Nebulizer Kit
Device Facts
| Record ID | K192971 |
|---|---|
| Device Name | Nebulizer Kit |
| Applicant | Excellentcare Medical (Huizhou) , Ltd. |
| Product Code | CAF · Anesthesiology |
| Decision Date | Jul 8, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Nebulizer kit is used to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways. The Nebulizer kit is intended for adult patients consistent with the indication for aerosol medication in hospitals and sub-acute institutions.
Device Story
Small volume jet nebulizer; delivers aerosolized medication to respiratory system. Operates via Venturi effect: compressed air/oxygen enters converging nozzle, accelerates, creates vacuum, liquid medicine impacts rigid baffle, converts to aerosol droplets. Single-patient, multi-use; requires cleaning/disinfection between uses; 30-treatment service life. Used in hospitals/clinics; operated by healthcare professionals. Output is aerosolized medication for inhalation. Benefits patient by enabling targeted airway delivery of prescribed drugs.
Clinical Evidence
Bench testing only. Performance evaluated per FDA/CDRH-1993, USP 40<601>, and ISO 27427:2013. Aerosol characteristics (MMAD, GSD, respirable fraction/mass) compared against predicate using Albuterol sulfate, Ipratropium bromide, Cromolyn sodium, and Budesonide suspension at 4L/min and 8L/min flow rates. Biocompatibility testing per ISO 10993 series and gas pathway testing per ISO 18562 series performed. Cleaning/disinfection validation conducted per FDA reprocessing guidance and ASTM E1837-96.
Technological Characteristics
Pneumatic jet nebulizer; Venturi principle. Materials: Polypropylene (PP), Polystyrene (PS), Polyethylene (PE), Ethylene-vinyl acetate (EVA), Polyvinyl chloride (PVC). Gas source: compressed air or oxygen. Flow rate: 4-8 L/min. Max fill volume: 12 mL. Single-patient, multi-use (30 treatments). Biocompatibility per ISO 10993; gas pathway per ISO 18562. Non-sterile.
Indications for Use
Indicated for adult patients in hospitals and sub-acute institutions requiring aerosolized medication delivery via nebulization as prescribed by a physician.
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
- Disposable hand held nebulizer (VixOne) (K800562)
Submission Summary (Full Text)
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Excellentcare Medical (Huizhou) Ltd. % Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd. NO. 55 Shizhou middle road, Nanshan District Shenzhen, Guangdong 518000 China
# Re: K192971
Trade/Device Name: Nebulizer Kit Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 26, 2021 Received: June 10, 2021
# Dear Elly Xu:
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 L. Blakely, Ph.D. Assistant Director (Acting) 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) K192971
Device Name Nebulizer Kit
Indications for Use (Describe)
The Nebulizer kit is used to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways. The Nebulizer kit is intended for adult consistent with the indication in hospitals and sub-acute institutions.
Type of Use (Select one or both, as applicable)
| | <span> <span style="padding-right: 5px;"> </span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|---------------------------------------------------------------------------------------------------------|
| | <span> <span style="padding-right: 5px;"> </span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(k) Summary
# 510k number: K192971
# 1. Administrative Information
| Date of Summary prepared | May 26, 2021 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer information | Company name:<br>Excellentcare Medical (Huizhou) Ltd. |
| | Company address:<br>Shatou Industrial Zone. Yuanzhou Town. 516123<br>Huizhou Guangdong, China |
| | Contact person: Chunyu Zhao |
| | Phone: +86-752-6358312 |
| | Fax: +86-752-6358899<br>E-mail: bradleyzhao@aliyun.com |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: 1713A, 17th Floor, Block A, Zhongguan<br>Times Square, Nanshan District, Shenzhen |
| | Contact person: James Tsai |
| | E-Mail: james_tsai@cefda.com; |
| | field@cefda.com |
| Establishment registration<br>number | |
| 2. Device Information | |
| Type of 510(k) submission: | Traditional |
| Trade Name: | Nebulizer Kit |
| Classification name: | Nebulizer |
| Classification: | II |
| Review Panel: | Anesthesiology |
| Product Code: | CAF |
| Regulation Number: | 868.5630 |
| 3. Predicate Device Information | |
| Trade Name | Disposable hand held nebulizer (VixOne) |
| 510(k) Number | K800562 |
| Classification name | Nebulizer |
| Classification: | II |
| Review Panel: | Anesthesiology |
| Product code | CAF |
| Regulation No. | 868.5630 |
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### 4. Device Descriptions
The nebulizer kit is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air or oxygen is forced into the nebulizer through a converging nozzle, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The nebulizer kit is single-patient, multi-use; it requires a cleaning and disinfection process before each use, and the service life is for 30 aerosol treatments.
