(266 days)
No
The document describes a nebulizer system and a modification to its manufacturing process. There is no mention of AI or ML in the intended use, device description, performance studies, or key metrics. The focus is on the physical characteristics and performance of the aerosolized medication delivery.
No.
The device aerosolizes physician-prescribed medications for delivery to patients, but it does not directly provide therapy itself. It is a delivery system for therapeutic agents.
No
This device is a nebulizer system intended to aerosolize physician-prescribed medications for inhalation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components (Nebulizer, Aperture Plate, Oscillator washer, piezo) and a physical modification to the attachment process of these components. It is not solely software.
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 physician-prescribed medications for inhalation." This is a therapeutic delivery device, not a device used to perform tests on samples from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the mechanism of aerosolizing medication and its integration with ventilation systems. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies described are focused on the physical characteristics of the aerosolized medication (particle size, dose) and the device's performance in delivering it. These are not studies related to diagnostic accuracy or analytical performance on biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. This device's function is to deliver medication into the body, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.
Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
Product codes
CAF
Device Description
The Aerogen® Solo Nebulizer System consists of the Aerogen® Solo Nebulizer, which has the proposed modification outlined in these 510(k) applications, and the Aerogen® Pro-X Controller (K133360 for both components and system) or the Aerogen Solo Nebulizer can also be used alternatively with the reference device - Aerogen® USB Controller (K143719).
The Aerogen® Solo Nebulizer is intended to aerosolize physician-prescribed medications for inhalation which are approved for use with a general-purpose nebulizer. It is intended for use on and off mechanical ventilation or other positive pressure breathing assistance and is intended for both intermittent and continuous nebulization.
The Aerogen® Solo Nebulizer is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation.
This submission is for a modification of the attachment process of the Aperture Plate (AP) to the Oscillator washer, both are components of the core for the Aerogen® Solo Nebulizer. The current method of attachment of the Aperture Plate to the Oscillator washer is by means of Brazing, a metal fusion process, where a copper/gold filler washer is melted in the brazing process to form the bond. The piezo is then attached using a heat cured epoxy adhesive.
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 (29 days or older) and adult patients.
Intended User / Care Setting
Hospital: critical, acute, and sub-acute care settings, and during patient transport.
Homecare: on vent only in the homecare 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)
Non-clinical Performance Testing included:
- Comparative Particle Characterization testing via Cascade Impactor
- Flow rate of 28 LPM to the predicate which was tested with 3 drugs via Anderson Cascade o Impactor at 28.3 Lpm with the modified FAB device with one drug class also at 28.3 Lpm with an Anderson Cascade Impactor.
- Performance of the modified FAB with 3 drug classes at 15 Lpm with the NGI test device.
- Aerosol Performance Inter- and Intra-sample variability
- Performance of post-aging and degradation
Key results:
The performance testing and comparison of the indications for use, performance specifications to the predicate and reference demonstrate that the proposed modification to the Aerogen® Solo Nebulizer are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Total Dose (ug): Albuterol: 526.94 – 545.23, Ipratropium: 144.51 – 152.04, Budesonide: 229.62 – 245.20 (Proposed Modified Nebulizer, NGI @ 15 lpm)
- Particle size (MMAD) (microns): Albuterol: 2.90 – 3.23 (Predicate), 2.80 – 3.05 (Proposed, 28 lpm), 4.39 – 4.53 (Proposed, 15 lpm); Ipratropium: 3.07 – 3.42 (Predicate), 3.76 – 4.02 (Proposed, 15 lpm); Budesonide: 3.45 – 3.79 (Predicate), 4.90 – 5.01 (Proposed, 15 lpm).
- Geometric Std. Dev. (GSD): Albuterol: 2.09 – 2.35 (Predicate), 2.26 – 2.36 (Proposed, 28 lpm), 2.09 – 2.16 (Proposed, 15 lpm); Ipratropium: 1.80 – 1.93 (Predicate), 2.28 – 2.41 (Proposed, 15 lpm); Budesonide: 1.92 – 2.14 (Predicate), 2.06 – 2.14 (Proposed, 15 lpm).
- Total Respirable Dose (0.0-5 microns): Albuterol: 67.66 – 73.50 (Predicate), 70.88 – 73.94 (Proposed, 28 lpm), 54.42 – 56.10 (Proposed, 15 lpm); Ipratropium: 71.78 – 76.69 (Predicate), 59.57 – 63.06 (Proposed, 15 lpm); Budesonide: 62.32 – 66.90 (Predicate), 49.32 – 50.91 (Proposed, 15 lpm).
