AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

Device Description

AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called "AllNEB Breath Actuated Nebulizer." It demonstrates the device's substantial equivalence to a legally marketed predicate device, the AeroEclipse II Breath Actuated Nebulizer (K053605).

The core of the acceptance criteria and proof revolves around comparative performance testing, showing that the AllNEB device performs similarly to the predicate device across various aerosolization metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from the performance of the predicate device. The goal is to demonstrate "substantial equivalence," meaning the new device performs similarly to the predicate. The performance of the predicate device, AeroEclipse II Breath Actuated Nebulizer (K053605), serves as the "acceptance criteria," and the "Reported Device Performance" is that of the AllNEB device.

The tables provided in the 510(k) summary (pages 7-16) present a direct comparison of various aerosolization parameters for both the AllNEB (Subject Device) and the AeroEclipse II (Predicate Device) under different conditions (Breath Actuated Mode, Constant-Output Mode, Adult settings, Pediatric settings, and Simulated Breathing).

Key Performance Metrics (Acceptance Criteria are inferred to be "similar to predicate"):

MMAD (Mass Median Aerodynamic Diameter): A measure of the central tendency of the particle size distribution.
GSD (Geometric Standard Deviation): A measure of the spread or variability of the particle size distribution.
Total Dose Delivered: The total amount of medication delivered by the nebulizer.
Total Respirable Dose (0.5-5 µm): The amount of medication delivered as particles within the respirable range (able to reach the lower respiratory tract).
Coarse Particle Dose (>4.7 µm): The amount of medication delivered as larger particles.
Fine Particle Dose (<4.7 µm): The amount of medication delivered as smaller particles.
Ultra-Fine Particle Dose (<1.0 µm): The amount of medication delivered as very small particles.

Example Excerpt from the Tables (Acceptance Criteria vs. Reported Performance):

Metric (Albuterol Sulfate, Breath Actuated Mode – Adult settings, 5 lpm)	Acceptance Criteria (Predicate)	Reported Performance (AllNEB)	Comment
MMAD	2.03	1.51	Similar
GSD	1.70	2.43	Similar
Total Dose Delivered	1,367	1,228	Similar
Total Respirable Dose (0.5-5 um)	847	834	Similar
Coarse Particle Dose (>4.7 um)	350	218	Similar
Fine Particle Dose (<4.7 um)	1,017	1,010	Similar
Ultra-Fine Particle Dose (<1.0 um)	307	397	Similar

(Self-Correction: The "Similar" comment applies to all comparative data points presented in the submission, indicating that the observed differences were deemed acceptable for substantial equivalence for all the data points included in these tables.)

The acceptance criterion for each measured value is that the AllNEB device's performance is "similar" to that of the predicate device. The tables, consistently marked with "Similar" in the comment column, indicate that this criterion was met for all tested parameters and conditions.

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

The provided document does not specify the sample size (e.g., number of nebulizers tested, number of runs per nebulizer) used for the comparative performance testing. It presents the mean values for various measurements. The typical practice for such in vitro performance testing of nebulizer devices would involve multiple repetitions to ensure reproducibility and statistical validity, but the exact N is not given here.

The data provenance is also not explicitly stated regarding the country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) submission for a new device, the performance testing would undoubtedly be prospective and conducted by the manufacturer (Enchant Tek Co. Ltd.) as part of their pre-market submission requirements. The location of the sponsor (Taipei, TW) suggests the testing likely occurred in Taiwan or through a contract research organization.

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

This document describes the performance testing of a physical medical device (nebulizer) based on in vitro aerosolization characteristics, not a diagnostic AI/ML algorithm that requires expert adjudication of medical images or patient data.

Therefore, the concept of "experts used to establish the ground truth" in the sense of medical professionals (e.g., radiologists, pathologists) is not applicable here. The "ground truth" for the performance data is established by the methods and equipment used for aerosol particle sizing and dose measurement (e.g., cascade impactors, spectrophotometry), which are standard industry practices and governed by international standards (e.g., ISO 27427 for nebulizing systems). The "experts" would be the engineers and technicians proficient in running these highly standardized tests.

