(207 days)
Not Found
No
The device is a simple accessory (corrugated tube) for a nebulizer and the summary explicitly states that the principle of operation of the parent device remains the same. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
The device is described as an accessory to a nebulizer, designed to extend the patient interface, not to provide therapy itself. The nebulizer (K173367) is the therapeutic device.
No
This device is described as an accessory to a nebulizer, designed to extend the patient interface. Nebulizers are used for drug delivery, not for diagnosing medical conditions. The performance studies also focus on aerosol characterization and biocompatibility, not diagnostic accuracy.
No
The device is a corrugated tube with a mouthpiece, which is a physical accessory to a nebulizer. The description and performance studies focus on physical characteristics and biocompatibility, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the corrugated tube is an accessory to a nebulizer and is designed to extend the patient interface. Nebulizers are used to deliver medication to the lungs, which is a therapeutic purpose, not a diagnostic one.
- Device Description: The description reinforces that it's an accessory to a nebulizer and supplements its performance.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The performance studies focus on aerosol characteristics and biocompatibility, which are relevant to drug delivery and patient safety, not in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device's function is entirely related to the delivery of medication.
N/A
Intended Use / Indications for Use
The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extend the patient interface away from the nebulizer. The accessory is a single patient is intended to be used with either mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.
Product codes
CAF
Device Description
The corrugated tube with mouthpiece accessory is designed to work in conjunction with the cleared predicate device, MC300 * Nebulizer (K173367) to extend the patient interface away from the nebulizer.
In line with FDA's definition of a "medical device accessory", the corrugated tube with mouthpiece accessory is intended to supplement the performance of the parent device, MC300* Nebulizer (K173367).
The principle of operation of MC300* Nebulizer remains the same as cleared under K173367.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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)
7.1. Aerosol Characterization
Aerosol characterization testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The test results demonstrated substantially equivalent in-vitro performance between the subject device (corrugated tube with mouthpiece or mask) used with MC300* Nebulizer, and the predicate device, MC300* Nebulizer (K173367).
7.2. Biocompatibility Testing
Biological endpoints applicable to the corrugated tube with mouthpiece accessory are listed below. Materials were tested in accordance with ISO 10993-1 (2018) and the results satisfied the requirements. All in vitro and in vivo studies were performed and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables, and Chemical Characterization with a Biological Risk Assessment.
7.3. Dry Gas Pathway Testing
To support the safe use of the corrugated tube with mouthpiece accessory in dry gas conditions, a worst-case assessment of volatile organic compounds (VOCs) and fine particles (particulate matter PM2.5) was conducted. Testing results and risk assessment demonstrated that exposure during use of the corrugated tube with mouthpiece accessory is unlikely to result in toxicological effects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MMAD (µm) and GSD are provided in the aerosol characterization tables.
For Albuterol Sulfate (8 L/min): Subject device MMAD 2.9, GSD 2.2; Predicate device MMAD 2.9, GSD 2.2.
For Budesonide (8 L/min): Subject device MMAD 5.0, GSD 1.7; Predicate device MMAD 4.6, GSD 1.8.
For Ipratropium Bromide (8 L/min): Subject device MMAD 3.4, GSD 2.2; Predicate device MMAD 3.1, GSD 2.1.
For Albuterol Sulfate (13 psi (4 L/min)): Subject device MMAD 2.8, GSD 2.2; Predicate device MMAD 2.4, GSD 2.2.
For Budesonide (13 psi (4 L/min)): Subject device MMAD 4.7, GSD 1.7; Predicate device MMAD 4.6, GSD 1.9.
For Ipratropium Bromide (13 psi (4 L/min)): Subject device MMAD 2.4, GSD 2.2; Predicate device MMAD 2.9, GSD 1.9.
For MC300* Nebulizer with Supine Accessory with Mask (Subject Device with Mask) and MC300* Nebulizer with Mask (Predicate Device with Mask) at 8 L/min:
Albuterol Sulfate: Subject device MMAD 2.6, GSD 2.2; Predicate device MMAD 2.8, GSD 2.2.
