The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home. It is a single patient, multiple use device.

Device Description

The AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a holding chamber used for the administration of aerosolized medications. The AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products is designed to be used with a broad range of FDA approved pressurized metered dose inhaler (pMDI) or soft mist inhaler (SMI) pharmaceutical formulations prescribed by a healthcare provider. It is a single patient, multi-use device intended to be used by patients who are under the care or treatment of a licensed health care professional. This device is not used with a specific drug nor is it distributed with such drugs.

AI/ML Overview

The provided text describes two main evaluations for the AeroChamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC):

Change in Intended Use: Evaluating the device's performance with "Soft Mist Inhaler" (SMI) formulations, in addition to its existing use with Metered Dose Inhalers (MDIs).
Addition of a New Configuration: Evaluating the "Adult Small Mask" configuration.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to existing methods (SMI alone for the new intended use) or predicate devices (Adult Large Mask for the new VHC configuration). The goal is to demonstrate comparable performance and no new safety/effectiveness concerns.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion (Implicit)	Reported Device Performance (Summary)
Aerosol Characteristics (SMI Use - Adult Flow)	Maintain or improve aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD, GSD) when using SMI with VHC compared to SMI alone.	SMI Formulation 1 (2 APIs): Fine Particle Fraction (FPF) generally increased with VHC (e.g., Ipratropium bromide increased from 66.6% to 70.3-76.0%; Salbutamol increased from 65.5% to 68.5-77.0%). MMAD generally decreased, indicating smaller particles (e.g., Ipratropium bromide from 2.8 µm to 2.1-2.5 µm).
		SMI Formulation 2 (2 APIs): FPF generally increased with VHC (e.g., Tiotropium bromide from 60.5% to 67.7-79.0%). MMAD generally decreased (e.g., Tiotropium bromide from 3.2 µm to 2.1-2.8 µm).
		SMI Formulation 3 (1 API): FPF generally increased with VHC (e.g., Tiotropium bromide from 62.4% to 64.5-71.7%). MMAD generally decreased (from 3.1 µm to 2.4-2.7 µm).
Aerosol Characteristics (SMI Use - Pediatric Flow)	Maintain or improve aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD) when using SMI with VHC compared to SMI alone at pediatric flow rates.	SMI Formulation 1: FPF generally increased with VHC (e.g., Ipratropium bromide from 53.0% to 70.6-78.4%; Salbutamol from 51.9% to 72.8-77.9%). MMAD significantly decreased (e.g., Ipratropium bromide from 4.9 µm to 1.5-1.8 µm).
Aerosol Characteristics (New Adult Small Mask Configuration)	Comparable aerosol characteristics (e.g., Total Mass Recovered, Total Emitted Mass ex VHC, Fine Particle Dose, Fine Particle Fraction, MMAD, GSD) to the predicate "Adult Large Mask" configuration when used with pMDIs.	pMDI Formulations: Performance metrics (Total Mass Recovered, Fine Particle Dose, Fine Particle Fraction, MMAD) are generally similar between the Adult Small Mask (Subject Device) and Adult Large Mask (Predicate Device). For example, Ipratropium bromide FPF was 93.0% (Subject) vs 90.5% (Predicate).
Biocompatibility	Meet ISO 10993 standards for biological endpoints relevant to an externally communicating device with prolonged contact (e.g., cytotoxicity, sensitization, systemic toxicity, genotoxicity, extractables/leachables).	All listed ISO 10993 tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity, Extractables/Leachables with Biological Risk Assessment) were performed by an independent source. (The text states they were performed, implying successful completion, not explicit results).
Mechanical Testing	Demonstrate mechanical integrity and performance as expected for the device (e.g., environmental, flow performance, life cycle, drop, resistivity).	Environmental Testing, Flow Performance, Life Cycle Testing, Drop Testing, and Resistivity Verification were performed on the subject device. (The text states they were performed, implying successful completion).
Safety and Effectiveness	No new questions of safety and/or effectiveness are raised by the changes.	"The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC (facemask and mouthpiece configurations) used in combination with Soft Mist Inhaler formulations is comparable to use of a SMI formulation alone. Use of the VHC device with an SMI does not raise any new questions of safety and/or effectiveness.""The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask is substantially equivalent to the predicate (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Large Mask). Use of the subject device does not raise any new questions of safety and/or effectiveness."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size (number of devices or measurements per condition) for the aerosol characterization tests. It provides mean and standard deviation values for the aerosol characteristics, which suggests multiple measurements were taken for each condition.

