(135 days)
No
The document describes a simple jet nebulizer and its performance characteristics, with no mention of AI or ML.
Yes.
The device is intended to aerosolize prescribed medication for inhalation to the respiratory system, which is a therapeutic action.
No
The device is a nebulizer designed to deliver aerosolized medications. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (mouthpiece, nebulizer top, nozzle cover, nebulizer bottom, oxygen tubing) and performance studies related to aerosol characteristics and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize prescribed medication by a patient in the hospital, clinic or home care environment." This describes a therapeutic device used for drug delivery, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanical components and function of a nebulizer for delivering medication. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are related to aerosol characterization (drug delivery efficiency and particle size), biocompatibility, and emissions from the device itself. These are relevant to the safety and performance of a drug delivery device, not an IVD.
- Key Metrics: The key metrics measured (Total Mass, Total Output Rate, Fine Particle Fraction, etc.) are related to the performance of the nebulizer in delivering medication, not to the analysis of biological samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to detect diseases, conditions, or infections. This nebulizer's function is to deliver medication to the respiratory system, which is a therapeutic action.
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 300R 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 300R 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 300R Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300R Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the reorder 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
pediatic (ages 2 years and above) and adult
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 device 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.
Biocompatibility Testing: 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, Genotoxicity and Extractables/Leachables with a Biological Risk Assessment.
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. Food & Drug Administration' in blue text.
May 2, 2018
Trudell Medical International Marianne Tanton Director, Quality and Regulatory Affairs 725 Third Street London, Ontario N5V 5G4 Canada
Re: K173825
Trade/Device Name: MC 300*R Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: March 29, 2018 Received: April 2, 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
1
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.
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 medical devices and radiation-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.
Geeta K. Pamidimukkala -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) K173825
Device Name MC 300*R 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Prepared: 01-May-2018
1. Submitter
Trudell Medical International 725 Third Street London, Ontario N5V 5G4, Canada
Contact: Marianne Tanton Director, Quality and Requlatory Affairs Phone: 1-519-455-7060 Email: mtanton@trudellmed.com
2. Device Name
Trade Name: Common Name: Classification Name: Regulatory Class: Product Code:
MC 300*R Nebulizer Small Volume Nebulizer Nebulizer 21 CFR 868.5630 = CAF
3. Predicate Device
AeroEclipse* Durable (XL) Nebulizer - K080926 Trudell Medical International
The predicate device has not been subject to a recall.
4. Reference Device
MC 300* Nebulizer - K173367 Trudell Medical International
The predicate device has not been subject to a recall.
5. Device Description
The MC 300R 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 300R 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 300R Nebulizer consists of four components: mouthpiece, nebulizer top, nozzle cover, and nebulizer bottom. It is marketed with oxygen tubing. The MC 300R Nebulizer is not packaged with a mask, however the Disposable Aerosol Mask Assembly can be ordered per the reorder information on the IFU.
4
6. Principle of Operation
This device operates on the Venturi principle. 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.
7. 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.
8. Comparison to predicate device
The MC 300R Nebulizer and AeroEclipse Durable (XL) Nebulizer (K080926), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the MC 300*R Nebulizer and predicate, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices.
5
Table 1: Comparison to Predicate Device
| Element of Comparison | MC 300R Nebulizer
(Subject Device) | AeroEclipse Durable (XL)
Nebulizer
(Predicate Device - K080926) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MC 300R 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. | The AeroEclipse Durable (XL)
nebulizer is a single patient, reusable
device, intended to be used by
patients who are under the care or
treatment of a licensed health care
provider or physician. The device is
intended to be used by these patients
to administer aerosolized medication
prescribed by a physician or health
care professional. The intended
environments for use include the
home, hospitals and clinics. |
| Principle of Operation | Pneumatic Jet Nebulizer | |
| Environment of use | Hospital, Clinic or Home | |
| Patient population | Adult and pediatric patients
(ages 2 years and above) | All |
| Single Patient Use | | Yes |
| Aerosolization | Continuous during inhalation and
exhalation | Built-in mode selector for breath
actuated or continuous mode |
| Type of device | | Reusable Device for single patient use, prescription only, non-sterile |
| Manufacturing process | Plastic molding | |
| Type of gas source | Compressed air or oxygen | |
| Flow rate | 4-8 LPM | 2.75 – 8 LPM |
| Maximum Fill Volume | | 6 ml |
9. Performance Data
9.1 Aerosol Characterization
Aerosol characterization testing for the subject (Mouthpiece and Mask) and predicate device 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.
