(400 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and aerosol delivery performance of a mechanical holding chamber, with no mention of AI or ML.
Yes
The device is intended to aid in the delivery of aerosolized medications, which directly contributes to a therapeutic effect by ensuring proper drug delivery to the respiratory tract.
No
Explanation: The device is described as a "collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications." Its purpose is to facilitate medication delivery, not to diagnose a condition.
No
The device description clearly states it is a physical, collapsible holding chamber made of paperboard with valves, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the delivery of aerosolized medications via an MDI. This is a therapeutic delivery device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical structure and function of the device in facilitating drug delivery. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies described are focused on the physical characteristics of the aerosol delivered by the device (particle size, emitted dose) and the device's physical integrity and biocompatibility. These are relevant to a drug delivery device, not an IVD.
- Key Metrics: The key metrics measured (Total Emitted Dose, Particle Size, etc.) are related to the performance of the device in delivering medication, not to the analysis of biological samples.
In summary, the LiteAire is a medical device used for drug delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
NVP
Device Description
The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire® BASIC) and the modified LiteAire® Dual Valved, Collapsible MDI Holding Chamber (also referred to as the modified LiteAire®), are intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The subject devices feature a universal port designed for compatibility with most MDI medications. The subject devices are intended for use by a single patient and, when properly cared for, are reusable for up to one week. The devices consist of a collapsible paperboard housing and two one-way valves to control the direction of air flow when the patient inhales and exhales through the devices are popped-up by the user prior to use by pressing against the sides of the devices, can be collapsed flat between uses, and are anti-static. The intended environments of use include the home, hospitals and clinics. Note that the only differences between the modified LiteAire® and LiteAire® BASIC configurations is the removal of the window.
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
adults, adolescents and children ages 5 and up
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" (1993). Testing involved aerosol characterization of particle size distributions of three different MDI medications compared against the predicate device using an Andersen Cascade Impactor (ACI). Testing was performed at adult flow rates (28.3 L/min) and pediatric flow rates (12.0 L/min).
Sample Size: N=9 for Predicate LiteAire, LiteAire BASIC, and Modified LiteAire for each drug tested (AbS: Albuterol Sulfate (Proventil HFA), IpB: Ipratropium Bromide, (Atrovent HFA), Flu: Fluticasone Propionate (Flovent HFA)).
Key Results: Tables 3 and 4 provide data on Total Emitted Dose (µg), Coarse Particle Dose (µg), Fine Particle Dose (µg), MMAD (µm), and GSD (µm) for each device and drug at both adult and pediatric flow rates. The data includes mean values ± SD and 95% CI. A qualitative assessment of the tables shows a close resemblance in performance metrics between the subject devices and the predicate.
Biocompatibility Testing: The predicate device (K160109) was found to be biocompatible per ISO 10993-1. Biocompatibility was confirmed utilizing the FDA guidance document, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process". The subject devices are made with the same material formulations, manufacturing processes (including sterility), finished device geometry (including chamber volumes), and body/fluid contact characterization as the predicate device (K160109). The modifications of the subject devices from the predicate device do not result in changes to any direct or indirect tissue-contacting components.
Bench Performance Testing: The following performance tests were completed on the subject devices. All tests passed.
- Visual Inspection
- First Article Inspection
- Accelerated Aging
- Pop/Collapse
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
03/31/2022
Thayer Medical Corporation Christine Woeppel Quality Engineer 4575 S. Palo Verde Road, Suite 337 Tucson, Arizona 85714
Re: K210558
Trade/Device Name: LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: NVP Dated: February 25, 2022 Received: March 4, 2022
Dear Christine Woeppel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon Blakely Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210558
Device Name
LiteAire BASIC Dual Valved, Collapsible MDI Holding Chamber LiteAire Dual Valved, Collapsible MDI Holding Chamber
Indications for Use (Describe)
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healtheare professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square with a series of dots above it, arranged in a pattern that resembles a cloud or spray. Below the square, the words "THAYER MEDICAL" are printed in a bold, sans-serif font, with "THAYER" on top of "MEDICAL".
