(287 days)
Not Found
No
The document describes a standard ultrasonic nebulizer and its performance characteristics. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on physical and electrical safety, nebulization parameters, and biocompatibility.
Yes
The device is designed to aerosolize liquid medications for inhalation, delivering medicine to the lungs to treat patients, which directly aligns with the definition of a therapeutic device.
No
This device is a nebulizer designed to aerosolize liquid medications for inhalation; it delivers treatment, it does not diagnose conditions.
No
The device description explicitly details physical components made of various materials (ABS, silica gel, PC, PVC, PP, stainless steel) and describes it as a "small, handheld, internally powered general purpose nebulizer." The performance studies also include testing related to electrical safety, biocompatibility, and device life, which are characteristic of hardware devices. While software verification and validation are mentioned, this is for software contained in the medical device, not the device being solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "aerosolize liquid medications for inhalation by the patient." This describes a device used to deliver medication to the respiratory system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a nebulizer that creates a mist for inhalation. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on the device's ability to aerosolize medication effectively and safely.
Therefore, this device is a therapeutic medical device, specifically a nebulizer, and not an IVD.
N/A
Intended Use / Indications for Use
The portable (Ultrasonic) nebulizer is an ultrating mesh nebulizer 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, schools, and long-term care facilities. It is not intended for use with Pentamidine.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.
The Portable (Ultrasonic) nebulizer NBM-1 has the same working principle, specification, structure, intended use and software, the only differences is appearance.
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), defined by the prescribed medication, and adult patients
Intended User / Care Setting
hospital/ institutional settings, home, 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)
A series of safety and performance tests were conducted on the subject device, Portable (Ultrasonic) Nebulizer NBM-1.
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:
- A AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005+A1:2012, MOD)
- A IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system were conducted on the device, and three kind of drugs used for testing, albuterol sulfate, ipratropium bromide, cromolyn sodium. Testing established that, with respect to safety and performance for nebulizing systems, the device meets the applicable requirements of:
- A ISO 27427:2013 Anaesthetic and respiratory equipment-Nebulizing systems and components
- A FDA Guidance: Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
Biocompatibility testing was conducted on the nebulizer's mouthpiece, adult mask, kid mask, medicine cup and cover, button decoration ring, nebulizer piece, which are patient-contacting device components. The following biological compatibility tests were executed:
- In Vitro Cytotoxicity Test -ISO10993-5
- Skin Sensitization Test (polar and non polar) -ISO10993-10
- Intracutaneous Reactivity Test-ISO10993-10
- Acute Systemic Toxicity Test (polar and non polar) -ISO10993-11
- Material-mediated pyrogens Test -ISO10993-11
- Ames Test (polar and DMSO Extract)--ISO10993-3
- In Vitro Mammalian Chromosomal Aberration test -- ISO10993-3
- Subchronic systemic toxicity Test (polar and non polar) -ISO10993-11
- Subacute systemic Toxicity Test (polar and non polar) -ISO10993-11
- Muscle implant Test -ISO10993-6
- Chemical characterization study- ISO10993-18
- Toxicological risk assessment study-ISO10993-17
- Biocompatibility evaluation- ISO 18562-1
- Test for emissions of particulate matter ISO 18562-2
- Test for emissions of VOCs -ISO 18562-3
Under the parameters of the tests, it is concluded that they are biocompatible, and that there are no new issues of safety regarding their use as intended.
Software Verification and Validation Testing was conducted in accordance with FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1, 2005" and IEC 62304:2015 Medical device software - Software life-cycle processes.
Device life, shelf-life and battery life were tested with simulation method, and the device meets the applicable requirements.
Cleaning Validation was conducted, and the test result meets the applicable requirements.
