(135 days)
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.
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.
The provided text describes the MC 300R Nebulizer and its comparison to a predicate device, the AeroEclipse Durable (XL) Nebulizer. The device's substantial equivalence is established through non-clinical performance data, primarily aerosol characterization, biocompatibility testing, and dry gas pathway testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a typical pass/fail format for all tests. Instead, it presents performance data for the subject device (MC 300R Nebulizer) across various aerosol characteristics, and implicitly compares these to the performance of a predicate device (AeroEclipse Durable (XL) Nebulizer), as well as against relevant guidance documents. For biocompatibility and dry gas pathway testing, the "acceptance criteria" would be compliance with the specified ISO standards and successful completion of the toxicity assessments.
Given the information, the table below will summarize the reported performance data for the MC 300*R Nebulizer. The "acceptance criteria" in this context are primarily implied to be "comparable to the predicate device" and "in accordance with relevant guidance/standards."
| Acceptance Criteria (Implied / Standard) | Reported Device Performance (MC 300*R Nebulizer) - With Mouthpiece | Reported Device Performance (MC 300*R Nebulizer) - With Mask |
|---|---|---|
| Aerosol Characterization (at 8 l/min supplied air flow, 15 l/min cascade impactor flow) | ||
| 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) (%) | 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‡‡‡ |
| Biocompatibility Testing | Compliance with ISO 10993 standards (e.g., Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables/Leachables). Full battery of tests performed and met the requirements. | |
| Dry Gas Pathway Testing | Assessment of Emissions of volatile organic compounds (VOCs), Fine particles (PM2.5), and Inorganic gases (ozone, CO2, and CO). All assessments were conducted and demonstrated acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "sample size" for a test set in terms of patients or images. For the aerosol characterization, the data presented includes mean ± standard deviation, suggesting multiple measurements were taken for each characteristic and drug combination. However, the exact number of replicates is not provided.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It mentions that testing was "conducted in accordance with the relevant sections of the CDRH Guidance Document" and that biocompatibility and dry gas pathway tests were "performed by an independent source" or "conducted by an independent source." This suggests laboratory-based testing, not human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) because the study described is a non-clinical performance evaluation of a nebulizer device. There is no "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The performance is measured objectively through aerosol characterization, chemical analysis, and biological safety testing.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. There is no human interpretation or diagnostic decision-making involved that would require an adjudication method.
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
This information is not applicable (N/A). The device is a nebulizer, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable (N/A). This is a non-clinical performance study of a medical device (nebulizer), not an algorithm.
7. The type of ground truth used
As mentioned in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies does not apply here. The evaluation relies on:
- Physical measurements: For aerosol characteristics (e.g., particle size, mass output).
- Standardized laboratory tests: For biocompatibility (e.g., cytotoxicity assays) and dry gas pathway analysis (e.g., chemical emissions testing).
- Predicate device comparison: The performance of the subject device is implicitly compared to the predicate device to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no training set mentioned or implied, as this is a non-clinical device performance study, not an AI model development or evaluation.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reason as point 8.
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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
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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.
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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.
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Table 1: Comparison to Predicate Device
| Element of Comparison | MC 300*R Nebulizer(Subject Device) | AeroEclipse* Durable (XL)Nebulizer(Predicate Device - K080926) |
|---|---|---|
| Indications for Use | The MC 300*R Nebulizer is intendedto be used with pediatric (ages 2years and above) and adult patients, who are under the care of a licensedhealthcare provider or physician. The device is designed to aerosolizeprescribed medication for inhalationby a patient in the hospital, clinic orhome care environment. Thenebulizer is a single patient use device. | The AeroEclipse* Durable (XL)nebulizer is a single patient, reusabledevice, intended to be used bypatients who are under the care ortreatment of a licensed health careprovider or physician. The device isintended to be used by these patientsto administer aerosolized medicationprescribed by a physician or healthcare professional. The intendedenvironments for use include thehome, 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 andexhalation | Built-in mode selector for breathactuated 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
| AerosolCharacteristics | 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 IpratropiumBromide‡‡338.9 ± 29.9Budesonide‡‡‡ | 1604.3 ± 28.1 Albuterol†689.5 ± 16.3 IpratropiumBromide‡‡357 ± 19.3 Budesonide‡‡‡ |
| Total Output Rate (µg/s) | 7.1 ± 0.1 Albuterol†1.9 ± 0.2 IpratropiumBromide‡‡0.9 ± 0.1 Budesonide‡‡‡ | 3.7 ± 0.2 Albuterol†1.1 ± 0.1 IpratropiumBromide‡‡0.5 ± 0.0 Budesonide‡‡‡ |
| Fine Particle Fraction(0.98-5.39 µmaerodynamic diameter)(%) | 72.4 ± 0.4 Albuterol†72.0 ± 0.4 IpratropiumBromide‡‡64.6 ± 1.4 Budesonide‡‡‡ | 71.1 ± 0.9 Albuterol†69.3 ± 2.8 IpratropiumBromide‡‡65.9 ± 2.2 Budesonide‡‡‡ |
| Fine Particle Mass (µg) | 1081.2 ± 30.2 Albuterol†433.9 ± 23.3 IpratropiumBromide‡‡218.8 ± 17.0Budesonide‡‡‡ | 1150.1 ± 19.7 Albuterol†478.1 ± 22.3 IpratropiumBromide‡‡235.0 ± 6.6 Budesonide‡‡‡ |
| Fine Particle OutputRate (µg/s) | 5.1 ± 0.1 Albuterol†1.4 ± 0.1 IpratropiumBromide‡‡0.6 ± 0.1 Budesonide‡‡‡ | 2.7 ± 0.1 Albuterol†0.8 ± 0.1 IpratropiumBromide‡‡0.3 ± 0.0 Budesonide‡‡‡ |
| Particle Size (MMAD) | 2.6 µg Albuterol†2.7 µg IpratropiumBromide‡‡4.2 µg Budesonide‡‡‡ | 2.4 µg Albuterol†2.5 µg IpratropiumBromide‡‡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 MouseLymphoma 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.
§ 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).