Page 1 of 6
510(k) Summary
PREMARKET NOTIFICATION 510(K) SUMMARY
[As required by 21 CFR 807.92]
| Table 1. GENERAL INFORMATION | |
|---|---|
| Name of Submitter | Thayer Medical Corporation |
| Address | 4575 S Palo Verde Rd., Suite 337 |
| Tucson, AZ 85714 | |
| Phone Number | (520) 790-5393 |
| Contact Person | James Strickland, CEO |
| (520) 790-5393 | |
| Date of Preparation | 31 March 2022 |
| Name of Modified Subject Devices | Thayer Medical LiteAire® BASIC Dual-Valved, Collapsible MDI Holding Chamber (K210558) |
| Product Code: NVP | |
| Product Class: Class II | |
| Class Name: Holding Chambers, Direct Patient Interface | |
| Thayer Medical LiteAire® Dual-Valved, Collapsible MDI Holding Chamber (K210558) | |
| Product Code: NVP | |
| Product Class: Class II | |
| Class Name: Holding Chambers, Direct Patient Interface | |
| Name of the Predicate Device | Thayer Medical LiteAire® Dual-Valved, Collapsible MDI Holding Chamber (K160109) |
Device Description 1.1
The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire® BASIC) and the modified LiteAire® Dual Valved, Collapsible MDI Holding Chamber (also referred to as the modified LiteAire®), are intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The subject devices feature a universal port designed for compatibility with most MDI medications. The subject devices are intended for use by a single patient and, when properly cared for, are reusable for up to one week. The devices consist of a collapsible paperboard housing and two one-way valves to control the direction of air flow when the patient inhales and exhales through the devices are popped-up by the user prior to use by pressing against the sides of the devices, can be collapsed flat between uses, and are anti-static. The intended environments of use include the home, hospitals and clinics. Note that the only differences between the modified LiteAire® and LiteAire® BASIC configurations is the removal of the window.
4
Image /page/4/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square shape with a pattern of dots arranged in rows, with the dots becoming larger towards the center. Below the square is the text "THAYER MEDICAL" in a bold, sans-serif font, with the word "THAYER" stacked above the word "MEDICAL". A horizontal line is placed below the text.
Page 2 of 6 Traditional Bundled 510(k): Device Modification Thayer Medical Corporation Rev D LiteAire® & LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber
2022-03-31
Principle of Operation 1.2
The subject devices are comprised of a reservoir into which an aerosol medication is dispensed and a mouthpiece from which the patient inhales the dispensed medication. The reservoir and mouthpiece are separated by a one-way valve. The user inserts an MDI into the MDI Port, and then places their mouth over the mouthpiece of the holding chamber. As the user manually depresses the MDI, the aerosol plume is directed into the holding chamber of the device. Upon inhalation, the smaller aerosolized medication particles travel through the device's inhalation valve and into the patient's respiratory tract. The subject devices also incorporate a one-way exhalation valve that allows the patient to breathe out through the device while maintaining contact with the mouthpiece. This prevents poor medication dosing as the inhalation valve seals the chamber and exhausted air is instead routed through the exhalation valve and out of the device.
1.3 Intended Use
The LiteAire® BASIC and the modified LiteAire® are collapsible, disposable dual-valved holding chambers designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI). The LiteAire® BASIC and the modified LiteAire® feature a standard port designed for compatibility with standard MDI mouthpieces. They are non-sterile devices for single-patient use. The LiteAire® BASIC and the modified LiteAire® are intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healthcare professional.
The indications for use and intended use of the subject devices are identical to the predicate.
1.4 Comparison to the Predicate Device
The subject devices are substantially equivalent to the predicate device (K160109) in purpose, function, scientific technology and method of operation. Only minor differences exist between the subject devices and the predicate, which do not affect the safety or effectiveness of the subject devices.
| Table 2. DEVICE COMPARISON: LiteAire® Modifications | |||
|---|---|---|---|
| Cleared Predicate Device: |
| Changes from Predicate to Subject | |
| Attribute | LiteAire® (K160109) | Modified Subject Device:
LiteAire® BASIC | Modified Subject Device:
LiteAire® |
| Component
Design Features | Paperboard Housing | YES: The exterior dimensions
and shape of the paperboard
housing are unchanged.
