(244 days)
K062263 - Omron NE-U22
K150591 - Besmed
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on the physical mechanism (vibrating mesh) and standard engineering tests, not data-driven algorithms.
Yes
The device is designed to aerosolize liquid medications for inhalation by patients, which is a therapeutic function.
No
The device is a nebulizer designed to aerosolize liquid medications for inhalation, which is a treatment delivery function, not a diagnostic one.
No
The device description explicitly states it is a "small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol," indicating it is a hardware device. The performance studies also include hardware-related testing like electrical safety, EMC, and particle characterization.
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 liquid medications for inhalation by the patient." This describes a device used for delivering medication directly to the patient's respiratory system.
- Device Description: The description confirms it's a "handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol." This aligns with a drug delivery device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to gain information about a person's health. This nebulizer's function is to deliver medication into the body.
N/A
Intended Use / Indications for Use
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The Medication Cup contains the nebulizing module where aerosol will be generated. Prescribed medication is placed in the Cup, nebulized and inhaled via the integral mouthpiece.
The Medication Cup is single patient, multi-use. Cleaning is performed after each use by rinsing with distilled water and disinfected via immersion in boiled water for 10 minutes. The performance met its specification criteria of 90 days.
The cup medication capacity is 6 ml.
The Main Unit contains the 2 "AA" batteries and firmware to control the vibrating mesh module in the Medication Cup.
Portable Nebulizer aerosolizes upon turning on by pressing the ON/OFF button and turns off by pressing again or automatically after treatment completion in 30 minutes. To monitor nebulization status and device operating condition, there are different LED colors shown. Normal working condition is indicated by a green while an orange color signifies a malfunction.
There is one model of the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatic (5 years and older), defined by the prescribed medication, and adult patients
Intended User / Care Setting
hospital/institutional settings, home care use, schools, and long term care facilities.
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)
Non-Clinical Performance Testing:
- Shelf-life, Useful-life, and Durability Testing
- Simulated Life Cycle testing
- Cleaning
- Electrical Safety, EMC, EMC
- Particle Characterization per Cascade Impactor
- Intra- and Inter- Sample Variability
Electrical Safety and Electromagnetic Compatibility (EMC): Testing established that the device meets the applicable requirements of: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2007; (3) IEC 60601-1-11:2012.
Software Verification and Validation Testing: Conducted in accordance with FDA's Guidance 337. Software for this device is of a "moderate" level of concern.
Biocompatibility: ISO 10993-1 tests performed for External Communicating (Indirect gas pathway), Tissue / Bone / Dentin communicating, Surface Contact - Mucosal membrane with permanent duration of use (> 30 days). Tests included Cytotoxicity, Sensitization, Irritation, Sub-chronic Systemic toxicity, Acute Systemic Toxicity, Leachable and Extractables with Risk Based Assessment, Gas Emission VOC plus Inorganic compounds - CO, CO2, and Ozone, PM25. Concluded biocompatible with no new issues.
Cleaning and Disinfection Validation: Microbiological efficiency control tests validated manual cleaning and thermal disinfection methods in the IFU.
Particle Characterization: Comparative aerosol characterization (particle size distribution) performed between the subject and predicate device. Results were very similar to that of the predicate.
Overall, the results support the substantial equivalence argument.
Key Results for Adult Flow Rate (28 lpm):
Total Dose (ug): Albuterol – 1719 – 2082*; Ipratropium – 347 – 403*; Cromolyn – 13372 – 14329*
Particle size (MMAD) (Microns): Albuterol – 1.9 – 2.8*; Ipratropium – 2.0 – 2.7; Cromolyn – 2.1 – 2.8
Geometric Std. Dev. (GSD): Albuterol – 1.9 – 2.6; Ipratropium – 2.1 – 2.6*; Cromolyn – 2.3 – 2.8
Total Respirable Dose (0.5-5 microns): Albuterol – 1274 – 1487*; Ipratropium – 237 – 275*; Cromolyn – 8645 – 9954*
Coarse Particle Dose (>4.7 micron): Albuterol – 279 – 726; Ipratropium – 85 – 138; Cromolyn – 3723 – 4676*
Fine Particle Dose (4.7 micron): Albuterol – 913-1214; Ipratropium - 213-291; Cromolyn - 7240-10277
Fine Particle Dose (
§ 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
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November 28, 2017
MicroBase Technology Corporation % Paul Dryden Consultant MicroBase Technology Corporation c/o ProMedic, LLC. 24301 Woodsage Dr. Bonita Springs, Florida 34134
Re: K170916
Trade/Device Name: Portable Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: October 19, 2017 Received: October 23, 2017
Dear Paul Dryden:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tara A. Ryan-S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170916
Device Name
Portable Nebulizer
Indications for Use (Describe)
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
| 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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MicroBase Technology Corporation No. 756, Jiadong Road Bade District, Taoyuan City 33464, Taiwan
| Official Contact: | Molly Hsieh
General Manager
Tel - 011-886-3-376-7555
Fax - 011-886-3-376-7557 |
|----------------------------|----------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Portable Nebulizer |
| Common/Usual Name: | Nebulizer (Direct Patient Interface |
| Classification Name: | Nebulizer (Direct Patient Interface
Product Classification – CAF
21 CFR 868.5630
Class II |
| Predicate Devices: | K062263 - Omron NE-U22 |
Device Description:
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
Components
The Medication Cup contains the nebulizing module where aerosol will be generated. Prescribed medication is placed in the Cup, nebulized and inhaled via the integral mouthpiece.
