The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

Device Description

The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.

AI/ML Overview

The document provided outlines the K170886 510(k) premarket notification for the HOMED Mesh Nebulizer, comparing it to a predicate device, the Omron NE-U22 (K062263). The study described focuses on demonstrating substantial equivalence, primarily through non-clinical performance testing related to aerosol particle characterization, rather than human-in-the-loop clinical studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HOMED Mesh Nebulizer are primarily established through comparative testing against a predicate device (Omron NE-U22). The goal is to demonstrate "substantial equivalence" in terms of performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implied by Predicate Performance)	HOMED Mesh Nebulizer Performance
Particle Size (MMAD)	Similar to Predicate (Omron NE-U22) Ranges
Ventolin	2.850-3.148 µm (Adult Flow)	2.792-2.922 µm (Adult Flow)
	2.996-3.575 µm (Pediatric Flow)	3.177-3.388 µm (Pediatric Flow)
Budesonide	2.686-2.761 µm (Adult Flow)	2.532-2.577 µm (Adult Flow)
	2.778-2.997 µm (Pediatric Flow)	2.739-2.850 µm (Pediatric Flow)
Atrovent	2.761-3.103 µm (Adult Flow)	2.412-2.552 µm (Adult Flow)
	2.782-3.077 µm (Pediatric Flow)	2.805-2.920 µm (Pediatric Flow)
Geometric Std. Dev. (GSD)	Similar to Predicate Ranges
Ventolin	2.814-3.011 (Adult Flow)	2.818-2.866 (Adult Flow)
	2.533-2.736 (Pediatric Flow)	2.450-2.767 (Pediatric Flow)
Budesonide	3.112-3.221 (Adult Flow)	3.115-3.165 (Adult Flow)
	2.813-2.964 (Pediatric Flow)	2.933-3.011 (Pediatric Flow)
Atrovent	2.824-3.070 (Adult Flow)	2.746-2.845 (Adult Flow)
	2.778-3.019 (Pediatric Flow)	2.580-2.746 (Pediatric Flow)
Total Respirable Dose (0.5-5 µm) / %	Similar to Predicate Ranges
Ventolin	62.1-64.9% (Adult Flow)	64.8-67.2% (Adult Flow)
	55.7-64.5% (Pediatric Flow)	55.5-62.6% (Pediatric Flow)
Budesonide	63.4-65.4% (Adult Flow)	64.0-65.7% (Adult Flow)
	60.1-63.3% (Pediatric Flow)	61.3-63.2% (Pediatric Flow)
Atrovent	61.3-67.0% (Adult Flow)	67.3-69.1% (Adult Flow)
	54.1-73.6% (Pediatric Flow)	65.3-69.8% (Pediatric Flow)
Coarse Particle Dose (>4.7 µm) / %	Similar to Predicate Ranges
Ventolin	33.1-37.2% (Adult Flow)	30.4-32.2% (Adult Flow)
	33.9-43.7% (Pediatric Flow)	37.2-39.3% (Pediatric Flow)
Budesonide	28.2-31.0% (Adult Flow)	26.8-29.7% (Adult Flow)
	28.8-39.0% (Pediatric Flow)	30.7-32.1% (Pediatric Flow)
Atrovent	12.6-38.6% (Adult Flow)	23.1-25.9% (Adult Flow)
	6.0-57.6% (Pediatric Flow)	26.6-30.5% (Pediatric Flow)
Fine Particle Dose (<4.7 µm) / %	Similar to Predicate Ranges
Ventolin	62.6-66.4% (Adult Flow)	68.0-69.6% (Adult Flow)
	56.3-66.1% (Pediatric Flow)	60.6-62.8% (Pediatric Flow)
Budesonide	69.0-87.5% (Adult Flow)	70.3-73.2% (Adult Flow)
	61.0-71.1% (Pediatric Flow)	67.9-69.3% (Pediatric Flow)
Atrovent	61.6-76.3% (Adult Flow)	74.0-76.9% (Adult Flow)
	42.4-93.5% (Pediatric Flow)	69.5-73.4% (Pediatric Flow)
Ultra-fine Particle Dose (< 1.0 µm) / %	Similar to Predicate Ranges
Ventolin	3.4-5.0% (Adult Flow)	5.0-5.4% (Adult Flow)
	2.1-3.0% (Pediatric Flow)	2.2-2.6% (Pediatric Flow)
Budesonide	7.8% (Adult Flow)	8.9-9.2% (Adult Flow)
	6.7-7.4% (Pediatric Flow)	7.8-8.7% (Pediatric Flow)
Atrovent	6.8-8.4% (Adult Flow)	9.2-10.6% (Adult Flow)
	4.0-6.5% (Pediatric Flow)	5.1-6.9% (Pediatric Flow)
Total Delivered Dose (µg) / %	Similar to Predicate Ranges
Ventolin	21.3-23.6% (Adult Flow)	22.1-22.8% (Adult Flow)
	20.8-22.1% (Pediatric Flow)	21.1-21.9% (Pediatric Flow)
Budesonide	17.5-19.6% (Adult Flow)	18.0-18.6% (Adult Flow)
	15.9-16.8% (Pediatric Flow)	16.1-16.8% (Pediatric Flow)
Atrovent	17.6-19.1% (Adult Flow)	18.0-18.5% (Adult Flow)
	15.0-17.6% (Pediatric Flow)	16.0-16.7% (Pediatric Flow)
Shelf-life, Useful-life, Simulated Life Cycle	Demonstrated by testing	Met specification criteria of 90 days for Medicine Cup
Cleaning	Demonstrated by testing	Performed after each use via rinsing and boiling
Electrical Safety, EMC	Meets IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2012	Device met these requirements
Biocompatibility	Meets ISO 10993-1 tests	Concluded as biocompatible with no new issues
Software Level of Concern	Moderate	Moderate