4. Adjudication Method for the Test Set

As explained above, since this is a performance test for a physical device, not an AI/ML diagnostic system based on human interpretation, an "adjudication method" (like 2+1 or 3+1 reviewer consensus for image reads) is not applicable. The data are quantitative measurements obtained through standardized laboratory procedures.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic devices (especially those involving interpretation of medical images or signals) to assess how human performance (e.g., accuracy, efficiency) changes with and without AI assistance. The AllNEB is a drug delivery device, not a diagnostic tool requiring human interpretation of output.

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

Not Applicable. This question is relevant for AI/ML devices where the algorithm's performance can be evaluated independently. The AllNEB is a mechanical device, and its performance is inherently "standalone" in terms of its aerosolization characteristics (it functions as designed regardless of a human interface beyond its intended use).

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by physical measurements and testing using standardized laboratory equipment and methods. These methods quantitatively assess:

Particle size distribution (MMAD, GSD)
Drug delivery efficiency (Total Dose Delivered, Respirable Dose, etc.)

These measurements are considered the objective "ground truth" for the device's physical performance characteristics. The comparison is made against the results obtained with the predicate device using the same methodologies.

8. The Sample Size for the Training Set

Not Applicable. This device is a mechanical nebulizer, not an AI/ML algorithm that requires a "training set."

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

Not Applicable. As there is no training set for a mechanical device, there is no ground truth to be established for it.

Summary

FDA 510(k) Clearance Letter - AllNEB Breath Actuated Nebulizer

Page 1

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

Doc ID # 04017.07.05

April 29, 2025

Enchant Tek Co. Ltd.
℅ Paul Dryden
President
ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704

Re: K242354
Trade/Device Name: AllNEB
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: April 1, 2025
Received: April 1, 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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K242354 - 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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K242354 - Paul Dryden Page 3

Sincerely,

Ethan L. Nyberg -S

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K242354

Device Name
AllNEB Breath Actuated Nebulizer

Indications for Use (Describe)
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

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.

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
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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."

FORM FDA 3881 (8/23) Page 1 of 1

Page 5

K242354 510(k) Summary

Page 1 of 12

Date Prepared: 29-Apr-25

Sponsor: Enchant Tek Co. Ltd.
No. 210 Xiangzhong Rd.
Dongshan Township, Yilan County
Taipei, TW 26950
Tel +886- 03-959-3500

Sponsor Contact: Ling Leonard – QA/RA Supervisor

Submission Correspondent: Paul Dryden
ProMedic, LLC

Proprietary or Trade Name: AllNEB
Common/Usual Name: Nebulizer
Classification Name: Nebulizer (direct patient interface) 21CFR 868.5630
Product Code: CAF

Predicate Device: AeroEclipse II Breath Actuated Nebulizer – K053605
Common/Usual Name: Nebulizer
Classification Name: Nebulizer (direct patient interface) 21CFR 868.5630
Product Code: CAF

Device Description: AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.

Principle of Operation: The gas orifice is located in the center of the nebulizer. The driving gas (air or oxygen) passes through the small orifice and is deflected by a baffle on the actuator. The high velocity jet of gas produces a negative pressure behind it, which draws liquid up to the nozzle area. The deflected gas flow shears off the liquid being drawn up which generates the aerosol.

Indications for Use:
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.

Patient Population:
Pediatrics (5 years and older) to Adults.

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K242354 510(k) Summary

Page 2 of 12

Environments of use:
Home, hospitals, and clinics.

