(207 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, assuming the "device" refers to the "Corrugated tube with mouthpiece accessory":
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance data in terms of aerosol characterization and biocompatibility testing. The acceptance criteria generally revolve around demonstrating substantial equivalence to the predicate device (MC300* Nebulizer) for these metrics. The reported performance refers to the actual test results of the subject device in comparison to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied by equivalence claims) | Reported Device Performance (Subject Device vs. Predicate Device) |
|---|---|---|
| Aerosol Characterization | Substantially equivalent in-vitro performance (Total Mass, Fine Particle Fraction, Fine Particle Mass, MMAD, GSD) to the predicate device across various medications (Albuterol Sulfate, Budesonide, Ipratropium Bromide) and flow rates (8 L/min, 13 psi (4 L/min), and with mask at 8 L/min). | For 8 L/min (Mouthpiece): * Albuterol: Total Mass (1248.8±57.8 µg vs 1409.0±84.5 µg), FPF (70.5±1.1% vs 69.1±1.9%), FPM (905.7±51.9 µg vs 974.4±76.7 µg), MMAD (2.9 µm vs 2.9 µm), GSD (2.2 vs 2.2) * Budesonide: Total Mass (403.6±54.6 µg vs 381.2±21.4 µg), FPF (53.6±8.2% vs 58.9±4.5%), FPM (212.9±9.9 µg vs 223.9±14.5 µg), MMAD (5.0 µm vs 4.6 µm), GSD (1.7 vs 1.8) * Ipratropium: Total Mass (535.3±28.2 µg vs 583.2±17.1 µg), FPF (70.3±0.9% vs 70.7±1.8%), FPM (376.6±22.1 µg vs 412.7±17.2 µg), MMAD (3.4 µm vs 3.1 µm), GSD (2.2 vs 2.1)For 13 psi (4 L/min) (Mouthpiece): * Albuterol: Total Mass (1394.4±121.8 µg vs 1348.8±158.9 µg), FPF (71.6±3.5% vs 72.0±2.5%), FPM (995.9±67.0 µg vs 971.3±124.8 µg), MMAD (2.8 µm vs 2.4 µm), GSD (2.2 vs 2.2) * Budesonide: Total Mass (358.1±16.5 µg vs 383.3±21.8 µg), FPF (59.5±3.9% vs 59.4±7.0%), FPM (213.0±16.5 µg vs 227.8±22.8 µg), MMAD (4.7 µm vs 4.6 µm), GSD (1.7 vs 1.9) * Ipratropium: Total Mass (513.3±40.3 µg vs 555.4±35.8 µg), FPF (74.4±1.1% vs 72.1±2.4%), FPM (381.8±28.2 µg vs 400.8±32.2 µg), MMAD (2.4 µm vs 2.9 µm), GSD (2.2 vs 1.9)With Mask at 8 L/min: * Albuterol: Total Mass (1396.7±124.7 µg vs 1435.4±92.2 µg), FPF (71.5±1.3% vs 69.5±2.1%), FPM (999.7±103.9 µg vs 997.5±72.5 µg), MMAD (2.6 µm vs 2.8 µm), GSD (2.2 vs 2.2) * Budesonide: Total Mass (356.3±13.0 µg vs 333.5±22.8 µg), FPF (64.2±1.7% vs 61.3±7.1%), FPM (228.8±9.6 µg vs 203.6±16.6 µg), MMAD (4.3 µm vs 4.5 µm), GSD (1.8 vs 1.8) * Ipratropium: Total Mass (607.9±33.5 µg vs 570.5±29.8 µg), FPF (73.4±1.4% vs 70.3±1.9%), FPM (446.1±26.0 µg vs 401.3±21.2 µg), MMAD (2.6 µm vs 3.1 µm), GSD (2.1 vs 2.0) |
| Biocompatibility Testing | All biological endpoints applicable to the corrugated tube with mouthpiece accessory must satisfy the requirements of ISO 10993-1 (2018). | 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. The results satisfied the requirements of ISO 10993-1 (2018). |
| Dry Gas Pathway Testing | Exposure to volatile organic compounds (VOCs) and fine particles (PM2.5) during use of the corrugated tube with mouthpiece accessory must be unlikely to result in toxicological effects under worst-case dry gas conditions. | Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects. |
2. Sample Size Used for the Test Set and Data Provenance:
- Aerosol Characterization: The tables indicate results as "mean ± standard deviation," implying multiple measurements were taken for each metric under different conditions and for different medications. However, the exact sample size (number of nebulizer units tested for each condition) is not explicitly stated in the provided text. The data provenance is not specified (e.g., country of origin). The study appears to be prospective laboratory testing conducted to evaluate the device's performance.
