(451 days)
No
The summary describes a standard vibrating mesh nebulizer and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is designed to aerosolize physician-prescribed liquid medications for inhalation, indicating its use in treating medical conditions.
No
Explanation: The device is described as a nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation. Its function is to deliver medication, not to diagnose a condition.
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 physical hardware device. The performance studies also include hardware-specific testing like electrical safety, EMC, and biocompatibility. While software verification and validation were performed, this is common for devices with embedded software and does not make it a software-only device.
Based on the provided information, the HOMED Mesh Nebulizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "aerosolize physician-prescribed liquid medications for inhalation to a patient." This describes a device used to deliver medication to a patient, not a device used to perform tests on samples taken from a patient.
- Device Description: The description focuses on the mechanism of generating aerosol for inhalation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on testing.
- Performance Studies: The performance studies focus on the device's ability to aerosolize medication effectively and safely, not on diagnostic accuracy or performance with biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The HOMED Mesh Nebulizer's function is entirely focused on drug delivery.
N/A
Intended Use / Indications for Use
The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.
Product codes
CAF
Device Description
The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
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
patients 5 years and older
Intended User / Care Setting
Home, hospital, and sub-acute care settings.
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)
We performed a number of non-clinical tests to demonstrate that the HOMED Mesh Nebulizer is equivalent to the predicate K062263 - Omron NE-U22 nebulizer.
- Shelf-life, Useful-life, Simulated Life Cycle testing
- Cleaning
- Electrical Safety, EMC, EMC
- Particle Characterization per Cascade Impactor
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 60601-1-2:2014; (3) IEC 60601-1-11:2012.
Software 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 tests included: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Irritation, Sub-chronic Systemic toxicity, Acute Systemic Toxicity, Pyrogen, Genotoxicity, Implantation, 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.
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. Particle size characterization (MMAD) was verified after two years of real-time aging using both cascade impactor technique.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062263 – Omron NE-U22
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2018
Shenzhen Homed Medical Device Co,.Ltd. Shengming Shi Manager of Technical Regulation Department 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road Tongsheng Community, Dalang Street, Longhua New District Shenzhen, 518109 Cn
Re: K170886
Trade/Device Name: HOMED Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 22, 2018 Received: May 23, 2018
Dear Shengming Shi:
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 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);
1
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 comprehensive regulatory information about medical devices and radiation-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.
Amy K. Levelle -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)
K170886
Device Name
HOMED Mesh Nebulizer (Model JLN-MBXXX; XXX: 001~005)
Indications for Use (Describe)
The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.
Type of Use (Select one or both, as applicable)
| XX Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (7/17)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
3
K170886
Shenzhen Homed Medical Device Co., Ltd 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road, Tongsheng Community Dalang Street, Longhua New District Shenzhen 518 10 9, PRC
| Official Contact: | Shengming Shi
Manager of Technical Regulation Department
Tel – 011 0755-29821675 |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | HOMED Mesh 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 HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
Components
The Medicine 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 Medicine 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 or AC Adaptor and firmware to control the vibrating mesh module in the Medicine Cup.
The HOMED Mesh 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, the housing may be offered in various colors, but the unit is fundamentally identical.
Indications for Use:
The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for
4
510(k) Summary Page 2 of 7 June 21, 2018
Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.
Principle of Operation / Technology
The HOMED Mesh 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 0.25 ml/min |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Nebulizer components
cleanable | Yes | Yes |
| Software driven | No | Yes |
| Power source | 2 - “AA” Battery | 2 - “AA” battery
AC Adaptor |
| Power consumption | 1.5 W | 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 Total Dose were substantially equivalent to
the predicate. | |
| 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 June 21, 2018
Substantial Equivalence Discussion
The HOMED Mesh 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.
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.
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 similar for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.
Technology - The design as a vibrating mesh nebulizer which is the similar principle of operation.
Discussion - The technology is similar 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 HOMED Mesh Nebulizer is equivalent to the predicate K062263 - Omron NE-U22 nebulizer.
- Shelf-life, Useful-life, Simulated Life Cycle testing ●
- Cleaning ●
- Electrical Safety, EMC, EMC ●
- Particle Characterization per Cascade Impactor
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 60601-1-2:2014; (3) IEC 60601-1-11:2012.
7
510(k) Summary Page 5 of 7 June 21, 2018
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 ●
- Intracutaneous Reactivity ●
- Irritation
- Sub-chronic Systemic toxicity
- Acute Systemic Toxicity
- Pyrogen
- Genotoxicity
- Implantation
- 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.
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.
| Features | Predicate | Proposed |
|---|---|---|
| Omron NE-22 K062263 | Mesh Nebulizer | |
| Particle Characterization per Cascade Impactor @ 28 lpm - Adult Flow | ||
| Particle size (MMAD) | ||
| Ventolin | 2.850-3.148 | 2.792-2.922 |
| Budesonide | 2.686-2.761 | 2.532-2.577 |
| Atrovent | 2.761-3.103 | 2.412-2.552 |
| Geometric Std. Dev. (GSD) | ||
| Ventolin | 2.814-3.011 | 2.818-2.866 |
| Budesonide | 3.112-3.221 | 3.115-3.165 |
| Atrovent | 2.824-3.070 | 2.746-2.845 |
Table 3 - Comparative Aerosol Performance - Adult Flow Rate - 28 Ipm
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| 510(k) Summary | ||
|---|---|---|
| Page 6 of 7 | ||
| June 21, 2018 | ||
| Total Respirable Dose (0.5-5 $\mu$ ) / % | ||
| Ventolin | 62.1-64.9% | 64.8-67.2% |
| Budesonide | 63.4-65.4% | 64.0-65.7% |
| Atrovent | 61.3-67.0% | 67.3-69.1% |
| Coarse Particle Dose (>4.7 $\mu$ ) / % | ||
| Ventolin | 33.1-37.2% | 30.4-32.2% |
| Budesonide | 28.2-31.0% | 26.8-29.7% |
| Atrovent | 12.6-38.6% | 23.1-25.9% |
| Fine Particle Dose (4.7 $\mu$ ) / % | ||
| Ventolin | 33.9-43.7% | 37.2-39.3% |
| Budesonide | 28.8-39.0% | 30.7-32.1% |
| Atrovent | 6.0-57.6% | 26.6-30.5% |
| Fine Particle Dose ( |