However, three slight
modifications were made (1) | YES: The exterior dimensions
and shape of the paperboard
housing are unchanged.
However, two slight
modifications were made (1) |
| | | the top panel of the inner
barrier was expanded, (2) the
inhalation vent was changed
from an elongated rectangle to
a series of four circles, and (3)
the window opening was
eliminated. | the top panel of the inner
barrier was expanded, and (2)
the inhalation vent was
changed from an elongated
rectangle to a series of four
circles. |
| | One-way exhalation valve | | No Change |
| | One-way inhalation valve | No Change | |
| | Polymer Window | YES: No Window | No Change |
| | Location and pattern of
Adhesive is limited to and
controlled within general
areas. | YES: Location and pattern of Adhesive is still limited to and
controlled within the same general areas; however, the
application/deliberate placement is more precisely controlled
within those areas. | No Change |
| | Graphic Design | YES: The graphics displayed on the outside of the subject devices
are different than those of the predicate | |
| Assembly Method | Pop-up | No Change | |
| Housing
Configuration | Collapsible | No Change | |
| Patient Interface | Mouthpiece between lips | No Change | |
| | Fingers pinch sides | No Change | |
| Chamber Volume | 184 mL | No Change | |
| Anti-Static
Properties | Anti-Static | No Change | |
| Shelf-life | 5 years | No Change | |
| Use-life | Device can be used for up
to 1 week before disposal | No Change | |
| Cleaning | Device cannot be washed | No Change | |
| Sterility | Non-sterile | No Change | |
| Materials | Paperboard, Vegetable-
based Inks, Aqueous
Coating, Acrylic Adhesive,
PET and Polypropylene
Components | No Change | |
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Image /page/5/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of the words "THAYER MEDICAL" in a bold, sans-serif font, with "THAYER" stacked on top of "MEDICAL". Above the words is a stylized graphic of a series of dots arranged in a semi-circular pattern, with the dots increasing in size from top to bottom. The logo is simple and modern, and the use of dots suggests a connection to technology or innovation.
Rev D 2022-03-31
Non-Clinical Testing Summary 1.5
1.5.1. Aerosol Characterization
Aerosol characterization testing was performed in accordance with relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators" (1993). Testing involved aerosol characterization of particle size distributions of three different MDI medications compared against the predicate device using an Andersen Cascade
6
Image /page/6/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of the words "THAYER MEDICAL" in a bold, sans-serif font, with "THAYER" stacked above "MEDICAL". Above the text is a black square with a pattern of white circles inside, resembling a stylized atom or molecule. Above the square, there are several rows of black dots, decreasing in number as they move upwards, creating a visual effect of dispersion or radiation.
Rev D 2022-03-31
Impactor (ACI). Tables 3 and 4 include a summary of the testing performed at adult flow rates (28.3 L/min) and pediatric flow rates (12.0 L/min).
