The Aerogen USB Controller System includes the Aeroneb® Professional and Aeroneb® Solo Nebulizers, which are intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.

The Aeroneb® Professional Nebulizer is intended for multiple patient use in hospital environment and single patient use in home environment. Aeroneb® Solo Nebulizer is for single patient use. Both nebulizers are for pediatric (29 days or older) and adult patients.

Device Description

The Aerogen USB Controller System includes the previously cleared Aeroneb® Professional and Solo Nebulizers. The Aerogen USB Controller is an alternative controller to the existing Aeroneb® Pro and Aeroneb® Pro-X Controllers. The power source for the Aerogen USB Controller is the Aerogen USB AC/DC Adapter.

The Aerogen USB Controller System utilises the following components:

Aeroneb® Pro or Solo Nebulizers
Aerogen USB Controller
T-Piece
AC/DC Adapter and Clips

The Aerogen USB Controller can be used to power the Aeroneb® Pro and Solo nebulizers in both the hospital and homecare environments. For homecare use, it is operated on vent only.

The Aerogen USB Controller provides two modes of operation; a 30 minute and a 6 hour nebulization cycle. The particular mode to be used depends on the accompanying nebulizer. The Aeroneb Pro® nebulizer can be used in the 30 minute intermittent mode only, whereas the Aeroneb® Solo nebulizer can be used in both the 30 minute intermittent and 6 hour modes.

AI/ML Overview

The medical device in question is the Aerogen USB Controller System, which comprises the Aerogen USB Controller and the existing Aeroneb® Professional and Aeroneb® Solo Nebulizers. The study described focuses on demonstrating the substantial equivalence of the new Aerogen USB Controller to previously cleared controllers for the nebulizers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (for MMAD Droplet Size)	Reported Device Performance (MMAD Droplet Size)
MMAD Droplet Size (Aeroneb Pro)	1 to 5 µm	Successfully achieved (within 1 to 5 µm)
MMAD Droplet Size (Aeroneb Solo)	1 to 5 µm	Successfully achieved (within 1 to 5 µm)
Associated aerosol characteristics	Acceptable	Assessed and demonstrated to be acceptable
Electrical Safety	Compliance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012	Successfully performed, CB Test Certificate issued
Electromagnetic Compatibility	Compliance with IEC 60601-1-2 Edition 3: 2007-03	Successfully performed, CB Test Certificate issued
Software Level of Concern	Moderate	Identified as Moderate
Software Safety Classification	Class B (IEC 62304:2006)	Identified as Class B
Design Verification and Validation	Met all required design inputs	All applicable tests successfully completed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for the cascade impaction testing, nor does it detail the provenance of the data in terms of country of origin or whether it was retrospective or prospective. It mentions "cascade impaction testing was performed: using an Aeroneb Pro nebulizer and an Aeroneb Solo nebulizer with a USB Controller and one drug - Salbutamol Sulphate (Albuterol)." This suggests a controlled laboratory test setup rather than clinical data from human subjects.

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

This information is not provided in the document. The "ground truth" for the performance testing (specifically MMAD) was laboratory measurement using an 8-stage Andersen Cascade Impactor (ACI) against a predefined specification range. This is an objective measurement rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As noted above, the primary performance criteria (MMAD) were determined through objective laboratory measurement using a device (8-stage Andersen Cascade Impactor), not through expert review requiring adjudication.

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

An MRMC comparative effectiveness study was not performed. This device is a nebulizer controller, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

A standalone performance evaluation was performed for the device's functional characteristics. The cascade impaction testing (MMAD droplet size and other aerosol characteristics) evaluated the nebulizer's performance with the new USB controller in a laboratory setting, independent of human interaction beyond operating the device for the test. The electrical safety and EMC testing were also standalone assessments of the device's compliance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the primary performance characteristic (MMAD Droplet Size) was based on objective laboratory measurements using an 8-stage Andersen Cascade Impactor against a pre-defined and scientifically accepted specification range (1 to 5 µm). For electrical safety and EMC, the ground truth was compliance with recognized international standards. For software, it was adherence to FDA guidance and a consensus standard (IEC 62304:2006).

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The Aerogen USB Controller System is a hardware device with associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" section refers to a Level of Concern Assessment and Safety Classification, meaning the software development followed established, verified engineering practices, not a machine learning training paradigm.

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

This information is not provided and is not applicable as there was no AI/ML training set. The "ground truth" for the software's safety and level of concern was established by adherence to FDA guidance (2005 FDA Guidance) and an international consensus standard (IEC 62304:2006) for software development in medical devices.

