The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing.

The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.

Device Description

The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber.

Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.

AI/ML Overview

This document is a 510(k) clearance letter for the AdheResp Smart Breath-actuated Mesh Nebulizer. It outlines the device's characteristics and its equivalence to predicate devices, particularly focusing on performance data related to aerosol delivery.

Here’s the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided text is a 510(k) summary and clearance letter. It summarizes findings and states that acceptance criteria were met, but it does not provide the detailed study protocols, raw data, or the explicit acceptance criteria values themselves in a direct, quantifiable manner for all aspects. Instead, it presents comparative performance data and lists categories of testing. Therefore, some information will be inferred from the context or noted as 'not explicitly stated' if the document does not provide it.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each parameter in a "limit" vs. "result" format. Instead, it presents comparative performance data against a predicate device and states that the subject device "met its acceptance criteria" and that its performance is "similar." For the purpose of this table, I will present the reported performance of the Subject Device and mention the comparison to the Predicate. The implicit acceptance criterion for the comparative performance data is that the subject device's performance is demonstrably non-inferior or similar to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (Subject Device)
Particle Size (MMAD): Similar to predicate device	15 LPM: Albuterol 3.98 ±0.18 µm, Ipratropium 3.984 ±0.11 µm, USP Cromolyn 4.07 ±0.14 µm (Predicate generally higher MMAD)
	30 LPM: Albuterol 3.48 ±0.15 µm, Ipratropium 3.39 ±0.21 µm, USP Cromolyn 3.58 ±0.15 µm (Predicate generally higher MMAD)
Geometric Standard Deviation (GSD): Similar to predicate	15 LPM: Albuterol 1.82 ±0.03, Ipratropium 1.94 ±0.10, USP Cromolyn 1.88 ±0.02 (Predicate generally higher GSD)
	30 LPM: Albuterol 1.89 ±0.09, Ipratropium 1.98 ±0.16, USP Cromolyn 1.90 ±0.07 (Predicate generally higher GSD)
Total Delivered Dose (mg): Similar to predicate	15 LPM: Albuterol 4.25 ±0.36, Ipratropium 0.45 ±0.07, USP Cromolyn 16.23 ±1.35 (Subject generally slightly higher or similar to Predicate)
	30 LPM: Albuterol 3.83 ±0.29, Ipratropium 0.40 ±0.04, USP Cromolyn 14.65 ±1.09 (Subject generally slightly higher or similar to Predicate)
Respirable Dose <5µm [mg]: Similar to predicate	15 LPM: Albuterol 2.71 ±0.32, Ipratropium 0.28 ±0.03, USP Cromolyn 10 ±0.85 (Subject generally higher than Predicate)
	30 LPM: Albuterol 2.67 ±0.21, Ipratropium 0.27 ±0.03, USP Cromolyn 9.95 ±0.71 (Subject generally higher than Predicate)
Coarse Particle Dose <4.7µm [mg]: Similar to predicate	15 LPM: Albuterol 1.47 ±0.10, Ipratropium 0.15 ±0.02, USP Cromolyn 5.85 ±0.65 (Subject generally lower or similar to Predicate)
	30 LPM: Albuterol 1.05 ±0.28, Ipratropium 0.11 ±0.01, USP Cromolyn 4.55 ±0.72 (Subject generally lower or similar to Predicate)
Fine Particle Dose <4.7µm [mg]: Similar to predicate	15 LPM: Albuterol 2.56 ±0.30, Ipratropium 0.27 ±0.03, USP Cromolyn 9.41 ±0.65 (Subject generally higher than Predicate)
	30 LPM: Albuterol 2.54 ±0.21, Ipratropium 0.26 ±0.03, USP Cromolyn 9.46 ±0.48 (Subject generally higher than Predicate)
Ultra-Fine Particle Dose <1µm [mg]: Similar to predicate	15 LPM: Albuterol LOD, Ipratropium 0.01 ±0.00, USP Cromolyn LOD (Similar to Predicate)
	30 LPM: Albuterol 0.21 ±0.06, Ipratropium 0.02 ±0.01, USP Cromolyn 0.58 ±0.05 (Similar to Predicate)
Nebulization Rate: Must meet specified rate	>0.25 ml/min (Similar to predicate)
Inter- and Intra-sample Variability: Must meet criteria	Met acceptance criteria (no specific values given)
Minimum Breath Actuation Tests: Must meet criteria	Met acceptance criteria (no specific values given)
Biocompatibility (ISO 10993 & ISO 18562): Must pass tests	Applicable ISO 10993 and ISO 18652 testing was performed and passed.
Reprocessing, Sterility, and Shelf-Life: Must pass tests	Cleaning Validation, Aging, Simulated Life (cleaning, aging, drop) were performed and passed. (implicitly met acceptance criteria related to these tests)

