(186 days)
The AeroEclipse* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, 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.
The subject device. AeroEclipse* ONE BAN (Breath Actuated Nebulizer) is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, thus significantly reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home. Liquid medication is placed in the medication cup of the nebulizer bottom, into which the nebulizer top sub-assembly is attached. The air supply tubing provides the interface for the pressurized air. Aerosol is inhaled by the patient via the oral interface of the mouthpiece. As the patient inhales, ambient air travels down through the nebulizer, creating a pressure drop which causes the actuator, connected to the diaphragm to move down into the nebulizing position. As inhalation continues, aerosol is created and inhaled through the mouthpiece. When inhalation ceases, the actuator returns to the up position thereby eliminating the pressure drop which leads to the device discontinuing the creation of an aerosol. As the patient inhales through the mouthpiece, the actuator drops, and the creation of aerosol begins again. The overall device is comprised of a nebulizer bottom with nozzle feature, a nebulizer top sub-assembly, a mouthpiece and air supply tubing.
The provided document is a 510(k) premarket notification for a medical device, specifically a nebulizer (AeroEclipse* ONE BAN). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study involving AI or human readers.
Therefore, the document does not contain the information requested regarding:
- Acceptance Criteria for an AI-powered device: This document is for a mechanical nebulizer, not an AI device.
- Study proving device meets acceptance criteria: There is no AI performance study described.
- Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods: These details are specific to AI model validation, not mechanical device testing.
- MRMC comparative effectiveness study or standalone AI performance: Not applicable to this type of device submission.
- Training set information for an AI model: No AI model is being submitted.
Instead, the document details physical performance testing (aerosol characterization, design verification), biocompatibility, and dry gas pathway testing to ensure the safety and effectiveness of the nebulizer. The primary objective is to show that the new device is "substantially equivalent" to an already cleared predicate device.
Key relevant points from the document regarding its performance evaluation:
- Device Type: AeroEclipse* ONE BAN (Breath Actuated Nebulizer) - a mechanical device for administering aerosolized medication.
- Performance Data:
- Aerosol Characterization: Performed in accordance with CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). Results "demonstrated substantially equivalent in-vitro performance" to the predicate device.
- Design Verification Testing: Included Flow Performance, Drop Testing, Environmental Testing, and Life Cycle Testing. Results "demonstrate the subject device... meets the requirements outlined in the design verification plan."
- Biocompatibility Testing: Not performed, as materials are identical to the cleared predicate device.
- Dry Gas Pathway Testing: Included assessments for volatile organic compounds (VOCs), fine particles (PM2.5), and inorganic gases (ozone, CO2, CO) per ISO 18562. "Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects."
- Clinical Performance Summary: "Not applicable. The determination of substantial equivalence is not based on Clinical Performance data."
In summary, this document is for a traditional medical device and does not involve AI or the associated acceptance criteria and study designs you've inquired about.
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July 17, 2020
Trudell Medical International Marianne Tanton Director, Ouality and Regulatory Affairs 725 Baransway Drive London, N5V 5G4 Ca
Re: K200063
Trade/Device Name: AeroEclipse* ONE BAN Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: June 16, 2020 Received: June 18, 2020
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
James J. Lee Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200063
Device Name AeroEclipse* ONE BAN
Indications for Use (Describe)
The AeroEclipse* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, 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.
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: 17 July 2020
1. Submitter
Trudell Medical International 725 Baransway Drive 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: | AeroEclipse* ONE BAN |
|---|---|
| Common Name: | Nebulizer |
| Classification Name: | Nebulizer 21 CFR 868.5630 |
| Regulatory Class: | II |
| Product Code: | CAF |
3. Predicate Device
AeroEclipse* II BAN - K053605 Manufacturer: Trudell Medical International (TMI)
The predicate device has not been subject to a recall.
4. Device Description
The subject device. AeroEclipse* ONE BAN (Breath Actuated Nebulizer) is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, thus significantly reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.
Liquid medication is placed in the medication cup of the nebulizer bottom, into which the nebulizer top sub-assembly is attached. The air supply tubing provides the interface for the pressurized air. Aerosol is inhaled by the patient via the oral interface of the mouthpiece. As the patient inhales, ambient air travels down through the nebulizer, creating a pressure drop which causes the actuator, connected to the diaphragm to move down into the nebulizing position. As inhalation continues, aerosol is created and inhaled through the mouthpiece. When inhalation ceases, the actuator returns to the up position thereby eliminating the pressure drop which leads to the device discontinuing the creation of an aerosol. As the patient inhales through the mouthpiece, the actuator drops, and the creation of aerosol begins aqain.