Budesonide: Subject device MMAD 4.3, GSD 1.8; Predicate device MMAD 4.5, GSD 1.8.
Ipratropium Bromide: Subject device MMAD 2.6, GSD 2.1; Predicate device MMAD 3.1, GSD 2.0.
Predicate Device(s)
Reference Device(s)
Not Found
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Trudell Medical International Marianne Tanton Director, Quality and Regulatory Affairs 725 Baransway Drive London, Ontario N5V 5G4 Canada
Re: K203400
Trade/Device Name: Corrugated tube with mouthpiece accessory Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 20, 2021 Received: May 21, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203400
Device Name
Corrugated tube with mouthpiece accessory
Indications for Use (Describe)
The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extend the patient interface away from the nebulizer. The accessory is a single patient is intended to be used with either mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.
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
Prepared: 14 June 2021
1. Submitter
Trudell Medical International 725 Baransway Drive London, Ontario N5V 5G4, Canada
Contact: Marianne Tanton Director, Quality and Regulatory Affairs Phone: 1-519-455-7060 Email: mtanton@trudellmed.com
2. Device Name
| Trade Name: | None |
|---|---|
| Common Name: | Corrugated tube with mouthpiece accessory |
| Classification Name: | Nebulizer 21 CFR 868.5630 |
| Regulatory Class: | II |
| Product Code: | CAF |
3. Predicate Device
MC300* Nebulizer - K173367 Trudell Medical International
The predicate device has not been subject to a recall.
4. Device Description and Principle of Operation
The corrugated tube with mouthpiece accessory is designed to work in conjunction with the cleared predicate device, MC300 * Nebulizer (K173367) to extend the patient interface away from the nebulizer.
In line with FDA's definition of a "medical device accessory", the corrugated tube with mouthpiece accessory is intended to supplement the performance of the parent device, MC300* Nebulizer (K173367).
The principle of operation of MC300* Nebulizer remains the same as cleared under K173367.
5. Indications for Use
The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extent interface away from the nebulizer. The accessory is a single patient use device that is intended to be used with either
*Trademarks and registered trademarks of Trudell Medical International
4
mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.
The MC300* Nebulizer indications for use remains the same as cleared under K173367.
6. Comparison to predicate device
The predicate device, MC300* Nebulizer (K173667) and the subject device (corrugated tube with mouthpiece) used with MC300* Nebulizer, are identical in purpose, function, core technology and method of operation.
The purpose of this submission is the addition of corrugated tube with mouthpiece accessory for use with the predicate device, MC300* Nebulizer (K173367). Table 1 provides a comparison of the subject and predicate devices.
| Element of
Comparison | Corrugated tube with
mouthpiece to be used
with MC300* Nebulizer
(Subject Device) | MC300* Nebulizer
K173367
(Predicate Device) | Comparison |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The nebulizer indications
for use remains the same
as cleared under K173367.
The corrugated tube is an
accessory to the MC 300®
Nebulizer. It is designed to
work in conjunction with the
MC 300® Nebulizer to
extend the patient interface
away from the nebulizer.