| | | Predicate LiteAire
(N=9) | LiteAire BASIC
(N=9) | Modified
LiteAire (N=9) |
|-------------------------------------------------|-------------------------------------------|-----------------------------|-----------------------------|------------------------------|
| Drug | Parameter | | | |
| AbS: Albuterol
Sulfate
(Proventil HFA) | Total Emitted Dose (µg) ± SD,
95% CI | 56.06 ± 6.94
50.73–61.40 | 54.75 ± 4.96
50.94–58.45 | 53.85 ± 2.66
51.81–55.90 |
| | Coarse Particle Dose (µg) ± SD,
95% CI | BLOQ*
BLOQ* | 0.09 ± 0.26
-0.11–0.29 | 0.16 ± 0.31
-0.08–0.40 |
| | Fine Particle Dose (µg) ± SD, 95% CI | 56.06 ± 6.94
50.73–61.40 | 54.66 ± 4.99
50.83–58.50 | 53.85 ± 2.57
51.72–55.67 |
| | MMAD (µm) ± SD,
95% CI | 2.15 ± 0.05
2.12–2.19 | 2.17 ± 0.05
2.14–2.21 | 2.24 ± 0.06
2.19–2.28 |
| | GSD (µm) ± SD,
95% CI | 1.44 ± 0.07
1.39–1.49 | 1.43 ± 0.08
1.37–1.49 | 1.41 ± 0.02
1.39–1.43 |
| IpB: Ipratropium
Bromide,
(Atrovent HFA) | Total Emitted Dose (µg) ± SD,
95% CI | 7.39 ± 0.55
6.96–7.81 | 7.46 ± 0.61
6.99–7.92 | 7.71 ± 0.62
7.10–8.25 |
| | Coarse Particle Dose (µg) ± SD,
95% CI | BLOQ*
BLOQ* | BLOQ*
BLOQ* | BLOQ*
BLOQ* |
| | Fine Particle Dose (µg) ± SD,
95% CI | 7.39 ± 0.55
6.96–7.81 | 7.46 ± 0.61
6.99–7.92 | 7.71 ± 0.62
7.10–8.25 |
| | MMAD (µm) ± SD,
95% CI | 0.51 ± 0.06
0.46–0.55 | 0.57 ± 0.14
0.46–0.67 | 0.60 ± 0.09
0.53–0.66 |
| | GSD (µm) ± SD,
95% CI | 4.79 ± 0.70
4.26–5.33 | 3.90 ± 1.81
2.51–5.29 | 3.44 ± 0.95
2.71–4.17 |
| Flu: Fluticasone
Propionate
(Flovent HFA) | Total Emitted Dose (µg) ± SD,
95% CI | 40.96 ± 5.23
36.94–44.98 | 41.27 ± 6.33
36.41–46.14 | 38.43 ± 11.26
28.72–44.55 |
| | Coarse Particle Dose (µg) ± SD,
95% CI | BLOQ*
BLOQ* | BLOQ*
BLOQ* | BLOQ*
BLOQ* |
| | Fine Particle Dose (µg) ± SD,
95% CI | 40.96 ± 5.23
36.94–44.98 | 41.27 ± 6.33
36.41–46.14 | 38.43 ± 11.26
29.78–47.09 |
| | MMAD (µm) ± SD,
95% CI | 2.49 ± 0.17
2.358–2.619 | 2.52 ± 0.03
2.50–2.54 | 2.54 ± 0.06
2.50–2.59 |
| | GSD (µm) ± SD,
95% CI | 1.39 ± 0.02
1.38–1.41 | 1.41 ± 0.03
1.39–1.43 | 1.46 ± 0.05
1.426–1.499 |
- Below Limit of Quantitation (BLOQ)
TABLE 4: Particle size distribution characterization of the predicate and subject devices at pediatric simulated inhalation rate (12.0 L/min).
| Drug | Parameter | Predicate LiteAire
(N=9) | LiteAire BASIC
(N=9) | Modified
LiteAire (N=9) |
|----------------------------------------------|---------------------------------------|-----------------------------|-------------------------|----------------------------|
| AbS: Albuterol
Sulfate
(Proventil HFA) | Total Emitted Dose ( $\mu$ g) ± SD, | 56.06 ± 6.94 | 54.75 ± 4.96 | 53.85 ± 2.66 |
| | 95% CI | 50.73 – 61.40 | 50.94 – 58.45 | 51.81 – 55.90 |
| | Coarse Particle Dose ( $\mu$ g) ± SD, | BLOQ* | 0.09 ± 0.26 | 0.16 ± 0.31 |
| | 95% CI | BLOQ* | -0.11 – 0.29 | -0.08 – 0.40 |
7
Image /page/7/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of the words "THAYER MEDICAL" stacked on top of each other in a bold, sans-serif font. Above the words is a graphic of a square shape made up of several small circles. The circles are arranged in a pattern that resembles a cloud or a burst of energy.