	Subject DeviceAllNEB –K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment
Manufacturer	Enchant	Trudell Medical International
Prescriptive	Rx	Rx	Similar
Classification	21 CFR 868.5630 - CAFNebulizer - Direct patient interface	21 CFR 868.5630 - CAFNebulizer - Direct patient interface	Similar
Indications for use	AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.	The AeroEclipse* II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.	The predicate device does not disclose the patient age range.
Intended Use Environment	Home or in hospitals and clinics	Home or in hospitals and clinics	Similar
Principle of Operation	Pneumatic Jet Nebulizer	Pneumatic Jet Nebulizer	Similar
Aerosolization Mode	Built-in mode selector for breath actuated or continuous mode	Built-in mode selector for breath actuated or continuous mode	Similar
Single Patient Use	Yes	Yes	Similar
Type of Device	Single patient use, multiple use, prescription only, non-sterile	Single patient use, multiple use, prescription only, non-sterile	Similar
Type of gas source	Compressed air or oxygen	Compressed air or oxygen	Similar
Flow Rate	5 – 8 lpm (liters per minute)	2.75 – 8 lpm (liters per minute)	Similar
Maximum Fill Volume	6ml	6ml	Similar
Basic Components	BAN with Mouthpiece, Oxygen Tubing	BAN with Mouthpiece, Oxygen Tubing	SimilarOxygen tubing is user supplied

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K242354 510(k) Summary

Page 3 of 12

	Subject DeviceAllNEB –K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment
Biocompatibility	Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent DurationISO 10993-1 and ISO 18562-1	Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration	Similar

	Subject DeviceAllNEB - 242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Comparative Performance

Breath Actuated Mode – Adult settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.51	2.03	Albuterol Sulfate	2.03	2.23	Similar
Ipratropium Bromide	1.47	1.90	Ipratropium Bromide	1.93	2.23	Similar
Cromolyn Sodium	1.50	1.87	Cromolyn Sodium	2.00	2.07	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	2.43	1.67	Albuterol Sulfate	1.70	1.63	Similar
Ipratropium Bromide	2.13	1.67	Ipratropium Bromide	1.67	1.70	Similar
Cromolyn Sodium	2.29	1.70	Cromolyn Sodium	1.70	1.73	Similar

Total Dose Delivered

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1,228	1,293	Albuterol Sulfate	1,367	1,474	Similar
Ipratropium Bromide	188	208	Ipratropium Bromide	203	242	Similar
Cromolyn Sodium	5,255	5,781	Cromolyn Sodium	5,868	6,505	Similar

Page 8

K242354 510(k) Summary

Page 4 of 12

	Subject DeviceAllNEB -K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Total Respirable Dose (0.5-5 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	834	862	Albuterol Sulfate	847	899	Similar
Ipratropium Bromide	129	136	Ipratropium Bromide	132	138	Similar
Cromolyn Sodium	3,635	4,070	Cromolyn Sodium	3,681	4,030	Similar

Coarse Particle Dose (>4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	218	258	Albuterol Sulfate	350	426	Similar
Ipratropium Bromide	30	43	Ipratropium Bromide	48	76	Similar
Cromolyn Sodium	868	904	Cromolyn Sodium	1,411	1,549	Similar

Fine Particle Dose (<4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1,010	1,035	Albuterol Sulfate	1,017	1,048	Similar
Ipratropium Bromide	158	165	Ipratropium Bromide	155	167	Similar
Cromolyn Sodium	4,388	4,877	Cromolyn Sodium	4,456	4,957	Similar

Ultra-Fine Particle Dose (<1.0 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	397	317	Albuterol Sulfate	307	275	Similar
Ipratropium Bromide	62	52	Ipratropium Bromide	50	52	Similar
Cromolyn Sodium	1,704	1,463	Cromolyn Sodium	1,369	1,501	Similar

Constant-Output Mode – Adult settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.46	2.06	Albuterol Sulfate	2.07	2.20	Similar
Ipratropium Bromide	1.51	2.06	Ipratropium Bromide	1.93	2.10	Similar
Cromolyn Sodium	1.52	2.03	Cromolyn Sodium	1.97	2.30	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	2.04	1.62	Albuterol Sulfate	1.63	1.63	Similar
Ipratropium Bromide	2.56	1.62	Ipratropium Bromide	1.67	1.67	Similar
Cromolyn Sodium	2.24	1.67	Cromolyn Sodium	1.63	1.67	Similar

Total Dose

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1,232	1,367	Albuterol Sulfate	1,376	1,463	Similar

Page 9

K242354 510(k) Summary

Page 5 of 12

	Subject DeviceAllNEB -K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Delivered
| Ipratropium Bromide | 193 | 219 | Ipratropium Bromide | 200 | 248 | Similar |
| Cromolyn Sodium | 5,246 | 5,674 | Cromolyn Sodium | 5,783 | 6,339 | Similar |

