(382 days)
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.
The proposed devices are portable size, curvaceous body design that is convenient to hold, Which are battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum.
For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liguid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system.
There are 3 models included, MY-123/MY-125/ the three models have same intended use, mechanism of action, principle and specification. The difference between three models is appearance.
The provided text describes a 510(k) premarket notification for an Ultrasonic Mesh Nebulizer (K201397). This submission focuses on demonstrating substantial equivalence to a predicate device (Intelligent Mesh Nebulizer, K171549) rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance metrics for an AI/CAD/imaging device.
Therefore, the requested information regarding acceptance criteria, study design for proving device performance, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.
The document primarily provides a comparison of the proposed device's characteristics and performance to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are implicitly that the new device performs "as well as" the predicate device in terms of aerosol delivery characteristics and various safety tests.
Here's how the provided information aligns with your request, highlighting the differences:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of clearly defined acceptance criteria with pass/fail thresholds for clinical performance (as would be typical for an AI/CAD device), the document presents a comparative table showing the performance characteristics of the Subject Device (Ultrasonic Mesh Nebulizer) against the Predicate Device (Intelligent Mesh Nebulizer).
The "acceptance" in this context is based on the new device being sufficiently similar to and performing comparably to the legally marketed predicate device across various parameters.
| Item | Predicate Device (Intelligent Mesh Nebulizer - K171549) | Subject Device (Ultrasonic Mesh Nebulizer) | Remark (Comparison for Substantial Equivalence) |
|---|---|---|---|
| General Comparison | |||
| K Number | K171549 | / | / |
| Sponsor | Qingdao Future Medical Technology Co., Ltd | Shenzhen Ivankaca Technology Co., Ltd | / |
| Trade/Device Name | Intelligent Mesh Nebulizer | Ultrasonic Mesh Nebulizer | / |
| Model(s) | NEB002 | MY-123, MY-125, MY-126 | / |
| Regulation Number | 21 CFR 868.5630 | 21 CFR 868.5630 | same |
| Regulation Name | Nebulizer | Nebulizer | same |
| Classification Name | Nebulizer (Direct Patient Interface) | Nebulizer (Direct Patient Interface) | same |
| Regulatory Class | Class II | Class II | same |
| Product Code | CAF | CAF | same |
| Review Panel | Anesthesiology | Anesthesiology | same |
| Intended Use/Indications for Use | Designed to aerosolized liquid medications for inhalation by patient, used with pediatric (>4 years) and adult patients in home, hospital, sub-acute care settings. Not for Pentamidine. | Designed to aerosolized liquid medications for inhalation by patient, used with pediatric (>4 years) and adult patients in home, hospital, sub-acute care settings. Not for Pentamidine. | same |
| Prescription/OTC | Prescription | Prescription | same |
| Performance Comparison | |||
| Lithium battery | 3.7Vd.c. | 3.7Vd.c. | Same |
| Nebulizing Method | Vibrating Mesh | Vibrating Mesh | same |
