(624 days)
Not Found
No
The description focuses on the mechanical operation of a jet nebulizer and performance metrics related to aerosol characteristics, with no mention of AI or ML.
Yes
The device is described as a nebulizer kit that aerosolizes medication for delivery to the airways, which is a therapeutic function.
No
The device is a nebulizer kit, which is used to deliver aerosolized medication to the airways. Its described function is to convert liquid medicine into an aerosol for inhalation treatment, not to diagnose a medical condition. The performance studies focus on the characteristics of the aerosol produced and the device's ability to deliver medication, rather than diagnostic metrics.
No
The device description clearly outlines a physical nebulizer kit with components like a nozzle, baffle, and requiring compressed air or oxygen, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medication approved for nebulization and prescribed by a physician for delivery to the airways." This describes a device used to administer treatment directly to a patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details how the device converts liquid medication into an aerosol for inhalation. This is a drug delivery mechanism, not a diagnostic test.
- Performance Studies: The performance studies focus on the characteristics of the aerosolized medication (particle size, mass, etc.) and the device's ability to deliver it effectively and safely (biocompatibility, emissions, cleaning). These are performance metrics for a drug delivery device, not for a diagnostic test.
- Key Metrics: The key metrics listed (Total Mass, MMAD, GSD, Respirable fraction, Respirable Mass) are all related to the physical properties of the aerosol and its delivery, not to the detection or measurement of substances in biological samples.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This nebulizer kit does not perform any such tests. It is a therapeutic device used for drug delivery.
N/A
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 consistent with the indication in hospitals and sub-acute institutions.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Adult
Intended User / Care Setting
hospitals and sub-acute institutions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility evaluation: The biocompatibility evaluations of the proposed device were conducted in accordance with the International Standard ISO 10993-1 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.
- 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).
- 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 Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry 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), Ipratropium 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. There is not significant statistical difference in aerosol particles characteristics between nebulizer kit and VixOne.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include Total Mass, Particle Size-MMAD, Geometric Standard Deviation (GSD), Respirable fraction, and Respirable Mass. Specific values are provided for both the proposed device and predicate device under different supplied air flow rates (8L/min and 4L/min) and for various drugs (Albuterol sulfate, Ipratropium bromide, Cromolyn sodium, and Budesonide Suspension).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
510k number: K192971
1. Administrative Information
| Date of Summary prepared | May 26, 2021 |
|---|---|
| Manufacturer information | Company name: |
| Excellentcare Medical (Huizhou) Ltd. | |
| Company address: | |
| Shatou Industrial Zone. Yuanzhou Town. 516123 | |
| Huizhou Guangdong, China | |
| Contact person: Chunyu Zhao | |
| Phone: +86-752-6358312 | |
| Fax: +86-752-6358899 | |
| E-mail: bradleyzhao@aliyun.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: 1713A, 17th Floor, Block A, Zhongguan | |
| Times Square, Nanshan District, Shenzhen | |
| Contact person: James Tsai | |
| E-Mail: james_tsai@cefda.com; | |
| field@cefda.com | |
| Establishment registration | |
| 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 |
4
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 | ||||
| use/Indicati | ||||
| on for Use | The nebulizer kit is designed 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 for aerosol | ||||
| medication in hospitals and sub- | ||||
| acute institutions. | A handheld, pneumatic nebulizer | |||
| designed to aerosolize | ||||
| prescription drugs for inhalation | ||||
| by a patient. Its use is indicated | ||||
| whenever a healthcare | ||||
| professional administers or | ||||
| prescribes medical aerosol | ||||
| products to a patient using a | ||||
| small volume nebulizer | Same | |||
| Technology | Pneumatic Jet Nebulizer | Pneumatic Jet Nebulizer | Same | |
| Operation | ||||
| principle | Venturi | Venturi | Same | |
| Environme | ||||
| nt of use | Hospital, clinic | Hospital, clinic | Same | |