The Medication Cup is single patient, multi-use. Cleaning is performed after each use by rinsing with distilled water and disinfected via immersion in boiled water for 10 minutes. The performance met its specification criteria of 90 days.
The cup medication capacity is 6 ml.
The Main Unit contains the 2 "AA" batteries and firmware to control the vibrating mesh module in the Medication Cup.
Portable Nebulizer aerosolizes upon turning on by pressing the ON/OFF button and turns off by pressing again or automatically after treatment completion in 30 minutes. To monitor nebulization status and device operating condition, there are different LED colors shown. Normal working condition is indicated by a green while an orange color signifies a malfunction.
There is one model of the subject device.
Indications for Use:
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liguid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
4
510(k) Summary Page 2 of 7 November 27, 2017
Principle of Operation / Technology
The Portable Nebulizer operates by electrically activating piezoelectric ceramic actuator (PZT) which then transduces the vibration generated to the adjacent supporting plate and polymer mesh bearing numerous apertures. The vibration actively pushes out the liquid medication by physically breaking surface tension of the solution through mesh holes thereby achieving final nebulization. Aerosol generation can subsequently be modulated the vibration frequency that is controlled by the firmware stored within Main Unit to maintain a frequency of approximate 117 kHz, nebulization rate of > 0.25 ml/min and a power consumption of 30 days)
And
Surface Contact
Mucosal membrane
Duration of Use - permanent (> 30 days) | External Communicating
(Indirect gas pathway)
Tissue / Bone / Dentin communicating
Duration of Use - permanent (> 30 days)
And
Surface Contact
Mucosal membrane
Duration of Use - permanent (> 30 days) |
| MMAD | MMAD, GSD, Total Respirable Dose, and
the predicate. | Total Dose were substantially equivalent to |
| GSD | | |
| Total Respirable Dose | | |
| Total Dose | | |
| Features | Predicate
Omron NE-U22
K062263 | Proposed
Portable Nebulizer |
| Software | | |
| Level of Concern | Moderate | Moderate |
| Device Specific | Yes | Yes |
| Dependent on external
devices | No | No |
| Signals | LED and tone sounds | LED and tone sounds |
Table 2 – Comparison of Proposed vs. Predicate Device
6
510(k) Summary Page 4 of 7 November 27, 2017
Substantial Equivalence Discussion
The Portable Nebulizer is viewed as substantially equivalent to the predicate device because:
Indications for Use – The proposed indications for use are to aerosolize commonly prescribed medications.
Discussion - The indications for use are identical for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.
The exclusion of the reference to pentamidine is no longer included in nebulizer indications for use, K150591, and has been removed.
Patient Population - The patient population of adult and pediatric (defined by the prescribed medication) patients that is consistent with the indications for the aerosol medication. This is similar to the predicate - K062263 - Omron NE-U22 nebulizer.
Discussion - The patient population is similar for the proposed device and the predicate -K062263 - Omron NE-U22 nebulizer. The predicate does not describe the pediatric population, however other reference nebulizers have defined the patient population as "pediatric (2 years and older) and / or as "defined by the prescribed medication" - K150591 - Besmed. Thus the differences in the description of the patient population compared to the predicate can be found to be substantially equivalent.
Environment of Use – The proposed environments of use are common and usual for handheld nebulizers, namely Hospital/institutional settings, home care use, schools and long term care facilities.