The acceptance criteria for the nebulizer's performance are primarily based on demonstrating comparable performance to the predicate device across various aerosol characteristics (MMAD, GSD, different particle doses, total delivered dose) for different medications and flow rates. This is explicitly stated in "Summary of Non-Clinical Performance Testing" and demonstrated by Tables 3 and 4 where the proposed device's performance values consistently fall within or are very similar to the ranges reported for the predicate device, or are directly compared to show "very similar" results.

Study Details:

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

Sample Size: The document does not specify exact sample sizes for the particle characterization tests (e.g., how many nebulizer units were tested, or how many runs were performed for each medication/flow rate). It presents 95% confidence intervals for the results, implying repeat measurements were taken.
Data Provenance: The data appears to be from non-clinical laboratory testing ("We performed a number of non-clinical tests") conducted by the manufacturer, Shenzhen Homed Medical Device Co,.Ltd., presumably in China (the manufacturer's location is in Shenzhen, PRC). The data is prospective as it's generated specifically for this premarket submission to demonstrate equivalence.

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

This information is not applicable in this context. The "ground truth" for nebulizer performance in this 510(k) submission is established by objective physical measurements using standardized cascade impaction techniques and comparison to the predicate device's measured performance. There are no human experts "establishing ground truth" in the way a radiologist might for an AI image analysis system.

4. Adjudication Method for the Test Set:

This is not applicable. As the "ground truth" is based on objective physical measurements, there is no need for expert adjudication.

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

No, an MRMC study was NOT done. This submission is for a medical device (nebulizer) that delivers medication, not an AI or imaging diagnostic device that involves human interpretation of cases. The study focuses on the physical performance characteristics of the nebulizer, not on improving human reader performance.

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

This question is partially applicable given the software component ("Software driven - Yes - firmware"). The software verification and validation testing ("Software Verification and Validation Testing") was conducted. The specific performance of the software (firmware) is related to its control of the vibrating mesh module (e.g., maintaining 117 kHz frequency, nebulization rate, power consumption) and LED indicators. While an explicit "standalone performance study" in the context of diagnostic accuracy isn't mentioned, the software V&V and the overall device performance (particle characterization) inherently demonstrate the algorithm's correct function in controlling the nebulization process. The "Level of Concern" for the software is "moderate," indicating that software failure could lead to a delay in appropriate medical care.

7. The Type of Ground Truth Used:

The ground truth for the device's technical performance (e.g., particle size, delivered dose) is based on objective, standardized laboratory measurements using a cascade impactor, following established protocols (e.g., "Particle Characterization per Cascade Impactor").
For other aspects like electrical safety and biocompatibility, the ground truth is established by compliance with recognized consensus standards (e.g., IEC 60601-1, ISO 10993-1).

8. The Sample Size for the Training Set:

This is not applicable. This document describes a 510(k) submission for a physical medical device (nebulizer), not an AI/Machine Learning model that requires a "training set" in the conventional sense. The "firmware" is mentioned, implying some level of software control, but it's not an adaptive learning algorithm.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as point 8. There is no training set for an AI model. For the device's development and manufacturing, the "ground truth" for its design and desired performance would have been established through engineering specifications, previous research, and predicate device analysis.

