Ultrasonic Mesh Nebulizer
Device Facts
| Record ID | K201397 |
|---|---|
| Device Name | Ultrasonic Mesh Nebulizer |
| Applicant | Shenzhen Ivankaca Technology Co., Ltd. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jun 14, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine.
Device Story
Portable, battery-powered vibrating mesh nebulizer; delivers aerosolized medication to lower respiratory tract. Input: liquid medication in 8ml capacity cup. Operation: 3.7V DC lithium battery powers circuit; piezoelectric ceramic vibrates at ~110kHz; high-speed vibration of metal mesh plate forces liquid through micro-holes to create low-velocity aerosol. Output: fine aerosol particles delivered via mask or mouthpiece. Used in home, hospital, or sub-acute settings by patients or clinicians. Healthcare providers use device to administer prescribed respiratory medications; output affects clinical decision-making by enabling targeted pulmonary drug delivery. Benefits: portable, efficient medication delivery for respiratory conditions.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), electrical safety/EMC, software validation, and particle size distribution testing using Salbutamol, Budesonide, and Ipratropium bromide.
Technological Characteristics
Vibrating mesh nebulizer; 3.7V DC internal lithium battery; 110kHz vibration frequency. Materials: PP1120, TPE (TE-KJ3025TM), PC2456, Silicone GA1053, Stainless 304. Dimensions: ~42-49mm(L) x 47-56mm(W) x 109-120mm(H). Connectivity: USB charging. Software: Moderate level of concern. Standards: ISO 10993-1, ISO 18562, AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11.
Indications for Use
Indicated for pediatric (>4 years) and adult patients requiring aerosolized liquid medication inhalation in home, hospital, and sub-acute care settings. Not for use with Pentamidine.
Regulatory Classification
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.
Predicate Devices
- Intelligent Mesh Nebulizer (model: NEB002) (K171549)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Shenzhen Ivankaca Technology Co., Ltd % Long Yang Coo Shenzhen Hlongmed Biotech Co., Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C Shenzhen, 518054 Cn
Re: K201397
Trade/Device Name: Ultrasonic Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: June 14, 2021 Received: June 14, 2021
### Dear Long 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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Brandon Blakely, PhD Acting Assistant Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia 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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# Indications for Use
510(k) Number (if known) K201397
Device Name Ultrasonic Mesh Nebulizer
Indications for Use (Describe)
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: line-through;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(K) number is: Date of Summary: 2021.6.2
#### 1. Submitter information
Manufacturer Name: Shenzhen Ivankaca Technology Co.,Ltd
Address: 3/F, Building B, No.45 lixin road, NanWan, Longgang, Shenzhen, Guangdong, China
Contact Person and Title: Sam WONG/General manager
Tel: 0086- 755-28510161
Fax: 0086- 755-28510161
Email: 798401644@qq.com
Date Prepared: June 2, 2021
### 2. Contact person
#### 2.1 Primary Contact Person
Long Yang (COO)
Shenzhen Hlongmed Biotech Co.,Ltd
1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
#### 2.2 Secondary Contact Person
Sam WONG/General manager Shenzhen Ivankaca Technology Co.,Ltd Tel: 0086- 755-28510161
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### 3. Proposed device
| Type of 510(k) submission | Traditional |
|---------------------------|--------------------------------------|
| Trade Name name | Ultrasonic Mesh Nebulizer |
| Common Name | Nebulizer |
| Model(s) | MY-123, MY-125, MY-126 |
| Classification Name | Nebulizer (Direct Patient Interface) |
| Classification | II |
| Review Panel | Anesthesiology |
| Product Code | CAF |
| Regulation Class | II |
| Regulation Number | 21 CFR 868.5630 |
### 4. Predicate device
### 510(k) Number:
K171549
### Predicate Device Name:
Intelligent Mesh Nebulizer (model: NEB002)
#### Manufacturer:
Qingdao Future Medical Technology Co., Ltd
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
### 5. Description of Proposed Device
The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.
The proposed devices are portable size, curvaceous body design that is convenient to hold, Which are battery powered, 3.7V d.c. internally lithium battery. The medication
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container capacity is 8ml maximum.