- Coarse Particle Dose (>4.7 micron): Albuterol: 27.00 – 31.11 (Predicate), 28.73 – 32.03 (Proposed, 28 lpm), 46.69 – 48.78 (Proposed, 15 lpm); Ipratropium: 23.62 – 28.21 (Predicate), 39.87 – 43.38 (Proposed, 15 lpm); Budesonide: 32.31 – 36.12 (Predicate), 53.51 – 54.99 (Proposed, 15 lpm).
- Fine Particle Dose (
§ 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 and 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.
May 10, 2024
Aerogen Ltd. % Paul Dryden Consultant Aerogen Ltd. c/o ProMedic LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K232507
Trade/Device Name: Aerogen®Solo Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: April 16, 2024 Received: April 16, 2024
Dear Paul Dryden:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232507
Device Name
Aerogen® Solo Nebulizer System and Aerogen® USB Controller System
Indications for Use (Describe)
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.
Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physicianprescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
| Type of Use (Select one or both, as applicable) |
|---|
| Research Use (Part 21 CFR 801.2 Label D) |
| Over-The-Counter Use (21 CFR 801.2 Label C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| Date Prepared: | 10-May-24 |
|---|---|
| Sponsor: | Aerogen Ltd |
| Galway Business Park, | |
| Dangan, Galway, Ireland. | |
| Tel - + 353-91-540400 | |
| Sponsor Contact: | Thelma Marley |
| Senior Manager of Global Strategic Regulatory Affairs | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | Aerogen® Solo Nebulizer System |
| Common/Usual Name: | Nebulizer |
| Classification CFR: | 868.5630 |
| Product Code: | CAF |
| Classification Name: | Nebulizer |
| Primary Predicate Device: | K133360 - Aeroneb® Solo Nebulizer System / Aeroneb® Solo |
| Proprietary or Trade Name: | Adapter |
| Common/Usual Name: | Nebulizer |
| Classification CFR: | 868.5630 |
| Product Code: | CAF |
| Classification Name: | Nebulizer |
| Reference Device: | K143719 – Aerogen® USB Controller System |
| Proprietary or Trade Name: | Nebulizer |
| Common/Usual Name: | 868.5630 |
| Classification CFR: | CAF |
| Product Code: | Nebulizer |
| Classification Name: |
Device Description:
The Aerogen® Solo Nebulizer System consists of the Aerogen® Solo Nebulizer, which has the proposed modification outlined in these 510(k) applications, and the Aerogen® Pro-X Controller (K133360 for both components and system) or the Aerogen Solo Nebulizer can also be used alternatively with the reference device - Aerogen® USB Controller (K143719).
The Aerogen® Solo Nebulizer is intended to aerosolize physician-prescribed medications for inhalation which are approved for use with a general-purpose nebulizer. It is intended for use on and off mechanical ventilation or other positive pressure breathing assistance and is intended for both intermittent and continuous nebulization.
The Aerogen® Solo Nebulizer is designed to operate in-line with standard ventilator circuits and mechanical ventilators. It operates without changing patient ventilator parameters and can be refilled without interrupting ventilation.
5
This submission is for a modification of the attachment process of the Aperture Plate (AP) to the Oscillator washer, both are components of the core for the Aerogen® Solo Nebulizer. The current method of attachment of the Aperture Plate to the Oscillator washer is by means of Brazing, a metal fusion process, where a copper/gold filler washer is melted in the brazing process to form the bond. The piezo is then attached using a heat cured epoxy adhesive.
Indications for Use:
The Aerogen® Solo Nebulizer System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment.
Aerogen® Solo Nebulizer is for single-patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
The Aerogen® USB Controller System includes the Aerogen® Solo Nebulizer, which is intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
Aerogen® Solo Nebulizer is for single patient use. The Aerogen Solo nebulizer is for pediatric (29 days or older) and adult patients.
Predicate and Reference
We have selected a primary predicate and reference device which cover the 2 different controllers which both utilize the Aerogen® Solo nebulizer. Therefore the modified Aerogen® Solo nebulizer will still be used with each controller model thus the rationale for including both.
We present a comparison of the proposed device and a Solo nebulizer predicate in Table 1 and then discuss the table and any differences. Table 2 presents the comparative particle characterization performance of the predicate vs. the modified nebulizer.
