(125 days)
No
The description focuses on the mechanical function of a jet nebulizer and aerosol characterization testing, with no mention of AI or ML capabilities.
Yes
The device is intended to aerosolize prescribed medication for inhalation to the respiratory system, which is a therapeutic action.
No
This device is designed to aerosolize prescribed medication for inhalation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (mouthpiece, nebulizer top, nozzle cover, nebulizer bottom, oxygen tubing) and describes it as a "small volume jet nebulizer," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a nebulizer designed to "aerosolize prescribed medication by a patient in the hospital, clinic or home care environment." This is a drug delivery device, not a diagnostic test.
- Intended Use: The intended use is to deliver medication to the respiratory system, not to analyze biological samples for diagnostic purposes.
The device's function and intended use fall under the category of medical devices used for treatment, specifically drug delivery, rather than diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
respiratory system
Indicated Patient Age Range
pediatric (ages 2 years and above) and adult patients
Intended User / Care Setting
licensed healthcare provider or physician / hospital, clinic or home care environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Total Mass (µg), Total Output Rate (µg/s), Fine Particle Fraction (0.98-5.39 μm aerodynamic diameter) (%), Fine Particle Mass (µg), Fine Particle Output Rate (µg/s), Particle Size (MMAD), GSD
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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);
1
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
2
Indications for Use
510(k) Number (if known) K173367
Device Name MC 300* Nebulizer
Indications for Use (Describe)
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.
| 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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3
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
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.
4
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 of
Comparison | MC 300* Nebulizer
(Subject Device) | VixOne™ Nebulizer
(Predicate Device - K926055) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | A handheld, pneumatic nebulizer
designed to aerosolize prescription
drugs for inhalation by a patient. Its
use is indicated whenever a
healthcare professional administers or
prescribes medical aerosol products to
a patient using a small volume
nebulizer. |
| 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 not
specified |
| Single Patient Use | Yes | |
| Aerosolization | Continuous during inhalation and exhalation | |
| Type of device | Disposable, prescription only, non-sterile | |
| Manufacturing
process | 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
5
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.
| Aerosol
| Characteristics | Particle Characterization | ||
|---|---|---|---|
| Subject Device with | |||
| Mouthpiece | Subject Device with | ||
| Mask* | Predicate Device | ||
| Total Mass (µg) | 1473.9 ± 52.1 Albuterol† | ||
| 614.4 ± 17.9 Ipratropium | |||
| Bromide†† | |||
| 366.5 ± 16.3 | |||
| Budesonide††† | 1604.3 ± 28.1 Albuterol† | ||
| 689.5 ± 16.3 Ipratropium | |||
| Bromide†† | |||
| 357 ± 19.3 Budesonide††† | 1316.5 ± 81.7 Albuterol† | ||
| 555.2 ± 39.0 Ipratropium | |||
| Bromide†† | |||
| 486.6 ± 41.0 Budesonide††† | |||
| Total Output Rate (µg/s) | 6.6 ± 0.4 Albuterol† | ||
| 1.7 ± 0.2 Ipratropium | |||
| Bromide†† | |||
| 0.9 ± 0.1 Budesonide††† | 3.7 ± 0.2 Albuterol† | ||
| 1.1 ± 0.1 Ipratropium | |||
| Bromide†† | |||
| 0.5 ± 0.0 Budesonide††† | 5.1 ± 0.5 Albuterol† | ||
| 1.7 ± 0.3 Ipratropium | |||
| Bromide†† | |||
| 0.9 ± 0.2 Budesonide††† | |||
| Fine Particle Fraction | |||
| (0.98-5.39 μm | |||
| aerodynamic diameter) | |||
| (%) | 73.4 ± 1.3 Albuterol† | ||
| 73.4 ± 1.1 Ipratropium | |||
| Bromide†† | |||
| 63.2 ± 0.7 Budesonide††† | 71.1 ± 0.9 Albuterol† | ||
| 69.3 ± 2.8 Ipratropium | |||
| Bromide†† | |||
| 65.9 ± 2.2 Budesonide††† | 58.1 ± 2.3 Albuterol† | ||
| 59.8 ± 2.3 Ipratropium | |||
| Bromide†† | |||
| 52.6 ± 2.6 Budesonide††† | |||
| Fine Particle Mass (µg) | 1082.7 ± 57.3 Albuterol† | ||
| 456.2 ± 15.3 Ipratropium | |||
| Bromide†† | |||
| 231.5 ± 10.1 | |||
| Budesonide††† | 1150.1 ± 19.7 Albuterol† | ||
| 478.1 ± 22.3 Ipratropium | |||
| Bromide†† | |||
| 235.0 ± 6.6 Budesonide††† | 764.2 ± 32.9 Albuterol† | ||
| 331.8 ± 20.0 Ipratropium | |||
| Bromide†† | |||
| 246.2 ± 21.1 Budesonide††† | |||
| Fine Particle Output | |||
| Rate (µg/s) | 4.8 ± 0.3 Albuterol† | ||
| 1.3 ± 0.1 Ipratropium | |||
| Bromide†† | |||
| 0.6 ± 0.0 Budesonide††† | 2.7 ± 0.1 Albuterol† | ||
| 0.8 ± 0.1 Ipratropium | |||
| Bromide†† | |||
| 0.3 ± 0.0 Budesonide††† | 3.0 ± 0.2 Albuterol† | ||
| 1.3 ± 0.1 Ipratropium | |||
| Bromide†† | |||
| 0.5 ± 0.1 Budesonide††† | |||
| Particle Size (MMAD) | 2.8 µg Albuterol† | ||
| 2.8 µg Ipratropium | |||
| Bromide†† | |||
| 4.4 µg Budesonide††† | 2.4 µg Albuterol† | ||
| 2.5 µg Ipratropium | |||
| Bromide†† | |||
| 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
6
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 Mouse |
| Lymphoma 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.