(244 days)
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.
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The Portable Nebulizer, a vibrating mesh nebulizer system, underwent non-clinical performance testing to demonstrate its equivalence to the predicate device, Omron NE-U22 (K062263). The assessment primarily focused on aerosol characterization, electrical safety, software verification, biocompatibility, and cleaning/disinfection validation.
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric with defined thresholds. Instead, it presents a comparative analysis against the predicate device to support substantial equivalence. The reported device performance is generally considered acceptable if it is "similar" or "substantially equivalent" to the predicate, or if it meets established standards.
| Feature | Acceptance Criteria (Implied: Similar to predicate or meeting standards) | Reported Device Performance |
|---|---|---|
| Indications for Use | To aerosolize liquid medications for inhalation; pediatric (5 years and older) and adult patients in various settings. | "The indications for use are identical for the proposed device and the predicate." Pediatric population description refined but deemed substantially equivalent to predicate based on other reference nebulizers. |
| Patient Population | Pediatric (defined by prescribed medication) and adult patients. | "The patient population is similar for the proposed device and the predicate." Pediatric age range (5 years and older) considered substantially equivalent to predicate based on other reference devices. |
| Environment of Use | Hospital/institutional settings, home care, schools, long term care facilities. | "The environment of use is identical for the proposed device and the predicate." |
| Technology / Principle of Operation | Vibrating mesh nebulizer. | "The technology is identical for the proposed device as compared to the predicate." |
| Nebulization rate | ≥ 0.25 ml/min (Predicate: 0.25 ml/min to 0.9 ml/min). | Reported: ≥ 0.25 ml/min. |
| Power consumption | < 1.5 W (Predicate: 1.5 W). | Reported: < 1.5 W. |
| Electrical Safety Standards | Compliance with IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-11:2012. | "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 Level of Concern | Moderate. | "The software for this device is of a 'moderate' level of concern." Software Verification and Validation testing conducted in accordance with FDA's Guidance 337. |
| Biocompatibility | ISO 10993-1 tests (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 | Effective cleaning and disinfection by methods stated in IFU. | "All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU." |
| Particle Size (MMAD) | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1.9–2.8*, Ipratropium 2.0–2.7, Cromolyn 2.1–2.8. For pediatric flow: Albuterol 3.31–4.95*, Ipratropium 4.34–5.72*, Cromolyn 3.68–5.38*. Overall deemed "very similar compared to that of the predicate." |
| Total Dose | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1719–2082*, Ipratropium 347–403*, Cromolyn 13372–14329*. For pediatric flow: Albuterol 2159–2592, Ipratropium 429–505, Cromolyn 17733–18426. Overall deemed "very similar compared to that of the predicate." |
| Total Respirable Dose (0.5-5 microns) | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1274–1487*, Ipratropium 237–275*, Cromolyn 8645–9954*. For pediatric flow: Albuterol 1071–1596*, Ipratropium 198–219*, Cromolyn 7925–10601*. Overall deemed "very similar compared to that of the predicate." |
| Other Particle Characteristics (GSD, Coarse, Fine, Ultra-fine Particle Dose) | Similar to predicate (ranges provided in Tables 3 & 4). | Generally shown to be within "very similar" ranges compared to the predicate. Asterisks indicate values that are higher/lower than predicate ranges, but the overall conclusion is still "substantially equivalent." |
| Shelf-life, Useful-life, Durability Testing | Not explicitly stated but implied to meet performance criteria. | Testing was performed. Specific performance not detailed in this summary. |
| Simulated Life Cycle Testing | Not explicitly stated but implied to meet performance criteria. | Testing was performed. Specific performance not detailed in this summary. |
Note: Asterisks () in the "Reported Device Performance" column for particle characterization often indicate that the device's range is different from the predicate's range. However, the overall conclusion in the document is that the results support a substantial equivalence argument.*
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes (number of units or test replicates) for all non-clinical tests. For the particle characterization, the tables show ranges of values for different medications (Albuterol, Ipratropium, Cromolyn), which suggests multiple tests were conducted for each.
