(462 days)
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 proposed device is a vibrating mesh nebulizer that uses low frequency vibration to create aerosol and delivers 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 device is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available. Which is battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum. The proposed device consists of two parts: physical device and APP software. For physical device, it is pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liquid 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. For APP software, it consists of interactive games, Aerosol Flow rate adjustment, power off and information display which could enhance entertainment and users' adherence to the nebulizer during treatment. It could be connected to the physical device by bluetooth. Firstly, when users inhale and exhale, the flow pressure could trigger two single-way switches(inhalation switch and exhalation switch) seprately on atomizing cup, then it could transmit signal to CPU of the device by sensor and the signal will be transmitted to the APP further by bluetooth to control playing interactive games. Secondly, the APP could calculate atomizing time and dosage according to the information transmitted from physical device, and display them in the games. There are 2 models included, NEB001/NEB002, the two models have same intended use, mechanism of action, principle and specification. The only difference between two models is that the model NEB001 has two parts, Physical Device and App software, the NEB001 has the function of Bluetooth for connection between the physical device and App; the model NEB002 only has physical devcie.
The provided text is a 510(k) summary for the "Intelligent Mesh Nebulizer" and primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance (e.g., accuracy, sensitivity, specificity, or human reader improvement with AI assistance).
The document specifically states:
- "No clinical study is included in this submission." (Page 8)
- The "Intelligent Mesh Nebulizer" uses an "APP software" that consists of "interactive games, Aerosol Flow rate adjustment, power off and information display which could enhance entertainment and users' adherence to the nebulizer during treatment." And it can be "connected to the physical device by bluetooth." (Page 5). This suggests the software component is more for user engagement and control rather than a diagnostic or analytical AI.
- The tests mentioned are primarily for electrical safety, biocompatibility, electromagnetic compatibility, software validation (general, not necessarily for AI performance), particle size distribution, wireless data integrity, and wireless coexistence.
Therefore, I cannot provide the requested information regarding AI algorithm acceptance criteria or a study proving its performance, as this information is not present in the provided text.
Based on the context of the document, the "acceptance criteria" discussed are related to the device's physical and functional performance as a nebulizer and its compliance with relevant medical device standards, not AI performance.
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Image /page/0/Picture/0 description: The image contains 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 square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 31, 2018
Qingdao Future Medical Technology Co., Ltd. % Ray Wang Official Correspondent Beijing Believe Technology Service Co., Ltd. 5-402, Bldg #27, YangGuangYiShang, No.56, LiangXiang East Rd., FangShan Beijing, 102401 CHINA
Re: K171549
Trade/Device Name: Intelligent Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: July 23, 2018 Received: July 30, 2018
Dear Ray 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 (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
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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171549
Device Name Intelligent Mesh Nebulizer
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K171549
-
- Date of Preparation
08/30/2018
- Date of Preparation
-
Sponsor 2.
Qingdao Future Medical Technology Co., Ltd.
Room 401 Building F, No. 169 Zhuzhou Road, Laoshan District, QingDao City Shangdong Province, China Contact Person: Wang WeiLai Position: General Manager Tel: 86-18669802350 Fax:86-532-55677725 Email: wang.weilai@smartdean.com
- Submission Correspondent 3.
Beijing Believe Technology Service Co., Ltd.
5-402, Building #27, YangGuangYiShang, No. 56, LiangXiang East Rd., FangShan District, BeiJing, China 102401 Contact Person: Ray Wang Position: General Manager Tel: 86-18910677558 Fax:86-10-59120817 Email: Ray.wang@believe-med.com
-
- Identification of Proposed Device
Trade Name: Intelligent Mesh Nebulizer Common Name: Nebulizer Model(s): NEB001/NEB002
- Identification of Proposed Device
Regulatory Information: Classification Name: Nebulizer (Direct Patient Interface)
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Classification: II; Product Code: CAF; Regulation Number: 21 CFR 868.5630; Review Panel: Anesthesiology;
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.
- Device Description 5.
The proposed device is a vibrating mesh nebulizer that uses low frequency vibration to create aerosol and delivers 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 device is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available. Which is battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum.
The proposed device consists of two parts: physical device and APP software.
For physical device, it is pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liquid 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.
For APP software, it consists of interactive games, Aerosol Flow rate adjustment, power off and information display which could enhance entertainment and users' adherence to the nebulizer during treatment. It could be connected to the physical device by bluetooth.
