards: AAMI/ANSI ES60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-8, IEC 60601-1-11, ISO 10651-6.

Indications for Use

Indicated for adult patients with respiratory insufficiency capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. Contraindicated for patients who cannot spontaneously breathe or who are fully dependent on mechanical ventilation.

Regulatory Classification

Identification

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

Predicate Devices

• Breathe Technologies – NIOV Ventilator (BT-V2S) (K131562)

Reference Devices

• Chad Evolution Model OM-900 (K103392)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

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

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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:

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<br>Breathe Ventilator, BT-V2S<br>K131562 | Proposed TAV Systems |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification<br>& Product code: | Class II/ONZ | Class II/ONZ |
| Prescription Device: | Yes | Yes |
| Device Description: | The Predicate Ventilator, with<br>accessories is a small, wearable,<br>ventilator that interfaces with<br>proprietary nasal and tracheostomy<br>breathing circuits. | The New Aera Tidal AssistTM<br>Ventilation (TAV) system, with<br>accessories is a small, wearable,<br>ventilator that interfaces with<br>proprietary nasal breathing circuits. |
| Indications for Use: | The Breathe Technologies Ventilator,<br>with accessories, is a volume assist<br>ventilator intended to aid adult<br>patients with respiratory<br>insufficiency. It is designed for<br>patients who are capable of<br>spontaneously breathing a minimum<br>tidal volume of 3.5cc/kg of predicted<br>body weight. The device is designed<br>for continuous applications such as<br>patient ambulation, physical therapy,<br>occupational therapy, respiratory<br>therapy, and other rehabilitation<br>efforts in an institutional or home<br>care environment. The device is<br>intended for operation by trained<br>personnel, patients or caregivers<br>under the direction of a physician. | The New Aera Tidal AssistTM<br>Ventilator, with accessories, is a<br>volume assist ventilator intended to<br>aid adult patients with respiratory<br>insufficiency. It is designed for<br>patients who are capable of<br>spontaneously breathing a minimum<br>tidal volume of 3.5cc/kg of predicted<br>body weight. The device is designed<br>for continuous applications such as<br>patient ambulation, physical therapy,<br>occupational therapy, respiratory<br>therapy, and other rehabilitation<br>efforts in an institutional or home<br>care environment. The device is<br>intended for operation by trained<br>personnel, patients or caregivers<br>under the direction of a physician. |
| Technical Method: | The device consists of two<br>components: a ventilator and a<br>patient interface. The device is a<br>light-weight, portable, electronically<br>timed and controlled volume assist<br>ventilator. The device delivers bolus<br>volumes of 50-250ml. The device<br>delivers augmented volumes that are<br>blended in the interface, patient's<br>airway and lung with ambient air<br>provided by the patient's spontaneous<br>breath | The device consists of three<br>components: a regulator adapter,<br>ventilator and a patient interface. The<br>device is a light-weight, portable,<br>electronically timed and controlled<br>volume assist ventilator. The device<br>delivers bolus volumes of 50-250ml.<br>The device delivers augmented<br>volumes that are blended in the<br>interface, patient's airway and lung<br>with ambient air provided by the<br>patient's spontaneous breath |
| Method of Flow<br>Control: | Electronically controlled proportional<br>valve | Electronically controlled proportional<br>valve |
| Delivered Gas: | Oxygen or air | Oxygen or air |
| Gas Supply<br>Compatibility: | DISS 1240 connection | DISS 1240 connection and other<br>compatible regulated oxygen or air<br>sources |
| Attribute | Predicate<br>Breathe Ventilator, BT-V2S<br>K131562 | Proposed TAV Systems |
| Patient Interface and<br>Delivery Method: | An interface with relatively large<br>opening(s) through which the user can<br>spontaneously breathe through.<br>Pressurized nozzles are located within<br>the interface to entrain ambient air<br>through these openings during oxygen<br>delivery in order to augment the<br>delivered volume. | An interface with relatively large<br>opening(s) through which the user can<br>spontaneously breathe through.<br>Pressurized nozzles are located within the<br>interface to entrain ambient air through<br>these openings during oxygen delivery in<br>order to augment the delivered volume. |
| Trigger Sensitivity: | User adjustable fixed pressure setting | Preset relative flow trigger setting with<br>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,<br>patient triggered | Up to 40 breaths/minute,<br>patient triggered |
| Additional Delivery<br>Modes: | Not offered | Capable of delivering pulsed-dose oxygen<br>(Conserve Mode), as well as continuous<br>flow oxygen (Constant Mode). |
| Total Delivered<br>Volume (oxygen and<br>entrained ambient<br>air): | The NIOV System delivers tidal<br>volumes of up to 1,150 ml by providing<br>positive inspiratory pressure with a<br>maximum pressure up to 18 cmH2O<br>(Breathe Technologies PM-00-0057-A) | The TAV System delivers tidal volumes<br>of up to 1,150 ml by providing positive<br>inspiratory pressure with a maximum<br>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<br>and<br>High 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 Alarm<br>Low 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-V2S<br>K131562 | |
| Battery Alarm: | Low Battery (< 25%, or ~1 hour<br>remaining) | 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 size<br>options | Multiple sizes | Universal size |
| Standards: | IEC 60601-1<br>IEC 60601 - 2- 12<br>ASTM F1100-90<br>ASTM F1246-91 | AAMI / ANSI ES60601-1:2005<br>IEC 60601-1-2: 2007<br>IEC 60601-1-8<br>IEC 60601-1-11<br>ISO 10651-6 |
| Biocompatibility: | ISO 10993-1 | ISO 10993-1<br>Cytotoxicity<br>Sensitization<br>Irritation<br>Leachable / Extractables<br>Risk Based Assessment<br>VOC<br>PM2.5 |

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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 adjust…