Heated Breathing Tube

K243244 · Guangdong Eda Technology Co., Ltd. · BZE · Jul 25, 2025 · Anesthesiology

Device Facts

• Record ID: K243244
• Device Name: Heated Breathing Tube
• Applicant: Guangdong Eda Technology Co., Ltd.
• Product Code: BZE · Anesthesiology
• Decision Date: Jul 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor. The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.

Device Story

Compressor Nebulizer system; consists of compressor unit and nebulizer kit (cup, air tube, mask/mouthpiece). Operates on Venturi principle: motor-driven compressed air creates high-speed airflow through small pipe; negative pressure draws liquid to barrier; high-speed impact converts liquid to aerosol mist. Used in home, hospital, or sub-acute settings by patients or caregivers. Provides aerosolized medication for inhalation to treat respiratory disorders. Device includes shell, motor, pump, air filter, and optional PCB (models NB-1102/1103).

Clinical Evidence

No clinical data. Bench testing only. Performance validated via particle size characterization (MMAD, GSD, respirable dose/fraction) per FDA 1993 guidance, electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993 series and ISO 18562 series).

Technological Characteristics

Pneumatic (gas-powered) jet nebulizer; AC powered. Components: compressor, motor, pump, air filter, nebulizer kit. Models NB-1102/1103 include PCB. Standards: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility per ISO 10993 and ISO 18562.

Indications for Use

Indicated for pediatric (ages 2+) and adult patients with respiratory disorders requiring aerosolized medication via pneumatic nebulizer in home, hospital, or sub-acute settings.

Regulatory Classification

Identification

A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

Predicate Devices

• NE-C801 Nebulizer Compressor System (K110860)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 25, 2025

GuangDong EDA Technology Co., Ltd
% Todd Courtney
Vice President, Regulatory Affairs
Mcra.llc
803 7th Street, NW, 3rd Floor
Washington, District of Columbia 20001

Re: K243244
Trade/Device Name: Heated Breathing Tube
Regulation Number: 21 CFR 868.5270
Regulation Name: Breathing System Heater
Regulatory Class: Class II
Product Code: BZE,
Dated: May 23, 2024
Received: October 11, 2024

Dear Todd Courtney:

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"

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

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K243244 - Todd Courtney
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 ([e-mail]) or phone [phone] or 301-796-7100).

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K243244 - Todd Courtney
Page 3

Sincerely,

John S. Bender-S
2025.07.25 11:32:24 -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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| 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. |
| --- | --- |
| 510(k) Number (if known) K243244 | |
| Device Name Heating Breathing Tube | |
| Indications for Use (Describe) The Heated Breathing Tube is intended to be used for non-invasive respiratory therapy, such as CPAP/BiPAP therapy. It provides air connection between positive pressure ventilation, respiratory humidification therapy instrument, and ventilation mask, nasal cannula, trachea cannula etc. With the function of heating inside breathing tube, it can prevent condensation of the therapy air in the tube. This device is single patient use only for adults. | |
| 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "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." | |

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2025/6/4

1. Submission sponsor

Name: JOYTECH Healthcare Co., Ltd.

Address: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100 Zhejiang, China.

Contact person: Cong Jing

Title: Regulatory manager

E-mail: [e-mail]

Tel: [phone]

2. Submission correspondent

Name: Chonconn Consulting Co., Ltd.

Address: No. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China 518067

Contact person: Yang Jie

E-mail: [e-mail]

Tel: [phone]

3. Subject Device Information

| Trade/Device Name | Compressor Nebulizer |
| --- | --- |
| Model | NB-1100, NB-1101, NB-1102, NB-1103 |
| Common Name | Nebulizer |
| Regulatory Class | Class II |
| Classification | 21CFR §868.5630 / Nebulizer |
| Submission type | Traditional 510(K) |

4. Predicate Device Information

K110860, NE-C801 Nebulizer Compressor System, Omron Healthcare, Incorporated

5. Device Description

The compressor Nebulizer is mainly composed of the compressor and nebulizer kit(Optional). The compressor is mainly composed of shell, compressed motor, pump, fuse wire, air filter, power cord and plug (NB-1100,NB-1101,NB-1102,NB-1103 applicable), PCB (only model NB-1102,NB-1103applicable). The device is equipped with a nebulizer kit including Nebulizer Cup, Air Tube, Mouthpiece(Optional), Adult Mask(Optional), Child Mask(Optional) to easily delivery the medical aerosol. The Nebulizer kit is available in three models/configurations as below.

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NK-101: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask, Mouthpiece;
NK-301: Nebulizer Cup, Air Tube, Adult Mask and/or Child Mask;
NK-501: Nebulizer Cup, Air Tube, Mouthpiece

This device operates on the Venturi principle. According to the principle of Venturi, the compressed air of the motor is used to form a high-speed air flow through the small pipe mouth. The negative pressure generated drives the liquid or other fluid to spray together on the barrier, and under the high-speed impact makes the droplets turn into mist particles to spray from the outlet trachea.