Discussion - The environment of use is identical for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.
Technology - The design as a vibrating mesh nebulizer which is the identical principle of operation.
Discussion - The technology is identical for the proposed device as compared to the predicate -K062263 – Omron NE-U22 nebulizer.
Summary of Non-Clinical Performance Testing
We performed a number of non-clinical tests to demonstrate that the Portable Nebulizer is equivalent to the predicate K062263 - Omron NE-U22 nebulizer.
- Shelf-life, Useful-life, and Durability Testing
- Simulated Life Cycle testing ●
- Cleaning ●
- Electrical Safety, EMC, EMC ●
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510(k) Summary Page 5 of 7 November 27, 2017
- Particle Characterization per Cascade Impactor
- . Intra- and Inter- Sample Variability
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: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2007; (3) IEC 60601-1-11:2012.
Software Verification and Validation Testing
Verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA's Guidance 337, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is of a "moderate" level of concern, since a failure or latent flaw in the software could lead to a delay in delivery of appropriate medical care.
Biocompatibility
The materials in patient / drug contact are characterized as:
- External Communicating (Indirect gas pathway)
- Tissue / Bone / Dentin communicating
- . Duration of Use - permanent (> 30 days)
And
- Surface Contact ●
- Mucosal membrane
- Duration of Use permanent (> 30 days) .
Discussion - We performed ISO 10993-1 tests to support biocompatibility. They included:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Sub-chronic Systemic toxicity ●
- Acute Systemic Toxicity ●
- Leachable and Extractables with Risk Based Assessment .
- Gas Emission VOC plus Inorganic compounds - CO, CO2, and Ozone
- PM25 ●
Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.
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: (1) a manual cleaning method and a thermal disinfection method. All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU.
Particle Characterization
Comparative aerosol characterization (particle size distribution) performed between the subject and predicate device. The following tables summarize the results, in all the results very similar compared to that of the predicate.
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510(k) Summary Page 6 of 7 November 27, 2017
| Features | Predicate
Omron NE-U22
K062263 | | Proposed
Portable Nebulizer | |
|----------------------------------------------------------------------|--------------------------------------|-------------|--------------------------------|----------------|
| Particle Characterization per Cascade Impactor @ 28 lpm – Adult Flow | | | | |
| Total Dose (ug) | Albuterol – | 1232 – 1362 | Albuterol – | 1719 – 2082* |
| | Ipratropium – | 240 – 295 | Ipratropium – | 347 – 403* |
| | Cromolyn – | 7648 – 9249 | Cromolyn – | 13372 – 14329* |
| Particle size (MMAD)
(Microns) | Albuterol – | 2.5 – 3.6 | Albuterol – | 1.9 – 2.8* |
| | Ipratropium – | 1.8 – 4.2 | Ipratropium – | 2.0 – 2.7 |
| | Cromolyn – | 1.9 – 3.0 | Cromolyn – | 2.1 – 2.8 |
| Geometric Std. Dev.
(GSD) | Albuterol – | 2.1 – 3.0 | Albuterol – | 1.9 – 2.6 |
| | Ipratropium – | 2.4 – 3.7 | Ipratropium – | 2.1 – 2.6* |
| | Cromolyn – | 2.3 – 3.0 | Cromolyn – | 2.3 – 2.8 |
| Total Respirable Dose
(0.5-5 microns) | Albuterol – | 659 – 965 | Albuterol – | 1274 – 1487* |
| | Ipratropium – | 97 – 201 | Ipratropium – | 237 – 275* |
| | Cromolyn – | 4337 – 6601 | Cromolyn – | 8645 – 9954* |
| Coarse Particle Dose
(>4.7 micron) | Albuterol – | 373 – 631 | Albuterol – | 279 – 726 |
| | Ipratropium – | 82 – 145 | Ipratropium – | 85 – 138 |
| | Cromolyn – | 2312 – 3206 | Cromolyn – | 3723 – 4676* |
| Fine Particle Dose
(4.7 micron) | Albuterol – 1121-1626
Ipratropium – 273-302
Cromolyn - 10302-11415 | Albuterol – 913-1214
Ipratropium - 213-291
Cromolyn - 7240-10277 |
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510(k) Summary Page 7 of 7 November 27, 2017
| Features | Predicate
Omron NE-U22
K062263 | | Proposed
Portable Nebulizer | |
|-----------------------------------------------|--------------------------------------|-----------|--------------------------------|-------------|
| Fine Particle Dose
(