(266 days)
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.
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.
The provided documentation is a 510(k) premarket notification for a medical device, specifically the Aerogen® Solo Nebulizer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against a set of predefined acceptance criteria for a novel device. As such, the document does not contain information on rigorous acceptance criteria and the detailed study design typically seen for a new device's proven performance.
However, it does present "Comparative Particle Characterization Performance" data (Table 2) which can be interpreted as the performance data for the modified device in comparison to its predicate. The "Acceptance Criteria" in this context would be the demonstration that the modified device performs similarly to the predicate device, thereby maintaining substantial equivalence.
Here's an attempt to extract the requested information based on the provided document, interpreting "acceptance criteria" as "similarity to predicate device performance" for the purpose of 510(k) clearance:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) showing substantial equivalence, the "acceptance criteria" for the modified device are implicitly that its performance parameters should be within a similar range or deemed not clinically significant compared to the predicate device. The document explicitly states "Similar Cascade Impactor performance and NGI performance" in the comparison column, implying this is the "acceptance" based on the presented data.
| Features | Acceptance Criteria (Predicate Range @ 28 lpm) | Reported Device Performance (Modified @ 28 lpm) | Reported Device Performance (Modified @ 15 lpm - NGI) | Comparison (Achieved Acceptance) |
|---|---|---|---|---|
| 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 (<4.7 micron) | Albuterol: 66.33 – 72.07 Ipratropium: 68.58 – 73.84 Budesonide: 59.36 – 64.17 | Albuterol: 67.97 – 71.27 | Albuterol: 51.23 – 53.31 Ipratropium: 56.62 – 60.13 Budesonide: 45.01 – 46.49 | Similar Cascade Impactor performance and NGI performance |
| Ultra-fine Particle Dose (< 1.0 micron) | Albuterol: 5.91 – 9.93 Ipratropium: 1.85 – 4.19 Budesonide: 2.36 – 4.51 | Albuterol: 10.13 – 12.02 | Albuterol: 2.86 – 3.70 Ipratropium: 8.24 – 12.89 Budesonide: 2.78 – 3.41 | Similar Cascade Impactor performance and NGI performance |
Note: For "Total Dose (ug)", the predicate values are "N/A" and the comparison states "Additional data provided," which doesn't directly fit the "acceptance criteria" comparison. The acceptance is implied by the provision of this new data for the modified device at 15 Lpm.
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes (number of nebulizers tested) used for the particle characterization testing. It refers to 95% confidence intervals, which implies statistical analysis was performed on a sample. The data provenance is not explicitly mentioned (e.g., country of origin), but it is bench testing ("Non-clinical Performance Testing") rather than patient data, and it is prospective in the sense that the tests were conducted on the modified device for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a 510(k) submission for a nebulizer, a physical medical device. The "ground truth" for its performance is established through objective engineering and laboratory measurements (e.g., cascade impactor, NGI) of physical parameters like particle size and dose. This is not a study involving human experts establishing ground truth for diagnostic accuracy (e.g., radiologists for medical images). Therefore, this question is not applicable in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human adjudication of results; it's a bench performance study.
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
Not applicable. This device is a nebulizer, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm; it's a physical device. The performance tests ("Aerosol Performance Inter- and Intra-sample variability") are analogous to standalone performance of the physical nebulizer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by physical measurements using standardized laboratory equipment (Cascade Impactor, NGI) and methods to characterize aerosol properties. This is a form of objective, empirical measurement rather than subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
Not applicable. This device is a nebulizer, not an AI/machine learning model that requires a training set. The "training" for a physical device involves its design, engineering, and manufacturing processes, which are guided by established principles, standards, and previous device iterations (like the predicate).
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" in the context of a physical device like a nebulizer in the way it's understood for AI/ML.