The data provenance is not specified in terms of country of origin. The study appears to be entirely retrospective for the purpose of this 510(k) submission, utilizing pre-existing test data to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The nature of the non-clinical tests (e.g., electrical safety, biocompatibility, particle characterization) typically relies on objective measurements and established standards, rather than expert interpretation of a "ground truth" in the way a clinical study would.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for the non-clinical tests described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple experts to establish a "ground truth" for diagnostic accuracy or similar endpoints. The tests performed here are objective engineering and material science evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
An MRMC study was not performed as this device is a nebulizer and not an AI-powered diagnostic device involving human readers or interpretation.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable as the device is a medical device (nebulizer), not an algorithm or AI system. The "software" mentioned refers to firmware controlling the vibrating mesh, not a standalone AI diagnostic tool.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by:
- Established Standards: For electrical safety (IEC 60601 series), biocompatibility (ISO 10993-1), and software verification (FDA Guidance 337).
- Objective Measurements: For particle characterization (using Cascade Impactor and laser light scattering techniques), nebulization rate, power consumption, etc.
- Comparison to Predicate Device: The performance of the Portable Nebulizer is compared directly to the legally marketed Omron NE-U22 (K062263) as key evidence for substantial equivalence.
8. The Sample Size for the Training Set:
This is not applicable as this is a traditional medical device (nebulizer) and not an AI/ML-based device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8.
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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
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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
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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 HsiehGeneral ManagerTel - 011-886-3-376-7555Fax - 011-886-3-376-7557 |
|---|---|
| Proprietary or Trade Name: | Portable Nebulizer |
| Common/Usual Name: | Nebulizer (Direct Patient Interface |
| Classification Name: | Nebulizer (Direct Patient InterfaceProduct Classification – CAF21 CFR 868.5630Class 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.
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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 <1.5 W.
| Features | Proposed Portable Nebulizer |
|---|---|
| Indications for use | The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. |
| Environment of Use | The device may be used with pediatric (5 years old or greater), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities. |
| Patient Population | |
| Contraindications | None |
| Vibrating mesh technology | Yes |
| Software driven | Yes - firmware |
| Patient Interface | Mouthpiece |
| Nebulizer components cleanable | Yes – Medication Cup and mouthpiece |
| Operating conditions | 10°C to 40°C 30% to 85% RH |
| Storage conditions | -20°C to 70°C, 20% to 75% RH |
| Power Source | DC – 2 – AA Alkaline batteries |
Table 1 - Performance Specifications
Comparison to Predicate
Tables 2 provides a comparison of the proposed device to the predicate.
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510(k) Summary
Page 3 of 7 November 27, 2017
| Features | PredicateOmron NE-U22K062263 | ProposedPortable Nebulizer |
|---|---|---|
| Indications for use | The Omron NE-U22 is an ultrasonic(vibrating mesh) nebulizer system designedto aerosolize liquid medications forinhalation by the patient. | The Portable Nebulizer is a vibrating meshnebulizer system designed to aerosolizeliquid medications for inhalation by thepatient. |
| Patient Population | The device may be used with pediatric andadult patients | The device may be used with pediatric (5years and older), defined by the prescribedmedication, and adult patients |
| Environment of Use | in the home, hospital, and sub-acute caresettings.. | in hospital/institutional settings, home careuse, schools, and long term care facilities. |
| Contraindications | It is not intended for use withPentamidine. | None |
| Principle of Operation | Vibrating mesh | Vibrating mesh |
| Aerosolization | Continuous during inhalation andexhalation | Continuous during inhalation andexhalation |
| Compressed gas source | None needed | None needed |
| Reservoir volume | 7 ml | 6 ml |
