(236 days)
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 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.
- 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.
The provided FDA 510(k) clearance letter and summary for JOYTECH Healthcare Co., Ltd.'s Compressor Nebulizer (K243468) primarily details the substantial equivalence of the new device to a predicate device, focusing on non-clinical performance testing, specifically particle size characterization.
It's important to note that this document does not describe a study involving human subjects or artificial intelligence (AI). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications for a nebulizer, evaluated through laboratory testing against a predicate device and relevant standards. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, adjudication methods, and training sets for algorithms are not applicable to this specific device clearance.
Below is an interpretation of the provided information within the framework of your request, focusing on the relevant parts and explicitly stating where information is not available or not applicable.
Acceptance Criteria and Device Performance for JOYTECH Compressor Nebulizer (K243468)
The acceptance criteria for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (Omron Compressor Nebulizer Systems NE-C801, K110860) and by meeting relevant performance standards, particularly regarding aerosol particle characterization. The 'study' proving this is primarily the "Particle Size characterization testing" detailed in the submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by performing "comparative particle test comparison" against the predicate device. The goal is to show that the proposed device performs similarly or equivalently to the predicate across key aerosolization parameters. The performance data provided is the direct result of this testing.
Table: Comparative Particle Test Comparison (Summary of Select Parameters)
| Test Item | Endpoint (Acceptance Criteria Implicitly Compared to Predicate) | Subject Device (JOYTECH NB-1103) Performance (Range across drugs/interfaces) | Predicate Device (OMRON NEC801) Performance (Range across drugs/interfaces) | Comparison Result (as per Submitter) |
|---|---|---|---|---|
| MMAD ($\mu$m) | Particle size distribution suitable for inhalation therapy, comparable to predicate. | 3.413 - 5.757 | 3.7 - 6.248 | Equivalent / Similar |
| GSD | Particle size distribution uniformity, comparable to predicate. | 1.764 - 2.381 | 1.605 - 2.141 | Equivalent / Similar |
| Respirable Dose ($\mu$g) | Amount of drug delivered in respirable range, comparable to predicate. | 51.307 - 1628.633 | 50.723 - 1239.14 | Equivalent / Similar |
| Respirable Fraction (%) | Proportion of aerosolized drug in respirable range, comparable to predicate. | 39.103 - 67.958 | 31.781 - 63.741 | Equivalent / Similar |
| Total Delivered Dose ($\mu$g) | Total amount of drug delivered, comparable to predicate. | 112.976 - 2562.202 | 146.303 - 2131.073 | Equivalent / Similar |
| Total Delivered Dose Fraction (%) | Proportion of initial drug dose delivered, comparable to predicate. | 21.305 - 49.063 | 27.55 - 40.801 | Equivalent / Similar |
| Fine Particle Fraction (%) (<4.7$\mu$m) | Percentage of particles less than 4.7 $\mu$m, comparable to predicate. | 35.454 - 64.77 | 27.946 - 60.533 | Equivalent / Similar |
| Coarse Particle Fraction (%) (>4.7$\mu$m) | Percentage of particles greater than 4.7 $\mu$m, comparable to predicate. | 35.232 - 64.547 | 39.467 - 72.054 | Equivalent / Similar |
| Ultra-Fine Particle Fraction (%) (<1.0$\mu$m) | Percentage of particles less than 1.0 $\mu$m, comparable to predicate. | Ranges provided are minimal/absent for Budesonide, otherwise 4.006-5.891 | Ranges provided are minimal/absent for Budesonide, otherwise 2.456-4.26 | Equivalent / Similar |
Note: The ranges represent the lowest and highest values across the tested drugs (Albuterol Sulfate, Ipratropium Bromide, Budesonide) and patient interfaces (adult mask, child mask, mouthpiece) for both adult and pediatric conditions. The "Comparison Result" is the submitter's statement from the document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The tables show mean and standard deviation values for each parameter, implying multiple measurements were taken for each drug and interface combination. However, the exact number of replicates (sample size for each data point in the tables) is not explicitly stated in the provided text. It is typically standard practice in such testing to perform a minimum of triplicate measurements.
