The nebulizer is intended to be used with pediatic (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

Device Description

The MC 300* Nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system. The device is intended to be used by pediatric (ages 2 years and above) and adult patients in hospital, clinic or home settings. The MC 300* Nebulizer is a single patient use device and may be used for multiple treatments. This device is not used with a specific drug nor is it distributed with such drugs. The MC 300* Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300* Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the information on the IFU.

AI/ML Overview

The provided text describes the acceptance criteria and the results of the studies conducted for the MC 300* Nebulizer.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MC 300* Nebulizer appear to be based on demonstrating "similar performance" or performance that does not affect safety or effectiveness, relative to the predicate device (VixOne™ Nebulizer, K926055), and compliance with relevant guidance documents and standards. The "performance" section primarily focuses on aerosol characteristics and biocompatibility.

Acceptance Criteria (Implied from comparison to predicate and guidance documents):

Aerosol Characteristics: Performance comparable to, or better than, the predicate device (VixOne™ Nebulizer) as assessed by the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). This includes metrics like Total Mass, Total Output Rate, Fine Particle Fraction, Fine Particle Mass, Fine Particle Output Rate, Particle Size (MMAD), and GSD for various medications. The subject device should demonstrate comparable or improved delivery of medication compared to the predicate.
Biocompatibility: Compliance with ISO 10993 series standards for biological endpoints applicable to an externally communicating device with tissue contact via gas pathway for permanent duration (>30 days). This includes tests for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and chemical characterization.
Dry Gas Pathway: Acceptable levels of emissions (VOCs, fine particles PM2.5, inorganic gases like ozone, CO2, and CO).

*Reported Device Performance (MC 300 Nebulizer vs. Predicate Device)**:

Aerosol Characteristics	Subject Device with Mouthpiece	Subject Device with Mask*	Predicate Device (VixOne™ Nebulizer)
Total Mass (µg)	Albuterol: 1473.9 ± 52.1	Albuterol: 1604.3 ± 28.1	Albuterol: 1316.5 ± 81.7
	Ipratropium Bromide: 614.4 ± 17.9	Ipratropium Bromide: 689.5 ± 16.3	Ipratropium Bromide: 555.2 ± 39.0
	Budesonide: 366.5 ± 16.3	Budesonide: 357 ± 19.3	Budesonide: 486.6 ± 41.0
Total Output Rate (µg/s)	Albuterol: 6.6 ± 0.4	Albuterol: 3.7 ± 0.2	Albuterol: 5.1 ± 0.5
	Ipratropium Bromide: 1.7 ± 0.2	Ipratropium Bromide: 1.1 ± 0.1	Ipratropium Bromide: 1.7 ± 0.3
	Budesonide: 0.9 ± 0.1	Budesonide: 0.5 ± 0.0	Budesonide: 0.9 ± 0.2
Fine Particle Fraction (0.98-5.39 μm aerodynamic diameter) (%)	Albuterol: 73.4 ± 1.3	Albuterol: 71.1 ± 0.9	Albuterol: 58.1 ± 2.3
	Ipratropium Bromide: 73.4 ± 1.1	Ipratropium Bromide: 69.3 ± 2.8	Ipratropium Bromide: 59.8 ± 2.3
	Budesonide: 63.2 ± 0.7	Budesonide: 65.9 ± 2.2	Budesonide: 52.6 ± 2.6
Fine Particle Mass (µg)	Albuterol: 1082.7 ± 57.3	Albuterol: 1150.1 ± 19.7	Albuterol: 764.2 ± 32.9
	Ipratropium Bromide: 456.2 ± 15.3	Ipratropium Bromide: 478.1 ± 22.3	Ipratropium Bromide: 331.8 ± 20.0
	Budesonide: 231.5 ± 10.1	Budesonide: 235.0 ± 6.6	Budesonide: 246.2 ± 21.1
Fine Particle Output Rate (µg/s)	Albuterol: 4.8 ± 0.3	Albuterol: 2.7 ± 0.1	Albuterol: 3.0 ± 0.2
	Ipratropium Bromide: 1.3 ± 0.1	Ipratropium Bromide: 0.8 ± 0.1	Ipratropium Bromide: 1.3 ± 0.1
	Budesonide: 0.6 ± 0.0	Budesonide: 0.3 ± 0.0	Budesonide: 0.5 ± 0.1
Particle Size (MMAD) (µm)	Albuterol: 2.8	Albuterol: 2.4	Albuterol: 4.1
	Ipratropium Bromide: 2.8	Ipratropium Bromide: 2.5	Ipratropium Bromide: 4.0
	Budesonide: 4.4	Budesonide: 4.1	Budesonide: 5.1
GSD	Albuterol: 2.1	Albuterol: 2.2	Albuterol: 2.3
	Ipratropium Bromide: 2.0	Ipratropium Bromide: 2.3	Ipratropium Bromide: 2.2
	Budesonide: 1.8	Budesonide: 1.9	Budesonide: 1.9