| Rev D |
|---|
| 2022-03-31 |
| | Fine Particle Dose (µg) ± SD, 95%
CI | 56.06 ± 6.94
50.73 - 61.40 | 54.66 ± 4.99
50.83 - 58.50 | 53.85 ± 2.57
51.72 - 55.67 |
|------------------------------------------------|-------------------------------------------------|-------------------------------------------|-------------------------------|-------------------------------|
| | MMAD (μm) ± SD,
95% CI | 2.15 ± 0.05
2.12 - 2.19 | 2.17 ± 0.05
2.14 - 2.21 | 2.24 ± 0.06
2.19 - 2.28 |
| | GSD (μm) ± SD,
95% CI | 1.44 ± 0.07
1.39 - 1.49 | 1.43 ± 0.08
1.37 - 1.49 | 1.41 ± 0.02
1.39 - 1.43 |
| IpB: Ipratropium
Bromide,
(Atrovent HFA) | Total Emitted Dose (µg) ± SD,
95% CI | 7.39 ± 0.55
6.96 - 7.81 | 7.46 ± 0.61
6.99 - 7.92 | 7.71 ± 0.62
7.10 - 8.25 |
| | Coarse Particle Dose (μg) ± SD,
95% CI | BLOQ*
BLOQ* | BLOQ*
BLOQ* | BLOQ*
BLOQ* |
| | Fine Particle Dose (μg) ± SD,
95% CI | 7.39 ± 0.55
6.96 - 7.81 | 7.46 ± 0.61
6.99 - 7.92 | 7.71 ± 0.62
7.10 - 8.25 |
| | MMAD (μm) ± SD,
95% CI | 0.51 ± 0.06
0.46 - 0.55 | 0.57 ± 0.14
0.46 - 0.67 | 0.60 ± 0.09
0.53 - 0.66 |
| | GSD (μm) ± SD,
95% CI | 4.79 ± 0.70
4.26 - 5.33 | 3.90 ± 1.81
2.51 - 5.29 | 3.44 ± 0.95
2.71 - 4.17 |
| | Flu: Fluticasone
Propionate
(Flovent HFA) | Total Emitted Dose (μg) ± SD,
95% CI | 40.96 ± 5.23
36.94 - 44.98 | 41.27 ± 6.33
36.41 - 46.14 |
| | | Coarse Particle Dose (μg) ± SD,
95% CI | BLOQ*
BLOQ* | BLOQ*
BLOQ* |
| | | Fine Particle Dose (μg) ± SD,
95% CI | 40.96 ± 5.23
36.94 - 44.98 | 41.27 ± 6.33
36.41 - 46.14 |
| | | MMAD (μm) ± SD,
95% CI | 2.49 ± 0.17
2.358 - 2.619 | 2.52 ± 0.03
2.50 - 2.54 |
| | | GSD (μm) ± SD,
95% CI | 1.39 ± 0.02
1.38 - 1.41 | 1.41 ± 0.03
1.39 - 1.43 |
- Below Limit of Quantitation (BLOQ)
1.5.2. Biocompatibility Testing
The predicate device (K160109) was found to be biocompatible per ISO 10993-1. Other than the removal of the window on the LiteAire® Basic, there are no differences in the materials used to create the modified (subject) devices. Biocompatibility was confirmed utilizing the FDA guidance document, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process". The subject devices are made with the same material formulations, manufacturing processes (including sterility), finished device geometry (including chamber volumes), and body/fluid contact characterization as the predicate device (K160109). The modifications of the subject devices from the predicate device do not result in changes to any direct or indirect tissue-contacting components. Additionally, the proposed changes to the subject devices did not add any new biocompatibility risks to the risk management process. Therefore, the biocompatibility requirements of the subject devices have been met.
1.5.3. Bench Performance Testing
The following performance tests were completed on the subject devices. All tests passed.
- Visual Inspection ●
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- First Article Inspection
- Accelerated Aging
- Pop/Collapse
1.5.4. Clinical Testing
Not applicable.
1.6 Substantial Equivalence Conclusion
We have demonstrated that the modification in design of the subject devices does not negatively impact the device performance and the modified (subject) devices continues to perform with substantial equivalence to the cleared (predicate) device.