Summary

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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, with the letters "FDA" in a blue box. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2018

Shenzhen Homed Medical Device Co,.Ltd. Shengming Shi Manager of Technical Regulation Department 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road Tongsheng Community, Dalang Street, Longhua New District Shenzhen, 518109 Cn

Re: K170886

Trade/Device Name: HOMED Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 22, 2018 Received: May 23, 2018

Dear Shengming Shi:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 medical devices and radiation-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.

Amy K. Levelle -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)

K170886

Device Name

HOMED Mesh Nebulizer (Model JLN-MBXXX; XXX: 001~005)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K170886

Shenzhen Homed Medical Device Co., Ltd 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road, Tongsheng Community Dalang Street, Longhua New District Shenzhen 518 10 9, PRC

Official Contact:	Shengming ShiManager of Technical Regulation DepartmentTel – 011 0755-29821675
Proprietary or Trade Name:	HOMED Mesh Nebulizer
Common/Usual Name:	Nebulizer (Direct Patient Interface)
Classification Name:	Nebulizer (Direct Patient Interface)Product Classification - CAF21 CFR 868.5630Class II
Predicate Devices:	K062263 – Omron NE-U22

Device Description:

The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.

Components

The Medicine Cup contains the nebulizing module where aerosol will be generated. Prescribed medication is placed in the Cup, nebulized and inhaled via the integral mouthpiece.

The Medicine Cup is single patient, multi-use. Cleaning is performed after each use by rinsing with distilled water and disinfected via immersion in boiled water for 10 minutes. The performance met its specification criteria of 90 days.

The cup medication capacity is 6 ml.

The Main Unit contains the 2 "AA" batteries or AC Adaptor and firmware to control the vibrating mesh module in the Medicine Cup.

The HOMED Mesh Nebulizer aerosolizes upon turning on by pressing the ON/OFF button and turns off by pressing again or automatically after treatment completion in 30 minutes. To monitor nebulization status and device operating condition, there are different LED colors shown. Normal working condition is indicated by a green while an orange color signifies a malfunction.

There is one model of the subject device, the housing may be offered in various colors, but the unit is fundamentally identical.

Indications for Use:

The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for

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510(k) Summary Page 2 of 7 June 21, 2018

Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

Principle of Operation / Technology

The HOMED Mesh Nebulizer operates by electrically activating piezoelectric ceramic actuator (PZT) which then transduces the vibration generated to the adjacent supporting plate and polymer mesh bearing numerous apertures. The vibration actively pushes out the liquid medication by physically breaking surface tension of the solution through mesh holes thereby achieving final nebulization. Aerosol generation can subsequently be modulated the vibration frequency that is controlled by the firmware stored within Main Unit to maintain a frequency of approximate 117 kHz, nebulization rate of > 0.25 ml/min and a power consumption of <1.5 W.

Features	Mesh Nebulizer
Indications for use	The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings
Environment of Use	liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and
Patient Population	older in the home, hospital, and sub-acute care settings
Vibrating mesh technology	Yes
Software driven	Yes - firmware
Patient Interface	Mouthpiece
Nebulizer components cleanable	Medicine Cup and Mouthpiece
Operating conditions	10°C to 40°C 30% to 75% RH
Storage conditions	-20°C to 70°C, 20% to 80% RH
Power Sources	2- “AA” Alkaline batteries – 3 VAC Adapter - 100-240 V, 50/60HzOutput 1.5 V, 1 A
Dimensions	77 mm (L) x 74 mm (W) x 48 mm (H)
Weigh	80 gr without batteries
MMAD	< 5 microns
Nebulization rate	≥ 0.25 ml / min
Medication capacity	6 ml

Table 1 - Performance Specifications

Comparison to Predicate

Tables 2 provides a comparison of the proposed device to the predicate.

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510(k) Summary

Page 3 of 7
June 21, 2018

Table 2 – Comparison of Proposed vs. Predicate Device
Features	PredicateOmron NE-U22K062263	ProposedPortable Nebulizer
Indications for use	The Omron NE-U22 is an ultrasonic(vibrating mesh) nebulizer system designedto aerosolize liquid medications forinhalation by the patient.	The HOMED Mesh Nebulizer is anultrasonic vibrating mesh nebulizer systemdesigned to aerosolize physician-prescribed liquid medications forinhalation to a patient except forPentamidine. The device may be used withpatients 5 years and older in the home,hospital, and sub-acute care settings.
Patient Population	The device may be used with pediatric andadult patients