# 5. Intended Use/ Indications for Use
The Nebulizer kit is used to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways. The Nebulizer kit is intended for adult patients consistent with the indication for aerosol medication in hospitals and sub-acute institutions.
## 6. Comparisons to predicate device
The subject Nebulizer kit and VixOne™ Nebulizer (K800562) are similar in purpose, function, core technology and method of operation, the following table provides a comparison of the two devices.
| Items | Proposed Device | Predicate Device (K800562) | Remark | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------|
| Intended<br>use/Indicati<br>on for Use | The nebulizer kit is designed to<br>aerosolize medication approved<br>for nebulization and prescribed<br>by a physician for delivery to the<br>airways. The Nebulizer kit is<br>intended for adult consistent with<br>the indication for aerosol<br>medication in hospitals and sub-<br>acute institutions. | A handheld, pneumatic nebulizer<br>designed to aerosolize<br>prescription drugs for inhalation<br>by a patient. Its use is indicated<br>whenever a healthcare<br>professional administers or<br>prescribes medical aerosol<br>products to a patient using a<br>small volume nebulizer | Same | |
| Technology | Pneumatic Jet Nebulizer | Pneumatic Jet Nebulizer | Same | |
| Operation<br>principle | Venturi | Venturi | Same | |
| Environme<br>nt of use | Hospital, clinic | Hospital, clinic | Same | |
| Patient<br>Population | Adult | Adult and pediatric | Similar | |
| Single<br>patient use<br>only | Yes | Yes | Same | |
| Anatomic<br>Site | Mouth | Mouth | Same | |
| Component<br>s | Nebulizer, A-type mouth piece,<br>T-piece, Corrugated tube, and<br>Air tube | Nebulizer, Mouth piece, T-piece,<br>Corrugated tube, and Air tube | Same | |
| Items | Proposed Device | Predicate Device (K800562) | Remark | |
| | Nebu<br>lizer<br>(inte<br>gral) | | | Same |
| Phot<br>os of<br>com<br>pone<br>nts | Nebu<br>lizer<br>(com<br>pone<br>nt) | | | Same |
| | Nebu<br>lizer<br>kit | | | Same |
| | Aerosolizati<br>on | Continuous during inhalation<br>and exhalation | Continuous during inhalation<br>and exhalation | Same |
| | Type of<br>device | Disposable, prescription only,<br>non-sterile | Disposable, prescription only,<br>non-sterile | Same |
| | Flow rate | 4-8L/min | 4-10L/min | Different |
| | Maximum<br>Fill Volume | 12 mL | 10mL | Different |
| | Materials | Polypropylene (PP),<br>Polystyrene (PS),<br>Polyethylene (PE),<br>Ethylene-vinyl acetate<br>copolymer (EVA),<br>Polyvinyl chloride (PVC) | Not publicly available | Different |
| | Type of gas<br>source | Compressed air or oxygen | Compressed air or oxygen | Same |
| | Biocompati<br>bility | Conform to FDA guidance of<br>Biological evaluation of medical<br>devices | Conform to FDA guidance of<br>Biological evaluation of medical<br>devices | Same |
| | Aerosol<br>particle<br>characterist<br>ics | The aerosol particle characteristics tests are carried out for the<br>proposed device and predicate device, the parameters of total mass,<br>MMAD, GSD, respirable fraction and respirable Mass are analyzed<br>and compared at a 95% confidence level, there is not significant<br>statistical difference between the two devices. | | Different |
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The proposed device of Nebulizer kit and the predicated device of VixOne™ Nebulizer are similar in purpose, function, core technology and method of operation, both the proposed device and predicated device have the similar patient population, type of gas source, biocompatibility performance, and there is not significant statistical difference in aerosol particles characteristics between nebulizer kit and VixOne. Only minor differences exist between the proposed device and predicate device.