The accessory is a single
patient use device that is
intended to be used with
either mouthpiece or mask
for pediatric (ages 2 years
and above) and adult
patients, who are under the
care of a licensed
healthcare provider or
physician. | 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. | Supplement |
| Principle of
Operation | The nebulizer's principle of
operation remains the
same as cleared under
K173367. | Pneumatic Jet Nebulizer | Supplement |
Table 1: Comparison to Predicate Device
*Trademarks and registered trademarks of Trudell Medical International
5
| Element of
Comparison | Corrugated tube with
mouthpiece to be used
with MC300* Nebulizer
(Subject Device) | MC300* Nebulizer
K173367
(Predicate Device) | Comparison |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------|
| | The corrugated tube with
mouthpiece is an accessory
to the MC300* Nebulizer. It
is designed to work in
conjunction with the
MC300* Nebulizer to
extend the patient interface
away from the nebulizer. | | |
| Environment of
use | Hospital, Clinic or Home | | Similar |
| Patient
population | Adult and pediatric patients
(ages 2 years and above) | | Similar |
| Single Patient
Use | Yes | | Similar |
| Aerosolization | Continuous during inhalation and exhalation | | Similar |
| Type of device | Disposable, single patient use, prescription only, non-
sterile | | Similar |
| Manufacturing
process | Plastic molding | | Similar |
Note: Type of gas source, flow rates and maximum fill volume are nebulizer characteristics and are not listed in the comparison table.
7. Performance Data
7.1. Aerosol Characterization
Aerosol characterization testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The test results demonstrated substantially equivalent in-vitro performance between the subject device (corrugated tube with mouthpiece or mask) used with MC300* Nebulizer, and the predicate device, MC300* Nebulizer (K173367). The results of the testing are summarized in Tables 2 to 4 below.
6
Table 2. Summary of Aerosol Characterization Test Results for Corrugated Tube with Mouthpiece (Subject Device) Used with MC300* Nebulizer and MC300* Nebulizer (K173367) (Predicate Device) at 8 L/min
| Metric | Albuterol Sulfate | Budesonide | Ipratropium Bromide | |||
|---|---|---|---|---|---|---|
| Subject Device | Predicate | |||||
| Device | Subject | |||||
| Device | Predicate | |||||
| Device | Subject | |||||
| Device | Predicate | |||||
| Device | ||||||
| Total Mass | ||||||
| (μg) | 1248.8±57.8 | 1409.0±84.5 | 403.6±54.6 | 381.2±21.4 | 535.3±28.2 | 583.2±17.1 |
| Fine Particle | ||||||
| Fraction | ||||||
| (0.98-5.39µm | ||||||
| aerodynamic | ||||||
| diameter) (%) | 70.5±1.1 | 69.1±1.9 | 53.6±8.2 | 58.9±4.5 | 70.3±0.9 | 70.7±1.8 |
| Fine Particle | ||||||
| Mass (µg) | 905.7±51.9 | 974.4±76.7 | 212.9±9.9 | 223.9±14.5 | 376.6±22.1 | 412.7±17.2 |
| MMAD (µm) | 2.9 | 2.9 | 5.0 | 4.6 | 3.4 | 3.1 |
| GSD | 2.2 | 2.2 | 1.7 | 1.8 | 2.2 | 2.1 |
Table 3. Summary of Aerosol Characterization Test Results for Corrugated Tube with Mouthpiece (Subject Device) Used with MC300* Nebulizer and MC300* Nebulizer (K173367) (Predicate Device) at 13 psi (4 L/min)
| Metric | Albuterol Sulfate | Budesonide | Ipratropium Bromide | |||
|---|---|---|---|---|---|---|
| Subject Device | Predicate | |||||
| Device | Subject | |||||
| Device | Predicate | |||||
| Device | Subject | |||||
| Device | Predicate | |||||
| Device | ||||||
| Total Mass | ||||||
| (µg) | 1394.4±121.8 | 1348.8±158.9 | 358.1±16.5 | 383.3±21.8 | 513.3±40.3 | 555.4±35.8 |
