(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.
§ 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).