Total Respirable Dose (0.5-5 um)
| Albuterol Sulfate | 5 lpm846 | 8 lpm957 | Albuterol Sulfate | 5 lpm880 | 8 lpm871 | Similar |
| Ipratropium Bromide | 132 | 152 | Ipratropium Bromide | 126 | 150 | Similar |
| Cromolyn Sodium | 3,687 | 3,787 | Cromolyn Sodium | 3,672 | 3,845 | Similar |

Coarse Particle Dose (>4.7 um)
| Albuterol Sulfate | 5 lpm208 | 8 lpm256 | Albuterol Sulfate | 5 lpm341 | 8 lpm446 | Similar |
| Ipratropium Bromide | 35 | 41 | Ipratropium Bromide | 48 | 68 | Similar |
| Cromolyn Sodium | 832 | 1,127 | Cromolyn Sodium | 1,450 | 1,831 | Similar |

Fine Particle Dose (<4.7 um)
| Albuterol Sulfate | 5 lpm1,025 | 8 lpm1,111 | Albuterol Sulfate | 5 lpm1,036 | 8 lpm1,017 | Similar |
| Ipratropium Bromide | 158 | 178 | Ipratropium Bromide | 152 | 180 | Similar |
| Cromolyn Sodium | 4,415 | 4,547 | Cromolyn Sodium | 4,332 | 4,508 | Similar |

Ultra-Fine Particle Dose (<1.0 um)
| Albuterol Sulfate | 5 lpm402 | 8 lpm299 | Albuterol Sulfate | 5 lpm303 | 8 lpm284 | Similar |
| Ipratropium Bromide | 62 | 49 | Ipratropium Bromide | 46 | 52 | Similar |
| Cromolyn Sodium | 1,661 | 1,340 | Cromolyn Sodium | 1,399 | 1,247 | Similar |

Breath Actuated Mode – Pediatric settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.37	2.19	Albuterol Sulfate	1.93	2.87	Similar
Ipratropium Bromide	1.39	2.24	Ipratropium Bromide	1.67	2.93	Similar
Cromolyn Sodium	1.32	2.12	Cromolyn Sodium	1.60	3.10	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.54	1.94	Albuterol Sulfate	2.57	1.97	Similar
Ipratropium Bromide	1.52	1.96	Ipratropium Bromide	2.93	2.00	Similar
Cromolyn Sodium	1.40	1.94	Cromolyn Sodium	2.17	2.13	Similar

Page 10

K242354 510(k) Summary

Page 6 of 12

	Subject DeviceAllNEB -K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Total Dose Delivered
| Albuterol Sulfate | 5 lpm1347.3 | 8 lpm1193 | Albuterol Sulfate | 5 lpm1709.4 | 8 lpm1515 | Similar |
| Ipratropium Bromide | 210.9 | 196 | Ipratropium Bromide | 250.7 | 245 | Similar |
| Cromolyn Sodium | 5436.7 | 5124 | Cromolyn Sodium | 6340.4 | 6474 | Similar |

Total Respirable Dose (0.5-5 um)
| Albuterol Sulfate | 5 lpm892.2 | 8 lpm805 | Albuterol Sulfate | 5 lpm927.4 | 8 lpm795 | Similar |
| Ipratropium Bromide | 140.5 | 132 | Ipratropium Bromide | 137.4 | 128 | Similar |
| Cromolyn Sodium | 3675.5 | 3595 | Cromolyn Sodium | 3657.4 | 3468 | Similar |

Coarse Particle Dose (>4.7 um)
| Albuterol Sulfate | 5 lpm266.1 | 8 lpm234 | Albuterol Sulfate | 5 lpm595.5 | 8 lpm570 | Similar |
| Ipratropium Bromide | 41.6 | 38 | Ipratropium Bromide | 84.2 | 95 | Similar |
| Cromolyn Sodium | 916.3 | 833 | Cromolyn Sodium | 1907.3 | 2326 | Similar |