| Vibration Frequency | Approx. 110KHz | Approx. 110KHz | same |
| Nebulization Rate/Aerosol Flow rate | 0.2ml/min minimum | 0.2ml/min minimum | same |
| Medicine Capacity | 8ml maximum, 0.5ml minimum | 8ml maximum, 0.5ml minimum | same |
| Nebulizer Components Cleanable | Yes | Yes | same |
| Use | Single Patient | Single Patient | same |
| Patient Connector | Mouthpiece or mask | Mouthpiece or mask | same |
| Dimensions (mm) | 50mm(L)×74mm(W)×111mm(H) | Approx. 42(L)x55(W)x109(H)mm (MY-123); 49(L)x56(W)x120(H)mm (MY-125); 45(L)x47(W)x120(H)mm (MY-126) | different |
| Weight (kg) | Approx. 106g | MY-123: 113±5g; MY-125: 116±5g; MY-126: 110±5g | different |
| Operating Conditions | 5°C to 40°C, 15% to 90% RH | 5°C to 40°C, 15% to 90% RH | same |
| Storage Conditions | -25°C to 70°C, ≤90% RH | -25°C to 70°C, ≤90% RH | same |
| Safety Comparison | |||
| Patient Contact Materials | PVC | PVC | same |
| Biocompatibility | Comply with 10993-1 | Comply with 10993-1 (various tests listed: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Ames Test, Chromosomal Aberration, Micronucleus Test, Subcutaneous Implantation Test, and ISO 18562 suite for respiratory gas pathways) | same (compliance) |
| Electrical safety | Comply with 60601-1 | Comply with 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, MOD) | same (compliance) |
| EMC | Comply with 60601-1-2 | Comply with 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 | same (compliance) |
| Comparative Particle Test | (Values for Salbutamol, Budesonide, Ipratropium bromide with Big mask) | (Values for Salbutamol, Budesonide, Ipratropium bromide with Mouthpiece, Small mask, Big mask) | Comparable ranges |
| MMAD(µm) | 3.70±0.66 (Salb.); 3.29±0.12 (Budes.); 3.87±0.72 (Ipra.) | Mouthpiece: 3.68±0.68, 3.28±0.08, 3.84 ± 0.66; Small mask: 3.75±0.63, 3.25±0.11, 3.85 ± 0.66; Big mask: 3.72±0.65, 3.31±0.10, 3.88 ± 0.68 | Considered comparable |
| GSD | 1.85±0.04 (Salb.); 2.50±0.033 (Budes.); 1.81±0.03 (Ipra.) | Mouthpiece: 1.84±0.03, 2.44±0.02, 1.83 ± 0.035; Small mask: 1.86±0.05, 2.46 ± 0.025, 1.84 ± 0.035; Big mask: 1.82 ± 0.035, 2.48 ± 0.031, 1.84 ± 0.032 | Considered comparable |
| Respirable fraction (1-5 µm) | 62.8% ± 11.3 (Salb.); 57.6% ± 9.8 (Budes.); 63.8% ± 11.6 (Ipra.) | Mouthpiece: 63.5% ± 10.5, 61.7% ± 10.5, 62.4% ± 10.6; Small mask: 63.8% ± 11.8, 60.8 % ± 11.6, 63.4% ± 11.3; Big mask: 64.5% ± 10.2, 58.8% ± 10.2, 64.5% ± 11.9 | Considered comparable |
| Fine particle fraction (FPF <5 µm) | 67.7% ± 10.2 (Salb.); 68.4% ± 10.8 (Budes.); 65.6% ± 12.3 (Ipra.) | Mouthpiece: 65.4% ± 11.4, 70.9% ± 11.3, 63.8% ± 12.1; Small mask: 64.8% ± 12.6, 69.6% ± 13.0, 64.6% ± 12.2; Big mask: 66.6% ± 13.0, 69.5% ± 10.3, 66.2% ± 12.4 | Considered comparable |
| Aerosol output (ml/min) | 0.32 ± 0.03 (Salb.); 0.26 ± 0.02 (Budes.); 0.33 ± 0.02 (Ipra.) | Mouthpiece: 0.29 ± 0.02, 0.27 ± 0.02, 0.35 ± 0.02; Small mask: 0.30 ± 0.03, 0.28 ± 0.02, 0.34 ± 0.02; Big mask: 0.32 ± 0.03, 0.28 ± 0.02, 0.35 ± 0.02 | Considered comparable |
| Delivered dose | 1.13ml ± 0.08 (Salb.); 1.24ml ± 0.12 (Budes.); 0.92ml ± 0.02 (Ipra.) | Mouthpiece: 1.12ml ± 0.06, 1.23ml ± 0.12, 0.93ml ± 0.02; Small mask: 1.12ml ± 0.08, 1.26ml ± 0.1, 0.93ml ± 0.02; Big mask: 1.14ml ± 0.08, 1.27ml ± 0.1, 0.94ml ± 0.02 | Considered comparable |
Conclusion from document: "The proposed devices are substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject devices are as safe, as effective, and performs as well as the legally marketed predicate device."
