(203 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and aerosol delivery performance of a valved holding chamber, with no mention of AI or ML.
No.
The device is described as a valved holding chamber for administering aerosolized medication, not as a therapeutic agent itself. It facilitates medication delivery but does not treat or cure conditions directly.
No
This device is a valved holding chamber designed to administer aerosolized medication, not to diagnose a condition.
No
The device description and performance studies clearly indicate this is a physical medical device (Valved Holding Chamber) used to administer medication, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer aerosolized medication from inhalers to patients. This is a therapeutic delivery device, not a diagnostic device that analyzes samples from the body.
- Device Description: The description clearly states it's a "holding chamber used for the administration of aerosolized medications." It facilitates the delivery of medication, not the diagnosis of a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The performance studies described focus on the device's ability to effectively deliver the aerosolized medication (aerosol characterization, flow performance, etc.), which is consistent with a drug delivery device, not an IVD.
N/A
Intended Use / Indications for Use
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, hospitals and clinics. It is a single patient, multiple use device.
Product codes (comma separated list FDA assigned to the subject device)
NVP
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.
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
adult and pediatric patients
Intended User / Care Setting
Physician or licensed healthcare professional; home, hospitals and clinics.
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)
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 included 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 included 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).
Additionally, aerosol characterization testing was performed for the addition of the AeroChamber Plus* Flow-Vu* Anti-Static VHC Adult Small Mask configuration 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.
Biocompatibility Testing was performed according to ISO 10993 standards, including tests for In Vitro Cytotoxicity, Irritation and Skin Sensitization, systemic toxicity (Acute Toxicity), genotoxicity (Bacterial Reverse Mutation Study and Mouse Lymphoma Assay), sample preparation and reference materials, establishment of allowable limits for leachable substances, and chemical characterization of materials.
Mechanical tests performed on the subject device include Environmental Testing, Flow Performance, Life Cycle Testing, Drop Testing, and Resistivity Verification.
Key results:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Values for Total Mass Recovered (µg), Total Emitted Mass ex VHC (µg), Fine Particle Dose (µg), Fine Particle Fraction (%), MMAD (µm), and GSD are provided in Tables 2-6 for various formulations and configurations. Specific numerical values are detailed in the tables for each drug (Ipratropium bromide, Salbutamol, Tiotropium bromide, Olodaterol HCl, Fluticasone Propionate, Albuterol Sulfate) across different groups (SMI alone, SMI with various VHC configurations).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in a sans-serif font, with the acronym in a blue square.
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
1
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
2
Indications for Use
510(k) Number (if known) K181649
Device Name
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber
Indications for Use (Describe)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
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.
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.
4
Section 5 - 510(k) Summary
6. Intended Use
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, hospitals and clinics. It is a single patient, multiple use device.
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 of
Comparison | AeroChamber Plus* Flow-
Vu* Anti-Static VHC Adult
Small Mask
(Subject Device) | AeroChamber Plus* Flow-
Vu* Anti-Static VHC Adult
Large Mask
(Predicate Device -
K112010) | Comparison |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification
Name | Holding Chambers, Direct Patient Interface, | | Similar |
| Product Code | NVP | | Similar |
| Regulation
Number | 21 CFR 868.5630 | | Similar |
| Classification
Type | Class II | | Similar |
| Intended Use | 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 AeroChamber Plus*
Flow-Vu* Anti-Static VHC is
intended to be used by
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. The intended
environments for use include
the home, hospitals and
clinics. | Similar |
Table 1: Comparison to Predicate Device
5
Section 5 - 510(k) Summary
| | the home, hospitals and
clinics. It is a single patient,
multiple use device. | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Patient Interface | VHC with Small Mask
VHC with Medium Mask
VHC with Adult Small Mask
VHC with Adult Large Mask
VHC with Mouthpiece
Device configurations
differentiated by color | VHC with Small Mask
VHC with Medium Mask
VHC with Adult Large Mask
VHC with Mouthpiece
Device configurations
differentiated by color | Similar
Addition of VHC with
Adult 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 and
Silicone 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).