For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liguid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system.
There are 3 models included, MY-123/MY-125/ the three models have same intended use, mechanism of action, principle and specification. The difference between three models is appearance.
The proposed devices have the components shown as following illustration:
Image /page/5/Figure/4 description: The image shows two diagrams of a device labeled "MY-123" with various parts labeled. The diagrams show the main unit, atomizing cup, mesh plate, lock, indicator light, on/off button, USB charging port, and the back from the main unit. There is also a diagram of the bottom of the main unit.
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Image /page/6/Figure/0 description: The image shows the text 'MY-125' in a simple, sans-serif font. The text is arranged horizontally, with 'MY' followed by a hyphen and then the number '125'. The text is black against a white background, providing a clear contrast.
Image /page/6/Figure/1 description: The image shows a diagram of a device with several labeled parts. The parts include a mesh plate, main unit, on/off button, indicator light, lock, atomizing cup, back from main, USB charging port, and bottom from main unit. The diagram shows the device from different angles to highlight the different parts.
MY-126
## Figure 1 Device Components illustration
The contents provided in the Table are description about the components.
| Main Unit | Provide electricity |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Atomizing<br>Cup | filled with medicine liquid |
| Mesh Plate | Create low velocity aerosol |
| ON/OFF<br>button | ON/OFF the nebulizer<br>Press the ON/OFF button for 3s to turn on the power and press turn off<br>again;<br>The nebulizer will shut down automatically after 5min operation. Press<br>on /off for 3S to start the machine when it is still in use |
| Indicator<br>light | Blue light on when the nebulizer works regularly;<br>Automatic turn off after blue light flashes when the battery is running<br>out electricity;<br>Blue lights flicker on when charging regularly;<br>Green light on while finishing charging; |
| USB<br>interface | Connect the nebulizer with the USB cable to 5Vd.c 1.0A min.<br>power supply to recharge . |
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| Mask | Transport the aerosol to patient's respiratory<br>system. |
|------------|-----------------------------------------------------------|
| Mouthpiece | Transport the aerosol to patient's respiratory<br>system. |
### Table 1 Main Components of Device introduction
The associated accessories include Mouthpiece, Adult Mask, Pediatric Mask, USB charging cable.
### 6. Intended Use/ Indications for Use
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
### 7. Technological Characteristics and Substantial Equivalence
| Item | Subject Device | Predicate device | Remark |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| General Comparison | | | |
| K | / | K171549 | / |
| Sponsor | Shenzhen Ivankaca Technology<br>Co.,Ltd | Qingdao Future Medical Technology<br>Co., Ltd | / |
| Trade/Device<br>Name | Ultrasonic Mesh Nebulizer | Intelligent Mesh Nebulizer | / |
| Model(s) | MY-123<br>MY-125<br>MY-126 | NEB002 | / |
| Regulation<br>Number | 21 CFR 868.5630 | 21 CFR 868.5630 | same |
| Regulation<br>Name | Nebulizer | Nebulizer | same |