Fine Particle Dose (<4.7 um)
| Albuterol Sulfate | 5 lpm1081.2 | 8 lpm959 | Albuterol Sulfate | 5 lpm1114.0 | 8 lpm945 | Similar |
| Ipratropium Bromide | 169.3 | 157 | Ipratropium Bromide | 166.5 | 150 | Similar |
| Cromolyn Sodium | 4520.4 | 4291 | Cromolyn Sodium | 4432.7 | 4148 | Similar |

Ultra-Fine Particle Dose (<1.0 um)
| Albuterol Sulfate | 5 lpm334.5 | 8 lpm217 | Albuterol Sulfate | 5 lpm348.0 | 8 lpm205 | Similar |
| Ipratropium Bromide | 47.7 | 37 | Ipratropium Bromide | 50.4 | 35 | Similar |
| Cromolyn Sodium | 1457.3 | 996 | Cromolyn Sodium | 1292.0 | 962 | Similar |

Constant-Output Mode – Pediatric settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.39	2.20	Albuterol Sulfate	1.70	2.77	Similar
Ipratropium Bromide	1.37	2.24	Ipratropium Bromide	1.97	2.77	Similar
Cromolyn Sodium	1.38	2.33	Cromolyn Sodium	1.77	2.73	Similar

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K242354 510(k) Summary

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	Subject DeviceAllNEBK242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer -K053605	Comment

Constant-Output Mode – Pediatric settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.39	2.20	Albuterol Sulfate	1.70	2.77	Similar
Ipratropium Bromide	1.37	2.24	Ipratropium Bromide	1.97	2.77	Similar
Cromolyn Sodium	1.38	2.33	Cromolyn Sodium	1.77	2.73	Similar

Page 12

K242354 510(k) Summary

Page 8 of 12

	Subject DeviceAllNEBK242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Simulated Breathing Comparison

Breath Actuated Mode Simulated Breathing – Adult settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.51	2.03	Albuterol Sulfate	2.03	2.23	Similar
Ipratropium Bromide	1.47	1.90	Ipratropium Bromide	1.93	2.23	Similar
Cromolyn Sodium	1.50	1.87	Cromolyn Sodium	2.00	2.07	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	2.43	1.67	Albuterol Sulfate	1.70	1.63	Similar
Ipratropium Bromide	2.13	1.67	Ipratropium Bromide	1.67	1.70	Similar
Cromolyn Sodium	2.29	1.70	Cromolyn Sodium	1.70	1.73	Similar

Total Dose Delivered

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	982	946	Albuterol Sulfate	1,074	1,092	Similar
Ipratropium Bromide	149	159	Ipratropium Bromide	155	181	Similar
Cromolyn Sodium	4,130	4,488		4,668	4,959	Similar

Total Respirable Dose (0.5-5 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	668	632	Albuterol Sulfate	665	666	Similar
Ipratropium Bromide	103	104	Ipratropium Bromide	101	103	Similar
Cromolyn Sodium	2,860	3,159	Cromolyn Sodium	2,922	3,076	Similar

Coarse Particle Dose (>4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	173	189	Albuterol Sulfate	275	315	Similar
Ipratropium Bromide	24	33	Ipratropium Bromide	36	56	Similar
Cromolyn Sodium	678	701	Cromolyn Sodium	1,130	1,179	Similar

Fine Particle Dose (<4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	809	757	Albuterol Sulfate	799	777	Similar
Ipratropium Bromide	125	126	Ipratropium Bromide	119	124	Similar
Cromolyn Sodium	3,451	3,787	Cromolyn Sodium	3,538	3,781	Similar

Page 13

K242354 510(k) Summary

Page 9 of 12

	Subject DeviceAllNEBK242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Ultra-Fine Particle Dose (<1.0 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	319	231	Albuterol Sulfate	242	204	Similar
Ipratropium Bromide	49	40	Ipratropium Bromide	38	39	Similar
Cromolyn Sodium	1,337	1,138	Cromolyn Sodium	1,085	1,150	Similar