| Nebulization rate | 0.25 ml/min to 0.9 ml/min | ≥ 0.25 ml/min |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Nebulizer componentscleanable | Yes | Yes |
| Software driven | No | Yes |
| Power source | 2- “AA” Battery | 2- “AA” battery |
| Power consumption | 1.5 W | < 1.5 W |
| Weight | 97 gm w/o batteries | 74 gm w/o batteries |
| Dimensions (mm) | 51 x 38 x 104 | 77 x 41 x 73 |
| Operating Conditions | 0 to 45°C / 30-85% RH | 10 to 40°C / 30-85% RH |
| Storage Conditions | -25 to +70°C / 10-90% RH | -20 to +70°C / 20-75% RH |
| User interface | On/Off switchLED indicators | On/Off switchLED indicators |
| Standards met | ES60601-1IEC 60601-1-2 | ES60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-11 |
| Materials per ISO10993-1 | External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicatingDuration of Use - permanent (> 30 days)AndSurface ContactMucosal membraneDuration of Use - permanent (> 30 days) | External Communicating(Indirect gas pathway)Tissue / Bone / Dentin communicatingDuration of Use - permanent (> 30 days)AndSurface ContactMucosal membraneDuration of Use - permanent (> 30 days) |
| MMAD | MMAD, GSD, Total Respirable Dose, andthe predicate. | Total Dose were substantially equivalent to |
| GSD | ||
| Total Respirable Dose | ||
| Total Dose | ||
| Features | PredicateOmron NE-U22K062263 | ProposedPortable Nebulizer |
| Software | ||
| Level of Concern | Moderate | Moderate |
| Device Specific | Yes | Yes |
| Dependent on externaldevices | No | No |
| Signals | LED and tone sounds | LED and tone sounds |
Table 2 – Comparison of Proposed vs. Predicate Device
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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 | PredicateOmron NE-U22K062263 | ProposedPortable 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 – | 657 – 934 | Albuterol – | 1290 – 1506* |
| Ipratropium – | 95 – 213 | Ipratropium – | 241 – 286* | |
| Cromolyn – | 4607 – 6771 | Cromolyn – | 8995 – 10307* | |
| Ultra-fine ParticleDose(< 1.0 micron) | Albuterol – | 97 – 154 | Albuterol – | 215 – 354* |
| Ipratropium – | 21 – 67 | Ipratropium – | 49 – 68 | |
| Cromolyn – | 1211 – 1574 | Cromolyn – | 1524 – 2736* | |
| Confidence level oftesting | 95% confidence level | 95% confidence level |
Table 3 – Comparative Aerosol Performance – Adult Flow Rate – 28 Ipm
Overall the results support substantial equivalence argument.
Table 4 – Comparative Aerosol Performance – Pediatric Flow Rate – 12 Ipm
| Features | PredicateOmron NE-U22K062263 | ProposedPortable Nebulizer |
|---|---|---|
| Particle Characterization per Cascade Impactor @ 12 lpm – Pediatric Flow | ||
| Total Dose (ug) | Albuterol – 1967-2379Ipratropium – 411-451Cromolyn – 16066-17807 | Albuterol – 2159-2592Ipratropium – 429-505Cromolyn – 17733-18426 |
| Particle size (MMAD)(Microns) | Albuterol – 5.09-6.91Ipratropium – 6.50 -6.97Cromolyn – 6.60-6.86 | Albuterol – 3.31-4.95*Ipratropium – 4.34-5.72*Cromolyn – 3.68-5.38* |
| Geometric Std. Dev.(GSD) | Albuterol – 2.25-2.85Ipratropium – 2.76-3.09Cromolyn – 2.71-3.52 | Albuterol – 2.03-2.72Ipratropium – 2.39-3.50Cromolyn – 2.56-2.89 |
| Total Respirable Dose(0.5-5 microns) | Albuterol – 711-942Ipratropium - 140-160Cromolyn - 5559-6501 | Albuterol – 1071-1596*Ipratropium - 198-219*Cromolyn - 7925-10601* |
| Coarse Particle Dose(>4.7 micron) | Albuterol – 1121-1626Ipratropium – 273-302Cromolyn - 10302-11415 | Albuterol – 913-1214Ipratropium - 213-291Cromolyn - 7240-10277 |
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510(k) Summary Page 7 of 7 November 27, 2017
| Features | PredicateOmron NE-U22K062263 | ProposedPortable Nebulizer | ||
|---|---|---|---|---|
| Fine Particle Dose(<4.7 micron) | Albuterol - | 743-856 | Albuterol - | 1026-1597* |
| Ipratropium - | 134-153 | Ipratropium - | 212-218* | |
| Cromolyn - | 5737-6418 | Cromolyn - | 8135-10507* | |
| Ultra-fine ParticleDose(< 1.0 micron) | Albuterol - | 65-80 | Albuterol - | 31-220 |
| Ipratropium - | 14-17 | Ipratropium - | 14-44 | |
| Cromolyn - | 808-969 | Cromolyn - | 887-1904 | |
| Confidence level oftesting | 95% confidence level | 95% confidence level |
Overall the results support substantial equivalence argument.
Particle size characterization (MMAD) was verified after two years of real-time aging using both cascade impactor technique and laser light scattering technique.
Substantial Equivalence Conclusion
As detailed, the indications for use, patient population, environment of use, technology or principle of operation and performance are substantially equivalent.
The differences between the proposed Portable Nebulizer and the predicate – K062263 – Omron Model NE-U22 based upon the comparative performance testing we can conclude that the proposed device can be determined to be substantially equivalent to the predicate.
§ 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).