| Classification<br>Name | Nebulizer (Direct Patient Interface) | Nebulizer (Direct Patient Interface) | same |
| Regulatory<br>Class | Class II | Class II | same |
| Product Code | CAF | CAF | same |
| Review Panel | Anesthesiology | Anesthesiology | same |
| Intended<br>Use/<br>Indications<br>for Use | The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine. | The Intelligent Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age) and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine. | same |
| Prescription/<br>OTC | Prescription | Prescription | same |
| Performance Comparison | | | |
| Lithium<br>battery | 3.7Vd.c. | 3.7Vd.c. | Same |
| Nebulizing<br>Method | Vibrating Mesh | Vibrating Mesh | same |
| Vibration<br>Frequency | Approx. 110KHz | Approx. 110KHz | same |
| Nebulization<br>Rate/Aerosol<br>Flow rate | 0.2ml/min minimum | 0.2ml/min minimum | same |
| Medicine<br>Capacity | 8ml maximum,0.5ml minimum | 8ml maximum,0.5ml minimum | same |
| Nebulizer<br>Components<br>Cleanable | Yes | Yes | same |
| Use | Single Patient | Single Patient | same |
| Patient<br>Connector | Mouthpiece or mask | Mouthpiece or mask | same |
| Dimensions<br>(mm) | Approx.<br>42(L)x55(W)x109(H)mm(MY-123)<br>49(L)x56(W)x120(H)mm(MY-125)<br>45(L)x47(W)x120(H)mm(MY-126) | 50mm(L)×74mm(W)×111mm(H) | different |
| Weight (kg) | MY-123:113±5g<br>MY-125:116±5g | Approx.106g | different |
| | MY-126: 110±5g | | |
| Operating<br>Conditions | 5°C to 40°C, 15% to 90% RH | 5°C to 40°C, 15% to 90% RH | same |
| Storage<br>Conditions | -25°C to 70°C, ≤90% RH | -25°C to 70°C, ≤90% RH | same |
| Safety Comparison | | | |
| Patient<br>Contact<br>Materials | PVC | PVC | same |
| Cytotoxicity<br>Sensitization<br>Irritation | Comply with 10993-1 | Comply with 10993-1 | same |
| Electrical<br>safety | Comply with 60601-1 | Comply with 60601-1 | same |
| EMC | Comply with 60601-1-2 | Comply with 60601-1-2 | same |
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Comparative particle test comparison can be refer to the following table:
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| Item | Subject Device | | | Subject Device | | | Subject Device | | | Intelligent Mesh Nebulizer (model:<br>NEB002) -K171549 | | |
|----------------------------------------|--------------------------|---------------------------|------------------------|--------------------------|---------------------------|------------------------|--------------------------|---------------------------|------------------------|--------------------------------------------------------|---------------------------|------------------------|
| | Mouthpiece | | | Small mask | | | Big mask | | | Big mask | | |
| | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide |
| MMAD(µm) | 3.68±0.68 | 3.28±0.08 | 3.84 ± 0.66 | 3.75±0.63 | 3.25±0.11 | 3.85 ± 0.66 | 3.72±0.65 | 3.31±0.10 | 3.88 ± 0.68 | 3.70±0.66 | 3.29±0.12 | 3.87 ± 0.72 |
| GSD | 1.84±0.03 | 2.44±0.02 | 1.83 ± 0.035 | 1.86±0.05 | 2.46 ± 0.025 | 1.84 ± 0.035 | 1.82 ± 0.035 | 2.48 ± 0.031 | 1.84 ± 0.032 | 1.85±0.04 | 2.50 ± 0.033 | 1.81 ± 0.03 |
| Respirable<br>fraction<br>1 - 5 µm | 63.5% ± 10.5 | 61.7% ± 10.5 | 62.4% ± 10.6 | 63.8% ± 11.8 | 60.8 % ± 11.6 | 63.4% ± 11.3 | 64.5% ± 10.2 | 58.8% ± 10.2 | 64.5% ± 11.9 | 62.8% ± 11.3 | 57.6% ± 9.8 | 63.8% ± 11.6 |
| Coarse particle<br>fraction >5 µm | 36.1% ± 11.3 | 29.1% ± 11.3 | 36.2% ± 12.1 | 33.4% ± 13.0 | 27.4% ± 13.0 | 35.4% ± 12.2 | 38% ± 10.8 | 30.5% ± 12.3 | 33.8% ± 12.4 | 37.2% ± 12.3 | 31.6% ± 11.9 | 34.4% ± 12.3 |