6
of
Section 5 - 510(k) Summary
Response to Interactive Review - dated 08Jan2019
Traditional 510(k) - K181649
| Aerosol
| Characteristics | Particle Characterization | ||||
|---|---|---|---|---|---|
| SMI alone | |||||
| (Group A) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Mouthpiece | |||||
| (Group B) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Small Mask | |||||
| (Group C) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Adult Large Mask | |||||
| (Group D) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Adult Small Mask | |||||
| (Group E) | |||||
| Total Mass | |||||
| Recovered (µg) | 18.4 ± 0.9 | ||||
| Ipratropium bromide | |||||
| 94.2 ± 4.2 | |||||
| Salbutamol | 20.3 ± 1.0 | ||||
| Ipratropium bromide | |||||
| 98.8 ± 4.6 | |||||
| Salbutamol | 19.0 ± 1.0 | ||||
| Ipratropium bromide | |||||
| 95.7 ± 3.9 | |||||
| Salbutamol | 18.9 ± 0.1 | ||||
| Ipratropium bromide | |||||
| 93.1 ± 2.0 | |||||
| Salbutamol | 19.6 ± 0.8 | ||||
| Ipratropium bromide | |||||
| 103.9 ± 4.4 | |||||
| Salbutamol | |||||
| Total Emitted | |||||
| Mass ex VHC | |||||
| (µg) | NA | 15.0 ± 0.6 | |||
| Ipratropium bromide | |||||
| 71.0 ± 3.2 | |||||
| Salbutamol | 15.9 ± 1.1 | ||||
| Ipratropium bromide | |||||
| 79.3 ± 3.2 | |||||
| Salbutamol | 14.3 ± 0.1 | ||||
| Ipratropium bromide | |||||
| 69.2 ± 1.1 | |||||
| Salbutamol | 16.9 ± 0.5 | ||||
| Ipratropium bromide | |||||
| 86.8 ± 2.1 | |||||
| Salbutamol | |||||
| Fine Particle | |||||
| Dose (µg) | 12.3 ± 0.8 | ||||
| Ipratropium bromide | |||||
| 61.7 ± 2.5 | |||||
| Salbutamol | 11.4 ± 0.9 | ||||
| Ipratropium bromide | |||||
| 54.8 ± 5.0 | |||||
| Salbutamol | 11.7 ± 0.8 | ||||
| Ipratropium bromide | |||||
| 54.6 ± 1.5 | |||||
| Salbutamol | 10.0 ± 0.5 | ||||
| Ipratropium bromide | |||||
| 47.4 ± 2.5 | |||||
| Salbutamol | 12.3 ± 0.4 | ||||
| Ipratropium bromide | |||||
| 61.3 ± 1.7 | |||||
| Salbutamol | |||||
| Fine Particle† | |||||
| Fraction (%) | 66.6 ± 3.3 | ||||
| Ipratropium bromide | |||||
| 65.5 ± 2.7 | |||||
| Salbutamol | 76.0 ± 3.2 | ||||
| Ipratropium bromide | |||||
| 77.0 ± 4.1 | |||||
| Salbutamol | 73.2 ± 0.6 | ||||
| Ipratropium bromide | |||||
| 68.9 ± 2.3 | |||||
| Salbutamol | 70.3 ± 3.2 | ||||
| Ipratropium bromide | |||||
| 68.5 ± 3.3 | |||||
| Salbutamol | 72.5 ± 2.6 | ||||
| Ipratropium bromide | |||||
| 70.6 ± 2.5 | |||||
| Salbutamol | |||||
| MMAD (µm) | 2.8 Ipratropium | ||||
| bromide | |||||
| 2.9 Salbutamol | 2.1 Ipratropium | ||||
| bromide | |||||
| 2.2 Salbutamol | 2.5 Ipratropium | ||||
| bromide | |||||
| 2.6 Salbutamol | 2.4 Ipratropium | ||||
| bromide | |||||
| 2.4 Salbutamol | 2.2 Ipratropium | ||||
| bromide | |||||
| 2.4 Salbutamol | |||||
| GSD | 2.6 Ipratropium | ||||
| bromide | |||||
| 2.5 Salbutamol | 2.2 Ipratropium | ||||
| bromide | |||||
| 2.2 Salbutamol | 2.4 Ipratropium | ||||
| bromide | |||||
| 2.5 Salbutamol | 3.3 Ipratropium | ||||
| bromide | |||||
| 3.3 Salbutamol | 2.5 Ipratropium | ||||
| bromide | |||||
| 2.5 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
Ac
Table 3: Summary of Performance Data – SMI Formulation 2 (2 APIs) at 30 L/min rticle Char C
| Aerosol
| Characteristics | Particle Characterization | ||||
|---|---|---|---|---|---|
| SMI alone | |||||
| (Group A) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Mouthpiece | |||||
| (Group B) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Small Mask | |||||
| (Group C) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Adult Large Mask | |||||
| (Group D) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Adult Small Mask | |||||
