Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and sub-acute care environments.

Device Description

The Solarys* Ventilator Aerosol Delivery System (AS) is a single-use (disposable) continuous nebulizer system designed for use with mechanically ventilated patients to aerosolize physician-prescribed medications for inhalation.

AI/ML Overview

The Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adult patients. The device was evaluated non-clinically to demonstrate substantial equivalence to its predicate device, the Aeroneb Professional Nebulizer System (K070642).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating that the performance of the Solarys* AS "raises no new issues of safety or effectiveness from the legally marketed predicate device." This was primarily evaluated through aerosol characterization testing, comparing the Solarys* AS against the predicate using common prescribed drugs.

Below is a table summarizing the aerosol characterization data for the Solarys* AS, with the understanding that these values, when compared to the predicate device (which are not explicitly provided in the text in a comparative table), were deemed substantially equivalent.

Particle Size Characterization	Drug Type	Reported Device Performance (Solarys* AS)	Equivalent to Predicate?
Filter / Breathing Simulator Data
Total Delivered Dose ex ETT (µg)	Albuterol	724	Yes
	Ipratropium Bromide	296	Yes
	Combivent (Albuterol)	1593	Yes
	Combivent (Ipratropium Bromide)	390	Yes
NGI Data
Particle Fraction Greater Than 8.64µm (%)	Albuterol	24.3	Yes
	Ipratropium Bromide	21.6	Yes
	Combivent (Albuterol)	26.3	Yes
	Combivent (Ipratropium Bromide)	26.5	Yes
Particle Fraction Between 0.98 - 8.64 µm (%)	Albuterol	70.2	Yes
	Ipratropium Bromide	73.4	Yes
	Combivent (Albuterol)	68.2	Yes
	Combivent (Ipratropium Bromide)	68.0	Yes
Particle Fraction Less Than 0.98 µm (%)	Albuterol	5.5	Yes
	Ipratropium Bromide	5.0	Yes
	Combivent (Albuterol)	5.5	Yes
	Combivent (Ipratropium Bromide)	5.5	Yes
MMAD (µm)	Albuterol	4.3	Yes
	Ipratropium Bromide	4.0	Yes
	Combivent (Albuterol)	4.6	Yes
	Combivent (Ipratropium Bromide)	4.7	Yes
GSD	Albuterol	2.8	Yes
	Ipratropium Bromide	2.8	Yes
	Combivent (Albuterol)	2.7	Yes
	Combivent (Ipratropium Bromide)	2.8	Yes

Note: The "Equivalent to Predicate?" column is based on the statement "demonstrates that the performance of the Solarys AS raises no new issues of safety or effectiveness from the legally marketed predicate device." Specific numerical comparisons for the predicate device were not provided in the summary.*

2. Sample Size and Data Provenance for the Test Set

Sample Size Used for the Test Set: Not explicitly stated as a numerical sample size (e.g., N=X devices). The evaluation involved testing with "3 commonly prescribed drugs" using the cascade impactor method and simulating normal device usage in a ventilator circuit with a "simulated adult mechanically ventilated patient." The results were based on "statistical analysis (95% confidence interval) of the observed data collected." This implies multiple measurements were taken for each drug and test condition to achieve statistical confidence.
Data Provenance: The study was a non-clinical, laboratory-based evaluation conducted by Trudell Medical International. The country of origin for the data is not specified beyond the manufacturer being in London, Ontario, CANADA. The data is prospective, generated specifically for this 510(k) submission.

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

Not applicable. This was a non-clinical performance study (aerosol characterization and engineering tests), not a study involving medical image interpretation or human expert judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical performance study without human-based adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data."

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

Yes, a standalone study was performed. The non-clinical tests (aerosol characterization, biocompatibility, and mechanical safety testing) evaluated the device's performance independently without human-in-the-loop interaction in a clinical setting. The "device's performance" was directly measured and compared to the predicate.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests was established through objective, laboratory-based measurements and experimental protocols.

For aerosol characterization: Measurements of Total Delivered Dose, Particle Fraction at various sizes, MMAD (Mass Median Aerodynamic Diameter), and GSD (Geometric Standard Deviation) obtained through cascade impactor methodology and collection at the exit of an ETT in a simulated patient model.
For biocompatibility: Adherence to ISO 10993-1 standards.
For mechanical safety: Specific engineering tests (simulated use, pressure, environmental limits, drop, leakage, strain relief fatigue/tensile testing).

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) submission for a nebulizer, not an AI/ML-based device that requires a training set.

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

Not applicable. As noted above, this is not an AI/ML-based device and does not involve a training set for an algorithm.

Summary

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K123614

Trudell Medical International

MAR 1 1 2013

Premarket Notification 510(k) Solarys* Ventilator Aerosol Delivery System

Section 5 – 510(k) Summary

Prepared: 20 November 2012

Trudell Medical International 510(k) Owner 725 Third Street London, Ontario N5V 5G4 CANADA Contact Person Darryl Fischer Associate Director, Global Regulatory Affairs Phone 1-519-455-7060 ext 2140 Fax 1-519-455-6329 e-mail dfischer@trudelimed.com

Device Name

Solarys* Ventilator Aerosol Delivery System Proprietary Common/Classification Nebulizer, Direct Patient Interface

Product Code	CAF
--------------	-----

Classification Regulation 868.5630

Predicate Device 510(k) Number Trade/Model Name(s) Manufacturer K070642 Aeroneb Professional Nebulizer System Aerogen Limited -Aeroneb Solo

Device Description

The Solarys* Ventilator Aerosol Delivery System (AS)

Amended 11 March 2013

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Section 5 -- 510(k) Summary

Intended Use

The Solarys* Ventilator Aerosol Delivery System (AS) is a nebulizer intended to deliver prescribed aerosolized medication to mechanically ventilated pediatric and adults patients able to use an Endotracheal Tube equal to or greater than 4.5 mm in diameter. The device is designed to operate in-line with ventilator circuits and mechanical ventilators in acute and subacute care environments.