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 to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 10, 2015

Aerogen Limited Martin Crehan Senior Regulatory Affairs Specialist Galway Business Park, Dangan Galway, Ireland

Re: K143719

Trade/Device Name: Aerogen USB Controller System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 2, 2015 Received: June 5, 2015

Dear Mr. Crehan:

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.

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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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5 Indications for Use Statement

510(k) Number (if known): K143719

Device Name:

Aerogen USB Controller System

Indications for Use:

Prescription Use X (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)

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510(k) Summary

Submitter's Name:	Aerogen Limited
Submitter's Address:	Galway Business Park,Dangan,Galway, Ireland.
Submitter's Telephone:	00-353-91-540400 (Reception)00-353-91-540459 (Martin Crehan)
Submitter's Fax:	00-353-91-584639
Submitter's Email:	mcrehan@aerogen.com
Contact Person:	Martin CrehanSenior Regulatory Affairs Specialist
Date Summary Prepared:	July 10, 2015
Proposed New/Modified Device:	Aerogen USB Controller System
Trade Name:	Aerogen USB Controller System
Appropriate Panel/Classification Name:	Anesthesiology/Nebulizer
Regulation Number:	21 CFR 868.5630
Classification of the Device:	Class II
Product Code:	CAF
Predicate (Cleared) Device(s):
Predicate 510(k) Number:Device:	K133360Aeroneb® Solo Nebulizer System /Aeroneb® Solo Adapter,
Clearance Date:	October 17, 2014
Predicate 510(k) Number:Device:	K120939Aeroneb Pro
Clearance Date:	April 26, 2012
Manufacturer:	Aerogen Limited

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Description of the Proposed Device:

The Aerogen USB Controller System includes the previously cleared Aeroneb® Professional and Solo Nebulizers. The Aeroneb® Professional Nebulizer was cleared as part of K021175, and Aeroneb® Solo Nebulizer was cleared as part of K070642. The Aerogen USB Controller is an alternative controller to the existing Aeroneb® Pro and Aeroneb® Pro-X Controllers. The power source for the Aerogen USB Controller is the Aerogen USB AC/DC Adapter.

The Aerogen USB Controller System utilises the following components:

Aeroneb® Pro or Solo Nebulizers ।
। Aerogen USB Controller
T-Piece -
-AC/DC Adapter and Clips

The Aerogen USB Controller can be used to power the Aeroneb® Pro and Solo nebulizers in both the hospital and homecare environments. For homecare use, it is operated on vent only.

Intended Use of the Device:

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Technological Characteristics Compared to the Predicate Device(s):

There is no change to the existing Aeroneb® Solo or Aeroneb® Professional Nebulizers. This 510(k) submission introduces an alternative controller for powering the Aeroneb® Solo or Aeroneb® Professional Nebulizers, and extends their use to the home environment.

The Pro-X Controller powers the Aeroneb® Solo Nebulizer for hospital use.
The Pro Controller powers the Aeroneb® Professional Nebulizer for hospital use. 트
The USB Controller powers both the Aeroneb® Solo Nebulizer and Aeroneb® Professional Nebulizer for hospital and home use.

The table below compares the Aerogen USB Controller with the existing Aerogen Nebulizer Controllers.

Component	15Minutes	30Minutes	6Hours	Continuous	Power Source
Aerogen USBController	N/A	√	√	N/A	5V USB AC/DC Adapter
Aerogen Pro-XController	N/A	√	N/A	√	9V AC/DC Adapter /Battery
Aerogen Pro Controller	√	√	N/A	N/A	9V AC/DC Adapter /Battery

Aerogen Controller Comparison - Modes of Operation / Power Source(s)

The Aerogen USB Controller System includes existing Aeroneb® Solo and Aeroneb Professional Nebulizers:

. There is no change to the nebulizers, in their general materials of construction and packaging, or in their form, function or performance characteristics,
. There is no change in nebulizer Operational Mode or principles; including Positioning, Medication Capacity and Feed / Loading.
트 The nebulizers continue to be used in the same manner in critical, acute and subacute care settings [Hospital]; with no change in the administered anatomical site or in the target patient population.
. The nebulizers are powered by the same principle, via a separate type Controller; which controls the relevant indicator lights and this facet of operation remains unchanged.
. The Indication for Use has been expanded to incorporate the Homecare environment in a limited capacity; the on-vent mode only. The introduction to this environment setting does not impact the classification of the Aeroneb® Pro and/or Solo Nebulizers.

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The Aerogen USB Controller System also includes the Aerogen USB Controller. The functionality of the Aerogen USB Controller will be similar to the Pro-X Controller, with 30 minute intermittent and 6 hour modes.