Constant-Output Mode Simulated Breathing – Adult settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.46	2.06	Albuterol Sulfate	2.07	2.20	Similar
Ipratropium Bromide	1.51	2.06	Ipratropium Bromide	1.93	2.10	Similar
Cromolyn Sodium	1.52	2.03	Cromolyn Sodium	1.97	2.30	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	2.04	1.62	Albuterol Sulfate	1.63	1.63	Similar
Ipratropium Bromide	2.56	1.62	Ipratropium Bromide	1.67	1.67	Similar
Cromolyn Sodium	2.24	1.67	Cromolyn Sodium	1.63	1.67	Similar

Total Dose Delivered

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	517	570	Albuterol Sulfate	560	601	Similar
Ipratropium Bromide	83	89	Ipratropium Bromide	85	106	Similar
Cromolyn Sodium	2,297	2,346		2,439	2,619	Similar

Total Respirable Dose (0.5-5 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	355	399	Albuterol Sulfate	357	357	Similar
Ipratropium Bromide	57	61	Ipratropium Bromide	54	64	Similar
Cromolyn Sodium	1,616	1,567	Cromolyn Sodium	1,550	1,589	Similar

Coarse Particle Dose (>4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	87	106	Albuterol Sulfate	139	184	Similar
Ipratropium Bromide	15	17	Ipratropium Bromide	21	29	Similar
Cromolyn Sodium	362	465	Cromolyn Sodium	612	758	Similar

Page 14

K242354 510(k) Summary

Page 10 of 12

	Subject DeviceAllNEBK242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Ultra-Fine Particle Dose (<1.0 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	319	231	Albuterol Sulfate	242	204	Similar
Ipratropium Bromide	49	40	Ipratropium Bromide	38	39	Similar
Cromolyn Sodium	1,337	1,138	Cromolyn Sodium	1,085	1,150	Similar

Constant-Output Mode Simulated Breathing – Adult settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.46	2.06	Albuterol Sulfate	2.07	2.20	Similar
Ipratropium Bromide	1.51	2.06	Ipratropium Bromide	1.93	2.10	Similar
Cromolyn Sodium	1.52	2.03	Cromolyn Sodium	1.97	2.30	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	2.04	1.62	Albuterol Sulfate	1.63	1.63	Similar
Ipratropium Bromide	2.56	1.62	Ipratropium Bromide	1.67	1.67	Similar
Cromolyn Sodium	2.24	1.67	Cromolyn Sodium	1.63	1.67	Similar

Total Dose Delivered

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	517	570	Albuterol Sulfate	560	601	Similar
Ipratropium Bromide	83	89	Ipratropium Bromide	85	106	Similar
Cromolyn Sodium	2,297	2,346		2,439	2,619	Similar

Total Respirable Dose (0.5-5 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	355	399	Albuterol Sulfate	357	357	Similar
Ipratropium Bromide	57	61	Ipratropium Bromide	54	64	Similar
Cromolyn Sodium	1,616	1,567	Cromolyn Sodium	1,550	1,589	Similar

Coarse Particle Dose (>4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	87	106	Albuterol Sulfate	139	184	Similar
Ipratropium Bromide	15	17	Ipratropium Bromide	21	29	Similar
Cromolyn Sodium	362	465	Cromolyn Sodium	612	758	Similar

Fine Particle Dose (<4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	430	463	Albuterol Sulfate	421	417	Similar
Ipratropium Bromide	68	72	Ipratropium Bromide	65	77	Similar
Cromolyn Sodium	1,935	1,881	Cromolyn Sodium	1,827	1,861	Similar

Ultra-Fine Particle Dose (<1.0 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	169	125	Albuterol Sulfate	124	117	Similar
Ipratropium Bromide	26	20	Ipratropium Bromide	20	22	Similar
Cromolyn Sodium	729	555	Cromolyn Sodium	589	513	Similar

Breath Actuated Mode Simulated Breathing – Pediatric settings

MMAD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.37	2.19	Albuterol Sulfate	1.93	2.87	Similar
Ipratropium Bromide	1.39	2.24	Ipratropium Bromide	1.67	2.93	Similar
Cromolyn Sodium	1.32	2.12	Cromolyn Sodium	1.60	3.10	Similar