All the test results demonstrate Portable (Ultrasonic) Nebulizer NBM-1 meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for aerosol performance were provided:
Particle Size (MMAD):
Subject: albuterol sulfate: 2.09±0.19, ipratropium bromide: 2.10±0.14, cromolyn sodium: 2.07±0.19
Predicate: albuterol sulfate: 2.27±0.21, ipratropium bromide: 2.37±0.35, cromolyn sodium: 2.27±0.25 (Adult); 3.73±0.35, 3.60±0.17, 3.73±0.21 (Pediatric)
Geometric Standard Deviation:
Subject: albuterol sulfate: 1.94±0.21, ipratropium bromide: 1.91±0.15, cromolyn sodium: 1.78±0.13
Predicate: albuterol sulfate: 1.80±0.20, ipratropium bromide: 1.73±0.12, cromolyn sodium: 1.67±0.06 (Adult); 2.10±0.17, 2.10±0.17, 1.90±0.10 (Pediatric)
Total Dose Delivered by device:
Subject: albuterol sulfate: 1,529±65, ipratropium bromide: 235±20, cromolyn sodium: 7,236±753
Predicate: albuterol sulfate: 1,541±65, ipratropium bromide: 242±4, cromolyn sodium: 6,983±852 (Adult); 1593.1±113.3, 250.2±10.4, 7394.3±445.5 (Pediatric)
Total Respirable Dose (0.5-5um):
Subject: albuterol sulfate: 1,048±106, ipratropium bromide: 156±13, cromolyn sodium: 5,341±589
Predicate: albuterol sulfate: 1,133±109, ipratropium bromide: 164±7, cromolyn sodium: 5,157±629 (Adult); 961.6±129.3, 150.8±7.1, 4581.7±571.2 (Pediatric)
Coarse Particle Dose (>4.7um):
Subject: albuterol sulfate: 397±57, ipratropium bromide: 66±9, cromolyn sodium: 1,626±224
Predicate: albuterol sulfate: 333±52, ipratropium bromide: 66±11, cromolyn sodium: 1,507±198 (Adult); 618.3±62.3, 95.5±7.8, 2715.4±198.6 (Pediatric)
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 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2023
Dongguan SIMZO Electronic Technology Co.Ltd. % Reanny Wang General Manager Shenzhen Reanny Medical Devices Management Consulting., Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518000 China
Re: K230379
Trade/Device Name: Portable (Ultrasonic) Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 9, 2023 Received: October 27, 2023
Dear Reanny Wang:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from John S. Bender -S. The date of the signature is 2023.11.27, and the time is 13:38:14 -05'00'.
for Ethan Nyberg Assistant Director DHT1C: Division of Sleep Disordered
2
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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230379
Device Name Portable (Ultrasonic) Nebulizer
Indications for Use (Describe)
The portable (Ultrasonic) nebulizer is an ultrating mesh nebulizer 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, schools, and long-term care facilities. It is not intended for use with Pentamidine.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) Summary
The assigned 510(k) number is: K230379
1.0 Information of Submitter and Correspondent
Submitter's information:
Name: Dongguan SIMZO Electronic Technology Co., Ltd. Address: No.6, Zhangzhou Road, Daojiao Town, Dongguan City, Guangdong Province, 523187, R.R. China Tel: +86-769-86339010 Fax: +86-769-22981193 Contact with: Jin Gang Website: www.simzo.net E-mail: dong@simzo.net
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. Address: Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518000, China Contact Person: Reanny Wanq E-mail: reanny@reanny.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Portable (Ultrasonic) Nebulizer |
| Model: | NBM-1 |
| Classification name: | Nebulizer (Direct Patient Interface) |
| Review Panel: | Anesthesiology |
| Product Code: | CAF |
| Device Class: | II |
| Regulation Number: | 868.5630 |
3.0 Predicate Device Information
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| Sponsor: | Qingdao Future Medical Technology Co., Ltd. |
|---|---|
| Device: | Intelligent Mesh Nebulizer |
| 510(K) Number: | K171549 |
4.0 Device Description
The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.
The Portable (Ultrasonic) nebulizer NBM-1 has the same working principle, specification, structure, intended use and software, the only differences is appearance.