6
Table 1 – Substantial Equivalence Comparative Table
| Features | Primary Predicate Aerogen Solo Nebulizer
K133360 (Reference noted K143719) | Proposed Aerogen Solo Nebulizer | Comparison |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Aerogen® Solo Nebulizer System includes
the Aerogen® Solo Nebulizer, which is
intended to aerosolize physician-prescribed
medications for inhalation to patients on and
off ventilation or other positive pressure
breathing assistance in the hospital
environment. | The Aerogen® Solo Nebulizer System includes
the Aerogen® Solo Nebulizer, which is intended
to aerosolize physician-prescribed medications
for inhalation to patients on and off ventilation
or other positive pressure breathing assistance in
the hospital environment. | Similar to the primary predicate. No
change to the indications for use
The Indications for Use provided are
similar to the intended use and
information provided elsewhere in the
Labeling for the predicate K133360 and
reference K143719. |
| | Aerogen® Solo Nebulizer is for single-patient
use. The Aerogen Solo nebulizer is for
pediatric (29 days or older) and adult patients. | Aerogen® Solo Nebulizer is for single-patient
use. The Aerogen Solo nebulizer is for pediatric
(29 days or older) and adult patients. | |
| | The Aerogen® USB Controller System
includes the Aerogen® Solo Nebulizer, which
is intended to aerosolize physician-prescribed
medications for inhalation to patients on and
off ventilation or other positive pressure
breathing assistance in the hospital
environment, and on vent only in the homecare
environment. | The Aerogen® USB Controller System includes
the Aerogen® Solo Nebulizer, which is intended
to aerosolize physician-prescribed medications
for inhalation to patients on and off ventilation
or other positive pressure breathing assistance in
the hospital environment, and on vent only in
the homecare environment. | |
| | Aerogen® Solo Nebulizer is for single patient
use. The Aerogen Solo nebulizer is for
pediatric (29 days or older) and adult patients. | Aerogen® Solo Nebulizer is for single patient
use. The Aerogen Solo nebulizer is for pediatric
(29 days or older) and adult patients. | |
| Patient Population | The device may be used with pediatric
(29 days or older) and adult patients | The device may be used with pediatric
(29 days or older) and adult patients | Similar, no change to patient population |
| Environment of
Use | Predicate:
The Aerogen® Solo System consists of the
Aerogen® Solo nebulizer and the Aerogen®
Pro-X Controller. It is intended for hospital use
only. | Predicate:
The Aerogen® Solo System consists of the
Aerogen® Solo nebulizer and the Aerogen®
Pro-X Controller. It is intended for hospital use
only. | Similar, no change to environment of
use |
| Features | Reference:
The Aerogen® USB Controller System with the Aerogen® Solo Nebulizer is intended for use in the hospital environment and on vent only in the homecare environment.
Primary Predicate Aerogen Solo Nebulizer K133360 (Reference noted K143719) | Reference:
The Aerogen® USB Controller System with the Aerogen® Solo Nebulizer is intended for use in the hospital environment and on vent only in the homecare environment.
Proposed Aerogen Solo Nebulizer | Comparison |
| Principle of Operation and rate | Vibrating mesh
Approximately 128 kHz | Vibrating mesh
Approximately 128 kHz | Similar, no change |
| Aerosolization | Continuous during inhalation and exhalation | Continuous during inhalation and exhalation | Similar, no change |
| Compressed gas source | N/A | N/A | Similar |
| Reservoir volume | Maximum 6 ml | Maximum 6 ml | Similar, no change |
| Flow rate | > 0.2ml/min | ≥ 0.2ml/min | Similar devices, no change to Duration of Use |
| Duration of Use | The Aerogen Solo Nebulizer
• Intermittent use for a maximum of 28 days (4 treatments per day.)
• For continuous use the life of the Aerogen Solo nebulizer and the Continuous Nebulization Tube Set have been validated for use for a maximum of 7 days. | The Aerogen Solo Nebulizer
• Intermittent use for a maximum of 28 days (4 treatments per day.)
• For continuous use the life of the Aerogen Solo nebulizer and the Continuous Nebulization Tube Set have been validated for use for a maximum of 7 days. | Similar, no change |
| Nebulizer components cleanable | No | No | Similar, no change |
| Software driven | No | No | Same device, no change to power source |
| Power source | Pro-X controller
USB Controller | Pro-X controller
USB Controller | Same device, no change to power source |
| Power consumption | The power consumption of the Aerogen® Solo nebulizer is $≤$ 2.0 watts. | The power consumption of the Aerogen® Solo nebulizer is $≤$ 2.0 watts. | Same device, no change to power consumption |
| Weight | Nebulizer Weight: 13.5g (0.5oz) nebulizer and plug | Nebulizer Weight: 13.5g (0.5oz) nebulizer and plug | Same device, no change to the Aerogen Solo Nebulizer weight |
| Nebulizer Dimensions (mm) | 67 mm H x 48 mm W x 25 mm D 2.6" H x 1.88" W x 1.1" D | 67 mm H x 48 mm W x 25 mm D 2.6" H x 1.88" W x 1.1" D | No change to Nebulizer dimensions |
| Operating Conditions | Aerogen® Solo Nebulizer System: | Aerogen® Solo Nebulizer System: | No change to operating conditions |
| Features | | | |
| | Maintains specified performance at circuit
pressures up to 90cm H20 and temperatures
from 5°C (41°F) up to 45°C (113°F).
