The AURA Family of Ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support through invasive or non-invasive interfaces to individuals that require such medical care. Specifically, the AURA Family of Ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.).

The AURA ventilator is a restricted medical device intended for use by qualified, trained, personnel under the direction of a physician.

The AURA ventilator is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Device Description

The AURA Ventilator provides ventilatory support for infant, pediatric and adult patients. The AURA ventilator is a prescription device that can be used in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician.

The AURA ventilator may be operated from AC or DC external power sources or from the integrated battery system. Any time the ventilator is connected to external power, the integrated battery system is charged, including while the ventilator is in use. The AURA ventilator has A/CMV, SIMV, SPONT and VTPC ventilatory modes (Pressure or Volume).

The controls of the AURA ventilator are easily found on the front touch screen and panel. The touch screen can be set up in Hospital, Transport or Basic functional Domains to provide the user with full or limited access. The AURA has a Trends screen for displaying data graphically. User Help screens present information for all controls and features. The AURA family of ventilators has models that can be differentiated based on whether or not the device has SpO2 monitoring capability.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AURA Ventilator (K121891) based on the provided text:

Important Note: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and describes the general types of testing performed. It does not detail specific acceptance criteria values (e.g., a specific pressure accuracy tolerance) or the direct results showing compliance with those values for each test. Instead, it broadly states that "all of which confirms that the device meets its design, performance, and electrical safety requirements" and "All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties."

Therefore, the table below reflects the categories of performance that were tested, as outlined in the "Nonclinical Data" section, rather than precise numerical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Category Tested)	Reported Device Performance and Compliance Statement
Volume Control	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Pressure Support	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Pressure Control	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Trigger Function	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
PEEP/Bias Flow	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Flow Patterns	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Air/Oxygen Entrainment/Monitoring	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Screens	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Waveforms	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Power Performance	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Intake Valve/Exhalation Resistance	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Respiration Rate, Inspiration time & I/E Ratio	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Functional Safety	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Alarms	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Endurance	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
O2 Cylinder Time Monitoring	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
SpO2 Monitoring (if applicable to model variant)	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Battery Time Monitoring	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Volume Target Pressure Control (VTPC)	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
SIMV	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Export Data	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Maintenance Due	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Usability Test on Less Trained Users	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Emergency/Transport and Environmental Safety	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."
Shipping Container	"All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling."

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify discrete "test sets" or their sample sizes in terms of patient data or case numbers. The testing described is
primarily nonclinical verification and validation testing on the device itself (e.g., performance of various ventilatory functions, electrical safety, usability).
Data Provenance: Not applicable as the testing described is primarily laboratory/engineering testing of the device, not a study involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for this type of nonclinical device testing is established by engineering specifications, regulatory standards, and generally accepted principles of ventilator function, rather than expert consensus on medical images or patient outcomes. The "Usability Test on Less Trained Users" implies involvement of human testers, but details on the number or their "qualifications" beyond being "less trained users" are not provided.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human readers are interpreting data (like medical images) and their discrepancies need to be resolved. This document describes device performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly described or conducted. The submission focuses on device performance and substantial equivalence to existing predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The "Nonclinical Data" section describes extensive verification and validation testing of the AURA ventilator's various functions (e.g., volume control, pressure support, alarms, battery life). This testing inherently evaluates the device's performance in a standalone capacity, ensuring it meets its specifications without human intervention during its functional operation. (Note: This is different from a standalone AI algorithm's performance in interpreting data.)

7. Type of Ground Truth Used

The ground truth used for the described nonclinical testing is based on engineering specifications, design requirements, and applicable regulatory/performance standards for ventilators.

8. Sample Size for the Training Set

Not applicable. This document describes the development and testing of a medical device (ventilator hardware/software), not an AI algorithm that requires a "training set" of data in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

K121891

9 2012

NOV

Image /page/0/Picture/1 description: The image shows the logo for Newport Medical. The word "Newport" is written in a cursive font, with the word "MEDICAL" written in block letters below it. The logo is black and white.

Breathing care into all we do.

510(k) Summary

AURA Ventilator

Tom Colonna

10 October 2012

l. Submitter Information:
Newport Medical Instruments, Inc. 1620 Sunflower Avenue Costa Mesa, CA 92626

Contact Person:

Senior Director, Regulatory Affairs

Summary Date:

Device Name

Proprietary:	AURA
Common:	Ventilator, Continuous, Facility Use;Ventilator, Continuous, Home Use
Classification:	II

Product Code: CBK; NOU CFR Section: 868.5895

III. Predicate Devices

The AURA is substantially equivalent to the following legally marketed predicate devices:

NEWPORT HT70® Ventilator cleared under K090888, K111146 ●
NEWPORT e360 cleared under K053502, K101803 .

IV. Device Description

ll.

{1}------------------------------------------------

V. Intended Use

The AURA family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support through invasive or non-invasive interfaces to individuals that require such medical care. Specifically, the AURA family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.).

The AURA ventilator is a restricted medical device intended for use by qualified, trained, personnel under the direction of a physician. The AURA ventilator is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

VI. Reason for the Submission

The purpose of this traditional 510(k) is to request authorization to market the AURA ventilator. The AURA ventilator includes the following features:

. A QuickStart feature for users to set-up the ventilator
Message for the evaluation of possible weaning .

The AURA ventilator has been determined to be substantially equivalent to other legally marketed predicate ventilators. The design and technology of used for the AURA ventilator are common to the HT70 ventilator.

VII. Nonclinical Data

The AURA ventilator has undergone extensive verification, validation and design performance safety testing, all of which confirms that the device meets its design, performance, and electrical safety requirements. The following testing was completed to verify the performance of the AURA ventilator:

Volume Control
Pressure Support
Pressure Control
Trigger Function
PEEP/Bias Flow
Flow Patterns
Air/Oxygen Entrainment/Monitoring
Screens
Waveforms
Power Performance
Intake Valve/Exhalation Resistance

{2}------------------------------------------------

Respiration Rate, Inspiration time & I/E Ratio
Functional Safety
Alarms
Endurance
O2 Cylinder Time Monitoring
SpO2 Monitoring
Battery Time Monitoring
Volume Target Pressure Control (VTPC)
SIMV
Export Data
Maintenance Due
Usability Test on Less Trained Users
Emergency/Transport and Environmental Safety
Shipping Container

·VIII. Conclusions

Verification and validation activities were conducted to establish the performance and safety characteristics of the Aura ventilator. All testing demonstrated that the AURA ventilator performs as intended and has acceptable mechanical properties when used in accordance with its labeling; the device is therefore suitable for its intended use. As the device's intended use, operating principles, ventilation modes and performance parameters are comparable to the referenced predicate devices. Therefore, the AURA ventilator is substantially equivalent to the predicate devices.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, with three curved lines representing its wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the symbol.

November 9, 2012

Mr. Tom Colonna

Senior Director, Regulatory Affairs Newport Medical Instrument, Incorporated 1620 Sunflower Avenue Costa Mesa, California 92626

Re: K121891

Trade/Device Name: AURA Family of Ventilators Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK; NOU Dated: October 10, 2012 Received: October 12, 2012

Dear Mr. Colonna:

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.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

{4}------------------------------------------------

Page 2 - Mr. Colonna

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number:

K121891

AURA Family of Ventilators Device Name:

Indications for Use:

The AURA ventilator is a restricted medical device intended for use by qualified, trained, personnel under the direction of a physician.

The AURA ventilator is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

$\qquad$

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K|2.189|

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).