| (Group E) | |||||
| Total Mass | |||||
| Recovered (µg) | 3.3 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.9 ± 0.1 | |||||
| Olodaterol HCl | 3.3 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.6 ± 0.1 | |||||
| Olodaterol HCl | 3.3 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.6 ± 0.2 | |||||
| Olodaterol HCl | 3.1 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.7 ± 0.1 | |||||
| Olodaterol HCl | 3.2 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.5 ± 0.2 | |||||
| Olodaterol HCl | |||||
| Total Emitted | |||||
| Mass ex VHC | |||||
| (µg) | NA | 2.2 ± 0.3 | |||
| Tiotropium bromide | |||||
| 1.8 ± 0.2 | |||||
| Olodaterol HCl | 2.6 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.6 ± 0.2 | |||||
| Olodaterol HCl | 2.1 ± 0.1 | ||||
| Tiotropium bromide | |||||
| 2.1 ± 0.1 | |||||
| Olodaterol HCl | 2.6 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 2.1 ± 0.2 | |||||
| Olodaterol HCl | |||||
| Fine Particle | |||||
| Dose (µg) | 2.0 ± 0.1 | ||||
| Tiotropium bromide | |||||
| 2.0 ± 0.1 | |||||
| Olodaterol HCl | 1.7 ± 0.3 | ||||
| Tiotropium bromide | |||||
| 1.4 ± 0.2 | |||||
| Olodaterol HCl | 1.8 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 1.5 ± 0.2 | |||||
| Olodaterol HCl | 1.6 ± 0.1 | ||||
| Tiotropium bromide | |||||
| 1.4 ± 0.1 | |||||
| Olodaterol HCl | 1.9 ± 0.2 | ||||
| Tiotropium bromide | |||||
| 1.5 ± 0.2 | |||||
| Olodaterol HCl | |||||
| Fine Particle+ | |||||
| Fraction (%) | 60.5 ± 1.4 | ||||
| Tiotropium bromide | |||||
| 60.5 ± 1.4 | |||||
| Olodaterol HCl | 79.0 ± 3.4 | ||||
| Tiotropium bromide | |||||
| 81.4 ± 3.8 | |||||
| Olodaterol HCl | 67.7 ± 1.8 | ||||
| Tiotropium bromide | |||||
| 69.4 ± 1.5 | |||||
| Olodaterol HCl | 68.8 ± 4.8 | ||||
| Tiotropium bromide | |||||
| 65.4 ± 2.4 | |||||
| Olodaterol HCl | 71.5 ± 1.9 | ||||
| Tiotropium bromide | |||||
| 72.4 ± 1.5 | |||||
| Olodaterol HCl | |||||
| MMAD (µm) | 3.2 Tiotropium | ||||
| bromide | |||||
| 3.3 Olodaterol HCl | 2.1 Tiotropium | ||||
| bromide | |||||
| 2.2 Olodaterol HCl | 2.7 Tiotropium | ||||
| bromide | |||||
| 2.8 Olodaterol HCl | 2.4 Tiotropium | ||||
| bromide | |||||
| 2.8 Olodaterol HCl | 2.4 Tiotropium | ||||
| bromide | |||||
| 2.4 Olodaterol HCl | |||||
| GSD | NM | 2.4 Tiotropium | |||
| bromide | |||||
| 2.2 Olodaterol HCl | 3.3 Tiotropium | ||||
| bromide | |||||
| 2.4 Olodaterol HCl | NM | 2.6 Tiotropium | |||
| bromide | |||||
| 2.7 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
7
Section 5 - 510(k) Summary
Table 4: Summary of Performance Data – SMI Formulation 3 (1 API) at 30 L/min
| Aerosol
| Characteristics | Particle Characterization | ||||
|---|---|---|---|---|---|
| SMI alone | |||||
| (Group A) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Mouthpiece | |||||
| (Group B) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Small Mask | |||||
| (Group C) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Adult Large Mask | |||||
| (Group D) | SMI with the | ||||
| AeroChamber Plus* | |||||
| Flow-Vu* aVHC | |||||
| Adult Small Mask | |||||
| (Group E) | |||||
| Total Mass | |||||
| Recovered (µg) | 2.9 ± 0.2 Tiotropium | ||||
| bromide | 2.8 ± 0.1 Tiotropium | ||||
| bromide | 3.2 ± 0.2 Tiotropium | ||||
| bromide | 3.0 ± 0.3 Tiotropium | ||||
| bromide | 3.1 ± 0.4 Tiotropium | ||||
| bromide | |||||
| Total Emitted | |||||
| Mass ex VHC | |||||
| (µg) | NA | 1.9 ± 0.1 Tiotropium | |||
| bromide | 2.5 ± 0.1 Tiotropium | ||||
| bromide | 2.1 ± 0.2 Tiotropium | ||||
| bromide | 2.5 ± 0.2 Tiotropium | ||||
| bromide | |||||
