(47 days)
The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Electric nasal aspirator (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.
The differences between BC026, BC025, and BC023 are as follows:
- BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels.
- BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function.
- BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature.
- BC026 and BC023 have 4 buttons, BC025 has 2 buttons.
- In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.
The provided FDA 510(k) clearance letter and summary for the Electric Nasal Aspirator do not contain specific acceptance criteria for device performance such as sensitivity, specificity, accuracy, or other diagnostic metrics. This device is a powered suction pump and not a diagnostic device that would typically have such performance criteria. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical safety and performance testing.
Therefore, many of the requested fields cannot be extracted directly from the provided text as they pertain to clinical performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment) that were explicitly not performed.
Here's the information that can be extracted, and an explanation for what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Type) | Standard Designation Number / Description | Reported Device Performance |
|---|---|---|
| Safety | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Conforms |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2:2020 IEC TR 60601-4-2: 2016 | Conforms |
| Home healthcare environment | IEC 60601-1-11:2020 | Conforms |
| Performance | Enterprise standard | Conforms |
| Biocompatibility | ISO 10993-1:2018 | Conforms |
| Software | ANSI AAMI IEC 62304:2006/A1:2016 | Conforms |
| Safety of Lithium battery | IEC 62133-2:2017 | Conforms |
| Safety of lamps | IEC 62471: 2006 | Conforms |
| Vacuum pressure | 52-60 Kpa (Predicate comparison) | 52-60 Kpa (Subject device) - Identical to predicate |
| Noise Level |
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.