Data Provenance: The studies are non-clinical, involving in vitro aerosol characterization testing and biocompatibility/mechanical testing. The data provenance is internal to the manufacturer (or contracted labs) conducting the tests in a controlled laboratory environment. There is no mention of country of origin for the data or whether it's retrospective or prospective, as it pertains to controlled lab testing, not clinical patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as the studies are non-clinical. The "ground truth" for aerosol characteristics is established by direct physical measurement using standardized laboratory techniques (e.g., cascade impaction, chemical analysis) based on recognized guidance documents ("Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" FDA/CDRH - 1993). Similarly, biocompatibility and mechanical testing follow ISO standards and engineering principles. There are no human "experts" establishing ground truth in the sense of clinical interpretation.

4. Adjudication Method for the Test Set

This question is not applicable as the studies are non-clinical. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For laboratory-based performance testing, the "ground truth" is determined by reference methods or validated instrumentation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The submitted information focuses on the physical and performance characteristics of a valved holding chamber, not a diagnostic imaging AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a physical medical device (a valved holding chamber), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance data presented (aerosol characteristics) is "standalone" in the sense that it measures the device's physical output without human intervention during the measurement process, but not in the context of an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical studies is based on:

Physical Measurement: For aerosol characteristics, the ground truth is the direct measurement of particle size distribution, mass recovery, and fine particle dose using validated laboratory equipment and methods (e.g., cascade impactors, chemical analysis) as per FDA/CDRH guidance.
Standardized Protocols: For biocompatibility, adherence to and successful completion of tests defined by ISO 10993 standards (e.g., in vitro cytotoxicity, in vivo sensitization).
Engineering Specifications/Industry Standards: For mechanical testing (e.g., environmental, flow performance, life cycle, drop, resistivity), performance against pre-defined engineering specifications or relevant industry standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as #8.

Summary

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January 11, 2019

Trudell Medical International Marianne Tanton Director, Quality and Regulatory Affairs 725 Third Street London, N5V 5G4 Canada

Re: K181649

Trade/Device Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: NVP Dated: December 12, 2018 Received: December 13, 2018

Dear Marianne Tanton:

We have reviewed vour 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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K181649

Device Name

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber

Indications for Use (Describe)

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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Section 5 - 510(k) Summary

Prepared: 08 Jan 2019

1. Submitter

Trudell Medical International 725 Third Street London, Ontario N5V 5G4, Canada

Contact: Marianne Tanton Director. Quality and Requlatory Affairs Phone: 1-519-455-7060 Email: mtanton@trudellmed.com

2. Device

Trade Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber Common Name: Holding Chamber Classification: Holding Chambers, Direct Patient Interface, 21 CFR 868.5630 Regulatory Class: II Product Code: NVP

3. Predicate Device

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber Trade Name: 510(k) Number: K112010 510(k) Owner: Trudell Medical International

The predicate device has not been subject to a recall.

4. Device Description

5. Principle of Operation

The VHC has two primary modes of operation, one is to contain an aerosol plume from a metered dose inhaler or soft mist inhaler and the second is to deliver the aerosol to the patient. The device is designed to allow for the potential delay between actuation of the metered dose inhaler and the inhalation breaths of the patient. The containment is accomplished by a valve acting as a movable barrier between the chamber and the mouthpiece or mask. The valve acts to direct the patient's exhalation away from the chamber to minimize any aerosol loss to the atmosphere between inhalation breaths. The chamber is sized to ensure the proper amount of aerosol is available for delivery through the valve.

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Section 5 - 510(k) Summary

6. Intended Use

7. Comparison to predicate device

The proposed AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products and the current AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products are similar in purpose, function, scientific technology and method of operation. Only minor differences exist between the subject AeroChamber Plus* Flow-Vu* Anti-Static VHC line of products and the predicate, which do not affect the safety or effectiveness of the subject device.

Table 1 provides a comparison of the subject and predicate device.