### 7. Brief discussions of the nonclinical tests
The proposed device conforms to the following standards:
## 7.1 Biocompatibility evaluation
The biocompatibility evaluations of the proposed device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA biocompatibility guidance, the proposed devices will be classified as external communication devices-tissue contact, and considering the cumulative exposure, the contact time will be permanent. The testing standards include the following:
-ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
-ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
-ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-ISO 10993-3: 2014 Biological evaluation of medical devices-Part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
-ISO 10993-6: 2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
-ISO 10993-17: 2002 Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances
-ISO 10993-18: 2020 Biological evaluation of medical devices-Part 18: Chemical characterization of medical device materials within a risk management process
# 7.2 Dry Gas Pathway Testing
Testing pertaining to the dry gas pathway and associated risk assessments/conclusions were conducted by an independent source. Testing included the assessments of Emissions of volatile organic compounds (VOCs), Fine particles (particulate matter PM2.5). The testing standards include the following:
-ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
-ISO 18562-2: 2017 Tests for emissions of volatile Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
-ISO 18562-3: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
#### 7.3 Performance data
Aerosol characterization tests for the proposed devices and predicate devices were conducted in accordance with the relevant sections of the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH-1993), USP 40<601> Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry
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Powder Inhalers, and ISO 27427:2013 Anaesthetic and respiratory equipment-Nebulizing systems and components. For each device, four drugs: Albuterol sulfate (2.5mg/3.0ml), lpratropium bromide (0.5mg/2.5ml), Cromolyn sodium (20mg/2ml) and Budesonide suspension (1mg/2ml) were tested respectively. The comparison items include Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), Respirable mass, Respirable Fraction and Total Mass. Also the variability of intra-sample and inter-sample was tested for the proposed devices.
| Aerosol<br>characteristics | Aerosol particle characteristics | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device (K192971) | Predicate Device (K800562) |
| Total Mass (µg) | 1146.80± 142.12 (Albuterol sulfate)<br>228.18±12.40 (Ipratropium<br>bromide)<br>6307.49±802.07 (Cromolyn<br>sodium)<br>467.07±34.11 (Budesonide<br>Suspension) | 1309.33± 137.13 (Albuterol sulfate)<br>213.81±15.03 (Ipratropium<br>bromide)<br>7172.85±626.18 (Cromolyn<br>sodium)<br>501.02±23.65 (Budesonide<br>Suspension) |
| Particle Size-<br>MMAD (µm) | 2.80± 0.23 (Albuterol sulfate)<br>2.14±0.22 (Ipratropium bromide)<br>2.66±0.20 (Cromolyn sodium)<br>3.32±0.18 (Budesonide<br>Suspension) | 2.55± 0.15 (Albuterol sulfate)<br>2.07±0.20 (Ipratropium bromide)<br>2.41±0.15 (Cromolyn sodium)<br>3.11±0.18 (Budesonide<br>Suspension) |
| Geometric<br>Standard<br>Deviation (GSD) | 2.49± 0.16 (Albuterol sulfate)<br>2.81±0.06 (Ipratropium bromide)<br>2.48±0.09 (Cromolyn sodium)<br>2.27±0.08 (Budesonide<br>Suspension) | 2.51± 0.05 (Albuterol sulfate)<br>3.01±0.16 (Ipratropium bromide)<br>2.56±0.09 (Cromolyn sodium)<br>2.20±0.12 (Budesonide<br>Suspension) |
