(62 days)
The Electronic 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 main unit, and the suction portion 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 is a 510(k) summary for an Electric Nasal Aspirator. This document describes its substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that "No clinical test data was used to support the decision of substantial equivalence."
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study to prove the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or presented.
The document focuses on demonstrating substantial equivalence through non-clinical testing, which includes various safety and performance benchmarks.
However, based on the non-clinical tests mentioned, we can infer the acceptance criteria and reported performance for those specific tests:
1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Tests)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Product service life meets predefined requirement. | Meets requirements; 5 years (longer than predicate) |
| Software functions as validated. | Validation performed (implies success) |
| Electromagnetic compatibility (EMC) meets standards. | Complies with ANSI AAMI IEC 60601-1-2:2014 & AMD 1:2021 |
| Electrical safety meets standards. | Complies with ANSI AAMI ES60601-1:2005 & AMD2:2021 |
| Usability meets standards. | Complies with IEC 60601-1-6 Ed 3.2 2020-07 |
| Function tests (Negative pressure, Max flow, Auto power-off, Noise) meet requirements. | Negative pressure |
§ 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.