Element ofComparison	AeroChamber Plus* Flow-Vu* Anti-Static VHC AdultSmall Mask(Subject Device)	AeroChamber Plus* Flow-Vu* Anti-Static VHC AdultLarge Mask(Predicate Device -K112010)	Comparison
ClassificationName	Holding Chambers, Direct Patient Interface,		Similar
Product Code	NVP		Similar
RegulationNumber	21 CFR 868.5630		Similar
ClassificationType	Class II		Similar
Intended Use	The AeroChamber PlusFlow-Vu Anti-Static ValvedHolding Chamber is intendedto be used by adult andpediatric patients who areunder the care or treatment ofa physician or licensedhealthcare professional. Thedevice is intended to be usedby these patients toadminister aerosolizedmedication from mostpressurized Metered DoseInhalers and Soft MistInhalers. The intendedenvironments for use include	The AeroChamber PlusFlow-Vu Anti-Static VHC isintended to be used bypatients who are under thecare or treatment of aphysician or licensedhealthcare professional. Thedevice is intended to be usedby these patients toadminister aerosolizedmedication from mostpressurized Metered DoseInhalers. The intendedenvironments for use includethe home, hospitals andclinics.	Similar

Table 1: Comparison to Predicate Device

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Section 5 - 510(k) Summary

	the home, hospitals andclinics. It is a single patient,multiple use device.
Patient Interface	VHC with Small MaskVHC with Medium MaskVHC with Adult Small MaskVHC with Adult Large MaskVHC with MouthpieceDevice configurationsdifferentiated by color	VHC with Small MaskVHC with Medium MaskVHC with Adult Large MaskVHC with MouthpieceDevice configurationsdifferentiated by color	SimilarAddition of VHC withAdult Small Mask

Principle of Operation	Valved Holding Chamber		Similar
Environment of Use	Hospital, Clinic or Home		Similar
Patient Population	Adult and pediatric patients		Similar
Type of Device	Prescription only, single patient use, non-sterile		Similar
Useful Life	Recommended replacement after 12 months of use		Similar
Material of Construction	Thermoplastic Polymer, Thermoplastic Elastomer andSilicone components		Similar
Manufacturing process	Plastic molding		Similar
Chamber Size	5.86" length x 1.75' Diameter		Similar
Chamber Volume	149 cc		Similar

8. Performance Data - Change in Intended Use for AeroChamber Plus* Flow-Vu* Anti-Static VHC product line

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). Testing involved aerosol characterization of SMI formulations in combination with the AeroChamber Plus* Flow-Vu* Anti-Static VHC (facemask & mouthpiece configurations) and results were compared to aerosol characterization data obtained for SMI without the VHC. Tables 2 to 4 include a summary of testing performed for three Soft Mist Inhaler formulations alone and in combination with the AeroChamber Plus* Flow-Vu* Anti-Static VHC at adult flow rate (30 L/min). Table 5 includes a summary of testing performed for one Soft Mist Inhaler formulation alone and in combination with the pediatric AeroChamber Plus* Flow-Vu* Anti-Static VHC at pediatric flow rate (15 L/min).

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Section 5 - 510(k) Summary

Response to Interactive Review - dated 08Jan2019

Traditional 510(k) - K181649

AerosolCharacteristics	Particle Characterization
	SMI alone(Group A)	SMI with theAeroChamber PlusFlow-Vu aVHCMouthpiece(Group B)	SMI with theAeroChamber PlusFlow-Vu aVHCSmall Mask(Group C)	SMI with theAeroChamber PlusFlow-Vu aVHCAdult Large Mask(Group D)	SMI with theAeroChamber PlusFlow-Vu aVHCAdult Small Mask(Group E)
Total MassRecovered (µg)	18.4 ± 0.9Ipratropium bromide94.2 ± 4.2Salbutamol	20.3 ± 1.0Ipratropium bromide98.8 ± 4.6Salbutamol	19.0 ± 1.0Ipratropium bromide95.7 ± 3.9Salbutamol	18.9 ± 0.1Ipratropium bromide93.1 ± 2.0Salbutamol	19.6 ± 0.8Ipratropium bromide103.9 ± 4.4Salbutamol
Total EmittedMass ex VHC(µg)	NA	15.0 ± 0.6Ipratropium bromide71.0 ± 3.2Salbutamol	15.9 ± 1.1Ipratropium bromide79.3 ± 3.2Salbutamol	14.3 ± 0.1Ipratropium bromide69.2 ± 1.1Salbutamol	16.9 ± 0.5Ipratropium bromide86.8 ± 2.1Salbutamol
Fine ParticleDose (µg)	12.3 ± 0.8Ipratropium bromide61.7 ± 2.5Salbutamol	11.4 ± 0.9Ipratropium bromide54.8 ± 5.0Salbutamol	11.7 ± 0.8Ipratropium bromide54.6 ± 1.5Salbutamol	10.0 ± 0.5Ipratropium bromide47.4 ± 2.5Salbutamol	12.3 ± 0.4Ipratropium bromide61.3 ± 1.7Salbutamol
Fine Particle†Fraction (%)	66.6 ± 3.3Ipratropium bromide65.5 ± 2.7Salbutamol	76.0 ± 3.2Ipratropium bromide77.0 ± 4.1Salbutamol	73.2 ± 0.6Ipratropium bromide68.9 ± 2.3Salbutamol	70.3 ± 3.2Ipratropium bromide68.5 ± 3.3Salbutamol	72.5 ± 2.6Ipratropium bromide70.6 ± 2.5Salbutamol
MMAD (µm)	2.8 Ipratropiumbromide2.9 Salbutamol	2.1 Ipratropiumbromide2.2 Salbutamol	2.5 Ipratropiumbromide2.6 Salbutamol	2.4 Ipratropiumbromide2.4 Salbutamol	2.2 Ipratropiumbromide2.4 Salbutamol
GSD	2.6 Ipratropiumbromide2.5 Salbutamol	2.2 Ipratropiumbromide2.2 Salbutamol	2.4 Ipratropiumbromide2.5 Salbutamol	3.3 Ipratropiumbromide3.3 Salbutamol	2.5 Ipratropiumbromide2.5 Salbutamol

