(463 days)
This device is designed for using intermittent suction to remove nasal secretion and mucus in Children (age 2-12 years old) at home environment.
AVITA NS1 Nasal Aspirator is a portable, DC powered device intended to provide the suction function to aspirate children's nasal secretion. The device consist of a pump that is driven by Two (2) 1.5V AA size alkaline batteries , soft aspiration tip , collection cup and Music IC with 12 Chord Melody.
The provided text describes a 510(k) summary for the AVITA Nasal Aspirator, Model NS1 Series. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document focuses on:
- Device Identification: Submitter, device name, classification, predicate devices.
- Intended Use: For intermittent suction to remove nasal secretions in children aged 2-12 at home.
- Device Description: Portable, DC-powered, uses AA batteries, soft aspiration tip, collection cup, and music IC.
- Performance Requirements: States conformance to IEC 60601-1 and IEC 60601-1-2 for operating specifications, safety, and EMC. This is a general statement of conformance to standards, not specific acceptance criteria or a study demonstrating achievement.
- Conclusion: Declares substantial equivalence to predicate devices based on "same intended use and similar technological characteristics" and "bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
- FDA Correspondence: A letter from the FDA confirming substantial equivalence and outlining regulatory requirements.
Therefore, I cannot populate the requested table or provide details about the study as the information is not present in the provided text.
To provide the requested information, the document would need to include:
- Specific quantifiable acceptance criteria (e.g., minimum suction pressure, maximum noise level, battery life, mucus removal efficiency).
- Details of a performance study conducted to measure these criteria. This would typically include:
- Study design (e.g., bench test, clinical trial).
- Methodology for measuring performance.
- Results of the measurements.
- Comparison of results against the acceptance criteria.
Without this information, I can only state that the document indicates the device conforms to IEC 60601-1 and IEC 60601-1-2 requirements and that "bench testing" was performed to demonstrate substantial equivalence, but it does not elaborate on the specific criteria, the test results, or the study details.
§ 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.