(287 days)
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.
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 pertain to a "Compressor Nebulizer" and a "Heated Breathing Tube," but the main body of the 510(k) summary and the comparative particle test tables focus on the "Compressor Nebulizer" (Model NB-1100, NB-1101, NB-1102, NB-1103) and its predicate "NE-C801 Nebulizer Compressor System." The "Heated Breathing Tube" mentioned in the clearance letter is inconsistent with the detailed submission summary. Therefore, the analysis will focus on the Compressor Nebulizer (JOYTECH NB-1103).
Based on the provided document, the acceptance criteria are implicitly derived from the comparative particle test results between the subject device (JOYTECH NB-1103) and the predicate device (OMRON NE-C801). The study aims to demonstrate substantial equivalence by showing that the differences in technological characteristics do not raise different questions of safety or effectiveness. The core of this demonstration lies in the comparative aerosol performance data.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a "pass/fail" format. Instead, it presents a comparison table and concludes that the devices are "Equivalent" or "Similar" for various parameters. For the aerosol performance metrics, the implication is that the subject device's performance should be comparable to, or within an acceptable range of, the predicate device's performance across different drug types and patient interfaces.
Given the structure, the reported device performance is the reported data in the comparative particle test tables. The "acceptance criteria" are implicitly that the subject device's performance metrics (MMAD, GSD, Respirable Dose, Respirable fraction, Total delivered Dose, Total delivered Dose fraction, Coarse Particle Fraction, Fine Particle Fraction, Ultra-Fine Particle Fraction) are comparable to (i.e., not significantly worse than) the predicate device.
Key Performance Metrics for Aerosol Performance (Based on Comparative Particle Test)
| Acceptance Criteria Category | Specific Metric | Predicate Device (OMRON NE-C801) Performance (Adult Mask, Albuterol Sulfate) | Subject Device (JOYTECH NB-1103) Performance (Adult Mask, Albuterol Sulfate) | Comparison Result/Implicit Acceptance |
|---|---|---|---|---|
| Aerosol Particle Size Distribution | MMAD (μm) | 4.173±0.126 | 3.466±0.173 | Subject device has smaller MMAD, potentially better penetration. Considered "Equivalent." |
| GSD | 1.845±0.046 | 1.988±0.033 | Slightly higher GSD for subject device, indicating a wider particle size distribution. Considered "Equivalent." | |
| Coarse Particle Fraction (%) (>4.7μm) | 45.607±2.486 | 35.924±2.212 | Subject device has lower coarse particle fraction. Considered "Equivalent." | |
| Fine Particle Fraction (%) (<4.7μm) | 54.393±2.486 | 64.076±2.212 | Subject device has higher fine particle fraction. Considered "Equivalent." | |
| Ultra-Fine Particle Fraction (%) (<1.0μm) | 3.207±0.351 | 5.891±0.795 | Subject device has higher ultra-fine particle fraction. Considered "Equivalent." | |
| Drug Delivery Efficiency | Respirable Dose (μg) | 1239.14±150.674 | 1628.633±99.49 | Subject device delivers more respirable dose. Considered "Equivalent." |
| Respirable fraction | 58.136±2.583 | 67.273±2.066 | Subject device has higher respirable fraction. Considered "Equivalent." | |
| Total delivered Dose (μg) | 2131.073±210.711 | 2418.382±90.219 | Subject device delivers more total dose. Considered "Equivalent." | |
| Total delivered Dose fraction (%) | 40.801±4.143 | 46.227±1.75 | Subject device has higher total delivered dose fraction. Considered "Equivalent." |
Note: The table above uses Albuterol Sulfate with an adult mask as an example condition. Similar comparisons are presented in the document for other drugs (Ipratropium Bromide, Budesonide), patient interfaces (mouthpiece), and pediatric conditions. The consistent conclusion (Explicitly stated in the document: "Equivalent") across these detailed comparisons serves as the overall acceptance criteria for aerosol performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Table: Comparative particle test comparison" and provides mean values with standard deviations (e.g., 3.466±0.173). This indicates that each reported value is the result of multiple measurements. However, the exact sample size (e.g., number of runs, 'n' for each mean and standard deviation calculation) for the particle characterization testing is not explicitly stated in the provided text.
The data provenance is not mentioned. It is a non-clinical test conducted for regulatory submission rather than a clinical study with patient data origins.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of testing (particle size characterization) is generally conducted in a laboratory setting using specialized equipment (e.g., cascade impactors) and established protocols (e.g., USP <1601> or <1602>). It does not involve human experts establishing a "ground truth" in the way a diagnostic imaging study would. The data generated is objective, quantitative measurements of aerosol properties by an instrument. Therefore, this question is not applicable to the type of non-clinical study described.
4. Adjudication Method for the Test Set
Since the ground truth is established through objective laboratory measurements rather than human interpretation, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical laboratory comparison of aerosol performance between the subject device and a predicate device. It assesses the physical characteristics of the aerosol produced, not human reader performance with or without AI assistance. This question is not applicable to this type of device and study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question typically applies to AI/software as a medical device (SaMD). The device in question is a Compressor Nebulizer, a physical medical device. Therefore, a standalone algorithm-only performance assessment is not applicable. The performance tested is the physical device's ability to generate aerosols.
7. The Type of Ground Truth Used
The ground truth for the device's performance (specifically aerosol characteristics) is established by objective, quantitative laboratory measurements of particle size, distribution, and drug delivery efficiency, as obtained using standard analytical methods (e.g., based on FDA guidance and potentially pharmacopeial standards for aerosol drug delivery systems). This is presented as "Particle Size characterization testing" on Page 13.
8. The Sample Size for the Training Set
The document describes non-clinical testing for a physical device, comparing its performance to a predicate device. There is no mention of a training set as this is not a machine learning or AI-based device. This question is not applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, this question is not applicable.
FDA 510(k) Clearance Letter - K243244
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
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"
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
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
Page 4
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.
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FORM FDA 3881 (8/23) 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.
Page 6
- 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 |
Page 7
| ITEM | Proposed Device | Predicate Device | Comparison Result |
|---|---|---|---|
| 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 |
Page 8
| ITEM | Proposed Device | Predicate Device | Comparison Result |
|---|---|---|---|
| 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.
Page 9
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 |
Page 10
| 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 |
|---|---|---|---|---|---|
| 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) | / | / | / | / |
Page 11
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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| 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 |
|---|---|---|---|---|---|
| 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.
§ 868.5270 Breathing system heater.
(a)
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.(b)
Classification. Class II (performance standards).