Table 2: Summary of Performance Data – SMI Formulation 1 (2 APIs) at 30 L/min

Percentage of particles between 0.54 & 6.40 µm aerodynamic diameter

Table 3: Summary of Performance Data – SMI Formulation 2 (2 APIs) at 30 L/min rticle Char C

AerosolCharacteristics	Particle Characterization
	SMI alone(Group A)	SMI with theAeroChamber PlusFlow-Vu aVHCMouthpiece(Group B)	SMI with theAeroChamber PlusFlow-Vu aVHCSmall Mask(Group C)	SMI with theAeroChamber PlusFlow-Vu aVHCAdult Large Mask(Group D)	SMI with theAeroChamber PlusFlow-Vu aVHCAdult Small Mask(Group E)
Total MassRecovered (µg)	3.3 ± 0.2Tiotropium bromide2.9 ± 0.1Olodaterol HCl	3.3 ± 0.2Tiotropium bromide2.6 ± 0.1Olodaterol HCl	3.3 ± 0.2Tiotropium bromide2.6 ± 0.2Olodaterol HCl	3.1 ± 0.2Tiotropium bromide2.7 ± 0.1Olodaterol HCl	3.2 ± 0.2Tiotropium bromide2.5 ± 0.2Olodaterol HCl
Total EmittedMass ex VHC(µg)	NA	2.2 ± 0.3Tiotropium bromide1.8 ± 0.2Olodaterol HCl	2.6 ± 0.2Tiotropium bromide2.6 ± 0.2Olodaterol HCl	2.1 ± 0.1Tiotropium bromide2.1 ± 0.1Olodaterol HCl	2.6 ± 0.2Tiotropium bromide2.1 ± 0.2Olodaterol HCl
Fine ParticleDose (µg)	2.0 ± 0.1Tiotropium bromide2.0 ± 0.1Olodaterol HCl	1.7 ± 0.3Tiotropium bromide1.4 ± 0.2Olodaterol HCl	1.8 ± 0.2Tiotropium bromide1.5 ± 0.2Olodaterol HCl	1.6 ± 0.1Tiotropium bromide1.4 ± 0.1Olodaterol HCl	1.9 ± 0.2Tiotropium bromide1.5 ± 0.2Olodaterol HCl
Fine Particle+Fraction (%)	60.5 ± 1.4Tiotropium bromide60.5 ± 1.4Olodaterol HCl	79.0 ± 3.4Tiotropium bromide81.4 ± 3.8Olodaterol HCl	67.7 ± 1.8Tiotropium bromide69.4 ± 1.5Olodaterol HCl	68.8 ± 4.8Tiotropium bromide65.4 ± 2.4Olodaterol HCl	71.5 ± 1.9Tiotropium bromide72.4 ± 1.5Olodaterol HCl
MMAD (µm)	3.2 Tiotropiumbromide3.3 Olodaterol HCl	2.1 Tiotropiumbromide2.2 Olodaterol HCl	2.7 Tiotropiumbromide2.8 Olodaterol HCl	2.4 Tiotropiumbromide2.8 Olodaterol HCl	2.4 Tiotropiumbromide2.4 Olodaterol HCl
GSD	NM	2.4 Tiotropiumbromide2.2 Olodaterol HCl	3.3 Tiotropiumbromide2.4 Olodaterol HCl	NM	2.6 Tiotropiumbromide2.7 Olodaterol HCl