Only minor differences exist between the existing Aerogen Pro and Aerogen Pro-X Controllers and the Aerogen USB Controller. The differences are as highlighted below:

. The controller types are physically different in form. The physical characteristics of the Controllers differ, with the Aerogen USB Controller being smaller in size and lighter in weight, and the length of the associated cable(s) differing to that of the existing Pro-X Controller (K133360) / Pro Controller (K120939).
. The Aerogen Pro and Pro-X Controllers are both powered from a 9V AC/DC Adapter, and can also be powered from an internal rechargeable battery. The Aerogen USB Controller is powered from a USB AC/DC Adapter only. Note: All the AC/DC Adapters are 60601 approved.

Discussion of Non-Clinical Tests Performed to Determine Substantial Equivalence:

(a) Electromaqnetic Compatibility/Electrical Safety

The Aerogen USB Controller System was subjected to the full suite of required electrical safety testing. This testing was successfully performed on behalf of Aerogen Limited by TUV Rheinland, and a CB Test Certificate and associated Test Listing Report were provided at the end of the process attesting to this fact.

The applicable standards used to demonstrate compliance for Electrical Safety and Electromagnetic Compatibility are as listed below:

FDARecognitionNumber	StandardDevelopingOrganization	StandardDesignationNumber and Date	Title of Standard
19-4	AAMI ANSI	ES60601-1:2005/(R)2012and A1:2012	C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text) Medical electricalequipment - Part 1: General requirementsfor basic safety and essentialperformance (IEC 60601-1:2005, MOD)
19-1	IEC	60601-1-2 Edition3: 2007-03	Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - Collateralstandard: Electromagnetic compatibility- Requirements and tests

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(b) Biocompatibility

All the materials of construction used in the Aeroneb® Pro and Solo Nebulizer . Systems remain unaltered.
트 The Aerogen USB Controller is the electrical power source used to drive the nebulizers, and does not come into contact with the aerosol being inhaled by the patient. Therefore it does not fall under the scope of a "medical device", per Clause 3.1 of ISO 10993-1:2009 and no additional or new biocompatibility testing is required, per Attachment C of the draft FDA Guidance issued on April 23, 2013.

(c) Software

A Software Level of Concern Assessment for the Aerogen USB Controller was . performed with reference to the 2005 FDA Guidance and documented; wherein the Level of Concern was identified as Moderate.
. In addition the Software Safety Classification was determined using the FDA Consensus Standard; IEC 62304:2006, and it was identified as Class B.
Finally for each software lifecycle phase; the associated activities, tasks and deliverables were defined. in coniunction with their specific requirements. The acceptance criteria for each deliverable were reviewed and it was confirmed that they had been successfully achieved in all instances.

(d) Cleaning / Sterilisation

The USB Controller is sold non-sterile, and does not require cleaning. .
In relation to the constituent nebulizers, please note the following: ■
- -Aeroneb® Solo Nebulizer:

This nebulizer is for single patient use only, and the nebulizer or any of its associated or constituent components do not require to be cleaned, disinfected or sterilized.

Aeroneb® Pro Nebulizer: -
This nebulizer is intended for multiple patient uses in the hospital environment and single patient use in the home environment, and it can be cleaned including boiling (in the home environment) and cleaned, disinfected and autoclaved (if so required) in the hospital environment, as documented in the Instruction Manual.

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(e) Design Verification and Validation Testing

All applicable design verification and validation tests were identified, conducted and successfully completed on the Aerogen USB Controller and the associated nebulizers. This testing demonstrated that the Aerogen USB Controller System met all the required design inputs.

In addition and in order to demonstrate substantial equivalence of the Aerogen USB Controller to the previously cleared Aeroneb Pro and Pro-X Controllers, cascade impaction testing was performed: using an Aeroneb Pro nebulizer and an Aeroneb Solo nebulizer with a USB Controller and one drug - Salbutamol Sulphate (Albuterol).

This testing was performed using the 8 stage Andersen Cascade Impactor (ACI).

The acceptance criteria were that both the tested nebulizers met the Specification Range of 1 to 5 um for MMAD Droplet Size, and this was successfully achieved.

In addition, a range of associated aerosol characteristics were assessed and demonstrated to be acceptable.

Based on the test results obtained for MMAD, and the additional assessed aerosol characteristics; the combination of the Aerogen USB Controller with the Aeroneb Pro and Solo nebulizers: provide results which meet the acceptance criteria for the nebulizers, and which are substantially equivalent to the previously cleared Aeroneb Pro and Pro-X Controllers.

Conclusion:

With the introduction of the Aerogen USB Controller System, the respective nebulizers will continue to be 'controlled' in exactly the same manner with no impact on safety and / or effectiveness.

Furthermore, Aerogen Limited has determined based on the review and results of testing detailed above; that the introduction of the Aerogen USB Controller System; is substantially equivalent to the existing predicate device.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).