- Data Provenance: The data is generated from laboratory performance testing of the device and its predicate. This is a non-clinical study.
- Country of Origin: The manufacturer, JOYTECH Healthcare Co., Ltd., is located in Hangzhou City, Zhejiang, China. The predicate manufacturer, Omron Healthcare, Incorporated, is typically based in Japan with a strong presence in the US. The testing itself would have been conducted in a certified lab, likely in China or an associated region.
- Retrospective or Prospective: This is prospective laboratory testing conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This study does not involve expert interpretation of medical images or patient data to establish a ground truth. Instead, it involves physical and chemical measurements (particle size and drug delivery) performed on the nebulizer using standardized laboratory methods outlined in FDA guidance and relevant ISO standards (e.g., ISO 18562 series). The "ground truth" is derived from these objective measurements and comparison to the predicate's performance.
4. Adjudication Method for the Test Set
Not applicable. As this is laboratory performance testing, there's no "adjudication" in the sense of reconciling human expert opinions. The results are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a medical device for drug delivery, not an AI diagnostic or assistive tool for human readers. Therefore, there is no human-in-the-loop performance to improve with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is hardware (a compressor nebulizer), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing is objective physical and chemical measurement data obtained through standardized laboratory protocols (e.g., cascade impaction for particle sizing, chemical analysis for drug quantity) rather than expert consensus, pathology, or outcomes data. The acceptability is determined by evaluating if these measurements are comparable to the well-established performance of a predicate device already on the market and align with general principles for effective nebulizer function.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or "ground truth" in the context of an AI model for this device.
FDA 510(k) Clearance Letter - JOYTECH Healthcare Co., Ltd.
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 2, 2025
JOYTECH Healthcare Co., Ltd.
℅ Jie Yang
Consultant
Chonconn Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen, Guangdong 518067
China
Re: K243468
Trade/Device Name: Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: June 6, 2025
Received: June 6, 2025
Dear Jie Yang:
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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K243468 - Jie Yang 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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K243468 - Jie Yang Page 3
Sincerely,
John S. Bender -S
2025.07.02 14:09:29 -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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K243468
Device Name
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
Indications for Use (Describe)
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.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
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: jingc@sejoy.com
Tel: +86-571-81957767
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: yangjie@chonconn.com
Tel: +86-755 33941160
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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2 / 10
- 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 DeviceCompressor NebulizerNB-1100, NB-1101, NB-1102, NB-1103K243468 | Predicate DeviceOmron Compressor Nebulizer Systems NE-C801K110860 | 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 compressorWall 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 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 6060 1-1IEC 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℃ to 40℃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℃ to 60℃10% to 95% RH | Similar |
| Dimensions (mm) | 267.9 mm × 157.3 mm × 104.6 mm170.2 mm × 144.4 mm × 117.9 mm246.3 mm × 121.6 mm × 148.5 mm286 mm × 154 mm × 134.5 mm | 142(W) x 72(D) x 98(H) | Similar |
| Weight(kg) | 1.554kg1.238kg1.413kg1.57kg | 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 NEC801) with adult mask | Subject Device (JOYTECH NB-1103) with Mouthpiece | Predicate device (OMRON NEC801) 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 |
|---|---|---|---|---|---|
| Ipratropium 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 |
| Ipratropium 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 |
| Ipratropium 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 |
| Ipratropium 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 |
| Ipratropium 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 NEC801) with child mask | Subject Device (JOYTECH NB-1103) with Mouthpiece | Predicate device (OMRON NEC801) 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 | |
| Budesonide (0.5 mg/2 ml) | 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 & A1:2012, C1:2009/(R)2012 & 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
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- 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.
§ 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).