Technological Characteristic Comparison to Predicate Device(s)

Common characteristics to both the Solarys* AS and the predicate device ;

operate primarily by atomizing bulk liquid containing medication into an aerosol form that can be inhaled
both have a reservoir that is part of the medication delivery system for extended treatments
both devices allow for refilling during extended treatments, without having to break the patient circuit

Relevant differences in operating principles of the Solarys* AS and the predicate device; - the Solarys* AS is a pneumatically driven nebulizer, whereas the Aerogen Solo system is a vibrating mesh nebulizer that is electrically driven.

No cleaning of the Solarys* AS system is required to maintain nebulizer performance (remains in the patient circuit for the duration of circuit life). The predicate device requires cleaning to prevent clogging of the vibrating mesh to maintain its performance with many formulations.

Non-Clinical Test Summary

Evaluation of the Solarys* AS and the predicate device was performed in accordance with the relevant sections of the CDRH Guidance Document "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODE/DCRD/ADDB -1993).

. Aerosol characterization testing for the Solarys* AS and the predicate device has been conducted with 3 commonly prescribed drugs using the cascade impactor method. The total mass of each drug emitted was determined by simulating normal device usage in a ventilator circuit and demonstrates that the performance of the Solarys* AS raises no new issues of safety or effectiveness from the legally marketed predicate device. Constant sampling through an
Amended 11 March 2013

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Premarket Notification 510(k) Solarys* Ventilator Aerosol Delivery System

Section 5 – 510(k) Summary

impactor at a fixed flow rate does not provide an accurate indication of the amount of medication potentially available in a clinically relevant situation, so in order to obtain a representative measurement of total emitted mass (TEM), a simulated adult mechanically ventilated patient was used to assess the mass of medication available at the exit of a 7.0 mm I.D. ETT. The aerosolized medication exiting the ETT was collected directly onto a polypropylene microfiber filter, connected to an adult mechanical test lung that was used as the patient model.

. Biocompatibility testing was conducted on the Solarys* AS device according to ISO 10993-1
Mechanical safety testing consisted of the following; .
- 0 Simulated use
- 0 Maximum pressure testing
- Environmental limit testing (operating limits and environmental storage and o transportation testing)
- Drop testing O
- o Connection leakage
- Strain relief fatigue and tensile testing o

The aerosol characterizations below have been defined based on statistical analysis (95% confidence interval) of the observed data collected using cascade impactor methodology.

Particle Size Characterization
			Combivent
	Albuterol	Ratio-Ipratropium	Albuterol	Ipratropium Bromide
Filter / Breathing Simulator Data
Total Delivered Dose ex ETT (µg)	724	296	1593	390
NGI Data
Particle Fraction Greater Than8.64µm (%)	24.3	21.6	26.3	26.5
Particle Fraction Between 0.98 -8.64 µm (%)	70.2	73.4	68.2	68.0
Particle Fraction Less Than 0.98µm (%)	5.5	5.0	5.5	5.5
MMAD (µm)	4.3	4.0	4.6	4.7
GSD	2.8	2.8	2.7	2.8

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Premarket Notification 510(k) Solarys * Ventilator Aerosol Delivery System

Trudell Medical International

Section 5 - 510(k) Summary

Clinical Performance Summary

Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data.

Conclusions from Testing

The Solarys* AS has been evaluated against a currently marketed (predicate) device for the determination of substantial equivalency. The Solarys* AS and the predicate device share common indications for use and usage environments. The devices are both single patient use, non-sterile, disposable and are available by prescription.

Performance data, gathered in accordance with "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH/ODE/DCRD/ADDB -1993), demonstrate that the Solarys* AS raises no new issues of safety or effectiveness from the legally marketed predicate device.

Amended 11 March 2013

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

March 11, 2013

Mr. Darryl Fischer, COM Associate Director, Global Regulatory Affairs Trudell Medical International 725 Third Street London Canada N5V 5G4

Re: K123614

Trade/Device Name: Solarys * Ventilator Aberosol Delivery System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 21, 2012 Received: December 26, 2012

Dear Fischer:

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

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Page 2 - Mr. Fischer

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/CDRH0ffices/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/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 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 for

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

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Indications for Use

510(k) Number:

Device Name: Solarys* Ventilator Aerosol Delivery System

K123614

Indications for Use:

Prescription Use: (Part 21 CFR 801 Subpart D)

AND/OR

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE) Albert E. Moyal: 5 Jan 1992 - 1992 - 1994 - 1994 - 1994 - 1994 - 1994 - 1994 - 1 for LS

'Division Sign-Off) rision of Anestheslology, General Hospital ection Control, Dental Devices

10(k) Number:

Page 1 of 1

Trade marks and registered trademarks of Trudell Medical International 11:00:00 14

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:::

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).