† Percentage of particles between 0.54 & 6.40 µm aerodynamic diameter

Not Measured as the 84" percentile was larger than the upper size limit (11.72 um aerodynamic diameter) of the impactor

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Section 5 - 510(k) Summary

Table 4: Summary of Performance Data – SMI Formulation 3 (1 API) at 30 L/min

AerosolCharacteristics	Particle Characterization
	SMI alone(Group A)	SMI with theAeroChamber PlusFlow-Vu aVHCMouthpiece(Group B)	SMI with theAeroChamber PlusFlow-Vu aVHCSmall Mask(Group C)	SMI with theAeroChamber PlusFlow-Vu aVHCAdult Large Mask(Group D)	SMI with theAeroChamber PlusFlow-Vu aVHCAdult Small Mask(Group E)
Total MassRecovered (µg)	2.9 ± 0.2 Tiotropiumbromide	2.8 ± 0.1 Tiotropiumbromide	3.2 ± 0.2 Tiotropiumbromide	3.0 ± 0.3 Tiotropiumbromide	3.1 ± 0.4 Tiotropiumbromide
Total EmittedMass ex VHC(µg)	NA	1.9 ± 0.1 Tiotropiumbromide	2.5 ± 0.1 Tiotropiumbromide	2.1 ± 0.2 Tiotropiumbromide	2.5 ± 0.2 Tiotropiumbromide
Fine ParticleDose (µg)	1.8 ± 0.1 Tiotropiumbromide	1.4 ± 0.1 Tiotropiumbromide	1.7 ± 0.1 Tiotropiumbromide	1.4 ± 0.2 Tiotropiumbromide	1.7 ± 0.1 Tiotropiumbromide
Fine Particle†Fraction (%)	62.4 ± 1.8Tiotropium bromide	71.7 ± 3.5Tiotropium bromide	68.1 ± 4.5Tiotropium bromide	64.5 ± 4.9Tiotropium bromide	66.7 ± 3.7Tiotropium bromide
MMAD (μm)	3.1	2.4	2.6	2.7	2.6
GSD	NM*	2.8	NM*	NM*	3.0

† Percentage of particles between 0.54 & 6.40 µm aerodynamic diameter

Not Measured as the 84" percentile was larger than the upper size limit (11.72 µm aerodynamic diameter) of the impactor

Table 5: Summary of Performance Data - SMI Formulation 1 at 15 L/min

AerosolCharacteristics	Particle Characterization
	SMI alone	SMI with the AeroChamber PlusFlow-VuAnti-Static VHC Small Mask	SMI with the AeroChamber Plus* Flow-Vu*Anti-Static VHC Medium Mask
Total MassRecovered (μg)	17.0 ± 0.8 Ipratropium bromide91.7 ± 8.1 Salbutamol	15.2 ± 1.0 Ipratropium bromide85.4 ± 7.9 Salbutamol	15.7 ± 1.1 Ipratropium bromide94.3 ± 10.9 Salbutamol
Total EmittedMass ex VHC(μg)	NA	11.0 ± 0.7 Ipratropium bromide56.0 ± 8.1 Salbutamol	10.6 ± 1.8 Ipratropium bromide60.4 ± 8.6 Salbutamol
Fine ParticleDose (μg)	9.0 ± 0.5 Ipratropium bromide47.7 ± 5.7 Salbutamol	7.7 ± 0.8 Ipratropium bromide40.2 ± 4.0 Salbutamol	8.2 ± 0.8 Ipratropium bromide46.7 ± 5.7 Salbutamol
Fine Particle†Fraction (%)	53.0 ± 0.8 Ipratropium bromide51.9 ± 2.8 Salbutamol	70.6 ± 6.5 Ipratropium bromide72.8 ± 10.7 Salbutamol	78.4 ± 9.3 Ipratropium bromide77.9 ± 8.1 Salbutamol
MMAD (μm)	4.9 Ipratropium bromide5.0 Salbutamol	1.8 Ipratropium bromide1.7 Salbutamol	1.5 Ipratropium bromide1.5 Salbutamol

Percentage of particles between between 0.98 & 5.39 µm aerodynamic diameter

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Section 5 - 510(k) Summary

9. Performance Data - Addition of AeroChamber Plus* Flow-Vu* Anti-Static VHC Adult Small Mask configuration

9.1 Aerosol Characterization (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask)

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) using three different commercially available pressurized Metered Dose Inhaler (pMDI) formulations. Table 6 includes a summary of testing performed for three pressurized Metered Dose Inhaler formulations in combination with the subject (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask) device and the predicate (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Large Mask) device.