Firstly, when users inhale and exhale, the flow pressure could trigger two single-way switches(inhalation switch and exhalation switch) seprately on atomizing cup, then it could transmit signal to CPU of the device by sensor and the signal will be transmitted to the APP further by bluetooth to control playing interactive games.
Secondly, the APP could calculate atomizing time and dosage according to the information transmitted from physical device, and display them in the games.
There are 2 models included, NEB001/NEB002, the two models have same intended use, mechanism of action, principle and specification.
The only difference between two models is that the model NEB001 has two parts, Physical Device
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and App software, the NEB001 has the function of Bluetooth for connection between the physical device and App; the model NEB002 only has physical devcie. The detailed difference shown as following:
| Model | NEB001 | NEB002 |
|---|---|---|
| Main Parts | Physical Device &APP software | Physical Device |
| NebulizationRate | Adjustable as 0.21 ml/min., 0.27ml/min.,/0.30ml/min., 0.32 ml/min., 0.35ml/min.Controlled by APP | 0.2ml/min minimum |
| DataTransmission | Bluetooth | N/A |
| The OS ofconnected smartdevice | Andriod 5.0 or higher | N/A |
The proposed device has the components shown as following illustration:
Image /page/5/Figure/5 description: This image shows a medical nebulizer and its parts. The nebulizer is composed of a mesh plate, atomizing cup, main unit, and a bottom piece. The main unit has an indicator light, charge indicator light, USB interface, and an active/stand-by button.
Figure 1 Physical Device Components illustration
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The contents provided in the Table 2 are description about the components.
| Main Unit | Provide electricity. |
|---|---|
| Atomizing Cup | Filled with medicine liquid. |
| Mesh plate | Create low velocity aerosol |
| PUSH button | Disassemble the nebulizer. |
| (ACTIVE/STAND-BY)button | Active/stand-by the nebulizer. |
| Indicator light | flash blue light when the battery is running outelectricity.Flash green light for 3s when there's no medicineliquid in the cup.Normally on green when the nebulizer workingregularly. |
| Charge indicatorlight | Charge indicator .normally on orange whencharging and tuns out to green while the chargingfinished. |
| USB interface | Connect wire and charging adaptor. |
| Mask | Transport the aerosol to patient's respiratorysystem. |
| Mouthpiece | Transport the aerosol to patient's respiratorysystem. |
| Adapter | Battery charging |
Table 2 Main Components of Physical Device introduction
Identification of Predicate Device 6.
Predicate Device #1: 510(k) Number K062263 Predicate Device Name Micro Air Vibrating Mesh Nebulizer (NE-U22) Manufacturer Omron Healthcare, Inc.
Predicate Device #2: 510(k) Number K132247 Predicate Device Name Ultrasonic Mesh Nebulizer NE105
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Manufacturer
Foshan Gaunying Electronics Co., Ltd.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
A IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance:
-
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests; which includes the tests as following:
- IEC CISPR 11:2016 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement;
- . IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test;
- IEC 61000-4-3:2010 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test;
- IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test;
-
IEC 60601-1-11:2015, Medical Electrical Equipment -- Part 1-11: General Requirements For The Basic Safety And Essential Performance - collateral standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment;
-
ISO 10993-5:2009 Biological Evaluation Of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity;
-
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization;
-
ISO 10993-3:2014 Biological Evaluation Of Medical Devices - Part 3: Tests For Genotoxicity, Carcinogenicity And Reproductive Toxicity;
-
ISO 10993-6:2007 Biological Evaluation Of Medical Devices - Part 6: Tests For Local Effects After Implantation;
-
ISO 10993-11:2006 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity;
-
Software Validation Test;
-
Particle Size Distribution testing with Cascade Impactor testing method AND Laser Light Scattering testing method, and three kind of drugs used testing, Pulmicort-contains Budesonide, BRICANYL-contains Terbutaline and Tobramycin in Physiological saline;
-
Wireless Data Integrity Testing (only for NEB001); A
-
A Wireless Coexistence Testing (only for NEB001);
-
Breath Detection Testing (only for NEB001); >
{8}------------------------------------------------
-
Aerosol Flow rate testing (only for NEB001);
-
Excessive Temperatures Test for battery, evaluate the device surface temperature when the inter battery under the "short" condition.