| Patient | ||||
| Population | Adult | Adult and pediatric | Similar | |
| Single | ||||
| patient use | ||||
| only | Yes | Yes | Same | |
| Anatomic | ||||
| Site | Mouth | Mouth | Same | |
| Component | ||||
| s | Nebulizer, A-type mouth piece, | |||
| T-piece, Corrugated tube, and | ||||
| Air tube | Nebulizer, Mouth piece, T-piece, | |||
| Corrugated tube, and Air tube | Same | |||
| Items | Proposed Device | Predicate Device (K800562) | Remark | |
| Nebu | ||||
| lizer | ||||
| (inte | ||||
| gral) | Same | |||
| Phot | ||||
| os of | ||||
| com | ||||
| pone | ||||
| nts | Nebu | |||
| lizer | ||||
| (com | ||||
| pone | ||||
| nt) | Same | |||
| Nebu | ||||
| lizer | ||||
| kit | Same | |||
| Aerosolizati | ||||
| on | Continuous during inhalation | |||
| and exhalation | Continuous during inhalation | |||
| and exhalation | Same | |||
| Type of | ||||
| device | Disposable, prescription only, | |||
| non-sterile | Disposable, prescription only, | |||
| non-sterile | Same | |||
| Flow rate | 4-8L/min | 4-10L/min | Different | |
| Maximum | ||||
| Fill Volume | 12 mL | 10mL | Different | |
| Materials | Polypropylene (PP), | |||
| Polystyrene (PS), | ||||
| Polyethylene (PE), | ||||
| Ethylene-vinyl acetate | ||||
| copolymer (EVA), | ||||
| Polyvinyl chloride (PVC) | Not publicly available | Different | ||
| Type of gas | ||||
| source | Compressed air or oxygen | Compressed air or oxygen | Same | |
| Biocompati | ||||
| bility | Conform to FDA guidance of | |||
| Biological evaluation of medical | ||||
| devices | Conform to FDA guidance of | |||
| Biological evaluation of medical | ||||
| devices | Same | |||
| Aerosol | ||||
| particle | ||||
| characterist | ||||
| ics | The aerosol particle characteristics tests are carried out for the | |||
| proposed device and predicate device, the parameters of total mass, | ||||
| MMAD, GSD, respirable fraction and respirable Mass are analyzed | ||||
| and compared at a 95% confidence level, there is not significant | ||||
| statistical difference between the two devices. | Different |
5
6
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 Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry
7
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
| characteristics | Aerosol particle characteristics | |
|---|---|---|
| Proposed Device (K192971) | Predicate Device (K800562) | |
| Total Mass (µg) | 1146.80± 142.12 (Albuterol sulfate) | |
| 228.18±12.40 (Ipratropium | ||
| bromide) | ||
| 6307.49±802.07 (Cromolyn | ||
| sodium) | ||
| 467.07±34.11 (Budesonide | ||
| Suspension) | 1309.33± 137.13 (Albuterol sulfate) | |
| 213.81±15.03 (Ipratropium | ||
| bromide) | ||
| 7172.85±626.18 (Cromolyn | ||
| sodium) | ||
| 501.02±23.65 (Budesonide | ||
| Suspension) | ||
| Particle Size- | ||
| MMAD (µm) | 2.80± 0.23 (Albuterol sulfate) | |
| 2.14±0.22 (Ipratropium bromide) | ||
| 2.66±0.20 (Cromolyn sodium) | ||
| 3.32±0.18 (Budesonide | ||
| Suspension) | 2.55± 0.15 (Albuterol sulfate) | |
| 2.07±0.20 (Ipratropium bromide) | ||
| 2.41±0.15 (Cromolyn sodium) | ||
| 3.11±0.18 (Budesonide | ||
| Suspension) | ||
| Geometric | ||
| Standard | ||
| Deviation (GSD) | 2.49± 0.16 (Albuterol sulfate) | |
| 2.81±0.06 (Ipratropium bromide) | ||
| 2.48±0.09 (Cromolyn sodium) | ||
| 2.27±0.08 (Budesonide | ||
| Suspension) | 2.51± 0.05 (Albuterol sulfate) | |
| 3.01±0.16 (Ipratropium bromide) | ||
| 2.56±0.09 (Cromolyn sodium) | ||
| 2.20±0.12 (Budesonide | ||
| Suspension) | ||
| Respirable | ||
| fraction (% 0.5- | ||
| 5µm) | 70.76± 1 (Albuterol sulfate) | |
| 71.32±3 (Ipratropium bromide) | ||
| 72.33±3 (Cromolyn sodium) | ||
| 68.09±2 (Budesonide Suspension) | 73.02± 2 (Albuterol sulfate) | |
| 68.86±1 (Ipratropium bromide) | ||
| 73.52±3 (Cromolyn sodium) | ||
| 71.82±4 (Budesonide Suspension) | ||
| Respirable Mass | ||
| (µg 0.5-5) | 810.89± 94.73 (Albuterol sulfate) | |
| 162.63±10.34 (Ipratropium | ||
| bromide) | ||
| 4576.38±739.65 (Cromolyn | ||
| sodium) | ||
| 318.22±27.49 (Budesonide | ||
| Suspension) | 956.45± 107.82 (Albuterol sulfate) | |
| 147.16±11.58 (Ipratropium | ||
| bromide) | ||
| 5273.70±512.70 (Cromolyn | ||
| sodium) | ||
| 359.25±7.21 (Budesonide | ||
| 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 | ||
| 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 | ||
| bromide) | 216.84±10.63 (Ipratropium | |
| bromide) | ||
| 5466.01±567.02 (Cromolyn | ||
| sodium) | 5987.10±715.04 (Cromolyn | |
| sodium) | ||
| 430.79±18.55 (Budesonide | ||
| Suspension) | 452.60±22.52 (Budesonide | |
| Suspension) | ||
| Particle Size- | ||
| 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) |
8
| 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 | ||
| Standard | ||
| 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 | ||
| fraction (% 0.5- | ||
| 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 | ||
| (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.