The overall device is comprised of a nebulizer bottom with nozzle feature, a nebulizer top sub-assembly, a mouthpiece and air supply tubing.
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5. Principle of Operation
The subject device. AeroEclipse* ONE BAN, is considered a jet nebulizer, with the driving gas and liquid traveling through separate orifice is located in the center of the nebulizer. The driving gas (air or oxygen), passes through the small orifice and is deflected by a baffle on the actuator. The high velocity jet of gas produces a negative pressure behind it, which draws liquid up to the nozzle area. The deflected gas flow shears off the liquid being drawn up which generates the aerosol.
6. Indications for Use
The AeroEclipse* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, 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.
7. Comparison to Predicate Device
The subject device, AeroEclipse* ONE BAN, is equivalent in terms of indications for use and technological characteristics to that of the predicate device, AeroEclipse* II BAN (K053605).
The difference between the subject and predicate devices involves the aerosolization mode which does not affect the safety or effectiveness of the subject device. The subject device operates in breath actuated mode only while the predicate device operates in both breath actuated and continuous mode. Table 1 provides a comparison of the subject and predicate devices.
| Element of Comparison | AeroEclipse* ONE BAN(Subject Device) | AeroEclipse* II BAN(Predicate Device - K053605) |
|---|---|---|
| Indications for Use | The AeroEclipse* ONE BreathActuated Nebulizer is intended tobe used with adults and pediatricpatients over 5 years old, who areunder the care or treatment of alicensed healthcare provider orphysician. The device is intendedto be used by these patients toadminister aerosolized medicationprescribed by a physician or healthcare professional. The intendedenvironments for use include thehome, hospitals and clinics. | The AeroEclipse* II Breath ActuatedNebulizer is intended to be used bypatients who are under the care ortreatment of a licensed healthcareprovider 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. |
Table 1: Comparison to Predicate Device
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| Principle of Operation | Pneumatic Jet Nebulizer |
|---|---|
| Environment of use | Hospital, Clinic or Home |
| Single Patient Use | Yes |
| Aerosolization Mode | Breath Actuated Mode onlyBuilt-in mode selector for breath actuated or continuous mode |
| Type of Device | Single patient use, multiple use, prescription only, non-sterile |
| Manufacturing process | Plastic molding |
| Type of gas source | Compressed air or oxygen |
| Flow Rate | 2.75 – 8 lpm (liters per minute) |
| Maximum Fill Volume | 6ml |
8. Performance Data
8.1. 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 results of the aerosol characterization testing demonstrated substantially equivalent in-vitro performance subject device, AeroEclipse* ONE BAN, and the predicate device, AeroEclipse* II BAN.
8.2 . Design Verification Testing
The following design verification tests were performed on the subject device, AeroEclipse* ONE BAN:
- Flow Performance ●
- . Drop Testing
- Environmental Testing ●
- Life Cycle Testing ●
Results demonstrate the subject device, AeroEclipse* ONE BAN meets the requirements outlined in the design verification plan. No new issues of safety and efficacy were identified as a result of the testing performed.
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9. Biocompatibility and Dry Gas Pathway
9.1. Biocompatibility Testing
No additional biocompatibility testing was performed to demonstrate compliance with ISO 10993-1 since the materials of construction of the subject device, AeroEclipse* ONE BAN, in its final finished form are identical to the materials of construction of the cleared commercial device, AeroEclipse* II BAN K053605, in formulation, processing and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
9.2. Dry Gas Pathway Testing
To support the safe use of the subject device, AeroEclipse* ONE BAN, testing pertaining to the dry gas pathway and associated risk assessments/conclusions per ISO 18562 were conducted. Testing included the following assessments:
- · Emissions of volatile organic compounds (VOCs), and
- · Fine particles (particulate matter PM2.5)
- · Inorganic gases (ozone, CO2, and CO)
Testing results and risk assessment demonstrated that exposure during use is unlikely to result in toxicological effects.
10. Clinical Performance Summary
Not applicable. The determination of substantial equivalence is not based on Clinical Performance data.
11. Conclusion
The AeroEclipse* ONE BAN is substantially equivalent to the predicate device, AeroEclipse* II BAN, cleared under K053605.
§ 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).