(58 days)
The Electronic Nasal Aspirator is 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 consists of main unit, and suction working together as one unit. The Electronic 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 provided text describes a 510(k) premarket notification for an Electric nasal aspirator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific performance metrics, and clinical study details (like sample size for test sets, expert qualifications, MRMC studies, effect size, etc.) for AI/ML-driven diagnostic devices is not extensively detailed for this product.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that a series of safety and performance tests were conducted and that the "Electric nasal aspirator meets the requirements of its predefined acceptance criteria and intended use." However, it does not provide a specific table of quantitative acceptance criteria alongside corresponding test results for parameters like "Product service life," "Software validation," or "Function test." Instead, it indicates compliance with recognized standards.
| Test Type | Standard Designation Number | FDA Recognition Status | Outcome for Device | Acceptance Criteria (implied) | Reported Performance (implied) |
|---|---|---|---|---|---|
| Safety | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Yes | Conforms | Compliance with standard | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms | Compliance with standard | Conforms |
| Home healthcare environment | IEC 60601-1-11:2020 | Yes | Conforms | Compliance with standard | Conforms |
| Performance | Enterprise standard | Yes | Conforms | Compliance with standard | Conforms |
| Biocompatibility | ISO 10993-1:2018; ISO 10993-10:2010; ISO 10993-5:2009. | Yes | Conforms | Compliance with standard | Conforms |
| Software | IEC 62304:2006+A1:2015 | Yes | Conforms | Compliance with standard | Conforms |
| Safety of Lithium battery | IEC 62133-2:2017 | Yes | Conforms | Compliance with standard | Conforms |
| Safety of lamps | IEC 62471: 2006 | Yes | Conforms | Compliance with standard | Conforms |
| Risk management | ISO 14971:2019 | Yes | Conforms | Compliance with standard | Conforms |
| Vacuum | Not explicitly stated as acceptance criteria, but listed in comparison table | N/A | 52-60Kpa | 52-60Kpa (implied by predicate) | 52-60Kpa |
| Noise Level | Not explicitly stated as acceptance criteria, but listed in comparison table | N/A |
§ 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.