GSD

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1.54	1.94	Albuterol Sulfate	2.57	1.97	Similar
Ipratropium Bromide	1.52	1.96	Ipratropium Bromide	2.93	2.00	Similar
Cromolyn Sodium	1.40	1.94	Cromolyn Sodium	2.17	2.13	Similar

Total Dose Delivered

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	1059.0	937	Albuterol Sulfate	1190.1	1,040	Similar
Ipratropium Bromide	166.7	153	Ipratropium Bromide	184.9	186	Similar
Cromolyn Sodium	4288.9	4,171	Cromolyn Sodium	5152.0	4,954	Similar

Total Respirable Dose (0.5-5 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	703.2	632	Albuterol Sulfate	645.8	548	Similar

Page 15

K242354 510(k) Summary

Page 11 of 12

	Subject DeviceAllNEB - K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Fine Particle Dose (<4.7 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	430	463	Albuterol Sulfate	421	417	Similar
Ipratropium Bromide	68	72	Ipratropium Bromide	65	77	Similar
Cromolyn Sodium	1,935	1,881	Cromolyn Sodium	1,827	1,861	Similar

Ultra-Fine Particle Dose (<1.0 um)

	5 lpm	8 lpm		5 lpm	8 lpm
Albuterol Sulfate	169	125	Albuterol Sulfate	124	117	Similar
Ipratropium Bromide	26	20	Ipratropium Bromide	20	22	Similar
Cromolyn Sodium	729	555	Cromolyn Sodium	589	513	Similar

Breath Actuated Mode Simulated Breathing – Pediatric settings

MMAD
| Albuterol Sulfate | 5 lpm1.37 | 8 lpm2.19 | Albuterol Sulfate | 5 lpm1.93 | 8 lpm2.87 | Similar |
| Ipratropium Bromide | 1.39 | 2.24 | Ipratropium Bromide | 1.67 | 2.93 | Similar |
| Cromolyn Sodium | 1.32 | 2.12 | Cromolyn Sodium | 1.60 | 3.10 | Similar |

GSD
| Albuterol Sulfate | 5 lpm1.54 | 8 lpm1.94 | Albuterol Sulfate | 5 lpm2.57 | 8 lpm1.97 | Similar |
| Ipratropium Bromide | 1.52 | 1.96 | Ipratropium Bromide | 2.93 | 2.00 | Similar |
| Cromolyn Sodium | 1.40 | 1.94 | Cromolyn Sodium | 2.17 | 2.13 | Similar |

Total Dose Delivered
| Albuterol Sulfate | 5 lpm1059.0 | 8 lpm937 | Albuterol Sulfate | 5 lpm1190.1 | 8 lpm1,040 | Similar |
| Ipratropium Bromide | 166.7 | 153 | Ipratropium Bromide | 184.9 | 186 | Similar |
| Cromolyn Sodium | 4288.9 | 4,171 | Cromolyn Sodium | 5152.0 | 4,954 | Similar |

Total Respirable Dose (0.5-5 um)
| Albuterol Sulfate | 5 lpm703.2 | 8 lpm632 | Albuterol Sulfate | 5 lpm645.8 | 8 lpm548 | Similar |
| Ipratropium Bromide | 111.1 | 103 | Ipratropium Bromide | 101.1 | 97 | Similar |
| Cromolyn Sodium | 2898.6 | 2,931 | Cromolyn Sodium | 2969.6 | 2,649 | Similar |

Coarse Particle Dose (>4.7 um)
| Albuterol Sulfate | 5 lpm207.5 | 8 lpm183 | Albuterol Sulfate | 5 lpm414.9 | 8 lpm389 | Similar |
| Ipratropium Bromide | 32.7 | 30 | Ipratropium Bromide | 62.4 | 72 | Similar |
| Cromolyn Sodium | 723.1 | 673 | Cromolyn Sodium | 1551.7 | 1786 | Similar |

