Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, with flowing lines suggesting movement or connection. The overall design is simple and professional, reflecting the department's role in public health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 19, 2017 Thayer Medical Corporation Jennifer Johnson Director of Research and Development 4575 South Palo Verde Road Suite 337 Tucson, Arizona 85714 Re: K160109 Trade/Device Name: Liteaire Dual Valved, Collapsible MDI Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: NVP Dated: April 19, 2017 Received: May 19, 2017 Dear Jennifer Johnson: 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Michael J. Ryan -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 Enclosure {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K160109 Device Name Thayer Medical 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 healthcare 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) #### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square with a pattern of dots at the top, resembling a stylized representation of light or energy emanating upwards. Below the square, the word "THAYER" is written in a bold, sans-serif font, followed by the word "MEDICAL" in a smaller font size. A horizontal line is placed under the word "MEDICAL". LiteAire® 510(k) Summary Page 1 of 9 # 510(k) Summary | Date Prepared | 09-May-17 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Information | Thayer Medical Corporation<br>4575 South Palo Verde Road, Suite 337<br>Tucson, Arizona 85714<br>Telephone (520) 790-5393<br>Facsimile (520) 790-5854 | | Official Contact | Jennifer Johnson, PhD<br>Director of Research and Development<br>Thayer Medical Corporation | | Proprietary or Trade Name | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding<br>Chamber | | Common/Usual Name | Holding chamber | | Classification Name | Holding Chambers, Direct Patient Interface<br>NVP - CFR 868.5630<br>Class II | | Predicate Device(s) | K993101 - Thayer Medical LiteAire® | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square with a series of dots arranged in a semi-circular pattern above the words "THAYER MEDICAL" in a bold, sans-serif font. The dots appear to be arranged in rows, with the number of dots decreasing as they move upwards, creating a visual effect of radiating outwards. LiteAire® 510(k) Summary Page 2 of 9 #### Device Description The Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber is intended for use in the inhalation of medications delivered via a pressurized metered dose inhaler (pMDI). The device consists of a collapsible paperboard housing and 2 one-way valves to control the direction of air flow when the patient inhales and exhales through the device. The LiteAire is not sterile, but clean and ready to use right out of the package. The LiteAire can be assembled by gently pushing in the edges of the device. The holding chamber can also be collapsed flat between uses and is anti-static. #### 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. #### Intended Use The intended environments for use include the home, hospitals and clinics. No cleaning, disinfection or sterilization of the LiteAire is needed. This product can be used right out of the package. Prior to use, ensure these instructions and the instructions supplied with the MDI have been read. Always follow your physician's instructions. #### Device Modifications from Predicate to Subject As indicated in Table 1, the subject device contains 5 modifications from the predicate device. First, the use assembly of the predicate device was changed from a fold-up form to a pop-up form and the volume of the chamber was increased. Next, the adhesive used in manufacture of the device was changed. Last, an anti-static designation and a shelf-life were added to the subject device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square with several rows of black dots at the top, resembling a stylized sun or burst. Below the square, the words "THAYER" and "MEDICAL" are stacked on top of each other in a bold, sans-serif font. A horizontal line is placed above and below the word "MEDICAL". | Table 1. Comparisons between the Predicate and Subject Devices. The center column indicates | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | whether that attribute for the Subject Device has changed from the Predicate Device. | | | | | Attribute | Predicate Device<br>LiteAire®<br>K993101 | Change<br>From<br>Predicate<br>to<br>Subject<br>(Yes or No) | Subject Device<br>LiteAire®<br>K160109 | | Regulation<br>No. | 21 CFR 868.5630 | No | 21 CFR 868.5630 | | Product Code | CAF | Yes1 | NVP | | Product Class | II | No | II | | Intended Use | The LiteAire is intended for independent<br>use by a single patient; each LiteAire<br>should be usable for multiple doses if<br>properly cared for.