Note: The table above clearly shows that the MC 300 Nebulizer (both with mouthpiece and mask) generally performs as well as, and in many critical aspects (e.g., Fine Particle Fraction, and often MMAD), better than the predicate device for aerosol characteristics.*

Biocompatibility Testing Summary:

ISO Standard compliance: 10993-5 (Cytotoxicity), 10993-10 (Irritation and Sensitization), 10993-11 (Acute Systemic Toxicity), 10993-3 (Genotoxicity), 10993-12 (Sample preparation), 10993-17 (Allowable limits for leachable substances), 10993-18 (Chemical characterization).
Result: All in vitro and in vivo studies were performed, and the results are presumed to be acceptable for substantial equivalence, though specific numerical results are not provided for each test, only that they were conducted by an independent source.

Dry Gas Pathway Testing:

Emissions of volatile organic compounds (VOCs)
Fine particles (particulate matter PM2.5)
Inorganic gases (ozone, CO2, and CO)
Result: Testing was conducted by an independent source, and associated risk assessments/conclusions were made, presumed to be acceptable for substantial equivalence.

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

Aerosol Characterization: The document implies that "testing was performed at both low and high supplied air flow rates," but the table presents data at "8 l/min supplied air flow rate to the nebulizer and 15 l/min flow rate through the cascade impactor." The phrasing "the table below reflects data" suggests that the displayed values are representative results from a set of tests rather than a single measurement. Standard deviations are provided, indicating multiple trials were conducted for each medication and configuration, typically 3-5 replicates for such tests, but the exact number of runs or samples for each data point (e.g., how many nebulizers were tested, how many times each nebulizer was run) is not explicitly stated.
Biocompatibility and Dry Gas Pathway Testing: The sample sizes for these tests are not specified in the document.
Data Provenance: Not explicitly stated. The submitter is Trudell Medical International from London, Ontario, Canada. Testing was conducted "by an independent source," but the country of origin of the testing laboratory is not mentioned. The data is presented as "performance testing" and "summary" of tests, implying prospective testing for the 510(k) submission.

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 information is not applicable to the type of device and testing described. The "ground truth" here is objective physical and chemical measurements (aerosol particle sizes, drug output, chemical emissions, biological reactions) rather than subjective expert interpretation of medical images or patient conditions. These measurements are performed by laboratory instruments and protocols, not by expert consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to independent review and dispute resolution by multiple experts, typically for diagnostic studies. The tests described are laboratory-based, objective measurements. The results are based on instrumental readings and established analytical methods.

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

A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that AI would assist human readers in interpreting. The MC 300* Nebulizer is a drug delivery device, not a diagnostic one incorporating AI.

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

A standalone algorithm performance study was not done. This device does not incorporate AI or algorithms that would operate independently.

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

The "ground truth" for the performance claims of the MC 300* Nebulizer is based on objective laboratory measurements in accordance with recognized standards and guidance documents:
- Aerosol Characterization: Physical measurements from cascade impactors and other analytical instruments to determine particle size distribution, drug mass output, etc. This is a direct physical measurement.
- Biocompatibility: Results from standardized in vitro and in vivo biological tests (e.g., ISO 10993 series protocols) and chemical analysis.
- Dry Gas Pathway: Analytical results from emission testing equipment.

