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.

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.

AI/ML Overview

The provided text describes modifications to a medical device (LiteAire Dual-Valved, Collapsible MDI Holding Chamber) and evaluates its substantial equivalence to a predicate device. The information presented focuses on non-clinical performance testing rather than a clinical study involving human readers or AI.

Here's an analysis of the provided text in the context of your questions:

1. A table of acceptance criteria and the reported device performance.

The document discusses performance in the context of non-clinical testing, specifically regarding the aerosolization efficiency of the device with different MDI products. The "acceptance criteria" are implied by the comparison to the predicate and the general expectation for an MDI holding chamber to deliver appropriate doses. The "reported device performance" is given in tables for Total Delivered Dose, Coarse Particle Dose, Fine Particle Dose, MMAD, and GSD.

Acceptance Criteria (Implied / Functional Requirements):

Aerosol Delivery Performance: The ability to effectively deliver the prescribed dose from an MDI, with appropriate particle size distribution, comparable to or better than predicate devices. This is assessed via "Total Emitted Dose, Course Particle Dose or Fine Particle Dose."
Mechanical Integrity: Maintain structural integrity and functionality (pop-ability, collapsibility, valve resistance) over expected shelf-life and under environmental stresses.
Biocompatibility: No adverse biological reactions when in contact with lung tissue, skin, and mucosal membranes.
Anti-static Properties: Exhibit anti-static properties to minimize drug adherence to the chamber walls.

Reported Device Performance:

The document provides specific data in Tables 2 and 3 for the subject device (K160109) with three different MDI products (Proventil HFA, Atrovent HFA, QVAR 80 mcg) at adult (28 L/min) and pediatric (12 L/min) flow rates. The values reported are 95% confidence intervals.

Table 1: Device Performance (Excerpts from Tables 2 & 3 Combined)

Performance Metric	MDI Product Tested (Example Range)	Flow Rate
Total Delivered Dose (µg/actuation)	39.77 – 77.62	Adult/Pediatric
Coarse Particle Dose (>4.7 µm) (µg/actuation)	0 – 3.42	Adult/Pediatric
Fine Particle Dose (<4.7 µm) (µg/actuation)	39.81 – 75.34	Adult/Pediatric
MMAD (µm)	0.48 – 2.44	Adult/Pediatric
GSD (µm)	0 – 6.08	Adult/Pediatric

Note: The specific ranges reflect the minimum and maximum observed across all MDI products and flow rates for each metric in the tables.

Additional Performance Points:

Shelf-life testing: "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 (Temperature and Humidity): "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: "The LiteAire has a surface resistivity of 1.0 x 10^10 Ω/sq (at 23°C/ 50% RH). This meets the requirement for being 'dissipative' or 'anti-static'."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective).

Sample Size: For Particle Characterization testing (Tables 2 & 3), the sample size was:
- 3 LiteAire devices / 3 ACI replicates each = 9 ACI runs/drug for each MDI product (Proventil HFA, Atrovent HFA, QVAR 80 mcg) and each flow rate (Adult 28 L/min, Pediatric 12 L/min).
Data Provenance: The document does not specify the country of origin for the data. The data appears to be prospective wet-lab testing conducted for the purpose of the 510(k) submission, not data collected from a clinical patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience).

This question is not applicable to the provided document. The "ground truth" for this device's performance is established through physical and chemical measurements (e.g., cascade impaction for particle size, resistance measurements for valves, surface resistivity) and biocompatibility testing, not through expert human interpretation of medical images or patient outcomes. Therefore, no experts in the sense of medical diagnosticians were used to establish "ground truth" for this type of performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set.

This question is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments to resolve discrepancies. The performance tests described here are objective, quantifiable measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.

This question is not applicable. The study described is a non-clinical performance evaluation of a mechanical medical device (MDI holding chamber), not a study involving AI assistance to human readers for diagnostic interpretation.

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

This question is not applicable. There is no algorithm or AI involved in the performance evaluation described. The device is a physical, non-electronic medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).

The "ground truth" for this device performance evaluation is based on objective physical and chemical measurements performed in a laboratory setting, in accordance with recognized standards (e.g., ISO 10993 for biocompatibility, ASTM-D-257 for anti-static properties, and implicit standards for aerosol characterization via cascade impaction). This is not a clinical ground truth derived from patient outcomes, pathology, or expert consensus. It's a "ground truth" of the device's functional characteristics.

8. The sample size for the training set.

This question is not applicable. This is a performance study of a physical device, not an AI model. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established.

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

Summary

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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

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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

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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.

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.