Fine Particle Dose (<4.7 um)
| Albuterol Sulfate | 5 lpm851.5 | 8 lpm754 | Albuterol Sulfate | 5 lpm775.3 | 8 lpm651 | Similar |
| Ipratropium Bromide | 134.0 | 123 | Ipratropium Bromide | 122.5 | 114 | Similar |
| Cromolyn Sodium | 3565.8 | 3,498 | Cromolyn Sodium | 3600.3 | 3,168 | Similar |

Ultra-Fine Particle Dose (<1.0 um)
| Albuterol Sulfate | 5 lpm262.8 | 8 lpm171 | Albuterol Sulfate | 5 lpm241.8 | 8 lpm141 | Similar |
| Ipratropium Bromide | 37.7 | 29 | Ipratropium Bromide | 37.0 | 26 | Similar |
| Cromolyn Sodium | 1151.2 | 810 | Cromolyn Sodium | 1051.7 | 735 | Similar |

Constant-Output Mode Simulated Breathing – Pediatric settings

MMAD
| Albuterol Sulfate | 5 lpm1.39 | 8 lpm2.20 | Albuterol Sulfate | 5 lpm1.70 | 8 lpm2.77 | Similar |
| Ipratropium Bromide | 1.37 | 2.24 | Ipratropium Bromide | 1.97 | 2.77 | Similar |
| Cromolyn Sodium | 1.38 | 2.33 | Cromolyn Sodium | 1.77 | 2.73 | Similar |

GSD
| Albuterol Sulfate | 5 lpm1.91 | 8 lpm1.97 | Albuterol Sulfate | 5 lpm3.17 | 8 lpm2.10 | Similar |
| Ipratropium Bromide | 1.72 | 1.96 | Ipratropium Bromide | 2.70 | 2.10 | Similar |
| Cromolyn Sodium | 1.50 | 1.96 | Cromolyn Sodium | 2.67 | 2.03 | Similar |

Page 16

K242354 510(k) Summary

Page 12 of 12

	Subject DeviceAllNEB - K242354	Predicate DeviceAeroEclipse II Breath ActuatedNebulizer - K053605	Comment

Total Dose Delivered
| Albuterol Sulfate | 5 lpm526 | 8 lpm463 | Albuterol Sulfate | 5 lpm592 | 8 lpm534 | Similar |
| Ipratropium Bromide | 80 | 72 | Ipratropium Bromide | 96 | 79 | Similar |
| Cromolyn Sodium | 2351 | 1970 | | 2561 | 2348 | Similar |

Total Respirable Dose (0.5-5 um)
| Albuterol Sulfate | 5 lpm355 | 8 lpm319 | Albuterol Sulfate | 5 lpm321 | 8 lpm271 | Similar |
| Ipratropium Bromide | 54 | 50 | Similar | 50 | 43 | Similar |
| Cromolyn Sodium | 1583 | 1376 | Similar | 1426 | 1254 | Similar |

Coarse Particle Dose (>4.7 um)
| Albuterol Sulfate | 5 lpm99 | 8 lpm87 | Similar | 5 lpm207 | 8 lpm206 | Similar |
| Ipratropium Bromide | 15 | 14 | Ipratropium Bromide | 36 | 27 | Similar |
| Cromolyn Sodium | 418 | 346 | Cromolyn Sodium | 838 | 846 | Similar |

Fine Particle Dose (<4.7 um)
| Albuterol Sulfate | 5 lpm427 | 8 lpm377 | Albuterol Sulfate | 5 lpm385 | 8 lpm328 | Similar |
| Ipratropium Bromide | 66 | 58 | Ipratropium Bromide | 61 | 52 | Similar |
| Cromolyn Sodium | 1933 | 1625 | Cromolyn Sodium | 1723 | 1502 | Similar |

Ultra-Fine Particle Dose (<1.0 um)
| Albuterol Sulfate | 5 lpm125 | 8 lpm85 | Albuterol Sulfate | 5 lpm112 | 8 lpm86 | Similar |
| Ipratropium Bromide | 19 | 12 | Ipratropium Bromide | 18 | 13 | Similar |
| Cromolyn Sodium | 572 | 348 | Cromolyn Sodium | 471 | 361 | Similar |

Discussion of Differences

The subject device differs in the following ways from the predicate:
The predicate device does not specify an age range.

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).