8. The sample size for the training set

Not applicable. This device is a medical device for drug delivery, not a Machine Learning/AI algorithm. Therefore, there is no "training set." The device itself undergoes physical and biological testing.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

February 28, 2018

Trudell Medical International Marianne Tanton Director, Quality and Regulatory Affairs 725 Third Street London, n5V 5G4 Ca

Re: K173367

Trade/Device Name: MC 300* Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: January 24, 2018 Received: January 25, 2018

Dear Marianne Tanton:

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 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);

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

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

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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Indications for Use

510(k) Number (if known) K173367

Device Name MC 300* Nebulizer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✘ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) - K173367 MC 300* Nebulizer Clarification Request 21Feb2018

Section 5 - 510(k) Summary

Prepared: 21 Feb2018

1. Submitter

Trudell Medical International 725 Third Street London, Ontario N5V 5G4, Canada

Contact: Marianne Tanton Director, Quality and Regulatory Affairs Tel: 1-519-455-7060 Email: mtanton@trudellmed.com

2. Device

Trade Name: Common Name: Classification Name: Regulatory Class: Product Code:

MC 300* Nebulizer Small Volume Nebulizer Nebulizer 21 CFR 868.5630 CAF

3. Predicate Device

VixOne™ Nebulizer, K926055 Westmed, Inc.

The predicate device has not been subject to a recall.

Reference Device

AeroEclipse* II Breath Actuated Nebulizer, K053605 Trudell Medical International

The reference device has not been subject to a recall.

4. Device Description

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Traditional 510(k) — K173367 MC 300* Nebulizer Clarification Request 21Feb2018

Section 5 - 510(k) Summary

5. Principle of Operation

Compressed air is driven through a converging nozzle, where it accelerates and emerges at a high velocity, creating a vacuum (venturi effect). The vacuum draws a liquid residing in a reservoir up through a cylindrical channel and into the emerging airstream formed by the nozzle, to mix with air and impact upon a rigid surface. This process uses energy from the airstream to convert liquid into small droplets called aerosol. Upon reaching the user aerosol is suitably refined to enter the lungs effectively.

6. Indications for Use

The nebulizer is intended to be used with pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication for inhalation by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

7. Comparison to predicate device

The MC 300* Nebulizer and VixOne™ Nebulizer (K926055), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the MC 300* Nebulizer and VixOne™ Nebulizer, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices.

Element ofComparison	MC 300* Nebulizer(Subject Device)	VixOne™ Nebulizer(Predicate Device - K926055)
Indications for Use	The nebulizer is intended to be used withpediatric (ages 2 years and above) andadult patients, who are under the care ofa licensed healthcare provider orphysician. The device is designed toaerosolize prescribed medication forinhalation by a patient in the hospital,clinic or home care environment. Thenebulizer is a single patient use device.	A handheld, pneumatic nebulizerdesigned to aerosolize prescriptiondrugs for inhalation by a patient. Itsuse is indicated whenever ahealthcare professional administers orprescribes medical aerosol products toa patient using a small volumenebulizer.
Technology	Pneumatic Jet Nebulizer
Environment of use	Hospital, Clinic or Home
Patient population	Adult and pediatric patients(ages 2 years and above)	All - specific patient population notspecified
Single Patient Use	Yes
Aerosolization	Continuous during inhalation and exhalation
Type of device	Disposable, prescription only, non-sterile
Manufacturingprocess	Plastic molding
Type of gas source	Compressed air or oxygen
Flow rates	4-8 LPM	4-10 LPM
Maximum Fill Volume	6 mL	10 mL

Table 1: Comparison to Predicate Device

*Trade marks and registered trademarks of Trudell Medical International

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Section 5 - 510(k) Summary

8. Performance Data

8.1 Performance Testing

Aerosol characterization testing for the subject (Mouthpiece and Mask) and predicate devices was conducted in accordance with the relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). Testing was performed at both low and high supplied air flow rates. The table below reflects data at 8 l/min supplied air flow rate to the nebulizer and 15 l/min flow rate through the cascade impactor. The table below also includes data from testing conducted with the medium mask, however, the nebulizer was also tested with small and large masks, which demonstrated similar performance to the medium mask.