The remaining points are largely not applicable because this is a medical device substantial equivalence submission (510k) for a nebulizer, not a software/AI device that requires extensive clinical validation of diagnostic performance.
2. Sample sized used for the test set and the data provenance:
- This document refers to "nonclinical tests" (biocompatibility, electrical safety, EMC, software V&V, shelf life, cleaning/disinfection, human factors, particle size distribution). These are lab-based tests, not clinical test sets with patient data.
- The "particle test comparison" table presents data from performance testing, likely derived from multiple runs/measurements for each nebulizer model and drug type. Specific "sample sizes" in terms of patients or independent cases are not relevant here.
- Data provenance (country, retrospective/prospective) is not mentioned as this is not a clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert consensus on medical images or clinical outcomes in this submission. The "ground truth" for the nonclinical tests would be defined by the testing standards and procedures themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process for a test set is described.
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:
- Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/CAD sense. The "ground truth" for proving substantial equivalence of a nebulizer involves demonstrating compliance with recognized standards (e.g., ISO, IEC for safety, electrical, biocompatibility) and comparable physical/performance characteristics (e.g., particle size distribution, nebulization rate) to a predicate device.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
Summary of what was done:
The manufacturer performed a series of non-clinical bench tests to demonstrate that their Ultrasonic Mesh Nebulizer (MY-123, MY-125, MY-126) is substantially equivalent to a legally marketed predicate device (Intelligent Mesh Nebulizer, K171549). These tests included:
- Biocompatibility testing
- Electrical Safety and Electromagnetic Compatibility (EMC) testing
- Software Verification and Validation Testing (for the device's embedded software, categorized as "moderate" level of concern)
- Simulated shelf life testing
- Battery cycle life testing
- Cleaning and Disinfection Validation
- Human factors validation testing
- Particle size distribution testing (using Salbutamol, Budesonide, and Ipratropium bromide, per FDA guidance for nebulizers). This is the primary "performance" test described, showing comparable MMAD, GSD, and particle fractions to the predicate.
The conclusion is based on a side-by-side comparison of these test results and technological characteristics with the predicate device, showing "no new issues of safety" and that the subject devices perform "as well as" the predicate. No clinical study was included in this submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Shenzhen Ivankaca Technology Co., Ltd % Long Yang Coo Shenzhen Hlongmed Biotech Co., Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C Shenzhen, 518054 Cn
Re: K201397
Trade/Device Name: Ultrasonic Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: June 14, 2021 Received: June 14, 2021
Dear Long Yang:
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
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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 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 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,
Brandon Blakely, PhD Acting 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
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Indications for Use
510(k) Number (if known) K201397
Device Name Ultrasonic Mesh Nebulizer
Indications for Use (Describe)
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(K) number is: Date of Summary: 2021.6.2
1. Submitter information
Manufacturer Name: Shenzhen Ivankaca Technology Co.,Ltd
Address: 3/F, Building B, No.45 lixin road, NanWan, Longgang, Shenzhen, Guangdong, China
Contact Person and Title: Sam WONG/General manager
Tel: 0086- 755-28510161
Fax: 0086- 755-28510161
Email: 798401644@qq.com
Date Prepared: June 2, 2021
2. Contact person
2.1 Primary Contact Person
Long Yang (COO)
Shenzhen Hlongmed Biotech Co.,Ltd
1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C
Tel: 0086-755-86664986
Fax: 0086-755-86664933
E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
Sam WONG/General manager Shenzhen Ivankaca Technology Co.,Ltd Tel: 0086- 755-28510161
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3. Proposed device
| Type of 510(k) submission | Traditional |
|---|---|
| Trade Name name | Ultrasonic Mesh Nebulizer |
| Common Name | Nebulizer |
| Model(s) | MY-123, MY-125, MY-126 |
| Classification Name | Nebulizer (Direct Patient Interface) |
| Classification | II |
| Review Panel | Anesthesiology |
| Product Code | CAF |
| Regulation Class | II |
| Regulation Number | 21 CFR 868.5630 |
4. Predicate device
510(k) Number:
Predicate Device Name:
Intelligent Mesh Nebulizer (model: NEB002)
Manufacturer:
Qingdao Future Medical Technology Co., Ltd
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
5. Description of Proposed Device
The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.