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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 Corporation4575 South Palo Verde Road, Suite 337Tucson, Arizona 85714Telephone (520) 790-5393Facsimile (520) 790-5854
Official Contact	Jennifer Johnson, PhDDirector of Research and DevelopmentThayer Medical Corporation
Proprietary or Trade Name	Thayer Medical LiteAire Dual-valved, Collapsible MDI HoldingChamber
Common/Usual Name	Holding chamber
Classification Name	Holding Chambers, Direct Patient InterfaceNVP - CFR 868.5630Class II
Predicate Device(s)	K993101 - Thayer Medical LiteAire®

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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

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.

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.

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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 DeviceLiteAire®K993101	ChangeFromPredicatetoSubject(Yes or No)	Subject DeviceLiteAire®K160109
RegulationNo.	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 independentuse by a single patient; each LiteAireshould be usable for multiple doses ifproperly cared for.It provides a combination of a holdingchamber with two valves designed to helpachieve more reproducible dosing, byreducing throat deposition of the MDI drugand by assisting the patient in overcomingany hand-breath coordination difficulties.The LiteAire is for use on the order of aphysician or other practitioner approved bylaw.	No2	The LiteAire is intended for independentuse by a single patient; each LiteAireshould be usable for multiple doses ifproperly cared for.It is a holding chamber with two valveswhich is designed to help: achieveconsistent dosing, reduce MDI drugdeposition in the throat and assist thepatient in overcoming any hand-breathcoordination difficulties.The LiteAire is for use on the order of aphysician or other practitioner approved bylaw.
Indicationsfor Use	The LiteAire is a collapsible, disposableaccessory device for use with a metereddose inhaler (MDI) canister andnozzle/mouthpiece provided by the MDIdrug manufacturer.It is designed to be used with virtually allMDI nozzles/mouthpieces. The LiteAire is anon-sterile device for single-patient use.The patient population comprises all usersof MDIs who are capable of actuating theMDI canister and inhaling through amouthpiece.	No2	The LiteAire is a collapsible, disposabledual-valved holding chamber designed toaid in the delivery of aerosolizedmedications delivered via a pressurizedmetered dose inhaler (MDI).The LiteAire features a standard portdesigned for compatibility with standardMDI mouthpieces. It is a non-sterile devicefor single-patient use.The LiteAire is intended to be used byadults, adolescents and children ages 5 andup who are able to use a holding chamberwithout the aid of a mask and who areunder the care or treatment of a physicianor licensed healthcare professional.
Environmentsfor Use	The environment of use is ordinary roomtemperature, ambient pressure andhumidity, in clinical or non-clinical settings.	No2	The intended environments of use includethe 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 DeviceLiteAire®K993101	ChangeFromPredicatetoSubject(Yes or No)	Subject DeviceLiteAire®K160109
Prescriptive	Yes	No	Yes
PatientPopulation	The target patient population comprises allusers of MDIs who are capable of actuatingthe MDI canister and inhaling through amouthpiece.	No	The LiteAire is intended to be used byadults, adolescents and children ages 5 andup who are able to use a holding chamberwithout the aid of a mask and who areunder the care or treatment of a physicianor licensed healthcare professional.
Single-patient,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
DeviceAssembly forUse	Fold-up	Yes	Pop-up
ChamberVolume	165 mL	Yes	184 mL
Anti-staticproperties	Not stated	Yes	Anti-Static
Shelf-life	Not stated	Yes	5 years
Table 1. Comparisons between the Predicate and Subject Devices. The center column indicateswhether that attribute for the Subject Device has changed from the Predicate Device.
Attribute	Predicate Device	ChangeFromPredicatetoSubject(Yes or No)	Subject Device
	LiteAire®K993101		LiteAire®K160109
HousingConfiguration	Collapsible	No	Collapsible
Patientinterface	Mouthpiece	No	Mouthpiece
Sterility	Non-sterile	No	Non-sterile

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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.

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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

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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)

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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.

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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(N=9)	Atrovent HFA(N=9)	QVAR 80 mcg(N=9)
Total Delivered Dose byDevice ( $\mu$ g/actuation)	53.87 – 77.62	6.15 – 10.02	65.74 – 76.01
Coarse Particle Dose(>4.7 $\mu$ m),( $\mu$ g/actuation)	0 – 2.81	0–0	0.69 – 1.82
Fine Particle Dose(<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

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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(N=9 ACI runs/drug) at Pediatric (12 L/min) flow rate
	MDI Product Tested(Number of Replicate ACI Runs)
	Proventil HFA(N=9)	Atrovent HFA(N=9)	QVAR 80 mcg(N=9)
Total Delivered Dose byDevice (µg/actuation)	39.77 - 66.53	5.96 - 10.03	59.89 - 74.16
Coarse Particle Dose(>4.7 µm), (µg/actuation)	0 - 2.28	0-0	0 - 3.42
Fine Particle Dose(<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.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).