(261 days)
The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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.
The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
This document outlines the acceptance criteria and the studies conducted to prove that the FORA NAS100 Electronic Nasal Aspirator meets these criteria.
1. Acceptance Criteria and Reported Device Performance
| Standard | Intended Use / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| IEC 60601-1: General requirements for basic safety and essential performance | To evaluate the basic safety and essential performance of medical electrical equipment and medical electrical systems. | All 10 general requirements met (Pass) including general requirements, testing ME equipment, classification, identification/marking, protection against excessive temperatures/other hazards, accuracy/protection against hazardous outputs, construction, protection against strangulation/asphyxiation, additional requirements for electromagnetic emissions, and alarm systems. |
| IEC 60601-1-11: Requirements for medical electrical equipment and systems used in the home healthcare environment | To evaluate the basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. | All 10 general requirements met (Pass) including general requirements, testing ME equipment, classification, identification/marking, protection against excessive temperatures/other hazards, accuracy/protection against hazardous outputs, construction, protection against strangulation/asphyxiation, additional requirements for electromagnetic emissions, and alarm systems. |
| IEC 60601-1-2: EMC Test Report | To maintain the essential performance and basic safety of EMC requirements in the presence of electromagnetic disturbances and emitted disturbances. | All 5 EMC requirements met (Pass): Enclosure port, ESD, RS, RF, PFMF. |
| ISO 14971: Risk Management Report | To ensure all hazards are controlled in an "acceptable region" before/after risk analysis, addressing wrong analytical results and serious impairment to patient health. | Risk distribution showed that all hazards are controlled in the "acceptable region". |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Thermometer (example component) | To assess if the device poses any direct or indirect tissue-contacting risks, indicated by Cytotoxicity, Skin Sensitization, and Irritation tests. | Cytotoxicity Test: No potential toxicity to L-929 cells (Test article extract did not show potential toxicity to L-929 cells, implying cell viability was not reduced to |
§ 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.