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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"
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(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
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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) 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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| Date Prepared: | 10-May-24 |
|---|---|
| Sponsor: | Aerogen LtdGalway Business Park,Dangan, Galway, Ireland.Tel - + 353-91-540400 |
| Sponsor Contact: | Thelma MarleySenior Manager of Global Strategic Regulatory Affairs |
| Submission Correspondent: | Paul DrydenProMedic, 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.
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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.
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Table 1 – Substantial Equivalence Comparative Table
| Features | Primary Predicate Aerogen Solo NebulizerK133360 (Reference noted K143719) | Proposed Aerogen Solo Nebulizer | Comparison |
|---|---|---|---|
| Indications for use | The Aerogen® Solo Nebulizer System includesthe Aerogen® Solo Nebulizer, which isintended to aerosolize physician-prescribedmedications for inhalation to patients on andoff ventilation or other positive pressurebreathing assistance in the hospitalenvironment. | The Aerogen® Solo Nebulizer System includesthe Aerogen® Solo Nebulizer, which is intendedto aerosolize physician-prescribed medicationsfor inhalation to patients on and off ventilationor other positive pressure breathing assistance inthe hospital environment. | Similar to the primary predicate. Nochange to the indications for useThe Indications for Use provided aresimilar to the intended use andinformation provided elsewhere in theLabeling for the predicate K133360 andreference K143719. |
| Aerogen® Solo Nebulizer is for single-patientuse. The Aerogen Solo nebulizer is forpediatric (29 days or older) and adult patients. | Aerogen® Solo Nebulizer is for single-patientuse. The Aerogen Solo nebulizer is for pediatric(29 days or older) and adult patients. | ||
| The Aerogen® USB Controller Systemincludes the Aerogen® Solo Nebulizer, whichis intended to aerosolize physician-prescribedmedications for inhalation to patients on andoff ventilation or other positive pressurebreathing assistance in the hospitalenvironment, and on vent only in the homecareenvironment. | The Aerogen® USB Controller System includesthe Aerogen® Solo Nebulizer, which is intendedto aerosolize physician-prescribed medicationsfor inhalation to patients on and off ventilationor other positive pressure breathing assistance inthe hospital environment, and on vent only inthe homecare environment. | ||
| Aerogen® Solo Nebulizer is for single patientuse. The Aerogen Solo nebulizer is forpediatric (29 days or older) and adult patients. | Aerogen® Solo Nebulizer is for single patientuse. 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 ofUse | Predicate:The Aerogen® Solo System consists of theAerogen® Solo nebulizer and the Aerogen®Pro-X Controller. It is intended for hospital useonly. | Predicate:The Aerogen® Solo System consists of theAerogen® Solo nebulizer and the Aerogen®Pro-X Controller. It is intended for hospital useonly. | Similar, no change to environment ofuse |