The proposed devices are portable size, curvaceous body design that is convenient to hold, Which are battery powered, 3.7V d.c. internally lithium battery. The medication
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container capacity is 8ml maximum.
For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liguid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system.
There are 3 models included, MY-123/MY-125/ the three models have same intended use, mechanism of action, principle and specification. The difference between three models is appearance.
The proposed devices have the components shown as following illustration:
Image /page/5/Figure/4 description: The image shows two diagrams of a device labeled "MY-123" with various parts labeled. The diagrams show the main unit, atomizing cup, mesh plate, lock, indicator light, on/off button, USB charging port, and the back from the main unit. There is also a diagram of the bottom of the main unit.
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Image /page/6/Figure/0 description: The image shows the text 'MY-125' in a simple, sans-serif font. The text is arranged horizontally, with 'MY' followed by a hyphen and then the number '125'. The text is black against a white background, providing a clear contrast.
Image /page/6/Figure/1 description: The image shows a diagram of a device with several labeled parts. The parts include a mesh plate, main unit, on/off button, indicator light, lock, atomizing cup, back from main, USB charging port, and bottom from main unit. The diagram shows the device from different angles to highlight the different parts.
MY-126
Figure 1 Device Components illustration
The contents provided in the Table are description about the components.
| Main Unit | Provide electricity |
|---|---|
| AtomizingCup | filled with medicine liquid |
| Mesh Plate | Create low velocity aerosol |
| ON/OFFbutton | ON/OFF the nebulizerPress the ON/OFF button for 3s to turn on the power and press turn offagain;The nebulizer will shut down automatically after 5min operation. Presson /off for 3S to start the machine when it is still in use |
| Indicatorlight | Blue light on when the nebulizer works regularly;Automatic turn off after blue light flashes when the battery is runningout electricity;Blue lights flicker on when charging regularly;Green light on while finishing charging; |
| USBinterface | Connect the nebulizer with the USB cable to 5Vd.c 1.0A min.power supply to recharge . |
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| Mask | Transport the aerosol to patient's respiratorysystem. |
|---|---|
| Mouthpiece | Transport the aerosol to patient's respiratorysystem. |
Table 1 Main Components of Device introduction
The associated accessories include Mouthpiece, Adult Mask, Pediatric Mask, USB charging cable.