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

Sample Size for Test Set:
- For the comparative performance testing (Breath Actuated Particle Characterization): "Testing was performed with 3 samples of each device in triplicate with the 3 drugs." This implies $3 \text{ devices} \times 3 \text{ replicates} = 9$ runs per drug per flow rate for both the subject and predicate devices.
Data Provenance: Not explicitly stated (e.g., country of origin). The study is non-clinical bench testing ("Bench testing," "Non-Clinical Testing Summary"), meaning it's a controlled lab environment, not patient data. It is a prospective study in the sense that the tests were conducted specifically for this submission.

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

Number of Experts: Not applicable. This device is a nebulizer, and the tests described are bench tests (e.g., particle size, dosage, flow rates). These are physical measurements, not interpretations of medical images or patient conditions that would require expert human readers to establish ground truth.
Qualifications of Experts: N/A, as noted above.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is not a study involving human interpretation of data, where adjudication of disagreements would be necessary. The performance data is derived from direct and repeatable physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. An MRMC study is typically performed for AI/CADe (Computer-Assisted Detection/Diagnosis) devices that assist human readers in interpreting medical images. This device is a nebulizer, a drug delivery system, and its performance is evaluated through bench testing.
Effect Size of Human Readers' Improvement: Not applicable, as no MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, in essence. The "AdheResp Smart Breath-actuated Mesh Nebulizer" itself has an algorithm for "Breath Actuation" that "Measures breath and averages the cycle, then delivers aerosol during the designated period." The "Breathe Actuated Particle Characterization Performance Comparison" is a standalone evaluation of the device's physical output based on this internal algorithm responding to simulated breathing patterns (15 LPM and 30 LPM). There is no "human-in-the-loop" for the output of the device itself.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's performance is established by standardized laboratory measurements using traceable equipment and protocols (e.g., measuring particle size, drug quantity, flow rates) under controlled conditions. This is considered an objective physical truth, not a subjective interpretation. The comparison is made against a legally marketed predicate device's performance.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physical medical device (nebulizer) with an embedded algorithm, not a machine learning/AI model that requires a "training set" of data in the typical sense for image recognition or diagnostic purposes. The device's "algorithm" is for controlling the nebulization based on breath patterns, which would be developed through engineering and control system design, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of a machine learning model. The "ground truth" for the device's operational parameters (like breath-actuation logic or aerosol delivery range) would be based on established engineering principles, physiological understanding of human breathing, and clinical requirements for drug delivery, validated through rigorous bench testing and potentially human factors testing, though the latter is not detailed in this summary.

Summary

FDA 510(k) Clearance Letter - AdheResp Smart Breath-actuated Mesh Nebulizer

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 20, 2025

HCmed Innovations Co., Ltd.
℅ Paul Dryden
Consultant
ProMedic Consulting LLC
131 Bay Point Drive NE
Saint Petersburg, Florida 33704

Re: K250583
Trade/Device Name: AdheResp Smart Breath-actuated Mesh Nebulizer
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: May 19, 2025
Received: May 19, 2025

Dear Paul Dryden:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250583 - Paul Dryden Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K250583 - Paul Dryden Page 3

Sincerely,

John S. Bender -S
2025.06.20 10:11:59 -04'00'

for Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250583

Device Name
AdheResp Smart Breath-actuated Mesh Nebulizer

Indications for Use (Describe)

