(267 days)
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.
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.
This document describes the 510(k) premarket notification for the Breeze Nebulizer (NBR-101), specifically focusing on its substantial equivalence to a predicate device rather than a study demonstrating it meets specific clinical performance acceptance criteria. As such, information regarding AI, ground truth, sample sizes for training/test sets, or expert involvement in establishing ground truth is not applicable.
The core of the submission relies on non-clinical testing to demonstrate safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various standards and regulations applied for different testing items. The reported performance is generally stated as meeting the requirements of these standards. Specific numerical acceptance criteria or detailed performance metrics are not provided in this summary.
| Testing Item | Standard and Regulations Applied | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility & Electrical Safety | IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | Meets requirements |
| IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (General) | Meets requirements | |
| Biocompatibility | ISO 10993-5:2009(E) Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. | Meets requirements |
| ISO 10993-10:2002/Amd.1:2006(E) Biological evaluation of medical devices --- Part 10: Tests for irritation and delayed-type hypersensitivity (7.4 Maximization test for delayed hypersensitivity) | Meets requirements | |
| ISO 10993-3:2003/(R)2009, Biological Evaluation Of Medical Devices - Part 3: Tests For Genotoxicity, Carcinogenicity, And Reproductive Toxicity. (Biocompatibility) | Meets requirements | |
| ISO 10993-6:2007/(R)2010, Biological Evaluation Of Medical Devices -- Part 6: Tests For Local Effects After Implantation. (Biocompatibility) | Meets requirements | |
| ISO 10993-11:2009, Biological Evaluation Of Medical Devices -- Part 11: Tests For Systemic Toxicity. (Biocompatibility) | Meets requirements | |
| ISO 10993-12:2012, Biological Evaluation Of Medical Devices -- Part 12: Sample Preparation And Reference Materials. (Biocompatibility) | Meets requirements | |
| Usability | IEC 60601-1-6:2006 Medical electrical equipment -Part 1-6: General requirements for safety -Collateral Standard: Usability. | Meets requirements |
| Performance | EN 13544-1:2007 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components | Meets requirements |
| EN 13544-2:2002+A1 - Respiratory therapy equipment - Part 2: Tubing and connectors | Meets requirements |
The document also provides a comparative table of characteristics between the proposed device and the predicate device, highlighting their similarities and differences. While this is not "acceptance criteria" in the traditional sense, it demonstrates how the device's characteristics are compared against a legally marketed device.
| Item | Proposed Device (Breeze Nebulizer NBR-101) | Predicate Device (Model Micro Air Vibrating Mesh Nebulizer NE-U22) |
|---|---|---|
| Classification | Class II | Class II |
| Product Code | CAF | CAF |
| Intended Use | Vibrating mesh nebulizer system to aerosolize liquid medications for inhalation by pediatric (ages 2 and above) and adult patients in the home. Not for Pentamidine. | Ultrasonic (vibrating mesh) nebulizer system to aerosolize liquid medications for inhalation by pediatric and adult patients in the home, hospital, and sub-acute care settings. Not for Pentamidine. |
| Technology | Vibrating mesh | Vibrating mesh |
| Environment of Use | Home | Home, Hospital, Sub-acute Institutions |
| Patient Population | Pediatric (ages 2 and above), adult | Pediatric and adult |
| Nebulizer components cleanable | Yes | Yes |
| Software driven | Yes | No |
| Vibrating Capacity | 107kHz | 180kHz |
| Button | ON/OFF Switch | ON/OFF Switch |
| Reservoir size | 8.0ml | 7.0ml |
| Nebulization Rate | 0.2~0.4 ml/min | 0.25-0.9 ml/min |
| Operation condition | 3℃ ~40℃; Max 70% RH | 0℃ ~ 45℃; 30% - 85% RH |
| Storage condition | -10℃~80℃; Max 70% RH | -25°C ~ 70°C; 10% - 90% RH |
| Power source | Four AAA batteries | Two AA batteries; AC adapter AC 120V (60Hz/DC3V) |
| Power consumption | 1.5W | 1.5W |
| Power indicator | LED | LED |
| Dimensions | 58mm(W) x 70mm(D) x 145mm(H) | 38mm(W) x 51mm(D) x 104mm(H) |
| Weight | Not specified in table | 123.6 g (without batteries) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical performance study. The studies mentioned are non-clinical (bench tests, safety tests), and the sample size for these engineering and regulatory compliance tests is not provided in this summary. The data provenance is from digiO2 International Co., Ltd. in New Taipei City, Taiwan, performing internal non-clinical testing. These are assumed to be prospective tests conducted for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a medical device that relies on non-clinical engineering and regulatory compliance testing rather than clinical data or expert-derived ground truth.
