(28 days)
The Baby 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.
Not Found
I am sorry, but the provided FDA 510(k) Clearance Letter for the "Baby Nasal Aspirator" does not contain information about acceptance criteria and a study proving the device meets those criteria.
This document is a formal clearance letter issued by the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory aspects such as:
- Device Identification: Trade name, regulation number, product code, regulatory class.
- Substantial Equivalence Determination: The FDA's finding that the device is equivalent to existing legal devices.
- Regulatory Requirements: Information about general controls (registration, listing, GMP, labeling, misbranding, adulteration), additional controls for Class II/III devices, Quality System (QS) regulation, medical device reporting, Unique Device Identification (UDI) system, and contact information for regulatory advice.
- Indications for Use: The stated purpose and target user group for the device.
The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
The letter does not include details on:
- Specific performance acceptance criteria for the device itself (e.g., suction pressure, battery life, noise levels).
- Any studies or test results demonstrating the device meets such criteria.
- Information about test set sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies (like MRMC studies) as these are typically associated with performance data for more complex or AI/imaging devices, not simple mechanical devices like a nasal aspirator.
For a device like a baby nasal aspirator, the "acceptance criteria" and "proof of meeting them" would typically involve:
- Bench testing: Measuring suction pressure, flow rate, durability, material biocompatibility, and safety (e.g., absence of sharp edges, proper battery compartment sealing).
- Biocompatibility testing: To ensure materials are safe for contact with human tissue.
- Electrical safety testing: If powered, to ensure it meets relevant electrical safety standards.
- Usability testing: To ensure it can be safely and effectively used by the intended users (parents or caregivers).
However, none of these specific test results or their underlying methodologies are detailed in the provided FDA clearance letter. The letter signifies regulatory clearance based on a review of the submitted documentation, which would have included these types of test reports, but it does not reproduce them within the letter itself.
§ 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.