Environment of Use	home, hospital, and sub-acute care settings
Contraindications	It is not intended for use withPentamidine.	It is not intended for use with Pentamidine.
Principle of Operation	Vibrating mesh	Vibrating mesh
Aerosolization	Continuous during inhalation andexhalation	Continuous during inhalation andexhalation
Compressed gas source	None needed	None needed
Reservoir volume	7 ml	6 ml
Nebulization rate	0.25 ml/min to 0.9 ml/min	> 0.25 ml/min
Duration of Use	Single patient, multi-use	Single patient, multi-use
Nebulizer componentscleanable	Yes	Yes
Software driven	No	Yes
Power source	2 - “AA” Battery	2 - “AA” batteryAC Adaptor
Power consumption	1.5 W	< 1.5 W
Weight	97 gm w/o batteries	80 gm w/o batteries
Dimensions (mm)	51 x 38 x 104	77 x 74 x 48
Operating Conditions	0 to 45°C / 30-85% RH	10 to 40°C / 30-75% RH
Storage Conditions	-25 to + 70°C / 10-90% RH	-20 to + 70°C / 20-70% RH
User interface	On/Off switchLED indicators	On/Off switchLED indicators
Standards met	ES60601-1IEC 60601-1-2	ES60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11
	Performance
Materials per ISO10993-1	External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicatingDuration of Use – permanent (> 30 days)AndSurface ContactMucosal membraneDuration of Use – permanent (> 30 days)	External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicatingDuration of Use – permanent (> 30 days)AndSurface ContactMucosal membraneDuration of Use – permanent (> 30 days)
MMAD	MMAD, GSD, Total Respirable Dose, and Total Dose were substantially equivalent tothe predicate.
GSD
Total Respirable Dose
Total Dose
Features	PredicateOmron NE-U22K062263	ProposedPortable Nebulizer
Software
Level of Concern	Moderate	Moderate
Device Specific	Yes	Yes
Dependent on externaldevices	No	No
Signals	LED and tone sounds	LED and tone sounds

Table 2 – Comparison of Proposed vs. Predicate Device

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510(k) Summary Page 4 of 7 June 21, 2018

Substantial Equivalence Discussion

The HOMED Mesh Nebulizer is viewed as substantially equivalent to the predicate device because:

Indications for Use - The proposed indications for use are to aerosolize commonly prescribed medications.

Discussion - The indications for use are identical for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Patient Population – The patient population of adult and pediatric (defined by the prescribed medication) patients that is consistent with the indications for the aerosol medication. This is similar to the predicate - K062263 - Omron NE-U22 nebulizer.

Discussion - The patient population is similar for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Environment of Use – The proposed environments of use are common and usual for handheld nebulizers, namely Hospital/institutional settings, home care use, schools and long term care facilities.

Discussion - The environment of use is similar for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Technology - The design as a vibrating mesh nebulizer which is the similar principle of operation.

Discussion - The technology is similar for the proposed device as compared to the predicate -K062263 – Omron NE-U22 nebulizer.

Summary of Non-Clinical Performance Testing

We performed a number of non-clinical tests to demonstrate that the HOMED Mesh Nebulizer is equivalent to the predicate K062263 - Omron NE-U22 nebulizer.

Shelf-life, Useful-life, Simulated Life Cycle testing ●
Cleaning ●
Electrical Safety, EMC, EMC ●
Particle Characterization per Cascade Impactor

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. Testing established that, with respect to electrical safety, the device meets the applicable requirements of: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2014; (3) IEC 60601-1-11:2012.

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510(k) Summary Page 5 of 7 June 21, 2018

Software Verification and Validation Testing

Verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA's Guidance 337, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is of a "moderate" level of concern, since a failure or latent flaw in the software could lead to a delay in delivery of appropriate medical care.

Biocompatibility

The materials in patient / drug contact are characterized as:

. External Communicating (Indirect gas pathway)
Tissue / Bone / Dentin communicating ●
. Duration of Use – permanent (> 30 days)

And

Surface Contact ●
Mucosal membrane ●
Duration of Use permanent (> 30 days) .

Discussion - We performed ISO 10993-1 tests to support biocompatibility. They included:

Cytotoxicity ●
Sensitization ●
Intracutaneous Reactivity ●
Irritation
Sub-chronic Systemic toxicity
Acute Systemic Toxicity
Pyrogen
Genotoxicity
Implantation
Gas Emission VOC plus Inorganic compounds CO. CO2, and Ozone ●
. PM25

Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.

Particle Characterization

Comparative aerosol characterization (particle size distribution) performed between the subject and predicate device. The following tables summarize the results, in all the results very similar compared to that of the predicate.