4. Adjudication method for the test set
Not applicable.
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 device is not an AI-powered diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" implicitly refers to the specified performance parameters and safety limits defined by the referenced international standards (e.g., IEC 60601-1, ISO 10993, EN 13544-1). Compliance with these standards serves as the benchmark.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
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Breeze Nebulizer (NBR-101) 510(k) Number: K133105
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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.,His-Chih Dist., New Taipei City 221,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- NE-U22 | |
|---|---|---|
| Manufacturer: | Omron Healthcare, Inc. | |
| Product Code: | CAF | |
| 510(k) Number: | K062263 |
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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 |
|---|---|
| ElectromagneticCompatibility &Electrical Safety | IEC 60601-1 Medical electrical equipment Part 1: Generalrequirements for basic safety and essential performance |
| IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment- Part 1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and tests. (General) | |
| Biocompatibility | ISO 10993-5:2009(E) Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity. |
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| ISO 10993-10:2002/Amd.1:2006(E) Biological evaluation ofmedical devices --- Part 10: Tests for irritation and delayed-typehypersensitivity (7.4 Maximization test for delayedhypersensitivity) | |
|---|---|
| ISO 10993-3:2003/(R)2009, Biological Evaluation OfMedical Devices - Part 3: Tests For Genotoxicity,Carcinogenicity, And Reproductive Toxicity.(Biocompatibility) | |
| ISO 10993-6:2007/(R)2010, Biological Evaluation OfMedical Devices -- Part 6: Tests For Local Effects AfterImplantation. (Biocompatibility) | |
| ISO 10993-11:2009, Biological Evaluation Of MedicalDevices -- Part 11: Tests For Systemic Toxicity.(Biocompatibility) | |
| ISO 10993-12:2012, Biological Evaluation Of Medical Devices-- Part 12: Sample Preparation And Reference Materials.(Biocompatibility) | |
| Usability | IEC 60601-1-6:2006 Medical electrical equipment -Part 1-6:General requirements for safety -Collateral Standard: Usability. |
| Performance | EN 13544-1:2007 - Respiratory therapy equipment - Part 1:Nebulizing systems and their components |
| EN 13544-2:2002+A1 - Respiratory therapy equipment - Part 2: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
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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(NBR-101) | Model Micro Air VibratingMesh Nebulizer (NE-U22)(K062263) |
| Classification | Class II | Class II |
| Product Code | CAF | CAF |
| Intended Use | The Breeze Nebulizer(NBR-101) is a vibrating meshnebulizer system designed toaerosolize liquid medications forinhalation by the patient. Thedevice may be used withpediatric (ages 2 years old andabove) and adult patients in thehome. It is not intended for usewith Pentamidine. | The Omron NE-U22 is anultrasonic (vibrating mesh)nebulizer system designed toaerosolize liquid medicationsfor inhalation by the patient.The device may be used withpediatric and adult patients inthe home, hospital, andsub-acute care settings.It is not intended for use withPentamidine. |
| Technology | Vibrating mesh | Vibrating mesh |
| Environmentof Use | Home | Home, Hospital, Sub-acuteInstitutions |
| PatientPopulation | Pediatric (ages 2 years old andabove)adult | Pediatric and adult |
| Nebulizercomponentscleanable | Yes | Yes |
| Softwaredriven | Yes | No |
| Characteristics | ||
| VibratingCapacity | 107kHz | 180kHz |
| Button | ON/OFF Switch | ON/OFF Switch |
| Reservoir size | 8.0ml | 7.0ml |
| NebulizationRate | 0.2~0.4 ml/min | 0.25-0.9 ml/min |
| Environment | ||
| Operationcondition | 3℃ ~40℃Max 70% RH | 0℃ ~ 45℃30% - 85% RH |
| Storagecondition | -10℃~80℃Max 70% RH | -25°C ~ 70°C10% - 90% RH |
| Power | ||
| Power source | Four AAA batteries | Two AA batteriesAC adapter AC 120V(60Hz/DC3V) |
| Powerconsumption | 1.5W | 1.5W |
| Powerindicator | LED | LED |
| Physical | ||
| Dimensions | 58mm(W) x 70mm(D)x145mm(H) | 38mm(W) x 51mm(D) x104mm(H) |
| Weight | 123.6 g (without batteries) |
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Breeze Nebulizer (NBR-101)
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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.
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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.
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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
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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'
§ 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).