## 6. Intended use & Indication for use

The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor.

The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.

## 7. Comparison to the Predicate Device

| ITEM | Proposed Device
Compressor Nebulizer
NB-1100, NB-1101, NB-1102, NB-1103
K243468 | Predicate Device
Omron Compressor
Nebulizer Systems NE-C801
K110860 | Comparison Result |
| --- | --- | --- | --- |
| Manufacture | JOYTECH Healthcare Co., Ltd. | Omron Healthcare, Incorporated | / |
| Product code | CAF | CAF | Same |
| Indications for Use | The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor.
The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings. | The NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings. | Same |

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| Principle of Operation | Yes Pneumatic (gas powered) jet nebulizer | Yes Pneumatic (gas powered) jet nebulizer | Same |
| --- | --- | --- | --- |
| Compressed gas source | Nebulizer compressor | Nebulizer compressor Wall air / oxygen with flow rate control | Equivalent |
| Aerosolization | Continuous during inhalation and exhalation | Continuous during inhalation and exhalation | Same |
| Typical flow rate | ≥6.5L/min | 8 lpm | Similar |
| Reservoir size | 8 ml | 7 ml | Similar |
| Power Source | AC | AC | Same |
| Components available in kit with nebulizer | Mouthpiece or mask | Mouthpiece or mask | Same |
| Component / Accessories intended use | All are single patient, multi-use | All are single patient, multi-use | Same |
| Nebulizer components cleanable | Yes | Yes | Same |
| Standards met | ANSI AAMI ES 60601-1
IEC 60601-1-2
IEC 60601-1-11 | IEC 6060 1-1
IEC 60601-1-2 | Equivalent |
| Operating conditions | +5°C to +40°C (+41°F to +104°F)/15% to 90% RH/ 860 hPa to 1060 hPa | 10°C to 40°C
30% to 85% RH | Similar |
| Storage conditions | -20°C to +55°C (-4°F to +131°F)/5% to 93% RH/ 700 hPa to 1060 hPa | -20°C to 60°C
10% to 95% RH | Similar |
| Dimensions (mm) | 267.9 mm × 157.3 mm × 104.6 mm
170.2 mm × 144.4 mm × 117.9 mm
246.3 mm × 121.6 mm × 148.5 mm
286 mm × 154 mm × 134.5 mm | 142(W) x 72(D) x 98(H) | Similar |
| Weight(kg) | 1.554kg
1.238kg
1.413kg
1.57kg | 0.270kg | Similar |

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| Aerosol performance | Table: Comparative particle test comparison | Table: Comparative particle test comparison | Equivalent |
| --- | --- | --- | --- |

As evidenced by the above table, both the subject and the predicate devices have same intended use, but the subject and predicate devices have different technological characteristics. However, performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate does not raise different questions of safety or effectiveness.

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Table: Comparative particle test comparison
Adult condition

| Test items | Drug | Subject Device (JOYTECH NB-1103) with adult mask | Predicate device (OMRON NE-C801) with adult mask | Subject Device (JOYTECH NB-1103) with Mouthpiece | Predicate device (OMRON NE-C801) with Mouthpiece |
| --- | --- | --- | --- | --- | --- |
| MMAD(μm) | Albuterol Sulfate (5 mg/2.5 ml) | 3.466±0.173 | 4.173±0.126 | 3.761±0.06 | 3.7±0.248 |
| | Ipratropium Bromide (0.5 mg/2 ml) | 3.413±0.061 | 4.227±0.383 | 3.954±0.032 | 4.067±0.16 |
| | Budesonide (0.5 mg/2 ml) | 4.781±0.102 | 6.06±0.352 | 5.344±0.025 | 5.704±0.124 |
| GSD | Albuterol Sulfate (5 mg/2.5 ml) | 1.988±0.033 | 1.845±0.046 | 2.013±0.016 | 1.993±0.029 |
| | Ipratropium Bromide (0.5 mg/2 ml) | 1.979±0.029 | 1.843±0.077 | 1.979±0.02 | 1.898±0.055 |
| | Budesonide (0.5 mg/2 ml) | 1.764±0.01 | 1.605±0.105 | 1.81±0.018 | 1.72±0.087 |
| Respirable Dose(μg) | Albuterol Sulfate (5 mg/2.5 ml) | 1628.633±99.49 | 1239.14±150.674 | 1556.481±102.075 | 1138.953±108.149 |
| | Ipratropium Bromide (0.5 mg/2 ml) | 153.331±4.765 | 147.57±11.505 | 145.246±2.803 | 132.881±16.413 |
| | Budesonide (0.5 mg/2 ml) | 82.049±1.341 | 63.292±10.329 | 78.617±1.532 | 63.24±4.57 |
| Respirable fraction | Albuterol Sulfate (5 mg/2.5 ml) | 67.273±2.066 | 58.136±2.583 | 60.726±0.999 | 63.741±3.979 |
| | Ipratropium Bromide (0.5 mg/2 ml) | 67.958±0.561 | 56.616±5.676 | 58.302±0.731 | 60.095±2.068 |
| | Budesonide (0.5 mg/2 ml) | 49.433±1.385 | 31.781±4.934 | 40.028±0.211 | 36.912±1.149 |