| Fine particle<br>fraction (FPF<5 µm) | 65.4% ± 11.4 | 70.9% ± 11.3 | 63.8% ± 12.1 | 64.8% ± 12.6 | 69.6% ± 13.0 | 64.6% ± 12.2 | 66.6% ± 13.0 | 69.5% ± 10.3 | 66.2% ± 12.4 | 67.7% ± 10.2 | 68.4% ± 10.8 | 65.6% ± 12.3 |
| Ultra-fine particle<br>fraction <1 µm | 2.7% ± 0.9 | 9.2% ± 0.8 | 1.79% ± 0.6 | 2.2% ± 0.8 | 8.8% ± 1.2 | 1.77% ± 0.5 | 2.8% ± 1.2 | 7.2% ± 0.9 | 1.8% ± 0.6 | 3.2% ± 0.6 | 7.5% ± 1.1 | 1.78% ± 0.6 |
| Item | Subject Device | | | Subject Device | | | Subject Device | | | Intelligent Mesh Nebulizer (model NEB002) -K171549 | | |
| | Mouthpiece | | | Small mask | | | Big mask | | | Big mask | | |
| | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide |
| residual (%) | 29.6% ±<br>5.2 | 26.9% ±<br>5.8 | 23.8% ±<br>3.53 | 28.6% ±<br>4.4 | 24.3% ±<br>5.4 | 23.6% ±<br>3.52 | 30.8% ±<br>5.8 | 24.17% ±<br>4.82 | 24.5% ±<br>3.58 | 31.5% ±<br>4.66 | 24.42% ±<br>4.96 | 26.3% ±<br>3.61 |
| rate of recovery (%) | 93.3% ±<br>3.66 | 96.4% ±<br>4.83 | 91.7% ±<br>4.52 | 91.7% ±<br>4.52 | 95.87% ±<br>3.85 | 92.6% ±<br>2.83 | 92.6% ±<br>2.83 | 95.07% ±<br>2.52 | 92.6% ±<br>2.83 | 91.2% ±<br>4.28 | 94.86% ±<br>2.65 | 93.3% ±<br>3.66 |
| Aerosol output and aerosol output rate | 1.94 ±<br>0.02 | 1.86 ±<br>0.011 | 1.94 ±<br>0.02 | 1.93 ±<br>0.05 | 1.88 ±<br>0.01 | 1.94 ±<br>0.02 | 1.95 ±<br>0.01 | 1.87 ±<br>0.01 | 1.93 ±<br>0.03 | 1.96 ±<br>0.01 | 1.85 ±<br>0.012 | 1.92 ±<br>0.02 |
| Aerosol output (ml)a | | | | | | | | | | | | |
| Aerosol output rate (ml/min)b | 0.29 ±<br>0.02 | 0.27 ±<br>0.02 | 0.35 ±<br>0.02 | 0.30 ±<br>0.03 | 0.28 ±<br>0.02 | 0.34 ±<br>0.02 | 0.32 ±<br>0.03 | 0.28 ±<br>0.02 | 0.35 ±<br>0.02 | 0.32 ±<br>0.03 | 0.26 ±<br>0.02 | 0.33 ±<br>0.02 |
| Dead volume (ml) | 0.06 ±<br>0.02 | 0.14 ±<br>0.011 | 0.06 ±<br>0.02 | 0.07 ±<br>0.05 | 0.12 ±<br>0.01 | 0.06 ±<br>0.02 | 0.05 ±<br>0.01 | 0.13 ±<br>0.01 | 0.07 ±<br>0.03 | 0.04 ±<br>0.01 | 0.15 ±<br>0.012 | 0.08 ±<br>0.02 |
| Respirable dose 1 - 5 um | 0.70ml ± | 0.758ml | 0.58ml | 0.71ml ± | 0.76ml ± | 0.59ml | 0.73ml ± | 0.78ml ± | 0.60ml | 0.72ml ± | 0.77ml ± | 0.58ml |
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| Item | Subject Device | | | Subject Device | | | Subject Device | | | Intelligent Mesh Nebulizer (model NEB002) -K171549 | | | | | |
|----------------|--------------------------|---------------------------|------------------------|--------------------------|---------------------------|------------------------|--------------------------|---------------------------|------------------------|----------------------------------------------------|---------------------------|------------------------|----------|--|--|
| | | | | | | | | | | | | | | | |
| | Mouthpiece | | | | Small mask | | | | Big mask | | | | Big mask | | |
| | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | Salbutamol<br>(Ventolin) | Budesonide<br>(Pulmicort) | Ipratropium<br>bromide | | | |
| | 0.11 | ±0.15 | ±0.11 | 0.12 | 0.20 | ±0.11 | 0.12 | 0.20 | ±0.12 | 0.12 | 0.18 | ±0.12 | | | |
| Delivered dose | 1.12ml ± 0.06 | 1.23ml ± 0.12 | 0.93ml ± 0.02 | 1.12ml ± 0.08 | 1.26ml ± 0.1 | 0.93ml ± 0.02 | 1.14ml ± 0.08 | 1.27ml ± 0.1 | 0.94ml ± 0.02 | 1.13ml ± 0.08 | 1.24ml ± 0.12 | 0.92ml ± 0.02 | | | |
a: Continue the treatment until the medicine cup is empty or the mist stops.
b: The treatment time for aerosol output rate is 1 min.