| Fine Particle | ||||||
| Fraction | ||||||
| (0.98-5.39µm | ||||||
| aerodynamic | ||||||
| diameter) (%) | 71.6±3.5 | 72.0±2.5 | 59.5±3.9 | 59.4±7.0 | 74.4±1.1 | 72.1±2.4 |
| Fine Particle | ||||||
| Mass (µg) | 995.9±67.0 | 971.3±124.8 | 213.0±16.5 | 227.8±22.8 | 381.8±28.2 | 400.8±32.2 |
| MMAD (µm) | 2.8 | 2.4 | 4.7 | 4.6 | 2.4 | 2.9 |
| GSD | 2.2 | 2.2 | 1.7 | 1.9 | 2.2 | 1.9 |
7
Table 4. Summary of Aerosol Characterization Test Results for MC300* Nebulizer with Supine Accessory with Mask (Subject Device with Mask) and MC300* Nebulizer with Mask (Predicate Device with Mask) at 8 L/min
| Albuterol Sulfate | Budesonide | Ipratropium Bromide | ||||
|---|---|---|---|---|---|---|
| Metric | Subject | |||||
| Device with | ||||||
| mask | Predicate | |||||
| Device with | ||||||
| mask | Subject | |||||
| Device with | ||||||
| mask | Predicate | |||||
| Device with | ||||||
| mask | Subject | |||||
| Device with | ||||||
| mask | Predicate | |||||
| Device with | ||||||
| mask | ||||||
| Total Mass (µg) | 1396.7±124.7 | 1435.4±92.2 | 356.3±13.0 | 333.5±22.8 | 607.9±33.5 | 570.5±29.8 |
| Fine Particle | ||||||
| Fraction (0.98- | ||||||
| 5.39µm | ||||||
| aerodynamic | ||||||
| diameter) (%) | 71.5±1.3 | 69.5±2.1 | 64.2±1.7 | 61.3±7.1 | 73.4±1.4 | 70.3±1.9 |
| Fine Particle | ||||||
| Mass (µg) | 999.7±103.9 | 997.5±72.5 | 228.8±9.6 | 203.6±16.6 | 446.1±26.0 | 401.3±21.2 |
| MMAD (µm) | 2.6 | 2.8 | 4.3 | 4.5 | 2.6 | 3.1 |
| GSD | 2.2 | 2.2 | 1.8 | 1.8 | 2.1 | 2.0 |
7.2. Biocompatibility Testing
Biological endpoints applicable to the corrugated tube with mouthpiece accessory are listed below. Materials were tested in accordance with ISO 10993-1 (2018) and the results satisfied the requirements. All in vitro and in vivo studies were performed and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables, and Chemical Characterization with a Biological Risk Assessment.
Table 5. Summary of Biocompatibility Testing Conducted
| ISO Standard | Test/ Assessment |
|---|---|
| 10993-1 | Biological Risk Assessment |
| 10993-5 | Cytotoxicity Study Using the ISO Elution Method |
| 10993-3 | Genotoxicity: Bacterial Reverse Mutation Study |
| 10993-3 | Genotoxicity: Mouse Lymphoma Assay |
| 10993-11 | Acute Systemic Toxicity Study in Mice |
8
| ISO Standard | Test/ Assessment |
|---|---|
| 10993-10 | Intracutaneous Study in Rabbits |
| 10993-10 | Guinea Pig Maximization Sensitization |
| 10993-17 | Establishment of allowable limits for leachable substances |
| 10993-12 | Solvent and Extraction Condition Verification for ISO 10993-18 Chemical |
| Characterization Program | |
| 10993-18 | Chemical characterization of materials |
7.3. Dry Gas Pathway Testing
To support the safe use of the corrugated tube with mouthpiece accessory in dry gas conditions, a worst-case assessment of volatile organic compounds (VOCs) and fine particles (particulate matter PM2.5) was conducted. Testing results and risk assessment demonstrated that exposure during use of the corrugated tube with mouthpiece accessory is unlikely to result in toxicological effects.
8. Clinical Performance Summary
Not applicable. The determination of substantial equivalence is not based on Clinical Performance data.
9. Conclusion
The non-clinical data demonstrate that the use of the corrugated tube with mouthpiece accessory used with MC300* Nebulizer (K173367) is safe and effective for use in patients for the delivery of aerosolized inhalation medications and is therefore substantially equivalent to the predicate device, MC300* Nebulizer, cleared under K173367.