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| Total delivered Dose (μg) | Albuterol Sulfate (5 mg/2.5 ml) | 2418.382±90.219 | 2131.073±210.711 | 2562.202±150.856 | 1788.603±272.194 |
| --- | --- | --- | --- | --- | --- |
| | Ipratropiμm Bromide (0.5 mg/2 ml) | 225.607±6.35 | 260.75±14 | 249.133±3.845 | 221.123±26.449 |
| | Budesonide (0.5 mg/2 ml) | 166.098±3.573 | 199.13±5.564 | 196.392±3.13 | 171.383±17.566 |
| Total delivered Dose fraction (%) | Albuterol Sulfate (5 mg/2.5 ml) | 46.227±1.75 | 40.801±4.143 | 49.063±2.955 | 34.316±5.245 |
| | Ipratropiμm Bromide (0.5 mg/2 ml) | 41.066±1.176 | 48.1±3.044 | 45.427±0.695 | 40.534±4.349 |
| | Budesonide (0.5 mg/2 ml) | 31.225±0.606 | 37.472±1.072 | 37.024±0.537 | 32.058±3.425 |
| Coarse Particle Fraction (%)(>4.7μm) | Albuterol Sulfate (5 mg/2.5 ml) | 35.924±2.212 | 45.607±2.486 | 42.39±0.981 | 39.467±4.121 |
| | Ipratropiμm Bromide (0.5 mg/2 ml) | 35.232±0.613 | 47.06±5.886 | 44.926±0.698 | 43.487±2.044 |
| | Budesonide (0.5 mg/2 ml) | 54.669±1.372 | 72.054±5.274 | 63.702±0.144 | 67.192±0.865 |
| Fine Particle Fraction (%) (<4.7μm) | Albuterol Sulfate (5 mg/2.5 ml) | 64.076±2.212 | 54.393±2.486 | 57.61±0.981 | 60.533±4.121 |
| | Ipratropiμm Bromide (0.5 mg/2 ml) | 64.77±0.612 | 52.94±5.886 | 55.074±0.698 | 56.513±2.044 |
| | Budesonide (0.5 mg/2 ml) | 45.333±1.373 | 27.946±5.274 | 36.298±0.144 | 32.808±0.865 |
| Ultra-Fine Particle Fraction (%) (<1.0μm) | Albuterol Sulfate (5 mg/2.5 ml) | 5.891±0.795 | 3.207±0.351 | 4.806±0.133 | 4.26±0.435 |
| | Ipratropiμm Bromide (0.5 mg/2 ml) | 5.093±0.416 | 2.456±1.207 | 4.006±0.252 | 2.932±0.23 |
| | Budesonide (0.5 mg/2 ml) | / | / | / | / |

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Pediatric condition

| Test items | Drug | Subject Device (JOYTECH NB-1103) with child mask | Predicate device (OMRON NE-C801) with child mask | Subject Device (JOYTECH NB-1103) with Mouthpiece | Predicate device (OMRON NE-C801) with Mouthpiece |
| --- | --- | --- | --- | --- | --- |
| MMAD(μm) | Albuterol Sulfate (5 mg/2.5 ml) | 3.651±0.126 | 4.313±0.355 | 3.707±0.113 | 4.475±0.275 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 3.727±0.045 | 4.464±0.365 | 3.846±0.076 | 4.521±0.36 |
| | Budsonide (0.5 mg/2 mel) | 5.249±0.036 | 5.82±0.411 | 5.757±0.029 | 6.248±0.373 |
| GSD | Albuterol Sulfate (5 mg/2.5 ml) | 2.253±0.023 | 2.066±0.052 | 2.361±0.028 | 2.141±0.011 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 2.257±0.037 | 2.093±0.045 | 2.381±0.021 | 2.129±0.027 |
| | Budesonide (0.5 mg/2 ml) | 2.082±0.032 | 1.946±0.039 | 2.139±0.02 | 1.999±0.023 |
| Respirable Dose(μg) | Albuterol Sulfate (5 mg/2.5 ml) | 999.897±53.773 | 981.97±130.406 | 1298.691±62.27 | 1008.827±116.221 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 90.589±7.122 | 113.967±14.919 | 128.632±3.083 | 106.836±13.229 |
| | Budesonide (0.5 mg/2 ml) | 51.307±3.217 | 55.097±4.08 | 56.223±0.77 | 50.723±8.793 |
| Respirable fraction | Albuterol Sulfate (5 mg/2.5 ml) | 64.296±1.681 | 57.134±4.819 | 62.503±1.297 | 54.422±3.494 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 63.278±0.395 | 55.054±4.774 | 60.641±1.078 | 54.084±4.865 |
| | Budesonide (0.5 mg/2 ml) | 45.429±0.443 | 37.724±4.958 | 39.103±0.225 | 33.385±3.354 |
| Total delivered Dose (μg) | Albuterol Sulfate (5 mg/2.5 ml) | 1554.763±66.546 | 1721.173±331.733 | 2081.438±132.873 | 1855.027±279.931 |
| | Ipratropium Bromide (0.5 mg/2 ml) | 143.129±10.902 | 207.123±28.684 | 212.202±5.762 | 197.53±16.536 |