AerosolCharacteristics	AeroChamber Plus* Flow-Vu* Anti-StaticVHC (Adult Small Mask)(Subject Device)	AeroChamber Plus* Flow-Vu* Anti-Static VHC(Adult Large Mask)(Predicate Device - K112010)
Total MassRecovered (µg)	20.0 ± 0.4 Ipratropium bromide122.6 ± 3.7 Fluticasone Propionate107.9 ± 3.8 Albuterol Sulfate	19.9 ± 0.4 Ipratropium bromide124.6 ± 5.7 Fluticasone Propionate100.6 ± 2.9 Albuterol Sulfate
Total Emitted Massex VHC (µg)	11.3 ± 0.5 Ipratropium bromide53.5 ± 5.2 Fluticasone Propionate52.9 ± 7.9 Albuterol Sulfate	10.4 ± 0.7 Ipratropium bromide58.1 ± 2.5 Fluticasone Propionate56.3 ± 2.6 Albuterol Sulfate
Fine Particle Dose(µg)	10.5 ± 0.4 Ipratropium bromide43.6 ± 5.6 Fluticasone Propionate43.7 ± 8.4 Albuterol Sulfate	9.4 ± 0.7 Ipratropium bromide47.4 ± 2.5 Fluticasone Propionate48.1 ± 3.1 Albuterol Sulfate
Fine ParticleFraction† (%)	93.0 ± 0.8 Ipratropium bromide81.4 ± 2. Fluticasone Propionate82.3 ± 3.7 Albuterol Sulfate	90.5 ± 0.8 Ipratropium bromide81.5 ± 1.8 Fluticasone Propionate85.4 ± 1.9 Albuterol Sulfate
Particle Size(MMAD) (μm)	1.0 Ipratropium bromide3.0 Fluticasone Propionate3.0 Albuterol Sulfate	1.1 Ipratropium bromide2.9 Fluticasone Propionate2.8 Albuterol Sulfate
GSD	NA* Ipratropium bromide1.7 Fluticasone Propionate1.8 Albuterol Sulfate	NA* Ipratropium bromide1.7 Fluticasone Propionate1.7 Albuterol Sulfate

Table 6: Summary of Performance Data

Percentage of particles between 0.54 & 3.99 um aerodynamic diameter.
Not Measured as the 16th percentile was smaller than the lower size limit (0.4µm aerodynamic diameter) of the impactor

9.2 Biocompatibility Testing (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask)

Biological endpoints applicable to an externally communicating device with prolonged contact duration (>24 h to 30 d) are listed below. All in vitro and in vivo studies were performed by an independent source and included the following battery of tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity and Extractables/Leachables with a Biological Risk Assessment.

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Section 5 - 510(k) Summary

ISO Standard	Biological Endpoint
10993-5	Tests for In Vitro Cytotoxicity
10993-10	Tests for Irritation and Skin Sensitization
10993-11	Tests for systemic toxicity (Acute Toxicity)
10993-3	Tests for genotoxicity (Bacterial Reverse Mutation Study and Mouse LymphomaAssay)
10993-12	Sample preparation and reference materials
10993-17	Establishment of allowable limits for leachable substances
10993-18	Chemical characterization of materials

Summary of Biocompatibility Testing Conducted

9.3 Mechanical Testing (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask)

The following mechanical tests were performed on the subject device:

. Environmental Testing
Flow Performance ●
Life Cycle Testing .
. Drop Testing
Resistivity Verification

10. Clinical Performance Summary

Not applicable, the determination of substantial equivalence is not based on Clinical Performance data.

11. Conclusion

Change in Intended Use for AeroChamber Plus* Flow-Vu* Anti-Static VHC product line:

The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC (facemask and mouthpiece configurations) used in combination with Soft Mist Inhaler formulations is comparable to use of a SMI formulation alone. Use of the VHC device with an SMI does not raise any new questions of safety and/or effectiveness.

Addition of AeroChamber Plus* Flow-Vu* Anti-Static VHC Adult Small Mask configuration:

The non-clinical data demonstrate that the AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Small Mask is substantially equivalent to the predicate (AeroChamber Plus* Flow-Vu* Anti-Static VHC, Adult Large Mask). Use of the subject device does not raise any new questions of safety and/or effectiveness.

Regulation Number and Section

§ 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).