-
Usability Study, performed for NEB001 and NEB002 respectively;
-
Particle Size Distribution testing for pediatric patients (mouthpiece and face mask), simulation flow rate at 7L/min for pediatric population (>4 years of old). Cascade Impactor testing method AND Laser Light Scattering testing method, and three kind of drugs used for each testing, Pulmicort-contains Budesonide, BRICANYL-contains Terbutaline and Tobramycin in Physiological saline;
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
| Table 3 General Comparison | ||||
|---|---|---|---|---|
| ITEM | Proposed Device | Predicate Device #1K062263 | Predicate Device #2K032849 | Remark |
| Product Code | CAF | CAF | CAF | Same |
| Regulation No. | 21 CFR 868.5630 | 21 CFR 868.5630 | 21 CFR 868.5630 | Same |
| Class | 2 | 2 | 2 | Same |
| Prescription/OTC | Prescription | Prescription | Prescription | Same |
| Intended Use | The Intelligent Mesh Nebulizerdesigned to aerosolized liquidmedications for inhalation bypatient, the device may be usedwith pediatric and adult patients inthe home, hospital and sub-acutecare settings.It is not intended for use withPentamidine. | The Omron NE-U22 is an ultrasonic(vibrating mesh) nebulizer systemdesigned to aerosolize liquidmedications for inhalation bypatient.The device may be used withpediatric and adult patients in thehome, hospital, and sub-acute caresettings.It is not intended for use withPentamidine. | The Aeroneb GoNebulizer, for use bypediatric and adult patients,is intended to aerosolizephysician-prescribedsolutions for inhalation thatare approved for use with ageneral-purpose nebulizer | Same |
- Substantially Equivalent (SE) Comparison 9.
| Table 4 Performance Comparison |
|---|
| -------------------------------- |
| ITEM | Proposed Device | Predicate Device #1K062263 | Predicate Device #2K032849 | Remark |
|---|---|---|---|---|
| Power Source | ZN-103450 Lithium battery:3.7Vd.c.AC Adapter AC 100-240Va.c. | Battery - 2 “AA”AC Adapter AC 120V (60Hz/DC 3V) | Battery—3 “AA”disposable or rechargeable batteries, 4.5 VDC, 350 | Similar |
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| 47-63Hz 0.4-0.2A | mA | |||
|---|---|---|---|---|
| NebulizingMethod | Vibrating Mesh | Vibrating Mesh | Vibrating mesh | Same |
| VibrationFrequency | Approx. 110KHz | Approx. 180KHz | Approx. 100 KHz | Similar |
| Aerosol Flow rate | 0.2ml/min minimum | 0.25 ml/min to 0.9 ml/min | / | Similar |
| Particle Size | 2.2µm±25% | Approx. 3 um | 1.96-2.26 um | Similar |
| Medicine Capacity | 8ml maximum,0.5ml minimum | 7 ml | 6 mL | Similar |
| NebulizerComponentsCleanable | Yes | Yes | Yes | Same |
| Use | Single Patient | Single Patient | Single Patient | Same |
| Patient Connector | Mouthpiece or mask | Mouthpiece | Mouthpiece or optionalmask | Same |
| WirelessConnection | Bluetooth(Model NEB001) | NA | NA | Difference |
| MobileApplication | Yes(Model NEB001) | NA | NA | Difference |
| Dimensions (mm) | 50mm(L)×74mm(W)×111mm(H) | 38(W) x 51(D) x 104(H) | 40 x 105 x 95 mm | Similar |
| Weight (kg) | Approx.106g | 97 g | 325 g | Similar |
| OperatingConditions | 5°C to 40°C, 15% to 90% RH | 0°C to 45°C, 30% to 85% RH | 5°C to 45°C to 95% RH | Similar |
| StorageConditions | -25°C to 70°C, ≤90% RH | -25°C to 70°C, 10% to 90% RH | -20°C to 60°C to 95% RH | Similar |
Table 5 Safety Comparison
| Item | Proposed Device | Predicate Device #1 | Predicate Device #2 | Remark |
|---|---|---|---|---|
| K062263 | K032849 | |||
| Patient ContactMaterials | PVC | Polypropylene | PVC | Similar |
| Cytotoxicity | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Comply with ISO 10993-1 | |
| SensitizationIrritation | Same | |||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