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| | Budesonide (0.5 mg/2 ml) | 112.976±7.384 | 146.303±20.144 | 143.774±1.357 | 151.83±13.266 |
| --- | --- | --- | --- | --- | --- |
| Total delivered Dose fraction (%) | Albuterol Sulfate (5 mg/2.5 ml) | 29.758±1.286 | 32.967±6.141 | 39.856±2.599 | 35.502±5.346 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 26.156±1.969 | 37.898±5.327 | 38.586±1.084 | 35.898±3.328 |
| | Budesonide (0.5 mg/2 ml) | 21.305±1.372 | 27.55±3.912 | 27.236±0.343 | 28.845±2.019 |
| Coarse Particle Fraction (%)(>4.7μm) | Albuterol Sulfate (5 mg/2.5 ml) | 38.54±1.74 | 46.27±4.824 | 40.247±1.363 | 48.871±3.508 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 39.612±0.434 | 48.266±4.606 | 42.12±0.969 | 49.191±4.684 |
| | Budesonide (0.5 mg/2 ml) | 58.453±0.481 | 66.472±4.87 | 64.547±0.227 | 70.463±3.126 |
| Fine Particle Fraction (%)(<4.7μm) | Albuterol Sulfate (5 mg/2.5 ml) | 61.461±1.741 | 53.73±4.824 | 59.753±1.363 | 51.129±3.508 |
| | Ipratropium Bromide(0.5 mg/2 ml) | 60.389±0.433 | 51.734±4.606 | 57.881±0.968 | 50.809±4.684 |
| | Budesonide (0.5 mg/2 ml) | 41.547±0.481 | 33.528±4.87 | 35.454±0.227 | 29.537±3.126 |
| Ultra-Fine Particle Fraction (%)(<1.0μm) | Albuterol Sulfate (5 mg/2.5 ml) | / | / | / | / |
| | Ipratropium Bromide(0.5 mg/2 ml) | / | / | / | / |
| | Budesonide (0.5 mg/2 ml) | / | / | / | / |

Note: "/" means that the raw data is below the detection limit LOD and cannot be calculated

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8. Non-Clinical tests summary

The following performance data were provided in support of the substantial equivalence determination.

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:

- ANSI AAMI ES60601-1:2005/(R)2012 &amp; A1:2012, C1:2009/(R)2012 &amp; A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Particle Size characterization testing:

Particle characterization testing was performed on the subject device with both proposed patient interface and on the predicate per FDA guidance “Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators” (FDA/CDRH – 1993).

Biocompatibility testing

According to FDA's 2023 Guidance entitled, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the following biological compatibility test need to be executed as follow:

In Vitro Cytotoxicity Test -ISO10993-5
Skin Sensitization Test(polar and non polar) -ISO10993-10
Intracutaneous Reactivity Test-ISO10993-23
Acute Systemic Toxicity Test (polar and non polar) -ISO10993-11
Material-mediated pyrogens Test -ISO10993-11
Bacterial Reverse Mutation Assay --ISO10993-3
In Vitro Mammalian Chromosomal Aberration test --ISO10993-3
Subacute systemic Toxicity Test (polar and non polar) -ISO10993-11
Subcutaneous Implantation Test -ISO10993-6
Chemical characterization study- ISO10993-18
Toxicological risk assessment study-ISO10993-17

9 / 10

{13}

Biocompatibility evaluation- ISO 18562-1
Test for emissions of particulate matter - ISO 18562-2
Test for emissions of VOCs -ISO 18562-3

## Device life testing
Device life were tested with simulation method, the device meets the applicable requirements.

## 9. Clinical Tests
Not applicable.

## 10. Conclusion
Substantial equivalence comparisons, performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.

10 / 10