(137 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 consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. 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. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
The provided text is a 510(k) clearance letter and summary for an Electric Nasal Aspirator. It details the device's characteristics and its comparison to a predicate device, along with the performance data submitted to demonstrate substantial equivalence.
However, the nature of this medical device (a nasal aspirator, essentially a suction pump) means the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering performance parameters (e.g., vacuum pressure, flow rate, safety standards) rather than clinical efficacy studies with human subjects that measure the device's ability to diagnose or treat a condition, which is what is typically discussed in the context of "human-in-the-loop performance," "ground truth," "expert consensus," and "MRMC studies" for AI/software-as-a-medical-device (SaMD).
Therefore, the requested information elements related to AI/SaMD (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance, ground truth for image analysis) are not applicable to this specific device submission. The "study" here is a series of bench tests and electrical/biocompatibility assessments.
Below is a breakdown of the applicable acceptance criteria and the "study" (bench testing) as described in the provided text, while explicitly stating when an element is not applicable.
Acceptance Criteria and Device Performance for Electric Nasal Aspirator (K244033)
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Subject Device) | Compliance/Remark |
|---|---|---|---|
| Intended Use | Intermittent removal of nasal secretions and mucus from children (age 2~12 years old) in a home environment. | Intermittent removal of nasal secretions and mucus from children (age 2~12 years old) in a home environment. | Same, Meets. |
| Patient Population | Age 2-12 years old | Age 2-12 years old | Same, Meets. |
| Vacuum Pressure | 52-60 KPa | 52-60 KPa | Same, Meets. |
| Music Function | Yes | Yes | Same, Meets. |
| Light Function | Yes | Yes | Same, Meets. |
| Motor Type | 3.7V DC | 3.7V DC | Same, Meets. |
| Operating Condition | 5℃(41℉) to 40℃(104℉); 15% to 93% R.H. | 5℃(41℉) to 40℃(104℉); 15% to 93% R.H. | Same, Meets. |
| Storage Condition | -10°C(-23℉) to 70°C (158℉); 10% to 95% R.H. | -10°C(-23℉) to 70°C (158℉); 10% to 95% R.H. | Same, Meets. |
| Expected Service Life | 2 years | 2 years | Same, Meets. |
| Type BF Applied Part | Type BF applied part | Type BF applied part | Same, Meets. |
| Water-Resistance | IP22 | IP22 | Same, Meets. |
| Biocompatibility | Tested to ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Skin Irritation) for silicone nasal aspiration tips (contact |
§ 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.