5.0 Indications for Use
The portable (Ultrasonic) nebulizer is an ultrasonic 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, schools, and long-term care facilities. It is not intended for use with Pentamidine.
6.0 Comparison to predicate device and conclusion
The subject device is substantially equivalent to predicate devices, K171549, Intelligent Mesh Nebulizer. The substantial equivalence chart is provided as follows:
| Eleme
nts of
Comparison | Predicate Device
(K171549) | Subject Device | Judgment |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Models | NEB001 | NBM-1 | -- |
| Company | Qingdao Future Medical Technology
Co., Ltd. | Dongguan SIMZO Electronic
Technology Co. Ltd. | -- |
| Eleme
nts of
Comparison | Predicate Device
(K171549) | Subject Device | Judgment |
| Models | NEB001 | NBM-1 | -- |
| Device Name | Intelligent Mesh Nebulizer | Portable (Ultrasonic) Nebulizer | -- |
| Product code | CAF | CAF | SE |
| Regulation # | 21CFR868.5630 | 21CFR868.5630 | SE |
| Intended use | The Intelligent Mesh Nebulizer
designed to aerosolized liquid
medications for inhalation by patient,
the device may be used with
pediatric (>4 years of age) and adult
patients in the home, hospital and
sub-acute care settings. It is not
intended for use with Pentamidine. | The ultrasonic nebulizer is an
ultrasonic vibrating mesh nebulizer
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.
lt is not intended for use with
Pentamidine. | SE, see
Remark 1 |
| Principle of
operation | Vibrating mesh | Vibrating mesh | SE |
| Ultrasonic
Oscillation
Frequency | Approx. 110KHz | 110 KHz ± 10KHz | SE |
| Aerosolizatio
n | Continuous during inhalation and
exhalation | Continuous during inhalation and
exhalation | SE |
| Compressed
gas source | None needed | None needed | SE |
| Medicine
Capacity | 8ml maximum,0.5ml minimum | 6 ml | Similar
see
Remark 2 |
| Nebulization
rate | ≥ 0.2 ml/min | >0.2mL/min. | SE |
| Aerosol
Performance | Table: Comparative particle test
comparison | Table: Comparative particle test
comparison | Similar, see
Remark 3 |
| Duration of
Use | Single patient, multi-use | Single patient, multi-use | SE |
| Eleme
nts of
Comparison | Predicate Device
(K171549) | Subject Device | Judgment |
| Models | NEB001 | NBM-1 | -- |
| Power supply | ZN-103450 Lithium battery: 3.7Vd.c.
AC Adapter AC 100-240Va.c. 47-
63Hz 0.4-0.2A | DC3.0V, 2×AA batteries | Difference,
see
Remark 4 |
| Waterproof | IP22 | IP22 | SE |
| Degree of
protection
against
electric shock | Type BF applied part | Type BF applied part | SE |
| Type of
protection
against
electric shock | Internally power equipment | Internally power equipment | SE |
| Model of
operation | Continuous operation | Continuous operation | SE |
| Power off | ON / OFF Button | On/Off button | SE |
| Operation
environment | 5°C to 40°C, 15% to 90% RH | 10 -40°C, 10%-95%RH | Similar,
see
Remark 5 |
| Storage
environment | -25°C to 70°C, ≤90% RH | -20°C to 70°C, 10%-95% RH | Similar,
see
Remark 5 |
| Patient
Connector | Mouthpiece or masks | Mouthpiece or masks | SE |
| Biocompatibil
ity | All the patient contacting materials