AerosolCharacteristics	Particle Characterization
	Subject Device withMouthpiece	Subject Device withMask*	Predicate Device
Total Mass (µg)	1473.9 ± 52.1 Albuterol†614.4 ± 17.9 IpratropiumBromide††366.5 ± 16.3Budesonide†††	1604.3 ± 28.1 Albuterol†689.5 ± 16.3 IpratropiumBromide††357 ± 19.3 Budesonide†††	1316.5 ± 81.7 Albuterol†555.2 ± 39.0 IpratropiumBromide††486.6 ± 41.0 Budesonide†††
Total Output Rate (µg/s)	6.6 ± 0.4 Albuterol†1.7 ± 0.2 IpratropiumBromide††0.9 ± 0.1 Budesonide†††	3.7 ± 0.2 Albuterol†1.1 ± 0.1 IpratropiumBromide††0.5 ± 0.0 Budesonide†††	5.1 ± 0.5 Albuterol†1.7 ± 0.3 IpratropiumBromide††0.9 ± 0.2 Budesonide†††
Fine Particle Fraction(0.98-5.39 μmaerodynamic diameter)(%)	73.4 ± 1.3 Albuterol†73.4 ± 1.1 IpratropiumBromide††63.2 ± 0.7 Budesonide†††	71.1 ± 0.9 Albuterol†69.3 ± 2.8 IpratropiumBromide††65.9 ± 2.2 Budesonide†††	58.1 ± 2.3 Albuterol†59.8 ± 2.3 IpratropiumBromide††52.6 ± 2.6 Budesonide†††
Fine Particle Mass (µg)	1082.7 ± 57.3 Albuterol†456.2 ± 15.3 IpratropiumBromide††231.5 ± 10.1Budesonide†††	1150.1 ± 19.7 Albuterol†478.1 ± 22.3 IpratropiumBromide††235.0 ± 6.6 Budesonide†††	764.2 ± 32.9 Albuterol†331.8 ± 20.0 IpratropiumBromide††246.2 ± 21.1 Budesonide†††
Fine Particle OutputRate (µg/s)	4.8 ± 0.3 Albuterol†1.3 ± 0.1 IpratropiumBromide††0.6 ± 0.0 Budesonide†††	2.7 ± 0.1 Albuterol†0.8 ± 0.1 IpratropiumBromide††0.3 ± 0.0 Budesonide†††	3.0 ± 0.2 Albuterol†1.3 ± 0.1 IpratropiumBromide††0.5 ± 0.1 Budesonide†††
Particle Size (MMAD)	2.8 µg Albuterol†2.8 µg IpratropiumBromide††4.4 µg Budesonide†††	2.4 µg Albuterol†2.5 µg IpratropiumBromide††4.1 µg Budesonide†††	4.1 µg Albuterol†4.0 µg Ipratropium Bromide††5.1 µg Budesonide†††
GSD	2.1 Albuterol†2.0 Ipratropium Bromide††1.8 Budesonide†††	2.2 Albuterol†2.3 Ipratropium Bromide††1.9 Budesonide†††	2.3 Albuterol†2.2 Ipratropium Bromide††1.9 Budesonide†††

Albuterol Sulfate Inhalation Solution, 833µg/ml

†† Ipratropium Bromide Inhalation Solution 250µg/ml

ttt Budesonide Suspension for Inhalation 0.25mg/ml

Disposable Aerosol Mask Assembly - Medium Mask

*Trade marks and registered trademarks of Trudell Medical International

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Traditional 510(k) - K173367 MC 300* Nebulizer Clarification Request 21Feb2018

Section 5 - 510(k) Summary

8.2 Biocompatibility Testing Summary

Biological endpoints applicable to an externally communicating device, tissue contact by way of gas pathway with permanent duration (> 30 days) are listed below. All in vitro and in vivo studies were performed by an independent source and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Extractables/Leachables with a Biological Risk Assessment.

Summary of Biocompatibility Testing Conducted

ISO Standard	Biological Endpoint
10993-5	Tests for In Vitro Cytotoxicity
10993-10	Tests for Irritation and Skin Sensitization
10993-11	Tests for systemic toxicity (Acute Toxicity)
10993-3	Tests for genotoxicity (Bacterial Reverse Mutation Study and MouseLymphoma Assay)
10993-12	Sample preparation and reference materials
10993-17	Establishment of allowable limits for leachable substances
10993-18	Chemical characterization of materials

8.3 Dry Gas Pathway Testing

Testing pertaining to the dry gas pathway and associated risk assessments/conclusions were conducted by an independent source. Testing included the following assessments:

· Emissions of volatile organic compounds (VOCs)
· Fine particles (particulate matter PM2.5)
· Inorganic gases (ozone, CO2, and CO)

9. Clinical Performance Summary

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

10. Conclusion

The non-clinical data demonstrate that the MC 300* Nebulizer is as safe and effective as the predicate and therefore substantially equivalent to the 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).