6. Intended Use/ Indications for Use
The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
7. Technological Characteristics and Substantial Equivalence
| Item | Subject Device | Predicate device | Remark |
|---|---|---|---|
| General Comparison | |||
| K | / | K171549 | / |
| Sponsor | Shenzhen Ivankaca TechnologyCo.,Ltd | Qingdao Future Medical TechnologyCo., Ltd | / |
| Trade/DeviceName | Ultrasonic Mesh Nebulizer | Intelligent Mesh Nebulizer | / |
| Model(s) | MY-123MY-125MY-126 | NEB002 | / |
| RegulationNumber | 21 CFR 868.5630 | 21 CFR 868.5630 | same |
| RegulationName | Nebulizer | Nebulizer | same |
| ClassificationName | Nebulizer (Direct Patient Interface) | Nebulizer (Direct Patient Interface) | same |
| RegulatoryClass | Class II | Class II | same |
| Product Code | CAF | CAF | same |
| Review Panel | Anesthesiology | Anesthesiology | same |
| IntendedUse/Indicationsfor Use | The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine. | 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. | same |
| Prescription/OTC | Prescription | Prescription | same |
| Performance Comparison | |||
| Lithiumbattery | 3.7Vd.c. | 3.7Vd.c. | Same |
| NebulizingMethod | Vibrating Mesh | Vibrating Mesh | same |
| VibrationFrequency | Approx. 110KHz | Approx. 110KHz | same |
| NebulizationRate/AerosolFlow rate | 0.2ml/min minimum | 0.2ml/min minimum | same |
| MedicineCapacity | 8ml maximum,0.5ml minimum | 8ml maximum,0.5ml minimum | same |
| NebulizerComponentsCleanable | Yes | Yes | same |
| Use | Single Patient | Single Patient | same |
| PatientConnector | Mouthpiece or mask | Mouthpiece or mask | same |
| Dimensions(mm) | Approx.42(L)x55(W)x109(H)mm(MY-123)49(L)x56(W)x120(H)mm(MY-125)45(L)x47(W)x120(H)mm(MY-126) | 50mm(L)×74mm(W)×111mm(H) | different |
| Weight (kg) | MY-123:113±5gMY-125:116±5g | Approx.106g | different |
| MY-126: 110±5g | |||
| OperatingConditions | 5°C to 40°C, 15% to 90% RH | 5°C to 40°C, 15% to 90% RH | same |
| StorageConditions | -25°C to 70°C, ≤90% RH | -25°C to 70°C, ≤90% RH | same |
| Safety Comparison | |||
| PatientContactMaterials | PVC | PVC | same |
| CytotoxicitySensitizationIrritation | Comply with 10993-1 | Comply with 10993-1 | same |
| Electricalsafety | Comply with 60601-1 | Comply with 60601-1 | same |
| EMC | Comply with 60601-1-2 | Comply with 60601-1-2 | same |
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Comparative particle test comparison can be refer to the following table:
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| Item | Subject Device | Subject Device | Subject Device | Intelligent Mesh Nebulizer (model:NEB002) -K171549 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mouthpiece | Small mask | Big mask | Big mask | |||||||||
| Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | |
| MMAD(µm) | 3.68±0.68 | 3.28±0.08 | 3.84 ± 0.66 | 3.75±0.63 | 3.25±0.11 | 3.85 ± 0.66 | 3.72±0.65 | 3.31±0.10 | 3.88 ± 0.68 | 3.70±0.66 | 3.29±0.12 | 3.87 ± 0.72 |
| GSD | 1.84±0.03 | 2.44±0.02 | 1.83 ± 0.035 | 1.86±0.05 | 2.46 ± 0.025 | 1.84 ± 0.035 | 1.82 ± 0.035 | 2.48 ± 0.031 | 1.84 ± 0.032 | 1.85±0.04 | 2.50 ± 0.033 | 1.81 ± 0.03 |