are compliance with ISO 10993 | All the patient contacting materials
are compliance with ISO 10993 | SE |
| Electrical
Safety | Compliance with IEC 60601-1 and
IEC 60601-1-11 | Compliance with IEC 60601-1 and
IEC 60601-1-11 | SE |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE |
| Dimensions
(mm) | 50mm(L)×74mm(W)×111mm(H) | 60mm×55mm×130mm | Similar,
see
Remark 6 |
| Weight (kg) | Approx. 106g | Approx. 110g | Similar,
see
Remark 6 |
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Simzo
| Item | Adult | Pediatric | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject | ||||||||||||
| (Ultrasonic) | ||||||||||||
| NBM-1) | device- | |||||||||||
| Nebulizer | ||||||||||||
| (Model: | Portable | |||||||||||
| (Model: | ||||||||||||
| NEB001) - | Predicate | |||||||||||
| Intelligent | ||||||||||||
| Mesh | ||||||||||||
| (K171549)- Nebulizer | Subject device- Portable (Ultrasonic) | |||||||||||
| Nebulizer (Model: NBM-1) | Predicate | |||||||||||
| Intelligent Mesh | ||||||||||||
| (K171549)- Nebulizer | ||||||||||||
| (model: NEB001) - | ||||||||||||
| albuterol | ||||||||||||
| sulfate | ipratropium | |||||||||||
| bromide | cromolyn | |||||||||||
| sodium | albuterol | |||||||||||
| sulfate | ipratropium | |||||||||||
| bromide | cromolyn | |||||||||||
| sodium | albuterol | |||||||||||
| sulfate | ipratropium | |||||||||||
| bromide | cromolyn | |||||||||||
| sodium | ||||||||||||
| Particle Size | ||||||||||||
| (MMAD) | 2.09±0.19 | 2.10±0.14 | 2.07±0.19 | 2.27±0.21 | 2.37±0.35 | 2.27±0.25 | 3.66±0.22 | 3.48±0.30 | 3.64±0.21 | 3.73±0.35 | 3.60±0.17 | 3.73±0.21 |
| Geometric | ||||||||||||
| Standard | ||||||||||||
| Deviation | 1.94±0.21 | 1.91±0.15 | 1.78±0.13 | 1.80±0.20 | 1.73±0.12 | 1.67±0.06 | 2.01±0.23 | 1.98±0.18 | 1.97±0.17 | 2.10±0.17 | 2.10±0.17 | 1.90±0.10 |
| Total Dose | ||||||||||||
| Delivered by | ||||||||||||
| device | 1,529±65 | 235±20 | 7,236±753 | 1,541±65 | 242±4 | 6,983±852 | 1593.1±113.3 | 250.2±10.4 | 7394.3±445.5 | 1624.2±81.2 | 247.4±5.2 | 7279.3±545.9 |
| Total | ||||||||||||
| Respirable | ||||||||||||
| Dose (0.5- | ||||||||||||
| 5um) | 1,048±106 | 156±13 | 5,341±589 | 1,133±109 | 164±7 | 5,157±629 | 961.6±129.3 | 150.8±7.1 | 4581.7±571.2 | 932.3±115.2 | 145.4±6.2 | 4369.4±201.8 |
| Coarse | ||||||||||||
| Particle Dose | ||||||||||||
| (>4.7um) | 397±57 | 66±9 | 1,626±224 | 333±52 | 66±11 | 1,507±198 | 618.3±62.3 | 95.5±7.8 | 2715.4±198.6 | 665.9±48.7 | 98.1±4.7 | 2790.8±338.0 |
| Fine Particle | ||||||||||||
| Dose | ||||||||||||
| (4 years of age=5 years and older) and adult patients. |
The handheld nebulizers are common and usual used for Hospital/institutional settings, home care use, schools and long-term care facilities. They are both compliance with IEC 60601-1, IEC 60601-1-2 and IEC60601-1-11 standards. The propose environments of subject device is identical for the predicate device, it will not raise any problems of safety or effectiveness.
Remark 2:
The "Medicine Capacity" of subject is within the predicate device. The subject device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the subject device didn't raise any problems of safety or effectiveness.
