BREEZE NEBULIZER (NBR-10X)

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Breeze Nebulizer (NBR-101) 510(k) Number: K133105 . # 510(k) Summary | 5.1 | Type of Submission: | Traditional | |-----|----------------------|-------------------------------------------------------------------------------------------| | 5.2 | Preparation Date: | 16th September 2013 | | 5.3 | Submitter: | digiO2 International Co., Ltd. | | | Address: | 4F-13, No. 79, Sec. 1, Hsin Tai Wu Rd.,<br>His-Chih Dist., New Taipei City 221,<br>Taiwan | | | Phone: | +886-2-2698-5678 | | | Fax: | +886-2-2698-9216 | | | Contact: | Crystal Lee (crystal@digio2.com) | | | Registration number: | 3007482861 | 5.4 Identification of the Device: | Proprietary/ | Breeze Nebulizer (NBR-101) | |------------------------|--------------------------------------| | Trade name: | | | Classification Name: | Nebulizer (Direct Patient Interface) | | Device Classification: | II | | Regulation Number: | 868.5630 | | Panel: | Anesthesiology | | Product Code: | CAF | #### 5.5 Identification of the Predicate Device: | Predicate Device Name: | Micro Air Vibrating Mesh Nebulizer Model<br>- NE-U22 | | |------------------------|------------------------------------------------------|--| | Manufacturer: | Omron Healthcare, Inc. | | | Product Code: | CAF | | | 510(k) Number: | K062263 | | {1}------------------------------------------------ Breeze Nebulizer (NBR-101) 510(k) Number: K133105 # 5.6 Intended Use and Indications for Use of the subject device. The Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (ages 2 years old and above) and adult patients in the home. It is not intended for use with Pentamidine. #### 5.7 Device Description Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer that 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. It is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. They are identical in purpose, function, core technology and method of operation. Breeze nebulizer (NBR-101) is a portable size, curvaceous body design that is convenient to hold, and ability to detect the amount of medications available and to turn off automatically. The open button is made of soft materials and gives off an ice blue light, coupled with an overall elegant white exterior. Breeze Nebulizer (NBR-101) is battery powered, 4 "AAA" and the dimensions is 58(W) X 145(H) X 70(D). The medication container capacity is 8ml maximum and the residual volume is approximately 0.1ml. #### 5.8 Non-clinical Testing A series of safety tests were performed to assess the performance of the Breeze Nebulizer. | Testing Item | Standard and regulations applied | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electromagnetic<br>Compatibility &<br>Electrical Safety | IEC 60601-1 Medical electrical equipment Part 1: General<br>requirements for basic safety and essential performance | | | IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment<br>- Part 1-2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic compatibility<br>- Requirements and tests. (General) | | Biocompatibility | ISO 10993-5:2009(E) Biological evaluation of medical devices –<br>Part 5: Tests for <i>in vitro</i> cytotoxicity. | {2}------------------------------------------------ | | ISO 10993-10:2002/Amd.1:2006(E) Biological evaluation of<br>medical devices --- Part 10: Tests for irritation and delayed-type<br>hypersensitivity (7.4 Maximization test for delayed<br>hypersensitivity) | |-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ISO 10993-3:2003/(R)2009, Biological Evaluation Of<br>Medical Devices - Part 3: Tests For Genotoxicity,<br>Carcinogenicity, And Reproductive Toxicity.<br>(Biocompatibility) | | | ISO 10993-6:2007/(R)2010, Biological Evaluation Of<br>Medical Devices -- Part 6: Tests For Local Effects After<br>Implantation. (Biocompatibility) | | | ISO 10993-11:2009, Biological Evaluation Of Medical<br>Devices -- Part 11: Tests For Systemic Toxicity.<br>(Biocompatibility) | | | ISO 10993-12:2012, Biological Evaluation Of Medical Devices<br>-- Part 12: Sample Preparation And Reference Materials.<br>(Biocompatibility) | | Usability | IEC 60601-1-6:2006 Medical electrical equipment -Part 1-6:<br>General requirements for safety -Collateral Standard: Usability. | | Performance | EN 13544-1:2007 - Respiratory therapy equipment - Part 1:<br>Nebulizing systems and their components | | | EN 13544-2:2002+A1 - Respiratory therapy equipment - Part 2:<br>Tubing and connectors | All the test results demonstrate Breeze Nebulizer (NBR-101) meets the requirements of its pre-defined acceptance criteria and intended uses. # 5.9 Clinical Testing No clinical test data was used to support the decision of safety and effectiveness. #### 5.10 EMC and Electrical safety The performance of the Breeze Nebulizer (NBR-101) is verified and validated according to FDA Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators", dated October 1, 1993, ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance and ANSVAAMI/IEC 60601-1-2:2007 {3}------------------------------------------------ Medical Electrical Equipment - Pant 1-2: General Requirements for Safety; Electromagnetic Compatibility. The Breeze Nebulizer (NBR-101) complies with to applicable ANSVAAMI ES60601-1 and ANSVAAMI/IEC 60601-1-2 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions. # 5.11 Substantial Equivalence Determination The Breeze Nebulizer (NBR-101) has similar intended use, similar fundamental scientific technology, and similar technological characteristics with the predicate device. Information described above can demonstrate the Breeze Nebulizer (NBR-101) is substantial equivalent to the predicate device. | | Proposed Device | Predicate Device | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Breeze Nebulizer<br>(NBR-101) | Model Micro Air Vibrating<br>Mesh Nebulizer (NE-U22)<br>(K062263) | | Classification | Class II | Class II | | Product Code | CAF | CAF | | Intended Use | The Breeze Nebulizer<br>(NBR-101) is a vibrating mesh<br>nebulizer system designed to<br>aerosolize liquid medications for<br>inhalation by the patient. The<br>device may be used with<br>pediatric (ages 2 years old and<br>above) and adult patients in the<br>home. It is not intended for use<br>with Pentamidine. | The Omron NE-U22 is an<br>ultrasonic (vibrating mesh)<br>nebulizer system designed to<br>aerosolize liquid medications<br>for inhalation by the patient.<br>The device may be used with<br>pediatric and adult patients in<br>the home, hospital, and<br>sub-acute care settings.<br>It is not intended for use with<br>Pentamidine. | | Technology | Vibrating mesh | Vibrating mesh | | Environment<br>of Use | Home | Home, Hospital, Sub-acute<br>Institutions | | Patient<br>Population | Pediatric (ages 2 years old and<br>above)<br>adult | Pediatric and adult | | Nebulizer<br>components<br>cleanable | Yes | Yes | | Software<br>driven | Yes | No | | Characteristics | | | | Vibrating<br>Capacity | 107kHz | 180kHz | | Button | ON/OFF Switch | ON/OFF Switch | | Reservoir size | 8.0ml | 7.0ml | | Nebulization<br>Rate | 0.2~0.4 ml/min | 0.25-0.9 ml/min | | Environment | | | | Operation<br>condition | 3℃ ~40℃<br>Max 70% RH | 0℃ ~ 45℃<br>30% - 85% RH | | Storage<br>condition | -10℃~80℃<br>Max 70% RH | -25°C ~ 70°C<br>10% - 90% RH | | Power | | | | Power source | Four AAA batteries | Two AA batteries<br>AC adapter AC 120V<br>(60Hz/DC3V) | | Power<br>consumption | 1.5W | 1.5W | | Power<br>indicator | LED | LED | | Physical | | | | Dimensions | 58mm(W) x 70mm(D)<br>x145mm(H) | 38mm(W) x 51mm(D) x<br>104mm(H) | | | Weight | 123.6 g (without batteries) | {4}------------------------------------------------ # Breeze Nebulizer (NBR-101) {5}------------------------------------------------ Breeze Nebulizer (NBR-101) 510(k) Number: K133105 #### 5.12 Similarity and differences The difference between the subject device and predicate device is the proposed device is software driven. The subject device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the difference of subject device and predicate device didn't raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in design, operation, intended use, method of preparation, and performance claims. # 5.13 Conclusion After analyzing bench tests, testing data, it can be concluded that Breeze Nebulizer (NBR-101) is as safe and effective as the predicate device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol consisting of three abstract human figures, stacked vertically. The figures are depicted with flowing lines, suggesting movement or progress. Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 24, 2014 digi02 International Co., Ltd. c/o Mr. Michael Lee, President AcmeBiotechs Co., Ltd. No.45, Minsheng Rd. Danshui Town New Taipei City, 251, Taiwan Re: K133105 Trade/Device Name: Breeze Nebulizer NBR-101 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF . ' Dated: May 20, 2014 Received: May 23, 2014 #### Dear Mr. Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. {7}------------------------------------------------ Page 2 -- Mr. Lee 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRII FOR Erin J. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Breeze Nebulizer (NBR-101) 510(k) Number: K133105 ### Indications for Use 510(k) Number (if known): Device Name: Breeze Nebulizer (NBR-101) Indications for Use: The Breeze Nebulizer (NBR-101) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (ages 2 years old and above) and adult patients in the home. It is not intended for use with Pentamidine. Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/8/Picture/12 description: The image shows the FDA logo. The logo is made up of the letters FDA, with each letter outlined in a thick black line. The letters are arranged in a horizontal line, with the F on the left, the D in the middle, and the A on the right. The logo is simple and easy to recognize. Anya C. Harry -S 2014.06.24 Page 1 of __ 13:15:54 -04'00'