| Respirablefraction1 - 5 µm | 63.5% ± 10.5 | 61.7% ± 10.5 | 62.4% ± 10.6 | 63.8% ± 11.8 | 60.8 % ± 11.6 | 63.4% ± 11.3 | 64.5% ± 10.2 | 58.8% ± 10.2 | 64.5% ± 11.9 | 62.8% ± 11.3 | 57.6% ± 9.8 | 63.8% ± 11.6 |
| Coarse particlefraction >5 µm | 36.1% ± 11.3 | 29.1% ± 11.3 | 36.2% ± 12.1 | 33.4% ± 13.0 | 27.4% ± 13.0 | 35.4% ± 12.2 | 38% ± 10.8 | 30.5% ± 12.3 | 33.8% ± 12.4 | 37.2% ± 12.3 | 31.6% ± 11.9 | 34.4% ± 12.3 |
| Fine particlefraction (FPF<5 µm) | 65.4% ± 11.4 | 70.9% ± 11.3 | 63.8% ± 12.1 | 64.8% ± 12.6 | 69.6% ± 13.0 | 64.6% ± 12.2 | 66.6% ± 13.0 | 69.5% ± 10.3 | 66.2% ± 12.4 | 67.7% ± 10.2 | 68.4% ± 10.8 | 65.6% ± 12.3 |
| Ultra-fine particlefraction <1 µm | 2.7% ± 0.9 | 9.2% ± 0.8 | 1.79% ± 0.6 | 2.2% ± 0.8 | 8.8% ± 1.2 | 1.77% ± 0.5 | 2.8% ± 1.2 | 7.2% ± 0.9 | 1.8% ± 0.6 | 3.2% ± 0.6 | 7.5% ± 1.1 | 1.78% ± 0.6 |
| Item | Subject Device | Subject Device | Subject Device | Intelligent Mesh Nebulizer (model NEB002) -K171549 | ||||||||
| Mouthpiece | Small mask | Big mask | Big mask | |||||||||
| Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | |
| residual (%) | 29.6% ±5.2 | 26.9% ±5.8 | 23.8% ±3.53 | 28.6% ±4.4 | 24.3% ±5.4 | 23.6% ±3.52 | 30.8% ±5.8 | 24.17% ±4.82 | 24.5% ±3.58 | 31.5% ±4.66 | 24.42% ±4.96 | 26.3% ±3.61 |
| rate of recovery (%) | 93.3% ±3.66 | 96.4% ±4.83 | 91.7% ±4.52 | 91.7% ±4.52 | 95.87% ±3.85 | 92.6% ±2.83 | 92.6% ±2.83 | 95.07% ±2.52 | 92.6% ±2.83 | 91.2% ±4.28 | 94.86% ±2.65 | 93.3% ±3.66 |
| Aerosol output and aerosol output rate | 1.94 ±0.02 | 1.86 ±0.011 | 1.94 ±0.02 | 1.93 ±0.05 | 1.88 ±0.01 | 1.94 ±0.02 | 1.95 ±0.01 | 1.87 ±0.01 | 1.93 ±0.03 | 1.96 ±0.01 | 1.85 ±0.012 | 1.92 ±0.02 |
| Aerosol output (ml)a | ||||||||||||
| Aerosol output rate (ml/min)b | 0.29 ±0.02 | 0.27 ±0.02 | 0.35 ±0.02 | 0.30 ±0.03 | 0.28 ±0.02 | 0.34 ±0.02 | 0.32 ±0.03 | 0.28 ±0.02 | 0.35 ±0.02 | 0.32 ±0.03 | 0.26 ±0.02 | 0.33 ±0.02 |
| Dead volume (ml) | 0.06 ±0.02 | 0.14 ±0.011 | 0.06 ±0.02 | 0.07 ±0.05 | 0.12 ±0.01 | 0.06 ±0.02 | 0.05 ±0.01 | 0.13 ±0.01 | 0.07 ±0.03 | 0.04 ±0.01 | 0.15 ±0.012 | 0.08 ±0.02 |
| Respirable dose 1 - 5 um | 0.70ml ± | 0.758ml | 0.58ml | 0.71ml ± | 0.76ml ± | 0.59ml | 0.73ml ± | 0.78ml ± | 0.60ml | 0.72ml ± | 0.77ml ± | 0.58ml |
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| Item | Subject Device | Subject Device | Subject Device | Intelligent Mesh Nebulizer (model NEB002) -K171549 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mouthpiece | Small mask | Big mask | Big mask | ||||||||||||
| Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | Salbutamol(Ventolin) | Budesonide(Pulmicort) | Ipratropiumbromide | ||||
| 0.11 | ±0.15 | ±0.11 | 0.12 | 0.20 | ±0.11 | 0.12 | 0.20 | ±0.12 | 0.12 | 0.18 | ±0.12 | ||||
| Delivered dose | 1.12ml ± 0.06 | 1.23ml ± 0.12 | 0.93ml ± 0.02 | 1.12ml ± 0.08 | 1.26ml ± 0.1 | 0.93ml ± 0.02 | 1.14ml ± 0.08 | 1.27ml ± 0.1 | 0.94ml ± 0.02 | 1.13ml ± 0.08 | 1.24ml ± 0.12 | 0.92ml ± 0.02 |
a: Continue the treatment until the medicine cup is empty or the mist stops.