Remark 3:
From the Table: Comparative particle test comparison, all of the parameters were similar with predicate device, there were no statistically measurable differences between the subject device and predicate device, they are substantially equivalent, and the subject device didn't raise any problems of safety or effectiveness.
Remark 4:
The "power supply" of subject device is difference with predicate device, the subject device use AA battery to supply power, the risk of AA battery is lower than Lithium battery. Otherwise, the subject device has been passed the test according to IEC 60601-1 standard, it will not raise any safety or effectiveness issue.
Remark 5:
The operation and storage environment of subject devices is difference with predicate device, and they are both compliance with IEC60601-1-11 standard, it will not raise any safety or effectiveness issue.
Remark 6:
The subject device has the similar specifications with the predicate device, such as dimensions, Weight, based on the nonclinical tests performed, those minor differences for specifications do not affects the safety and effective of the device.
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Conclusion:
The subject devices have all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject devices.
Thus, the subject devices are substantially equivalent to the predicate device.
7.0 Summary of Non-clinical performance testing
7.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device, Portable (Ultrasonic) Nebulizer NBM-1.
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:
- A AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005+A1:2012, MOD)
- A IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
Safety and performance:
Safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system were conducted on the device, and three kind of drugs used for testing, albuterol sulfate, ipratropium bromide, cromolyn sodium. Testing established that, with respect to safety and performance for nebulizing systems, the device meets the applicable requirements of:
- A ISO 27427:2013 Anaesthetic and respiratory equipment-Nebulizing systems and components
- A FDA Guidance: Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
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Biocompatibility testing
The nebulizer's mouthpiece, adult mask, kid mask, medicine cup and cover, button decoration ring, nebulizer piece are patient-contacting device components.
According to provision of ISO 10993-1:2018 annex A table A.1 and FDA's 2020 Guidance entitled,
" Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" evaluation testing, and consider the product character of Portable (Ultrasonic) Nebulizer, the following biological compatibility test need to be executed as follow:
- � In Vitro Cytotoxicity Test -ISO10993-5
- � Skin Sensitization Test(polar and non polar ) -ISO10993-10
- Intracutaneous Reactivity Test-ISO10993-10 �
- � Acute Systemic Toxicity Test (polar and non polar) -ISO10993-11
- � Material-mediated pyrogens Test -ISO10993-11
- � Ames Test (polar and DMSO Extract)--ISO10993-3
- � In Vitro Mammalian Chromosomal Aberration test -- ISO10993-3
- � Subchronic systemic toxicity Test (polar and non polar) -ISO10993-11
- � Subacute systemic Toxicity Test (polar and non polar) -ISO10993-11
- � Muscle implant Test -ISO10993-6
- � Chemical characterization study- ISO10993-18
- � Toxicological risk assessment study-ISO10993-17
- Biocompatibility evaluation- ISO 18562-1
- Test for emissions of particulate matter ISO 18562-2
- Test for emissions of VOCs -ISO 18562-3
Under the parameters of the tests, it is concluded that they are biocompatible, and that there are no new issues of safety regarding their use as intended.
Software Verification and Validation Testing
The software verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA ' s Guidance , " Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1, 2005" and IEC 62304:2015 Medical device software - Software life-cycle processes.
Device life testing, shelf-life testing, Battery life testing
Device life, shelf life and battery life were tested with simulation method, the device meets the applicable requirements.
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Cleaning Validation
The cleaning was conducted, the test result meets the applicable requirements.
All the test results demonstrate Portable (Ultrasonic) Nebulizer NBM-1 meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
7.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
8.0 Conclusions
Portable (Ultrasonic) Nebulizer NBM-1 has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the IEC 60601-1, IEC60601-1-11 standards and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the nebulizer meet the ISO 27427 standard and confirm the aerosol performance. These conclude that any differences in their characteristics do not raise any safety and effectiveness issues.
From the above information we conclude the subject device, NBM-1 is substantially equivalent to the predicate devices Intelligent Mesh Nebulizer.
9.0 Summary prepared date
October 27, 2023