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### Analysis for difference:
The proposed devices have the same Intended Use, Classification, Nebulizing Method, Vibration Frequency, Aerosol Flow rate, Medicine Capacity, Operation and use with the predicate device.
The proposed devices have the similar specifications with the predicate device, such as dimensions ,Weight, based on the nonclinical tests performed, those minor differences for specifications do not effects the safety and effective of the device.
The proposed devices are substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject devices are as safe, as effective, and performs as well as the legally marketed predicate device.
### 8. Non-clinical Test conclusion
The following performance data were provided in support of the substantial equivalence determination.
#### a.Biocompatibility testing
The nebulizer's mouthpiece, Big mask, Small mask, Atomizing cup, Seal ring, Atomizing cup cover, nozzle.Mesh plate are patient-contacting device components.
| No | patient-contacting<br>device components | associated<br>construction<br>component | materials of<br>for each | If<br>additive<br>contained | color | patient-contact<br>classifications per ISO<br>10993-1 |
|----|-----------------------------------------|-----------------------------------------|--------------------------|-----------------------------|-------|-------------------------------------------------------|
| 1 | mouthpiece | PP1120 | | no | | ● Surface Contact |
| 2 | Big mask | PP1120<br>TPE(TE-KJ3025TM) | | no | | ● Mucosal membrane<br>● Duration of Use(> 30 days) |
| 3 | Small mask | PP1120<br>TPE(TE-KJ3025TM) | | no | | |
| 4 | Atomizing cup | PC2456 | | no | | ● External |
| 5 | Seal ring | Silicone GA1053 | | no | | Communicating |
| 6 | Atomizing cup cover | PC2456 | | no | | (Indirect gas |
| 7 | nozzle | PC2456 | | no | | pathway) |
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| 8 | Mesh plate | Stainless304 | no | Tissue / Bone / Dentin communicating Duration of Use(> 30 days) |
|---|------------|--------------|----|-----------------------------------------------------------------|
|---|------------|--------------|----|-----------------------------------------------------------------|
A biocompatibility evaluation for the proposed device was conducted in accordance with FDA ' s 2020 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 evaluation included the following tests:
- In Vitro Cytotoxicity Test -ISO10993-5 A
- A Skin Sensitization Test(polar and non polar ) -ISO10993-10
- > Intracutaneous Reactivity Test-ISO10993-10
- A Acute Systemic Toxicity Test (polar and non polar) -ISO10993-11
- > Ames Test (polar and DMSO Extract)--ISO10993-3
- A In Vitro Mammalian Chromosomal Aberration test --ISO10993-3
- A Mammalian Erythrocyte Micronucleus Test(polar and non polar) --ISO10993-3
- A Subcutaneous Implantation Test--ISO10993-6
- A Test for emissions of VOCs and aldehydes-ISO 18562-3
- A Test for emissions of particulate matter ozone CO2 and CO- ISO 18562-2
- A Biocompatibility evaluation- ISO 18562-1
Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of safety regarding their use as intended.
#### b. 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:
- > AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005,
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- A IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11:2015 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
#### c. Software Verification and Validation Testing
The software for this device is of a "moderate" level of concern,Verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA 's Guidance , " Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1, 2005".
d. Simulated shelf life testing, battery cycle life testing
e. Cleaning and Disinfection Validation
#### f. human factors validation testing
g. Particle size distribution testing per Section VII of the FDA Guidance: Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, and three kind of drugs used for each testing. Salbutamol (Ventolin), Budesomide (Pulmicort) , Ipratropium bromide.
#### 9. Clinical Test Conclusion
No clinical study is included in this submission.
#### 10. Substantial Equivalence Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