b: The treatment time for aerosol output rate is 1 min.
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Analysis for difference:
The proposed devices have the same Intended Use, Classification, Nebulizing Method, Vibration Frequency, Aerosol Flow rate, Medicine Capacity, Operation and use with the predicate device.
The proposed devices have the similar specifications with the predicate device, such as dimensions ,Weight, based on the nonclinical tests performed, those minor differences for specifications do not effects the safety and effective of the device.
The proposed devices are substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject devices are as safe, as effective, and performs as well as the legally marketed predicate device.
8. Non-clinical Test conclusion
The following performance data were provided in support of the substantial equivalence determination.
a.Biocompatibility testing
The nebulizer's mouthpiece, Big mask, Small mask, Atomizing cup, Seal ring, Atomizing cup cover, nozzle.Mesh plate are patient-contacting device components.
| No | patient-contactingdevice components | associatedconstructioncomponent | materials offor each | Ifadditivecontained | color | patient-contactclassifications per ISO10993-1 |
|---|---|---|---|---|---|---|
| 1 | mouthpiece | PP1120 | no | ● Surface Contact | ||
| 2 | Big mask | PP1120TPE(TE-KJ3025TM) | no | ● Mucosal membrane● Duration of Use(> 30 days) | ||
| 3 | Small mask | PP1120TPE(TE-KJ3025TM) | no | |||
| 4 | Atomizing cup | PC2456 | no | ● External | ||
| 5 | Seal ring | Silicone GA1053 | no | Communicating | ||
| 6 | Atomizing cup cover | PC2456 | no | (Indirect gas | ||
| 7 | nozzle | PC2456 | no | pathway) |
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| 8 | Mesh plate | Stainless304 | no | Tissue / Bone / Dentin communicating Duration of Use(> 30 days) |
|---|---|---|---|---|
| --- | ------------ | -------------- | ---- | ----------------------------------------------------------------- |
A biocompatibility evaluation for the proposed device was conducted in accordance with 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" . The evaluation included the following tests:
- In Vitro Cytotoxicity Test -ISO10993-5 A
- A Skin Sensitization Test(polar and non polar ) -ISO10993-10
-
Intracutaneous Reactivity Test-ISO10993-10
- A Acute Systemic Toxicity Test (polar and non polar) -ISO10993-11
-
Ames Test (polar and DMSO Extract)--ISO10993-3
- A In Vitro Mammalian Chromosomal Aberration test --ISO10993-3
- A Mammalian Erythrocyte Micronucleus Test(polar and non polar) --ISO10993-3
- A Subcutaneous Implantation Test--ISO10993-6
- A Test for emissions of VOCs and aldehydes-ISO 18562-3
- A Test for emissions of particulate matter ozone CO2 and CO- ISO 18562-2
- A Biocompatibility evaluation- ISO 18562-1
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.
b. 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:
-
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,
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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
c. Software Verification and Validation Testing
The software for this device is of a "moderate" level of concern,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".
d. Simulated shelf life testing, battery cycle life testing
e. Cleaning and Disinfection Validation
f. human factors validation testing
g. Particle size distribution testing per Section VII of the FDA Guidance: Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, and three kind of drugs used for each testing. Salbutamol (Ventolin), Budesomide (Pulmicort) , Ipratropium bromide.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantial Equivalence Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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).