| 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 meshApproximately 128 kHz | Vibrating meshApproximately 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 controllerUSB Controller | Pro-X controllerUSB 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 circuitpressures up to 90cm H20 and temperaturesfrom 5°C (41°F) up to 45°C (113°F).Atmospheric Pressure: 450 to 1100 mbarsHumidity: 15% to 95% relative humidityNoise level: < 35 dB measured at 0.3 mdistance | Reference: Aerogen USB Controller System:Maintains specified performance at circuitpressures up to 90cm H20 and temperaturesfrom 5°C (41°F) up to 40°C (104°F).Atmospheric Pressure: 700 to 1060 mbarHumidity: 15% to 93% relative humidityNoise level: < 35 dB measured at 1m distance | ||
| Maintains specified performance at circuitpressures up to 90cm H20 and temperaturesfrom 5°C (41°F) up to 45°C (113°F).Atmospheric Pressure: 450 to 1100 mbarsHumidity: 15% to 95% relative humidityNoise level: < 35 dB measured at 0.3 mdistance | Reference: Aerogen USB Controller System:Maintains specified performance at circuitpressures up to 90cm H20 and temperaturesfrom 5°C (41°F) up to 40°C (104°F).Atmospheric Pressure: 700 to 1060 mbarHumidity: 15% to 93% relative humidityNoise level: < 35 dB measured at 1m distance | ||
| Primary Predicate Aerogen Solo NebulizerK133360 (Reference noted K143719) | Proposed Aerogen Solo Nebulizer | Comparison | |
| Storage Conditions | Aerogen Solo Nebulizer System:Transient Temperature Range: -20 to +60°C(-4 to +140°F)Atmospheric Pressure: 450 to 1100mbarsHumidity: 15 to 95% relative humidity | Aerogen Solo Nebulizer System:Transient Temperature Range: -20 to +60°C(-4 to +140°F)Atmospheric Pressure: 450 to 1100mbarsHumidity: 15 to 95% relative humidity | No change to storage conditions |
| Aerogen USB Controller Nebulizer System:Transient Temperature Range: -25 to +70 °C(-13 to +158 °F)Atmospheric Pressure: 450 to 1060 mbarsHumidity: Up to 93% relative humidity. | Aerogen USB Controller Nebulizer System:Transient Temperature Range: -25 to +70 °C(-13 to +158 °F)Atmospheric Pressure: 450 to 1060 mbarsHumidity: Up to 93% relative humidity. | ||
| Aging | Not done | Similar – additional testing of post-agingfor performance | |
| User interface | The medical device (Aerogen® SoloNebulizer) interfaces with the patient throughinhalation of the aerosolized medications whichare approved for inhalation. The aerosolizedmedications can be administered through theAerogen® Solo Nebulizer through a ventilatorcircuit or patient interface i.e. a mouthpiece or | The medical device (Aerogen® Solo Nebulizer)interfaces with the patient through inhalation ofthe aerosolized medications which are approvedfor inhalation. The aerosolized medications canbe administered through the Aerogen® SoloNebulizer through a ventilator circuit or patientinterface i.e. a mouthpiece or face mask The | No Change to the User Interface |
| Features | Primary Predicate Aerogen Solo NebulizerK133360 (Reference noted K143719) | Proposed Aerogen Solo Nebulizer | Comparison |
| Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 62366IEC 60601-1-11ISO 13544-1 | ISO 27427 supersedes ISO 13544-1.BiocompatibilityISO 10993-5ISO 10993-10ISO 10993-17ISO 10993-18ISO 10993-23ISO 18562-2ISO 18562-3ISO 18562-4EMC and SafetyIEC 60601 series remains unchanged | Similar and testing performed and isconsidered similar. |
| Materials per ISO 10993 | External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicating.Duration of Use – Long-term (permanent)duration (>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 thenew adhesive which was evaluatedunder ISO 10993-1 testing. |
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510(k) Summary
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510(k) Summary
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510(k) Summary
Page 6 of 10
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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%.