The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K250583 510(k) Summary

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Date Prepared: 13-Jun-25

Sponsor: HCmed Innovations Co., Ltd.
Rm.B, 10F., No.319, Sec.2, Dunhua S. Rd.
TEL: +886-02-2732-6596

Sponsor Contact: Michelle Pieh
michelle@hcmed-inno.com

Submission Correspondent: Paul Dryden
ProMedic, LLC

Proprietary or Trade Name: AdheResp Smart Breath-actuated Mesh Nebulizer

Classification Name: Nebulizer

Product Code: CAF

Predicate Device: Pulmogine® Vibrating Mesh Nebulizer – K202171

Classification Name: Nebulizer

Product Code: CAF

Reference Device: Respironics AAD – K042991

Classification Name: Nebulizer

Product Code: CAF

Device Description: The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber.

Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.

Indications for Use: The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for

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K250583 510(k) Summary

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patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.

Patient Population: Pediatrics equal to or greater than 5 years old to Adults who can coordinate breathing.

Environments of use: Hospital/institutional settings, home care use, schools, and long-term care facilities.

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K250583 510(k) Summary

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Comparison and Differences vs. Predicate and Reference

Subject Device	Predicate Device	Reference Device	Comment
AdheResp	HcMed Pulmogine®	Respironics AAD
K250583	K202171	K042991
Classification	21 CFR 868.5630 CAF - Nebulizer - Direct patient interface	21 CFR 868.5630 CAF - Nebulizer - Direct patient interface	21 CFR 868.5630 CAF - Nebulizer - Direct patient interface
Indications for use	The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing. The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.	The Pulmogine(r) Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities.	The intended purpose of the I-neb AAD System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the 1-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
Intended Use Environment	Hospital/institutional settings, home care use, schools, and long-term care facilities.	Hospital/institutional settings, home care use, schools, and long-term care facilities.	Home care, nursing home, sub-acute institution, or hospital environment
Principle of Operation	Vibrating Mesh	Vibrating Mesh	Vibrating Mesh
Aerosolization Mode	Breath actuated	Continuous only	Breath actuated
Breath Actuation	Delivers aerosol during a portion of the inhalation cycle	Continuous only during whole inhalation cycle	Delivers aerosol during a portion of the inhalation cycle

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K250583 510(k) Summary

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Subject Device	Predicate Device	Reference Device	Comment
AdheResp	HcMed Pulmogine®	Respironics AAD
K250583	K202171	K042991
Maximum Fill Volume	8+ml	10 ml	6ml
Components	Main unit with rechargeable batteryReservoir chamber – multiuseMouthpiece	Main unit with rechargeable batteryReservoir chamber – multi-useMouthpiece	Main unit with rechargeable batteryReservoir chamber – multi-useMouthpiece
Breath actuation	Pressure drop with sensor	Not applicable	Pressure drop with sensor
Algorithm for Inhalation Aerosol delivery	Measures breath and averages the cycle, then delivers aerosol during the designated period	Not applicable	Measures breath and averages the cycle, then delivers aerosol during the designated period
Aerosol delivery Range during Inhalation	40%~80%Default setting - 60%.	Not applicable	50%~80%Up to last 1 second of inhalation
Nebulization rate	>0.25 ml/min	>0.25 ml/min
Wireless connectivity	Yes	No	Yes
Biocompatibility	Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent DurationISO 10993-1 testingISO 18562 testing	Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent DurationISO 10993-1 testingISO 18562 testing	Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent DurationISO 10993-1 testingISO 18562 testing

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K250583 510(k) Summary

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Breathe Actuated Particle Characterization Performance Comparison to Predicate