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Table 2: Performance Data
| Aerosol
| Characteristics | Particle Characterization | |
|---|---|---|
| Continuous Nebulizer, | ||
| with Mouthpiece | ||
| (Subject Device) | ||
| (Job # 1668) | Continuous Nebulizer, | |
| with Mask* | ||
| (Subject Device) | ||
| (Job # 1655) | ||
| Total Mass (µg) | 1494.4 ± 38.4 Albuterol† | |
| 602.5 ± 34.5 Ipratropium | ||
| Bromide‡‡ | ||
| 338.9 ± 29.9 | ||
| Budesonide‡‡‡ | 1604.3 ± 28.1 Albuterol† | |
| 689.5 ± 16.3 Ipratropium | ||
| Bromide‡‡ | ||
| 357 ± 19.3 Budesonide‡‡‡ | ||
| Total Output Rate (µg/s) | 7.1 ± 0.1 Albuterol† | |
| 1.9 ± 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‡‡‡ | ||
| Fine Particle Fraction | ||
| (0.98-5.39 µm | ||
| aerodynamic diameter) | ||
| (%) | 72.4 ± 0.4 Albuterol† | |
| 72.0 ± 0.4 Ipratropium | ||
| Bromide‡‡ | ||
| 64.6 ± 1.4 Budesonide‡‡‡ | 71.1 ± 0.9 Albuterol† | |
| 69.3 ± 2.8 Ipratropium | ||
| Bromide‡‡ | ||
| 65.9 ± 2.2 Budesonide‡‡‡ | ||
| Fine Particle Mass (µg) | 1081.2 ± 30.2 Albuterol† | |
| 433.9 ± 23.3 Ipratropium | ||
| Bromide‡‡ | ||
| 218.8 ± 17.0 | ||
| Budesonide‡‡‡ | 1150.1 ± 19.7 Albuterol† | |
| 478.1 ± 22.3 Ipratropium | ||
| Bromide‡‡ | ||
| 235.0 ± 6.6 Budesonide‡‡‡ | ||
| Fine Particle Output | ||
| Rate (µg/s) | 5.1 ± 0.1 Albuterol† | |
| 1.4 ± 0.1 Ipratropium | ||
| Bromide‡‡ | ||
| 0.6 ± 0.1 Budesonide‡‡‡ | 2.7 ± 0.1 Albuterol† | |
| 0.8 ± 0.1 Ipratropium | ||
| Bromide‡‡ | ||
| 0.3 ± 0.0 Budesonide‡‡‡ | ||
| Particle Size (MMAD) | 2.6 µg Albuterol† | |
| 2.7 µg Ipratropium | ||
| Bromide‡‡ | ||
| 4.2 µg Budesonide‡‡‡ | 2.4 µg Albuterol† | |
| 2.5 µg Ipratropium | ||
| Bromide‡‡ | ||
| 4.1 µg Budesonide‡‡‡ | ||
| GSD | 2.1 Albuterol† | |
| 2.1 Ipratropium Bromide‡‡ | ||
| 1.9 Budesonide‡‡‡ | 2.2 Albuterol† | |
| 2.3 Ipratropium Bromide‡‡ | ||
| 1.9 Budesonide‡‡‡ |
† Albuterol Sulfate Inhalation Solution, 833µg/ml
†† Ipratropium Bromide Inhalation Solution 250µg/ml
††† Budesonide Suspension for Inhalation 0.25mg/ml
- Disposable Aerosol Mask Assembly – Medium Mask
- Disposable Aerosol Mask Assembly – Medium Mask
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9.2 Biocompatibility Testing
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, Genotoxicity 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 |
9.3 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)
10. Clinical Performance Summary
Not applicable, the determination of substantial equivalence is not based on Clinical Performance data.
11. Conclusion
The non-clinical data demonstrates that the MC 300*R Nebulizer is as safe and as effective as the predicate and therefore substantially equivalent to the predicate device.