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Table 2 – Comparative Aerosol Performance
| Features | Primary Predicate AerogenSolo NebulizerK133360Particle Characterization perCascade Impactor @ 28 lpm | ProposedModified NebulizerParticle Characterization perCascade Impactor @ 28 lpm | ProposedModified NebulizerParticle Characterization perNGI @ 15 lpm | Comparison |
|---|---|---|---|---|
| Total Dose (ug) | Albuterol: N/AIpratropium: N/ABudesonide: N/A | Albuterol: N/A | Albuterol: 526.94 – 545.23Ipratropium: 144.51 – 152.04Budesonide: 229.62 – 245.20 | Additional data provided |
| Particle size (MMAD)(microns) | Albuterol: 2.90 – 3.23Ipratropium: 3.07 – 3.42Budesonide: 3.45 – 3.79 | Albuterol: 2.80 – 3.05 | Albuterol: 4.39 – 4.53Ipratropium: 3.76 – 4.02Budesonide: 4.90 – 5.01 | Similar Cascade Impactorperformance and NGIperformance |
| Geometric Std. Dev.(GSD) | Albuterol: 2.09 – 2.35Ipratropium: 1.80 – 1.93Budesonide: 1.92 – 2.14 | Albuterol: 2.26 – 2.36 | Albuterol: 2.09 – 2.16Ipratropium: 2.28 – 2.41Budesonide: 2.06 – 2.14 | Similar Cascade Impactorperformance and NGIperformance |
| Total Respirable Dose(0.0-5 microns) | Albuterol: 67.66 – 73.50Ipratropium: 71.78 – 76.69Budesonide: 62.32 – 66.90 | Albuterol: 70.88 – 73.94 | Albuterol: 54.42 – 56.10Ipratropium: 59.57 – 63.06Budesonide: 49.32 – 50.91 | Similar Cascade Impactorperformance and NGIperformance |
| Coarse Particle Dose(>4.7 micron) | Albuterol: 27.00 – 31.11Ipratropium: 23.62 – 28.21Budesonide: 32.31 – 36.12 | Albuterol: 28.73 – 32.03 | Albuterol: 46.69 – 48.78Ipratropium: 39.87 – 43.38Budesonide: 53.51 – 54.99 | Similar Cascade Impactorperformance and NGIperformance |
| Fine Particle Dose(<4.7 micron) | Albuterol: 66.33 – 72.07Ipratropium: 68.58 – 73.84Budesonide: 59.36 – 64.17 | Albuterol: 67.97 – 71.27 | Albuterol: 51.23 – 53.31Ipratropium: 56.62 – 60.13Budesonide: 45.01 – 46.49 | Similar Cascade Impactorperformance and NGIperformance |
| Ultra-fine Particle Dose(< 1.0 micron) | Albuterol: 5.91 – 9.93Ipratropium: 1.85 – 4.19Budesonide: 2.36 – 4.51 | Albuterol: 10.13 – 12.02 | Albuterol: 2.86 – 3.70Ipratropium: 8.24 – 12.89Budesonide: 2.78 – 3.41 | Similar Cascade Impactorperformance and NGIperformance |
| Confidence level oftesting | 95% confidence level | 95% confidence level | 95% confidence level |
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Discussion of Substantial Equivalence
The proposed modification of the existing Aerogen® Solo Nebulizer System and Aerogen® USB Controller System to introduce a Fully Adhesive Bonded (F.A.B) Core to the Aerogen® Solo Nebulizer is viewed as substantially equivalent to the predicate device for the following reasons:
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.
Discussion -
The indications for use are the same for the proposed modified device and the predicate device. We have consolidated past intended use and information in previous labeling into a more complete indications for use description.
Patient Population -
Pediatric (29 days or older) through adult patients.
Discussion -
The patient population is the same for the proposed modified device and the predicates. The pediatric population is defined as 29 days or older for both the modified device and predicates.
Environment of Use -
The Aerogen® Solo Nebulizer System is intended for use in critical, acute, and sub-acute care settings, and during patient transport [Hospital].
The Aerogen® USB Controller System incorporating the Aerogen® Solo Nebulizer is intended for use in the hospital and homecare environments (on-vent only in the homecare environment).
Discussion -
The environment of use is the same for the proposed modified device and the predicate 510 (k)'s.
Technology -
The Aerogen® Solo Nebulizer technology consists of a domed vibrating mesh aperture plate, which receives liquid medication on its top surface. The plate vibrates and extrudes the liquid through the plate. It forms a fine droplet mist to create the characteristic aerosol. The fine particle mist enables drugs to be absorbed through the lungs while maintaining their integrity, providing a unique level of efficiency for the acute respiratory care market.
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Discussion -
The technology is the same for the proposed modified device and the predicate and reference.
Biocompatibility of Patient Contacting Materials -
The materials in patient / drug contact are characterized as:
- External Communicating (Indirect gas pathway)
- Tissue / Bone / Dentin communicating .
- . Duration of Use - permanent (> 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.
§ 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).