(332 days)
Not Found
No
The description focuses on the mechanical and electronic components of a nebulizer and does not mention any AI or ML capabilities. The software validation is for "Moderate" level of concern, which is typical for device control firmware, not complex AI/ML algorithms.
Yes
The device is designed to aerosolize liquid medications for inhalation, directly delivering medication to a patient for therapeutic purposes.
No
The device is described as a system designed to aerosolize liquid medications for inhalation, which is a therapeutic function, not a diagnostic one. Its purpose is to deliver medication, not to detect, monitor, or identify a disease or condition.
No
The device description clearly outlines a physical hardware device (Main Unit, Medication Reservoir, vibrating mesh, batteries, AC adaptor) that utilizes software (firmware) for control. It is not solely software.
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 therapeutic device used to deliver medication directly to the patient's respiratory system.
- Device Description: The description details a nebulizer that converts liquid medication into an aerosol for inhalation. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the device's ability to aerosolize medication effectively and safely (aerosol characterization, biocompatibility, electrical safety, software validation, cleaning/disinfection). These are relevant to a therapeutic device, not an IVD.
- Predicate Device: The predicate device is also a vibrating mesh nebulizer, which is a therapeutic device.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from the body to provide diagnostic information. This device operates in vivo (on the body) by delivering medication.
N/A
Intended Use / Indications for Use
The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid 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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Pulmogine® Vibrating Mesh Nebulizer, whose dimensions are 74 mm (L) x 46 mm (W) x 96 mm (H), is a small, dumbbell-shaped, handheld, and internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine® Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir.
The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor.
The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.
The Pulmogine® Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
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
pediatric (5 years and older) and adult
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 Testing: A series of including safety and performance tests were conducted on the proposed device, HCMed Pulmogine® Vibrating Mesh nebulizer, HCM-86C.
Biocompatibility tests: Cytotoxicity ISO10993-5: 2009, Intracutaneous Irritation Study ISO10993-10:2013, Sensitization Study ISO10993-10: 2013, CO/CO2/Ozone Analysis ISO18562-3:2017, EPA PM 2.5 & PM 10 Analysis ISO18562-2:2017, VOC Analysis ISO18562-3:2017, Acute Systemic Toxicity - ISO10993-11:2017, Chemical characterization and risk assessment ISO10993-18:2005, ISO18562-1:2017, Genotoxicity ISO10993-3:2014. Results were acceptable.
Electrical safety and electromagnetic compatibility (EMC): Complies with ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards for safety and IEC 60601-1-11:2015 standard for EMC.
Software validation test: Considered "Moderate" level of concern.
Performance test: Demonstrated the following aerosol characterizations at adult and pediatric flow rate are comparable to the predicate device: Delivered dose (ug), Mass median aerodynamic diameter / MMAD (um), Geometric standard deviation / GSD, Total respirable dose (0.5 5um), Coarse particle dose (> 4.7um), 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
HCMed Innovations Co., Ltd. Yiling Lee Supervisor, Regulatory Affairs Rm.B. 10F, No.319, Sec.2, Dunhua S. Rd., Da-an District, Taipei City, 10669 Tw
Re: K202171
Trade/Device Name: Pulmogine® Vibrating Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 31, 2020 Received: August 3, 2020
Dear Yiling Lee:
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 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
1
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 medical devices and radiation-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,
For Brandon Blakely Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202171
Device Name Pulmogine® Vibrating Mesh Nebulizer
Indications for Use (Describe)
The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid 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.
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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
I. Submitter
| Company: | HCMed Innovations Co., Ltd.
Rm.B, 10F, No.319, Sec.2, Dunhua S. Rd.,
Da-an District, Taipei City 10669, Taiwan
Tel: + 886-2-2732-6596 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Yiling Lee
Supervisor, Regulatory Affairs
yiling@hcmed-inno.com |
| Date of Submission: | July 1, 2021 |
Device II.
| Name of Device: | Pulmogine® Vibrating Mesh Nebulizer |
|---|---|
| Common/Usual Name: | Vibrating Mesh Nebulizer |
| Model Number: | HCM-86C |
| Classification Regulation: | 21 CFR 868.5630 |
| Product Code: | CAF |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Regulatory Class: | II |
| Classification Panel: | Anesthesiology |
III. Predicate Device
| Product Code | Manufacturer | 510(k) Number | Device Name |
|---|---|---|---|
| CAF | Omron Healthcare, Inc. | K062263 | Omron Micro Air Vibrating Mesh |
| Nebulizer, Model NE-U22 |
IV. Device Description
The Pulmogine® Vibrating Mesh Nebulizer, whose dimensions are 74 mm (L) x 46 mm (W) x 96 mm (H), is a small, dumbbell-shaped, handheld, and internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine® Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir.