<br>It provides a combination of a holding<br>chamber with two valves designed to help<br>achieve more reproducible dosing, by<br>reducing throat deposition of the MDI drug<br>and by assisting the patient in overcoming<br>any hand-breath coordination difficulties.<br>The LiteAire is for use on the order of a<br>physician or other practitioner approved by<br>law. | No2 | The LiteAire is intended for independent<br>use by a single patient; each LiteAire<br>should be usable for multiple doses if<br>properly cared for.<br>It is a holding chamber with two valves<br>which is designed to help: achieve<br>consistent dosing, reduce MDI drug<br>deposition in the throat and assist the<br>patient in overcoming any hand-breath<br>coordination difficulties.<br>The LiteAire is for use on the order of a<br>physician or other practitioner approved by<br>law. | | Indications<br>for Use | The LiteAire is a collapsible, disposable<br>accessory device for use with a metered<br>dose inhaler (MDI) canister and<br>nozzle/mouthpiece provided by the MDI<br>drug manufacturer.<br>It is designed to be used with virtually all<br>MDI nozzles/mouthpieces. The LiteAire is a<br>non-sterile device for single-patient use.<br>The patient population comprises all users<br>of MDIs who are capable of actuating the<br>MDI canister and inhaling through a<br>mouthpiece. | No2 | The LiteAire is a collapsible, disposable<br>dual-valved holding chamber designed to<br>aid in the delivery of aerosolized<br>medications delivered via a pressurized<br>metered dose inhaler (MDI).<br>The LiteAire features a standard port<br>designed for compatibility with standard<br>MDI mouthpieces. It is a non-sterile device<br>for single-patient use.<br>The LiteAire is intended to be used by<br>adults, adolescents and children ages 5 and<br>up who are able to use a holding chamber<br>without the aid of a mask and who are<br>under the care or treatment of a physician<br>or licensed healthcare professional. | | Environments<br>for Use | The environment of use is ordinary room<br>temperature, ambient pressure and<br>humidity, in clinical or non-clinical settings. | No2 | The intended environments of use include<br>the home, hospitals and clinics. | | Table 1. Comparisons between the Predicate and Subject Devices. The center column indicates | | | | | whether that attribute for the Subject Device has changed from the Predicate Device. | | | | | Attribute | Predicate Device<br>LiteAire®<br>K993101 | Change<br>From<br>Predicate<br>to<br>Subject<br>(Yes or No) | Subject Device<br>LiteAire®<br>K160109 | | Prescriptive | Yes | No | Yes | | Patient<br>Population | The target patient population comprises all<br>users of MDIs who are capable of actuating<br>the MDI canister and inhaling through a<br>mouthpiece. | No | The LiteAire is intended to be used by<br>adults, adolescents and children ages 5 and<br>up who are able to use a holding chamber<br>without the aid of a mask and who are<br>under the care or treatment of a physician<br>or licensed healthcare professional. | | Single-<br>patient,<br>multi-use | Yes | No | Yes | | Components | Paperboard housing | No | Paperboard housing | | | One-way exhalation valve | No | One-way exhalation valve | | | One-way inhalation valve | No | One-way inhalation valve | | | Polymer window | No | Polymer window | | Adhesive | 21 CFR 175.105 compliant | No | 21 CFR 175.105 compliant | | | Category = indirect food contact | No | Category = indirect food contact | | | Adhesive manufacturer A | Yes | Adhesive manufacturer B | | Device<br>Assembly for<br>Use | Fold-up | Yes | Pop-up | | Chamber<br>Volume | 165 mL | Yes | 184 mL | | Anti-static<br>properties | Not stated | Yes | Anti-Static | | Shelf-life | Not stated | Yes | 5 years | | Table 1. Comparisons between the Predicate and Subject Devices. The center column indicates<br>whether that attribute for the Subject Device has changed from the Predicate Device. | | | | | Attribute | Predicate Device | Change<br>From<br>Predicate<br>to<br>Subject<br>(Yes or No) | Subject Device | | | LiteAire®<br>K993101 | | LiteAire®<br>K160109 | | Housing<br>Configuration | Collapsible | No | Collapsible | | Patient<br>interface | Mouthpiece | No | Mouthpiece | | Sterility | Non-sterile | No | Non-sterile | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square with a series of dots arranged in a semi-circular pattern at the top, resembling a stylized representation of sound waves or a technological signal. Below the square, the words "THAYER MEDICAL" are stacked on top of each other, with "THAYER" appearing above "MEDICAL". A horizontal line underlines the word "MEDICAL", providing a sense of stability and grounding to the logo. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square with several circles inside, arranged in rows. The circles are smaller at the top and larger at the bottom. Above the square, there are several dots arranged in a semi-circle shape. Below the square, the words "THAYER MEDICAL" are written in bold, uppercase letters. 1 This change is due to a change in the FDA designation. 2 Although the wording has been changed, the intended meaning is the wording change from Predicate to Subject was to better convey the intended meaning. # Substantial Equivalence Discussion Table 1 compares the key features of the subject LiteAire with the identified predicate and demonstrates that the device is found to be substantially equivalent. In summary one can conclude that the substantial equivalence is met based upon the following: ## Indications for Use The indications for use are nearly identical for the subject device (K160109) when compared to the predicate, K993101. Discussion: Both devices are collapsible and disposable paperboard valved holding chambers which are to be used to aide in the delivery of metered dose inhaled (MDI) medication. Both devices were designed to be used with standard MDIs. Furthermore, both devices are non-sterile devices for single-patient use by patients who are able to inhale through the mouthpiece of a valved holding chamber without the need for a mask. ## Environment for Use The environments of use include the home, hospitals and clinics. Discussion: The environments of use are equivalent to the predicate K993101 – Thayer Medical LiteAire®. The predicate device (K993101) describes the environment of use to be clinical or non-clinical settings. The subject device (K160109) describes the environment {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Thayer Medical. The logo consists of the word "THAYER" in bold, uppercase letters above the word "MEDICAL" in smaller, uppercase letters. Above the words is a square shape filled with a pattern of dots that are arranged in rows, with the dots becoming smaller as they ascend. LiteAire® 510(k) Summary Page 6 of 9 of use to be homes, hospitals and clinics. Homes, hospitals and clinics are clinical and non-clinical settings. # Patient Population The patient populations include 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. This is equivalent to the patient population in the predicate that did not specify a patient population, but noted the patient population comprises all users of MDIs who are capable of actuating the MDI canister and inhaling through a mouthpiece. Discussion: The patient populations are equivalent to the patient populations for the predicate device, K993101 - Thayer Medical LiteAire®. # Technology and Construction The design, fabrication, shape, size, etc. are equivalent to the predicate, K993101 – Thayer Medical LiteAire®. Discussion: The designs of the predicate (K993101) and the subject (K160109) devices both incorporate a housing, a polymer window, a one-way valve for inhalation, a oneway valve for exhalation and a patient interface with a mouthpiece. The dimensional changes to the subject LiteAire® (K160109) were shown to result in substantially equivalent performance to the predicate device (K993101) (i.e. equal drug delivery). # Non-Clinical Testing Summary # Biocompatibility The device is considered to be externally communicating with lung tissue (aerosol mediated) and in direct (skin & mucosal membrane) contact with the patient. In order to assess device biocompatibility, the following tests were carried out: - Cytotoxicity testing, according to ISO 10993-5 - Sensitization testing, according to ISO 10993-10 - . Intracutaneous Irritation testing, according to ISO 10993-10 - Extractables & Leachables testing, according to ISO 10993-18 & 17 - . Off-gas testing (simulation of