Atmospheric Pressure: 450 to 1100 mbars
Humidity: 15% to 95% relative humidity
Noise level: 30 days) | External Communicating
(Indirect gas pathway)
Tissue / Bone / Dentin communicating.
Duration of Use – Long-term (permanent)
duration (>30 days) | The materials are similar except for the
new adhesive which was evaluated
under ISO 10993-1 testing. |
7
510(k) Summary
Page 4 of 10
8
510(k) Summary
Page 5 of 10
9
510(k) Summary
Page 6 of 10
10
Non-clinical Performance Testing included:
.
- Comparative Particle Characterization testing via Cascade Impactor
- Flow rate of 28 LPM to the predicate which was tested with 3 drugs via Anderson Cascade o Impactor at 28.3 Lpm with the modified FAB device with one drug class also at 28.3 Lpm with an Anderson Cascade Impactor.
- Performance of the modified FAB with 3 drug classes at 15 Lpm with the NGI test device.
- Aerosol Performance Inter- and Intra-sample variability ●
- Performance of post-aging and degradation
Comparative Particle Characterization Performance
Table 2 present summaries of the comparative test results of aerosol performance testing using a cascade impactor, running at a continuous flow rate of 15 LPM or 28.3 LPM. Indicated ranges correspond to confidence intervals with a confidence level of 95%.
11
Table 2 – Comparative Aerosol Performance
| Features | Primary Predicate Aerogen
Solo Nebulizer
K133360
Particle Characterization per
Cascade Impactor @ 28 lpm | Proposed
Modified Nebulizer
Particle Characterization per
Cascade Impactor @ 28 lpm | Proposed
Modified Nebulizer
Particle Characterization per
NGI @ 15 lpm | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Total Dose (ug) | Albuterol: N/A
Ipratropium: N/A
Budesonide: N/A | Albuterol: N/A | Albuterol: 526.94 – 545.23
Ipratropium: 144.51 – 152.04
Budesonide: 229.62 – 245.20 | Additional data provided |
| Particle size (MMAD)
(microns) | Albuterol: 2.90 – 3.23
Ipratropium: 3.07 – 3.42
Budesonide: 3.45 – 3.79 | Albuterol: 2.80 – 3.05 | Albuterol: 4.39 – 4.53
Ipratropium: 3.76 – 4.02
Budesonide: 4.90 – 5.01 | Similar Cascade Impactor
performance and NGI
performance |
| Geometric Std. Dev.
(GSD) | Albuterol: 2.09 – 2.35
Ipratropium: 1.80 – 1.93
Budesonide: 1.92 – 2.14 | Albuterol: 2.26 – 2.36 | Albuterol: 2.09 – 2.16
Ipratropium: 2.28 – 2.41
Budesonide: 2.06 – 2.14 | Similar Cascade Impactor
performance and NGI
performance |
| Total Respirable Dose
(0.0-5 microns) | Albuterol: 67.66 – 73.50
Ipratropium: 71.78 – 76.69
Budesonide: 62.32 – 66.90 | Albuterol: 70.88 – 73.94 | Albuterol: 54.42 – 56.10
Ipratropium: 59.57 – 63.06
Budesonide: 49.32 – 50.91 | Similar Cascade Impactor
performance and NGI
performance |
| Coarse Particle Dose
(>4.7 micron) | Albuterol: 27.00 – 31.11
Ipratropium: 23.62 – 28.21
Budesonide: 32.31 – 36.12 | Albuterol: 28.73 – 32.03 | Albuterol: 46.69 – 48.78
Ipratropium: 39.87 – 43.38
Budesonide: 53.51 – 54.99 | Similar Cascade Impactor
performance and NGI
performance |
| Fine Particle Dose
( 30 days)
Discussion -
Aerogen performed biocompatibility testing as listed in Table 1 and the results were acceptable for the intended use.
Comparative Performance and Specifications
Comparative bench testing supported that the modification to the Nebulizer is equivalent to the predicate. See Table 2 above.
Discussion of Differences and Substantial Equivalence Conclusion
The performance testing and comparison of the indications for use, performance specifications to the predicate and reference demonstrate that the proposed modification to the Aerogen® Solo Nebulizer are substantially equivalent.