The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor.
4
The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.
The Pulmogine® Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
V. Indications for Use
The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid 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.
VI. Non-clinical Testing
A series of including safety and performance tests were conducted on the proposed device, HCMed Pulmogine® Vibrating Mesh nebulizer, HCM-86C. These tests will be discussed in detail in the respective Volume of the submission.
V Biocompatibility
The materials in patient/drug contact are characterized as:
- External communicating device -
- Tissue communicating –
- -Permanent duration (> 30days)
And
- Surface contact -
- -Mucosal membrane
- Permanent duration (>30days) -
Therefore, we performed the following tests with guidance from ISO-10993-1 and the FDA biocompatibility guidance and the results were acceptable:
- Cytotoxicity ISO10993-5: 2009 ।
- Intracutaneous Irritation Study ISO10993-10:2013 -
5
- Sensitization Study ISO10993-10: 2013 -
- CO/CO2/Ozone Analysis ISO18562-3:2017 -
- EPA PM 2.5 & PM 10 Analysis ISO18562-2:2017 -
- VOC Analysis ISO18562-3:2017 -
- -Acute Systemic Toxicity - ISO10993-11:2017
- Chemical characterization and risk assessment ISO10993-18:2005, ISO18562--1:2017
- Genotoxicity ISO10993-3:2014 -
-
Electrical safety and electromagnetic compatibility (EMC) The device complies with ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards for safety and IEC 60601-1-11:2015 standard for EMC.
- V Software validation test
The software for this device was considered as a "Moderate" level of concern since failure or latent flaw in the software could directly result in minor injury to the patient or operator.
-
イ Performance test
To ensure proper performance in this application, the final products must demonstrate the following aerosol characterizations at adult and pediatric flow rate are comparable to the predicate device: -
Delivered dose (ug) -
-
Mass median aerodynamic diameter / MMAD (um) -
-
Geometric standard deviation / GSD -
-
Total respirable dose (0.5 5um) -
-
Coarse particle dose (> 4.7um) -
-
Fine particle dose ( Others
We also have performed tests as follows:
- Intra- and inter-sample variability -
- Cleaning and disinfection validation -
- Simulated lifetime testing -
All test results were acceptable per the acceptance criteria detailed in the corresponding protocols and test reports.
VII. Clinical test
6
No clinical test data was performed to support the determination of substantial equivalence.
VIII. Comparison of Technological Characteristics with the Predicate Device
The following technical and performance data were provided in support of the substantial equivalence determination.
| Product
information | Predicate Device | Proposed Device | Similar /
Different |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product name | Micro Air Vibrating Mesh
Nebulizer | Pulmogine® Vibrating Mesh
Nebulizer | N/A |
| Model number | NE-U22 | HCM-86C | N/A |
| Manufacturer | Omron Healthcare, Inc. | HCMed Innovations Co., Ltd. | N/A |
| K number | K062263 | Current submission | N/A |
| Product code | CAF | CAF | Similar |
| Regulation
number | 868.5630 | 868.5630 | Similar |
| Classification | II | II | Similar |
| Indications for
use | The Omron NE-U22 is an
ultrasonic (vibrating mesh)
nebulizer system designed to
aerosolize liquid medications
for inhalation by the patient. | The Pulmogine® Vibrating
Mesh Nebulizer is a system
designed to aerosolize liquid
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. | Similar |
| OTC/Rx only | Prescription only | Prescription only | Similar |
| Patient
Population | The device may be used with
pediatric and adult patients | Pediatric (5 years and older),
defined by the prescribed