volatile leachable/contaminant release in a hot vehicle) # Performance Testing including Comparative - . Shelf-life testing - o Pre- (new) vs. Post-aged (6 years) {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of the words "THAYER MEDICAL" in a sans-serif font, with "THAYER" stacked on top of "MEDICAL". Above the text is a graphic of a square with rounded corners, filled with a grid of circles. Above the square, there are three rows of dots that decrease in number from bottom to top. LiteAire® 510(k) Summary Page 7 of 9 - Results: There were no differences in appearance, pop-ability and ● collapsibility, Total Emitted Dose, Course Particle Dose or Fine Particle Dose between the new and aged devices. Furthermore, the inhalation and exhalation valve resistances of both devices were found to be acceptably low. - Environmental and mechanical testing (part of Simulated Life Cycle testing) ● - o Temperature and Humidity testing - Valve Resistance testing o - . Results: There were no differences in Total Emitted Dose, Course Particle Dose, Fine Particle Dose and breakability upon dropping between the new devices and devices exposed to high temperature and humidity. Furthermore, the inhalation and exhalation valve resistances of "exposed" devices were found to be acceptably low. - Anti-static surface resistivity testing (according to ASTM-D-257, NFPA-99 and ● MIL-PRF-81705D) - Results: A static dissipative or anti-static surface measures <1.0 X 1012 Ω/sq (at 23°C/ 50% RH). The LiteAire has a surface resistivity of 1.0 x 1010 Ω/sq (at 23°C/ 50% RH). This meets the requirement for being "dissipative" or "anti-static". - Particle Characterization testing via Cascade Impactor - Adult, 28 lpm - Pediatric, 12 Ipm o - . Results: Presented below in Tables 2 and 3. Values reported are the 95% confidence intervals. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square shape at the top, filled with a pattern of black dots that appear to be radiating outwards. Below the square, the words "THAYER" and "MEDICAL" are stacked on top of each other in a bold, sans-serif font. A horizontal line is placed under the word "MEDICAL". LiteAire® 510(k) Summary Page 8 of 9 Table 2. MDI with Holding Chamber, ACI runs: 3 LiteAire Devices/3 ACI replicates each (N=9 ACI runs/drug) at Adult (28 L/min) flow rate. The values reported are the 95% confidence intervals. | | MDI Product Tested | | | |-------------------------------------------------------------|--------------------------------|-----------------------|----------------------| | | (Number of Replicate ACI Runs) | | | | | Proventil HFA<br>(N=9) | Atrovent HFA<br>(N=9) | QVAR 80 mcg<br>(N=9) | | Total Delivered Dose by<br>Device ( $\mu$ g/actuation) | 53.87 – 77.62 | 6.15 – 10.02 | 65.74 – 76.01 | | Coarse Particle Dose<br>(>4.7 $\mu$ m),( $\mu$ g/actuation) | 0 – 2.81 | 0–0 | 0.69 – 1.82 | | Fine Particle Dose<br>(<4.7 $\mu$ m), ( $\mu$ g/actuation) | 54.49 – 75.34 | 6.15 – 10.02 | 64.24 – 75.00 | | MMAD ( $\mu$ m) | 2.11 – 2.44 | 0.48 – 0.88 | 0.99 – 1.15 | | GSD ( $\mu$ m) | 1.35 – 1.45 | 0 – 6.08 | 1.37 – 2.08 | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Thayer Medical. The logo consists of a square shape filled with a pattern of dots, with the word "THAYER" in bold letters above the word "MEDICAL". The dots are arranged in a way that they are more concentrated at the top of the square and gradually become less dense towards the bottom. | Table 3. MDI with Holding Chamber, ACI runs: 3 LiteAire Devices/3 ACI replicates each<br>(N=9 ACI runs/drug) at Pediatric (12 L/min) flow rate | | | | |------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------|----------------------| | | MDI Product Tested<br>(Number of Replicate ACI Runs) | | | | | Proventil HFA<br>(N=9) | Atrovent HFA<br>(N=9) | QVAR 80 mcg<br>(N=9) | | Total Delivered Dose by<br>Device (µg/actuation) | 39.77 - 66.53 | 5.96 - 10.03 | 59.89 - 74.16 | | Coarse Particle Dose<br>(>4.7 µm), (µg/actuation) | 0 - 2.28 | 0-0 | 0 - 3.42 | | Fine Particle Dose<br>(<4.7 µm), (µg/actuation) | 39.81 - 65.56 | 5.96 - 10.03 | 57.74 - 73.20 | | MMAD (µm) | 1.88 – 2.18 | 0.57 - 0.83 | 0.78 – 1.05 | | GSD (µm) | 1.32 - 1.40 | 1.21 - 2.02 | 1.48 – 1.82 | # Substantial Equivalence Conclusion We have demonstrated that the modifications in designs and features of the subject device do not impact the device performance and the subject device continues to perform substantially equivalent to the predicate device.