Comparative Performance Testing – Breath Actuated 15 LPM and 30 LPM

	Subject Device 15 LPM	Predicate 15 LPM	Subject Device 30 LPM	Predicate 30 LPM
MMAD [µm]
Albuterol	3.98 ±0.18	4.52 ±0.21	3.48 ±0.15	3.93 ±0.41
Ipratropium	3.984 ±0.11	4.29 ±0.17	3.39 ±0.21	3.66 ±0.18
USP Cromolyn	4.07 ±0.14	4.46 ±0.29	3.58 ±0.15	3.77 ±0.35
GSD
Albuterol	1.82 ±0.03	2.01 ±0.12	1.89 ±0.09	1.93 ±0.18
Ipratropium	1.94 ±0.10	2.15 ±0.14	1.98 ±0.16	2.09 ±0.11
USP Cromolyn	1.88 ±0.02	2.15 ±0.08	1.90 ±0.07	2.04 ±0.08
Total Delivered Dose (mg)
Albuterol	4.25 ±0.36	4.06 ±0.42	3.83 ±0.29	3.78 ±0.29
Ipratropium	0.45 ±0.07	0.45 ±0.08	0.40 ±0.04	0.40 ±0.06
USP Cromolyn	16.23 ±1.35	14.73 ±2.24	14.65 ±1.09	13.69 ±1.75
Respirable Dose <5µm [mg]
Albuterol	2.71 ±0.32	2.16 ±0.21	2.67 ±0.21	2.33 ±0.39
Ipratropium	0.28 ±0.03	0.24 ±0.04	0.27 ±0.03	0.24 ±0.03
USP Cromolyn	10 ±0.85	7.7 ±1.08	9.95 ±0.71	8.42 ±0.52
Coarse Particle Dose <4.7µm [mg]
Albuterol	1.47 ±0.10	1.56 ±0.19	1.05 ±0.28	1.20 ±0.39
Ipratropium	0.15 ±0.02	0.16 ±0.02	0.11 ±0.01	0.12 ±0.02
USP Cromolyn	5.85 ±0.65	5.51 ±0.09	4.55 ±0.72	4,57 ±1.12
Fine Particle Dose <4.7µm [mg]
Albuterol	2.56 ±0.30	2.01 ±0.19	2.54 ±0.21	2.16 ±0.21
Ipratropium	0.27 ±0.03	0.23 ±0.04	0.26 ±0.03	0.23 ±0.03
USP Cromolyn	9.41 ±0.65	7.35 ±0609	9.46 ±0.48	8.00 ±0.47
Ultra-Fine Particle Dose <1µm [mg]
Albuterol	LOD	LOD	0.21 ±0.06	0.20 ±0.04
Ipratropium	0.01 ±0.00	0.01 ±0.00	0.02 ±0.01	0.03 ±0.01
USP Cromolyn	LOD	LOD	0.58 ±0.05	0.58 ±0.11

Testing was performed with 3 samples of each device in triplicate with the 3 drugs. Testing was performed at flow rates of 15 L/min and 30 L/min. The above comparative results and performance are similar for both the proposed device and the predicate.

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K250583 510(k) Summary

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Substantial Equivalence Discussion

The tables above compare the key features of the subject device with the identified predicate and reference. The comparison demonstrates that the subject device can be found to be substantially equivalent to the predicate and any differences are addressed with the reference device.

Indications for Use –

The indications for use are similar for the subject device when compared to the predicate.

Technology and construction –

The technology and principle of operation is similar for the subject device when compared to the predicate and reference devices.

Environment of Use –

The environments of use are similar to the predicate device.

Patient Population –

The patient population is similar to the predicate device.

Non-Clinical Testing Summary –

Bench testing

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Nebulization rate
Inter- and Intra-sample Variability
Aerosol Performance
Comparative (Subject vs. Predicate) Aerosol Performance
Minimum Breath Actuation Tests

Biocompatibility

Applicable ISO 10993 and ISO 18652 testing was performed.

Reprocessing, Sterility, and Shelf-Life

Cleaning Validation
Aging
Simulated Life (cleaning, aging, drop)

Discussion of Differences

The subject device differs in the following ways from the predicate:

The predicate device is not breath actuated

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K250583 510(k) Summary

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It does not include wireless connectivity
These have been addressed by use of a reference device

Discussion of Differences

The differences between the subject and predicate and reference devices do not raise new concerns regarding the safety and effectiveness as demonstrated by performance testing.

Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.

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).