medication, and adult
patients. | Similar |
| Environment of
Use | in the home, hospital, and
sub-acute care settings. | Hospital / institutional
settings, home care use,
schools, and long-term care
facilities | Similar |
| Contraindications | It is not intended for use with
Pentamidine. | It is not intended for use with
Pentamidine. | Similar |
| Principle of
Operation | Vibrating mesh | Vibrating mesh | Similar |
| Aerosolization | Continuous during inhalation
and exhalation | Continuous during inhalation
and exhalation | Similar |
| Compressed gas
source | None needed | None needed | Similar |
| Reservoir volume | 7 ml | 10 ml | Different |
| Nebulization rate | 0.25 ml/min to 0.9 ml/min | ≥ 0.25 ml/min | Different |
| Duration of use | Single patient, multi-use | Single patient, multi-use | Similar |
| Nebulizer
components
cleanable | Yes | Yes | Similar |
| Software-driven | No | No | Similar |
| Power source | 2x AA Batteries | 2x 1.5V AA Alkaline
Batteries | Similar |
| Power
consumption | 1.5 W | Approx. 1.2 W | Similar |
| Weight | 97 gm w/o batteries | 75 gm w/o batteries | Different |
| Dimensions (mm) | 51 x 38 x 104 | 74 x 46 x 96 | Different |
| Operating
Conditions | 0 to 45°C / 30-85% RH | 5 to 40°C / 15-93% RH | Similar |
| Storage
Conditions | -25 to + 70°C / 10-90% RH | -25 to + 70°C / 30 days) | | Use – permanent (> 30 days) | | | | |
| | And | | And | | | | |
| | Surface Contact | | Surface Contact | | | | |
| | | Mucosal membrane | | Mucosal membrane | | | |
| | | Duration of Use - permanent | | Duration of Use - permanent | | | |
| | (> 30 days) | | | (> 30 days) | | | |
| @ Pediatric Flow | Albuterol | Ipratropium | Cromolyn | Albuterol | Ipratropium | Cromolyn | MMAD, |
| Rate | Sulfate | Bromide | Sodium | Sulfate | Bromide | Sodium | GSD, Total |
| MMAD (µm) | 3.77 ± 0.31 | 3.33 ± 0.21 | 3.17 ± 0.06 | 3.37 ± 0.23 | 3.20 ± 0.10 | 3.00 ± 0.20 | Dose |
| GSD | 2.45 ± 0.11 | 2.75 ± 0.22 | 3.17 ± 0.17 | 3.02 ± 0.37 | 2.92 ± 0.11 | 3.11 ± 0.15 | Delivered, |
| Total Dose | 1093 ± 229 | 369 ± 13 | 11796 ± | 1528 ±139 | 299 ± 22 | 11088 ± | and Total |
| Delivered (µg) | | | 354 | | | 463 | Respirable |
| Total Respirable | 1109 ± 128 | 187 ± 15 | 6259 ± 172 | 925 ± 152 | 173 ± 18 | 6167 ± 408 | Dose were |
| Dose (µg) | | | | | | | substantially |
| @ Adult Flow | Albuterol | Ipratropium | Cromolyn | Albuterol | Ipratropium | Cromolyn | equivalent to |
| Rate | Sulfate | Bromide | Sodium | Sulfate | Bromide | Sodium | the predicate |
| MMAD (µm) | 3.13 ± 0.31 | 3.20 ± 0.35 | 3.03 ± 0.15 | 2.94 ± 0.25 | 2.76 ± 0.37 | 2.39 ± 0.24 | device. |
| GSD | 3.40 ± 0.17 | 2.74 ± 0.08 | 2.98 ± 0.24 | 3.01 ± 0.31 | 3.39 ± 0.51 | 2.70 ± 0.30 | |
| Total Dose | 2215 ± 84 | 377 ± 28 | 13208 ± | 1596 ± 102 | 320 ± 15 | 11559 ± | |
| Delivered (µg) | | | 447 | | | 440 | |
| Total Respirable | 1093 ± 72 | 222 ± 28 | 7778 ± 457 | 950 ± 105 | 191 ± 20 | 7975 ± 764 | |
| Dose (µg) | | | | | | | |
9
| Software Level of
| Concern | Moderate | Moderate | Similar |
|---|---|---|---|
| Is the software | |||
| dependent on | |||
| external devices? | No | No | Similar |
Substantial Equivalence Conclusion
As detailed above, the indication for use, patient population, the environment of use, technology characteristics, and the principle of operation are substantially equivalent. The materials in patient contact of the two devices are not identical, but the results of the biocompatibility assay for HCMed Pulmogine® Vibrating Mesh Nebulizer determined with the same criteria verified that the proposed device meets the biocompatibility requirements. Therefore, it can be concluded that the proposed device, HCMed Pulmogine® Vibrating Mesh Nebulizer, HCM-86C, has a substantially equivalence safety and effectiveness profile as compared to the legally marketed predicate device, Omron Micro Air Vibrating Mesh Nebulizer, NE-U22.