| Fine Particle | |||||
| Dose (µg) | 1.8 ± 0.1 Tiotropium | ||||
| bromide | 1.4 ± 0.1 Tiotropium | ||||
| bromide | 1.7 ± 0.1 Tiotropium | ||||
| bromide | 1.4 ± 0.2 Tiotropium | ||||
| bromide | 1.7 ± 0.1 Tiotropium | ||||
| bromide | |||||
| Fine Particle† | |||||
| Fraction (%) | 62.4 ± 1.8 | ||||
| Tiotropium bromide | 71.7 ± 3.5 | ||||
| Tiotropium bromide | 68.1 ± 4.5 | ||||
| Tiotropium bromide | 64.5 ± 4.9 | ||||
| Tiotropium bromide | 66.7 ± 3.7 | ||||
| Tiotropium 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
| Aerosol
| Characteristics | Particle Characterization | ||
|---|---|---|---|
| SMI alone | SMI with the AeroChamber Plus* | ||
| Flow-Vu*Anti-Static VHC Small Mask | SMI with the AeroChamber Plus* Flow- | ||
| Vu*Anti-Static VHC Medium Mask | |||
| Total Mass | |||
| Recovered (μg) | 17.0 ± 0.8 Ipratropium bromide | ||
| 91.7 ± 8.1 Salbutamol | 15.2 ± 1.0 Ipratropium bromide | ||
| 85.4 ± 7.9 Salbutamol | 15.7 ± 1.1 Ipratropium bromide | ||
| 94.3 ± 10.9 Salbutamol | |||
| Total Emitted | |||
| Mass ex VHC | |||
| (μg) | NA | 11.0 ± 0.7 Ipratropium bromide | |
| 56.0 ± 8.1 Salbutamol | 10.6 ± 1.8 Ipratropium bromide | ||
| 60.4 ± 8.6 Salbutamol | |||
| Fine Particle | |||
| Dose (μg) | 9.0 ± 0.5 Ipratropium bromide | ||
| 47.7 ± 5.7 Salbutamol | 7.7 ± 0.8 Ipratropium bromide | ||
| 40.2 ± 4.0 Salbutamol | 8.2 ± 0.8 Ipratropium bromide | ||
| 46.7 ± 5.7 Salbutamol | |||
| Fine Particle† | |||
| Fraction (%) | 53.0 ± 0.8 Ipratropium bromide | ||
| 51.9 ± 2.8 Salbutamol | 70.6 ± 6.5 Ipratropium bromide | ||
| 72.8 ± 10.7 Salbutamol | 78.4 ± 9.3 Ipratropium bromide | ||
| 77.9 ± 8.1 Salbutamol | |||
| MMAD (μm) | 4.9 Ipratropium bromide | ||
| 5.0 Salbutamol | 1.8 Ipratropium bromide | ||
| 1.7 Salbutamol | 1.5 Ipratropium bromide | ||
| 1.5 Salbutamol |
- Percentage of particles between between 0.98 & 5.39 µm aerodynamic diameter
8
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.
| Aerosol
Characteristics | AeroChamber Plus* Flow-Vu* Anti-Static
VHC (Adult Small Mask)
(Subject Device) | AeroChamber Plus* Flow-Vu* Anti-Static VHC
(Adult Large Mask)
(Predicate Device - K112010) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Total Mass
Recovered (µg) | 20.0 ± 0.4 Ipratropium bromide
122.6 ± 3.7 Fluticasone Propionate
107.9 ± 3.8 Albuterol Sulfate | 19.9 ± 0.4 Ipratropium bromide
124.6 ± 5.7 Fluticasone Propionate
100.6 ± 2.9 Albuterol Sulfate |
| Total Emitted Mass
ex VHC (µg) | 11.3 ± 0.5 Ipratropium bromide
53.5 ± 5.2 Fluticasone Propionate
52.9 ± 7.9 Albuterol Sulfate | 10.4 ± 0.7 Ipratropium bromide
58.1 ± 2.5 Fluticasone Propionate
56.3 ± 2.6 Albuterol Sulfate |
| Fine Particle Dose
(µg) | 10.5 ± 0.4 Ipratropium bromide
43.6 ± 5.6 Fluticasone Propionate
43.7 ± 8.4 Albuterol Sulfate | 9.4 ± 0.7 Ipratropium bromide
47.4 ± 2.5 Fluticasone Propionate
48.1 ± 3.1 Albuterol Sulfate |
| Fine Particle
Fraction† (%) | 93.0 ± 0.8 Ipratropium bromide
81.4 ± 2. Fluticasone Propionate
82.3 ± 3.7 Albuterol Sulfate | 90.5 ± 0.8 Ipratropium bromide
81.5 ± 1.8 Fluticasone Propionate
85.4 ± 1.9 Albuterol Sulfate |
| Particle Size
(MMAD) (μm) | 1.0 Ipratropium bromide
3.0 Fluticasone Propionate
3.0 Albuterol Sulfate | 1.1 Ipratropium bromide
2.9 Fluticasone Propionate
2.8 Albuterol Sulfate |
| GSD | NA* Ipratropium bromide
1.7 Fluticasone Propionate
1.8 Albuterol Sulfate | NA* Ipratropium bromide
1.7 Fluticasone Propionate
1.7 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.
9
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 Lymphoma |
| Assay) | |
| 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.