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| Item | NEB001 | NEB002 | Aeroneb Go (K032849) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mouthpiece | mask | mouthpiece | mask | mouthpiece | mask | |||||||||||||
| Budesonide | Terbutaline | Tobramycin | Budesonide | Terbutaline | Tobramycin | Budesonide | Terbutaline | Tobramycin | Budesonide | Terbutaline | Tobramycin | Budesonide | Terbutaline | Tobramycin | Budesonide | Terbutaline | Tobramycin | |
| MMAD( $\mu$ m) | 2.09-2.29 | 2.09-2.25 | 2.11-2.27 | 2.10-2.30 | 2.11-2.27 | 2.17-2.25 | 2.08-2.28 | 2.09-2.25 | 2.09-2.25 | 2.11-2.27 | 2.15-2.25 | 2.10-2.28 | 2.09-2.19 | 2.00-2.12 | 1.96-2.06 | 2.04-2.12 | 1.87-2.01 | 1.95-2.09 |
| GSD ( $\mu$ m) | 2.05-2.13 | 2.02-2.10 | 2.04-2.12 | 2.12-2.20 | 1.92-2.00 | 2.11-2.19 | 2.03-2.11 | 2.01-2.09 | 2.02-2.10 | 1.98-2.10 | 1.89-2.07 | 1.94-2.02 | 2.01-2.13 | 1.91-2.05 | 1.81-1.93 | 2.14-2.24 | 1.78-1.86 | 2.05-2.15 |
| Particle mass collected by the cascade impactor | 443.53-536.77 | 668.64-801.88 | 1293.08-1466.32 | 409.32-522.00 | 667.78-777.42 | 1198.98-1284.48 | 441.53-534.77 | 672.93-806.17 | 1286.83-1460.07 | 439.90-516.88 | 671.39-778.11 | 1209.44-1322.10 | 503.01-571.57 | 757.27-851.79 | 1414.18-1510.96 | 476.37-562.91 | 788.88-844.16 | 1394.47-1462.83 |
| respirable particle fraction(%) (0.5-5 $\mu$ m) | 83.24-88.84 | 84.11-91.23 | 80.99-88..11 | 83.91-90.03 | 84.09-91.21 | 84.12-91..24 | 83.39-88.99 | 83.56-90.68 | 79.89-87..01 | 81.70-88.54 | 82.63-88.33 | 82.42-87..90 | 85.21-88.89 | 84.26-88.64 | 82.56-88..26 | 83.80-88.94 | 81.07-85.87 | 81.92-86..60 |
| coarse particle fraction(%) (>4.7 $\mu$ m) | 12.89-18.97 | 14.14-14.44 | 14.14-14..42 | 15.58-15.86 | 15.14-15.42 | 13.07-13..35 | 13.88-19.96 | 13.05-13.33 | 15.2-15.48 | 13.74-17.82 | 14.01-14.23 | 16.21-16..35 | 13.69-14.03 | 14.69-14.86 | 17.21-17..47 | 16.50-16.84 | 18.17-18.29 | 16.91-17..19 |
| ultra-fine particle fraction(%) | 11.37-15.47 | 9.99-14..89 | 7.67-12.57 | 10.67-15.57 | 7.78-12..68 | 7.80-11.90 | 11.09-15.19 | 9.99-14..89 | 8.67-13.57 | 9.27-11..43 | 8.20-12..36 | 9.33-10.45 | 13.57-18.31 | 14.60-17.08 | 14.38-16..86 | 10.12-14.22 | 11.32-15.50 | 9.89-15.83 |
| <1um) | ||||||||||||||||||
Table 6 Comparative particle test Comparison
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510(K) Summary
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Analysis for difference
The proposed device has the same Intended Use, Classification, Nethod, Operation and use with the predicate device.
The proposed device has the similar specifications with the predicate device, such as Power Source, Vibration Frequency, Aerosol Flow rate, Particle Size, Medicine Capacity, based on the nonclinical tests performed, those minor differences for similar specifications do not effects the safety and effective of the device.
The main differences are the functions of wireless connection and mobile application between the proposed device and predicate, the model NEB 001. For this difference, we have designed the proposed device as the FCC Part 15 rules and addressed the requirements of "Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". We have conducted the non-clinical test for such requirements or standards, such as software V&V testing, Testing of FCC Part 15 rules, IEC 60601-1-2 testing, Data Integrate Testing, Wireless Coexistence Testing, and we also conducted the risk management activities about the risks caused by wireless and mobile application as the guidance mentioned above.
The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.
10. Substantially Equivalent (SE) 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).