- Biocompatibility Testing: Similar to aerosol characterization, the exact sample sizes for each specific biological test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity) are not explicitly stated. The data provenance is not specified. This is also prospective laboratory testing.
- Dry Gas Pathway Testing: The sample size for this testing is not explicitly stated. The data provenance is not specified. This is prospective laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. The studies described are performance and safety (non-clinical) studies for a medical accessory, not diagnostic accuracy studies that involve human experts establishing a "ground truth" for interpretations. The "ground truth" in this context is based on established scientific methods and regulatory standards for aerosol characteristics and biocompatibility.
4. Adjudication Method for the Test Set:
- Not applicable. As these are performance and safety studies rather than diagnostic studies with human interpretation, there is no need for an adjudication method like 2+1 or 3+1. The results are objective measurements from laboratory tests.
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:
- No. An MRMC study is not mentioned as this relates to a medical accessory, not an AI-powered diagnostic device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical accessory (corrugated tube with mouthpiece), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant or applicable.
7. The Type of Ground Truth Used:
- Performance Standards and Scientific Methods:
- For Aerosol Characterization: The "ground truth" is defined by the objective physical and chemical properties of the aerosolized medication (e.g., mass, particle size distribution) as measured by established methods and referenced to relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). The comparison is against the predicate device's performance.
- For Biocompatibility Testing: The "ground truth" is compliance with international standards, specifically ISO 10993-1 (2018) and related sub-standards.
- For Dry Gas Pathway Testing: The "ground truth" is the assessment that exposure levels are unlikely to result in toxicological effects, based on scientific risk assessment principles.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical accessory, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a physical accessory, this question is not relevant.
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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
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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
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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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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
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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 ofComparison | Corrugated tube withmouthpiece to be usedwith MC300* Nebulizer(Subject Device) | MC300* NebulizerK173367(Predicate Device) | Comparison |
|---|---|---|---|
| Indications forUse | The nebulizer indicationsfor use remains the sameas cleared under K173367.The corrugated tube is anaccessory to the MC 300®Nebulizer. It is designed towork in conjunction with theMC 300® Nebulizer toextend the patient interfaceaway from the nebulizer.The accessory is a singlepatient use device that isintended to be used witheither mouthpiece or maskfor pediatric (ages 2 yearsand above) and adultpatients, who are under thecare of a licensedhealthcare provider orphysician. | The nebulizer is intended tobe used with pediatric(ages 2 years and above)and adult patients, who areunder the care of alicensed healthcareprovider or physician. Thedevice is designed toaerosolize prescribedmedication for inhalation bya patient in the hospital,clinic or home careenvironment. The nebulizeris a single patient usedevice. | Supplement |
| Principle ofOperation | The nebulizer's principle ofoperation remains thesame as cleared underK173367. | Pneumatic Jet Nebulizer | Supplement |
Table 1: Comparison to Predicate Device
*Trademarks and registered trademarks of Trudell Medical International
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| Element ofComparison | Corrugated tube withmouthpiece to be usedwith MC300* Nebulizer(Subject Device) | MC300* NebulizerK173367(Predicate Device) | Comparison |
|---|---|---|---|
| The corrugated tube withmouthpiece is an accessoryto the MC300* Nebulizer. Itis designed to work inconjunction with theMC300* Nebulizer toextend the patient interfaceaway from the nebulizer. | |||
| Environment ofuse | Hospital, Clinic or Home | Similar | |
| Patientpopulation | Adult and pediatric patients(ages 2 years and above) | Similar | |
| Single PatientUse | Yes | Similar | |
| Aerosolization | Continuous during inhalation and exhalation | Similar | |
| Type of device | Disposable, single patient use, prescription only, non-sterile | Similar | |
| Manufacturingprocess | 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.
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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 | PredicateDevice | SubjectDevice | PredicateDevice | SubjectDevice | PredicateDevice | |
| 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 ParticleFraction(0.98-5.39µmaerodynamicdiameter) (%) | 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 ParticleMass (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 | PredicateDevice | SubjectDevice | PredicateDevice | SubjectDevice | PredicateDevice | |
| 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 ParticleFraction(0.98-5.39µmaerodynamicdiameter) (%) | 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 ParticleMass (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 |
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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 | SubjectDevice withmask | PredicateDevice withmask | SubjectDevice withmask | PredicateDevice withmask | SubjectDevice withmask | PredicateDevice withmask |
| 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 ParticleFraction (0.98-5.39µmaerodynamicdiameter) (%) | 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 ParticleMass (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 |
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| 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 ChemicalCharacterization 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.
§ 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).