Features	Predicate	Proposed
	Omron NE-22 K062263	Mesh Nebulizer
Particle Characterization per Cascade Impactor @ 28 lpm - Adult Flow
Particle size (MMAD)
Ventolin	2.850-3.148	2.792-2.922
Budesonide	2.686-2.761	2.532-2.577
Atrovent	2.761-3.103	2.412-2.552
Geometric Std. Dev. (GSD)
Ventolin	2.814-3.011	2.818-2.866
Budesonide	3.112-3.221	3.115-3.165
Atrovent	2.824-3.070	2.746-2.845

Table 3 - Comparative Aerosol Performance - Adult Flow Rate - 28 Ipm

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510(k) Summary
Page 6 of 7
June 21, 2018
Total Respirable Dose (0.5-5 $\mu$ ) / %
Ventolin	62.1-64.9%	64.8-67.2%
Budesonide	63.4-65.4%	64.0-65.7%
Atrovent	61.3-67.0%	67.3-69.1%
Coarse Particle Dose (>4.7 $\mu$ ) / %
Ventolin	33.1-37.2%	30.4-32.2%
Budesonide	28.2-31.0%	26.8-29.7%
Atrovent	12.6-38.6%	23.1-25.9%
Fine Particle Dose (<4.7 $\mu$ ) / %
Ventolin	62.6-66.4%	68.0-69.6%
Budesonide	69.0-87.5%	70.3-73.2%
Atrovent	61.6-76.3%	74.0-76.9%
Ultra-fine Particle Dose (< 1.0 $\mu$ ) /
%Ventolin	3.4-5.0%	5.0-5.4%
Budesonide	7.8%	8.9-9.2%
Atrovent	6.8-8.4%	9.2-10.6%
Total Delivered Dose ( $\mu$ g) / %
Ventolin	21.3-23.6%	22.1-22.8%
Budesonide	17.5-19.6%	18.0-18.6%
Atrovent	17.6-19.1%	18.0-18.5%
95% confidence intervals

Table 4 – Comparative Aerosol Performance – Pediatric Flow Rate – 12 Ipm

Features	Predicate	Proposed
	Omron NE-22 K062263	Mesh Nebulizer
Particle Characterization per Cascade Impactor @ 12 lpm – Pediatric Flow
Particle size (MMAD)
Ventolin	2.996-3.575	3.177-3.388
Budesonide	2.778-2.997	2.739-2.850
Atrovent	2.782-3.077	2.805-2.920
Geometric Std. Dev. (GSD)
Ventolin	2.533-2.736	2.450-2.767
Budesonide	2.813-2.964	2.933-3.011
Atrovent	2.778-3.019	2.580-2.746
Total Respirable Dose (0.5-5 $\mu$ ) / %
Ventolin	55.7-64.5%	55.5-62.6%
Budesonide	60.1-63.3%	61.3-63.2%
Atrovent	54.1-73.6%	65.3-69.8%
Coarse Particle Dose (>4.7 $\mu$ ) / %
Ventolin	33.9-43.7%	37.2-39.3%
Budesonide	28.8-39.0%	30.7-32.1%
Atrovent	6.0-57.6%	26.6-30.5%
Fine Particle Dose (<4.7 $\mu$ ) / %
Ventolin	56.3-66.1%	60.6-62.8%
Budesonide	61.0-71.1%	67.9-69.3%
Atrovent	42.4-93.5%	69.5-73.4%
Ultra-fine Particle Dose (< 1.0 $\mu$ ) //
%Ventolin	2.1-3.0%	2.2-2.6%
Budesonide	6.7-7.4%	7.8-8.7%
Atrovent	4.0-6.5%	5.1-6.9%
Total Delivered Dose ( $\mu$ g) / %
Ventolin	20.8-22.1%	21.1-21.9%
Budesonide	15.9-16.8%	16.1-16.8%
Atrovent	15.0-17.6%	16.0-16.7%
95% confidence intervals

{9}------------------------------------------------

510(k) Summary Page 7 of 7 June 21, 2018

Particle size characterization (MMAD) was verified after two years of real-time aging using both cascade impactor technique.

Substantial Equivalence Conclusion

As detailed, the indications for use, patient population, environment of use, technology or principle of operation and performance are substantially equivalent.

The differences between the proposed HOMED Mesh Nebulizer and the predicate - K062263 -Omron Model NE-U22 based upon the comparative performance testing we can conclude that the proposed device can be determined to be substantially equivalent to the predicate.

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).