| Respirable<br>fraction (% 0.5-<br>5µm) | 70.76± 1 (Albuterol sulfate)<br>71.32±3 (Ipratropium bromide)<br>72.33±3 (Cromolyn sodium)<br>68.09±2 (Budesonide Suspension) | 73.02± 2 (Albuterol sulfate)<br>68.86±1 (Ipratropium bromide)<br>73.52±3 (Cromolyn sodium)<br>71.82±4 (Budesonide Suspension) |
| Respirable Mass<br>(µg 0.5-5) | 810.89± 94.73 (Albuterol sulfate)<br>162.63±10.34 (Ipratropium<br>bromide)<br>4576.38±739.65 (Cromolyn<br>sodium)<br>318.22±27.49 (Budesonide<br>Suspension) | 956.45± 107.82 (Albuterol sulfate)<br>147.16±11.58 (Ipratropium<br>bromide)<br>5273.70±512.70 (Cromolyn<br>sodium)<br>359.25±7.21 (Budesonide<br>Suspension) |
7.3.1 Aerosol particle characteristics (supplied air flow rate for nebulizer: 8L/min)
| | 7.3.2 Aerosol particle characteristics (supplied air flow rate for nebulizer: 4L/min) | |
|-----------------------------|---------------------------------------------------------------------------------------|-----------------------------------------|
| Aerosol<br>characteristics | Aerosol particle characteristics | |
| | Proposed Device (K192971) | Predicate Device (K800562) |
| Total Mass (µg) | 1031.51± 113.44 (Albuterol sulfate) | 1104.12± 72.02 (Albuterol sulfate) |
| | 199.78±15.60 (Ipratropium<br>bromide) | 216.84±10.63 (Ipratropium<br>bromide) |
| | 5466.01±567.02 (Cromolyn<br>sodium) | 5987.10±715.04 (Cromolyn<br>sodium) |
| | 430.79±18.55 (Budesonide<br>Suspension) | 452.60±22.52 (Budesonide<br>Suspension) |
| Particle Size-<br>MMAD (µm) | 4.71±0.11 (Albuterol sulfate) | 4.52± 0.13 (Albuterol sulfate) |
| | 3.21±0.17 (Ipratropium bromide) | 3.19±0.24 (Ipratropium bromide) |
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| | 4.25±0.18 (Cromolyn sodium) | 4.09±0.10 (Cromolyn sodium) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | 4.97±0.14 (Budesonide | 4.84±0.15 (Budesonide |
| | Suspension) | Suspension) |
| Geometric<br>Standard<br>Deviation (GSD) | 2.42± 0.05 (Albuterol sulfate) 2.76±0.16 (Ipratropium bromide) 2.52±0.01 (Cromolyn sodium) 2.53±0.13 (Budesonide Suspension) | 2.40± 0.07 (Albuterol sulfate) 2.71±0.11 (Ipratropium bromide) 2.48±0.05 (Cromolyn sodium) 2.59±0.15 (Budesonide Suspension) |
| Respirable<br>fraction (% 0.5-<br>5μm) | 52.17± 1 (Albuterol sulfate) 63.63±3 (Ipratropium bromide) 55.96±2 (Cromolyn sodium) 49.57±1 (Budesonide Suspension) | 54.06±1 (Albuterol sulfate) 64.3±3 (Ipratropium bromide) 57.79±1 (Cromolyn sodium) 50.55±0.1 (Budesonide Suspension) |
| Respirable Mass<br>(µg 0.5-5) | 538.94± 70.97 (Albuterol sulfate) 126.97±10.16 (Ipratropium bromide) 3056.41±297.19 (Cromolyn sodium) 213.50±8.65 (Budesonide Suspension) | 596.14± 35.20(Albuterol sulfate) 139.41±11.84 (Ipratropium bromide) 3460.11±416.01 (Cromolyn sodium) 228.69±9.93 (Budesonide Suspension) |
#### 7.4 Cleaning and Disinfection Validation
Microbiological efficiency control tests were conducted in order to validate the nebulizer cleaning and disinfection methods in the IFU. Testing involved validation of a manually cleaning method and a chemical disinfection method. All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU. The references include the following:
-FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
-ASTM E1837-96 (Reapproved 2014): Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices.
#### 8. Conclusions
Based on comparison information and testing data, including biocompatibility tests and aerosol particle performance tests, the nebulizer kit meets the requirements of its pre-defined acceptance criteria and intended use. Therefore, the proposed device is substantially equivalent to the predicate devices.
